[Federal Register Volume 81, Number 106 (Thursday, June 2, 2016)]
[Notices]
[Pages 35351-35356]
[FR Doc No: 2016-13028]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2016-0023; FRL-9946-86]

Certain New Chemicals; Receipt and Status Information for April
2016

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA)
to publish in the Federal Register a notice of receipt of a
premanufacture notice (PMN); an application for a test marketing
exemption (TME), both pending and/or expired; and a periodic status
report on any new chemicals under EPA review and the receipt of notices
of commencement (NOC) to

manufacture those chemicals. This document covers the period from April
1, 2016 to April 29, 2016.

DATES: Comments identified by the specific case number provided in this
document, must be received on or before July 5, 2016.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2016-0023, and the specific PMN number or TME
number for the chemical related to your comment, by one of the
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim
Rahai, Information Management Division, 7407M, Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-8593; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email 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 submitters of the actions addressed in this
document.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. What action is the Agency taking?

    This document provides receipt and status reports, which cover the
period from April 1, 2016 to April 29, 2016, and consists of the PMNs
and TMEs both pending and/or expired, and the NOCs to manufacture a new
chemical that the Agency has received under TSCA section 5 during this
time period.

III. What is the Agency's authority for taking this action?

    Under TSCA, 15 U.S.C. 2601 et seq., EPA classifies a chemical
substance as either an ``existing'' chemical or a ``new'' chemical. Any
chemical substance that is not on EPA's TSCA Inventory is classified as
a ``new'' chemical, while those that are on the TSCA Inventory are
classified as an ``existing'' chemical. For more information about the
TSCA Inventory go to: http://www.epa.gov/opptintr/newchems/pubs/inventory.htm.
    Anyone who plans to manufacture or import a new chemical substance
for a non-exempt commercial purpose is required by TSCA section 5 to
provide EPA with a PMN, before initiating the activity. Section 5(h)(1)
of TSCA authorizes EPA to allow persons, upon application, to
manufacture (includes import) or process a new chemical substance, or a
chemical substance subject to a significant new use rule (SNUR) issued
under TSCA section 5(a), for ``test marketing'' purposes, which is
referred to as a test marketing exemption, or TME. For more information
about the requirements applicable to a new chemical go to: http://www.epa.gov/oppt/newchems.
    Under TSCA sections 5(d)(2) and 5(d)(3), EPA is required to publish
in the Federal Register a notice of receipt of a PMN or an application
for a TME and to publish in the Federal Register periodic reports on
the status of new chemicals under review and the receipt of NOCs to
manufacture those chemicals.

IV. Receipt and Status Reports

    As used in each of the tables in this unit, (S) indicates that the
information in the table is the specific information provided by the
submitter, and (G) indicates that the information in the table is
generic information because the specific information provided by the
submitter was claimed as CBI.
    For the 58 PMNs received by EPA during this period, Table 1
provides the following information (to the extent that such information
is not claimed as CBI): 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/importer; the potential
uses identified by the manufacturer/importer in the PMN; and the
chemical identity.

                                               Table 1--PMNs Received From April 1, 2016 to April 29, 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       Projected end
              Case No.                 Date received   date for EPA    Manufacturer/ Importer             Use(s)                  Chemical identity
                                                          review
--------------------------------------------------------------------------------------------------------------------------------------------------------
P-16-0095...........................       4/11/2016       7/10/2016  CBI....................  (G) Flame retardant additive  (G) Phenol-formaldehyde
                                                                                resin.
P-16-0119...........................       4/20/2016       7/19/2016  CBI....................  (G) Intermediate............  (G) Chlorofluorocarbon.
P-16-0150...........................       4/26/2016       7/25/2016  CBI....................  (G) Intermediate............  (G) Chlorofluorocarbon.

P-16-0267...........................       4/20/2016       7/19/2016  Allnex USA, Inc........  (S) Electro-deposition        (G) Fatty acids, reaction
                                                                                primer.                       products with alkylamine,
                                                                                polymers with substituted
                                                                                carbomonocycle,
                                                                                substituted alkylamines,
                                                                                heteromonocycle and
                                                                                substituted alkanoate,
                                                                                lactates (salts).
P-16-0277...........................        4/1/2016       6/30/2016  Organic Dyestuffs        (S) Metalized dye for dyeing  (S) Chromate(1-), hydroxy[2-
                                                                       Corporation.             wool with good fastness       (hydroxy-ko)-3-[2-[2-
                                                                                properties.                   (hydroxy-ko)-1-
                                                                                naphthalenyl]diazenyl-kn1]-
                                                                                5-nitrobenzenesulfonato(3-
                                                                                )]-, sodium (1:1).
P-16-0279...........................        4/4/2016        7/3/2016  Akzo Nobel Surface       (G) Component in paints.....  (S) Hexanamide, n,-[3-
                                                                       Chemistry, LLC.                                        (dimethylamino)propyl]-,
                                                                                compd, with 2-
                                                                                methyloxirane polymer with
                                                                                oxirane mono (2-
                                                                                ethylhexyl) ether
                                                                                phosphate.
P-16-0281...........................       4/11/2016       7/10/2016  CBI....................  (G) Reactive polyol.........  (G) Fatty alcohols--dimers,
                                                                                trimmers, polymers.
P-16-0287...........................        4/1/2016       6/30/2016  CBI....................  (G) Hardener for epoxy        (G) Alkanoic acid, 2-
                                                                                coating.                      substituted-methyl ester,
                                                                                reaction products with
                                                                                aromatic diamine-
                                                                                [alkanediylbis(oxymethylen
                                                                                e)]bis[oxirane] polymer.
P-16-0289...........................        4/1/2016       6/30/2016  CBI....................  (G) Extrusion compounding     (G) Semi-aromatic
                                                                                resin molding resin.          polyamide.
P-16-0290...........................        4/1/2016       6/30/2016  CBI....................  (G) Fuel additive...........  (G) Copolymer of maleic
                                                                                acid and olefin.
P-16-0291...........................        4/3/2016        7/2/2016  CBI....................  (G) Curing agent............  (G) 1,3-
                                                                                cyclohexanedimethanamine
                                                                                adduct.
P-16-0292...........................        4/5/2016        7/4/2016  CBI....................  (S) Intermediate for use in   (G) Depolymerized waste
                                                                                the manufacture of polymers.  plastics.
P-16-0293...........................       4/13/2016       7/12/2016  Charkit Chemical         (S) Compounding of fragrance  (S) Octanoic acid,
                                                                       Corporation.             for industrial cleaners/      phenylmethyl ester.
                                                                                janitorial compounds,
                                                                                detergents, etc.
P-16-0299...........................       4/20/2016       7/19/2016  CBI....................  (S) Reactive (meth)acrylate   (G) Polyurethane,
                                                                                oligomer for ultra violet     methacrylate-blocked.
                                                                                cured 3d printed parts.
P-16-0300...........................        4/6/2016        7/5/2016  H.B. Fuller Company....  (G) Industrial adhesive.....  (G) Oxirane, 2-methyl-,
                                                                                polymer with 1,3-xylylene
                                                                                diisocyanate and oxirane,
                                                                                3-(trimethoxysilyl)propyl
                                                                                isocyanate.
P-16-0301...........................        4/6/2016        7/5/2016  CBI....................  (G) Intermediate............  (G) Propyl silsesquioxanes,
                                                                                hydrogen-terminated.
P-16-0302...........................        4/6/2016        7/5/2016  CBI....................  (G) Plastic additive........  (G) Organic modified propyl
                                                                                silsesquioxane.
P-16-0303...........................        4/7/2016        7/6/2016  CBI....................  (G) Use for the production    (G) Alkyl methyacrylate
                                                                                of acrylic resin for          polymer with styrene,
                                                                                waterborne exterior           amino acrylate and acrylic
                                                                                coatings composition.         acid, ammonium salt.
P-16-0304...........................        4/7/2016        7/6/2016  CBI....................  (G) Industrial adhesive.....  (G) Polyurea grease.
P-16-0305...........................        4/7/2016        7/6/2016  CBI....................  (G) Industrial Adhesive.....  (G) Polyurea grease.
P-16-0307...........................        4/8/2016        7/7/2016  CBI....................  (G) Open non dispersive use.  (G)
                                                                                Heteropolycycliccarboxylic
                                                                                acid, 1,3-dihydro-
                                                                                disubstituted-, polymer
                                                                                with 1,1'-methylenebis[4-
                                                                                isocyanatobenzene],
                                                                                reaction products with
                                                                                silica.
P-16-0308...........................        4/8/2016        7/7/2016  Itaconix Corporation...  (G) Reactive Monomer........  (S) Butanedioic acid, 2-
                                                                                methylene-, 1,4-bis (2-
                                                                                methylpropyl) ester.

P-16-0309...........................        4/8/2016        7/7/2016  CBI....................  (G) PMN substances are        (G) Bisamide mixture.
                                                                                intended for use as
                                                                                rheological or thixotropic
                                                                                agents used in the
                                                                                production of solvent based
                                                                                industrial coatings, high
                                                                                solid aromatic paints,
                                                                                adhesives, sealants, and
                                                                                other types of paints and
                                                                                topcoats.
P-16-0310...........................        4/8/2016        7/7/2016  CBI....................  (G) PMN substances are        (G) Bisamide mixture.
                                                                                intended for use as
                                                                                rheological or thixotropic
                                                                                agents used in the
                                                                                production of solvent based
                                                                                industrial coatings, high
                                                                                solid aromatic paints,
                                                                                adhesives, sealants, and
                                                                                other types of paints and
                                                                                topcoats.
P-16-0311...........................        4/8/2016        7/7/2016  CBI....................  (S) Coatings for wood metal   (G) Aromatic dicarboxylic
                                                                                and plastic.                  acid, polymer with alkyl
                                                                                dicarcoxylic acid, alkyl
                                                                                diol,
                                                                                hydroxy(hydroxyalkyl)alkyl
                                                                                carboxylic acid,
                                                                                methylenebis(isocyanatocyc
                                                                                loalkane) and
                                                                                alkylethylidene
                                                                                bis(phenyleneoxy)bis[alkyl
                                                                                alcohol].
P-16-0312...........................        4/8/2016        7/7/2016  CBI....................  (S) Coatings for wood metal   (G) Aromatic dicarboxylic
                                                                                and plastic.                  acid, polymer with
                                                                                cycloalkanemethanol,
                                                                                alkanediamine, alkanedioic
                                                                                acid, hydroxy-2-
                                                                                (hydroxyalkyl)-2-
                                                                                alkylcarboxylic acid,
                                                                                methylenebis[isocyanatocyc
                                                                                loalkane] and
                                                                                [(methylethylidene)bis(phe
                                                                                nyleneoxy)]bis[alkanol].
P-16-0313...........................       4/11/2016       7/10/2016  Honeyol, Inc...........  (S) Use in production of      (S) Tar acids (shale oil),
                                                                                resins (raw material used     c6-9-fraction,
                                                                                in the production of          alkylphenols, low-boiling.
                                                                                resins).
P-16-0314...........................       4/11/2016       7/10/2016  Firmenich, Inc.........  (G) As part of a fragrance    (S) Ethanone, 1-(5-propyl-
                                                                                formula.                      1,3-benzodioxol-2-yl)-
P-16-0315...........................       4/11/2016       7/10/2016  CBI....................  (S) Industrial rubber         (G) Alkyldiene, polymer,
                                                                                formulation.                  terminated
                                                                                alkoxysilylalkylcarbamate.
P-16-0316...........................       4/11/2016       7/10/2016  CBI....................  (G) Drilling chemical.......  (G) Aliphatic polyester.
P-16-0317...........................       4/11/2016       7/10/2016  CBI....................  (G) Drilling chemical.......  (G) Aliphatic polyester.
P-16-0322...........................       4/22/2016       7/21/2016  CBI....................  (G) Pulp bleaching catalyst.  (G) Manganese cyclic
                                                                                (tri)amine chloride
                                                                                complex.
P-16-0322...........................       4/22/2016       7/21/2016  CBI....................  (G) Textile bleaching         (G) Manganese cyclic
                                                                                catalyst.                     (tri)amine chloride
                                                                                complex.
P-16-0323...........................       4/13/2016       7/12/2016  Allnex USA, Inc........  (G) Coating resin...........  (G) Alkylaldehyde, reaction
                                                                                products with substituted
                                                                                carbomonocycle-substituted
                                                                                heteromonocycle-alkylene
                                                                                glycol bis
                                                                                [[[substituted(oxoneoalky)
                                                                                oxy]alkyl]amino]alky]
                                                                                ether polymer and alkyl
                                                                                substituted alkanediamine,
                                                                                acetate salts.
P-16-0324...........................       4/13/2016       7/12/2016  CBI....................  (G) Adhesive for open non-    (G) Ultra violet-curable
                                                                                descriptive use.              urethane acrylate.
P-16-0325...........................       4/13/2016       7/12/2016  CBI....................  (G) Oil & Gas extraction....  (G) Polymer of substituted
                                                                                acrylic acid and
                                                                                bromohexane.
P-16-0326...........................       4/27/2016       7/26/2016  Firmenich, Inc.........  (G) As part of a fragrance    (S) Propanoic acid, 2,2-
                                                                                formula.                      dimethyl-,1-methyl-2-(1-
                                                                                methylethoxy)-2-oxoethyl
                                                                                ester.
P-16-0327...........................       4/14/2016       7/13/2016  CBI....................  (G) Additive in rubber tires  (G) Alkenoic acid, polymer
                                                                                with alkylalkenoate,
                                                                                sodium salt.

P-16-0328...........................       4/19/2016       7/18/2016  CBI....................  (G) Intermediate............  (G) Terephthalic acid,
                                                                                polymer with
                                                                                alkanepolycarboxylic
                                                                                acids, alkanepolyols,
                                                                                isophthalic acid,
                                                                                polyetherpolyol, 1,1-
                                                                                methylenebis[isocyanatoben
                                                                                zene], phthalic anhydride
                                                                                and a substituted
                                                                                alkanepolyol.
P-16-0329...........................       4/19/2016       7/18/2016  CBI....................  (G) Adhesive component......  (G) Polymer of
                                                                                alkanepolycarboxylic
                                                                                acids, alkanepolyols,
                                                                                isophthalic acid,
                                                                                polyetherpolyols, 1,1-
                                                                                methylenebis[isocyanatoben
                                                                                zene], terephthalic acid,
                                                                                phthalic anhydride and a
                                                                                substituted alkanepolyol.
P-16-0330...........................       4/19/2016       7/18/2016  H.B. Fuller Company....  (G) Industrial adhesive.....  (G) Hydroxy functional
                                                                                triglyceride polymer with
                                                                                glycerol mono-ester and
                                                                                1,1'-methylenebis[4-
                                                                                isocyanatobenzene].
P-16-0331...........................       4/19/2016       7/18/2016  H.B. Fuller Company....  (G) Industrial adhesive.....  (G) Hydroxy functional
                                                                                triglyceride polymer with
                                                                                glycerol mono-ester and
                                                                                1,1'-
                                                                                methylenebis[isocyanatoben
                                                                                zene].
P-16-0332...........................       4/21/2016       7/20/2016  CBI....................  (G) Component of coating....  (G) Carbomonocycle
                                                                                phosphate metal salt.
P-16-0334...........................       4/22/2016       7/21/2016  Lamberti USA, Inc......  (G) Additive for industrial   (G) Polymeric amide.
                                                                                purposes.
P-16-0335...........................       4/22/2016       7/21/2016  Lamberti USA, Inc......  (G) Additive for industrial   (G) Polymeric amide.
                                                                                purposes.
P-16-0336...........................       4/22/2016       7/21/2016  CBI....................  (G) Fuel additive--           (G) Polyolefin ester.
                                                                                destructive use.
P-16-0337...........................       4/25/2016       7/24/2016  CBI....................  (S) Monomer.................  (G) Aliphatic acrylate.
P-16-0338...........................       4/26/2016       7/25/2016  CBI....................  (G) Dyestuff................  (G) Substituted xanthene
                                                                                derivative.
P-16-0339...........................       4/26/2016       7/25/2016  CBI....................  (G) Dyestuff................  (G) Azo derivatives.
P-16-0340...........................       4/26/2016       7/25/2016  Solazyme, Inc..........  (G) Feedstock for             (G) Glycerides, c8-18 and
                                                                                oleochemical industry.        c18 unsaturated, from
                                                                                fermentation.
P-16-0340...........................       4/26/2016       7/25/2016  Solazyme, Inc..........  (G) Renewable oil source for  (G) Glycerides, c8-18 and
                                                                                fuels.                        c18 unsaturated, from
                                                                                fermentation.
P-16-0341...........................       4/27/2016       7/26/2016  Perstorp Polyols.......  (G) Elastomer...............  (S) 2-oxepanone,
                                                                                homopolymer, ester with
                                                                                1,6-hexanediol.
P-16-0341...........................       4/27/2016       7/26/2016  Perstorp Polyols.......  (S) Industrial coatings.....  (S) 2-oxepanone,
                                                                                homopolymer, ester with
                                                                                1,6-hexanediol.
P-16-0341...........................       4/27/2016       7/26/2016  Perstorp Polyols.......  (S) Adhesive components.....  (S) 2-oxepanone,
                                                                                homopolymer, ester with
                                                                                1,6-hexanediol.
P-16-0342...........................       4/27/2016       7/26/2016  CBI....................  (S) Modified acrylic polymer  (G) Modified acrylic
                                                                                used as a dispersant for      polymer.
                                                                                deflocculation of pigments
                                                                                in industrial paints and
                                                                                coatings.
P-16-0343...........................       4/27/2016       7/26/2016  CBI....................  (S) Modified urethane         (G) Modified urethane
                                                                                polymer used as a             polymer.
                                                                                dispersant for
                                                                                deflocculation of pigments
                                                                                in industrial paints and
                                                                                coatings.
P-16-0344...........................       4/27/2016       7/26/2016  CBI....................  (S) Modified acrylic polymer  (G) Modified urethane
                                                                                used as a dispersant for      polymer.
                                                                                deflocculation of pigments
                                                                                in industrial paints and
                                                                                coatings.
P-16-0345...........................       4/28/2016       7/27/2016  CBI....................  (G) Processing aid..........  (G) Acrylamide, polymer
                                                                                with methacrylic acid
                                                                                derivatives.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    For the 31 NOCs received by EPA during this period, Table 2
provides the following information (to the extent that such information
is not claimed as CBI): The EPA case number assigned to the NOC; the
date the NOC was received by EPA; the projected date of commencement
provided by the submitter in the NOC; and the chemical identity.

                           Table 2--NOCs Received From April 1, 2016 to April 29, 2016
----------------------------------------------------------------------------------------------------------------
                                                      Projected date
              Case No.                 Date received        of                     Chemical identity
                                                       commencement
----------------------------------------------------------------------------------------------------------------
P-05-0522...........................       4/26/2016       3/31/2016  (S) [1,1'-biphenyl]-4-carboxaldehyde.
P-11-0243...........................        4/1/2016       3/12/2016  (G) Alkanedioic acid polymer with
                                                                       alkanediol and diisocyanatohexane.
P-13-0670...........................       4/25/2016        4/4/2016  (G) Alkyl-[4-
                                                                       (carbomonocyclesubstituted)carbomonocycle
                                                                       ]-(dialkyl-hydroxycarbomonocycle)alkane
                                                                       derivative.
P-13-0671...........................       4/25/2016        4/4/2016  (G) Alkyl-[4-
                                                                       (carbomonocyclesubstituted)carbomonocycle
                                                                       ]-(dialkyl-hydroxycarbomonocycle)alkane
                                                                       derivative.
P-14-0166...........................        4/4/2016        3/3/2016  (G) Fatty acid amide.
P-14-0185...........................        4/4/2016        3/5/2016  (G) Fatty acid amide acetate.
P-14-0800...........................       4/22/2016       4/11/2016  (G) Solvent red 252.
P-15-0046...........................       4/12/2016        4/1/2016  (S) Propanol, oxybis, polymer with
                                                                       bis(isocyanatomethyl)cyclohexane and
                                                                       alpha-hydro-omega-hydroxypoly(oxy-1,4-
                                                                       butanediyl).
P-15-0074...........................        4/8/2016       3/30/2016  (G) Trisiloxane alkoxylate.
P-15-0329...........................       4/12/2016       3/12/2016  (S) Urea, n, n``-1,6-hexanediylbis[n'-
                                                                       [(1s)-1-phenylethyl]-.
P-15-0382...........................       4/29/2016       4/20/2016  (G) Polyitaconic acid, sodium zinc salt.
P-15-0409...........................        4/5/2016       3/24/2016  (G) Substituted alkanolamine ether.
P-15-0515...........................       4/19/2016        4/7/2016  (G) 2-propenoic acid, 2-methyl, methyl
                                                                       ester, polymer with ethenylbenzene, ethyl
                                                                       2-propenoate, 2-oxiranylmethyl 2-methyl-2-
                                                                       propenoate and 1,2-propanediol mono(2-
                                                                       methyl-2-propenoate), reaction products
                                                                       with dialkylamine, carboxylate salt.
P-15-0567...........................        4/8/2016       3/10/2016  (S) Hexanedioic acid, polymer with 1,?6-
                                                                       ?hexanediol, 1,?3-?isobenzofurandione, 5-
                                                                       ?isocyanato-?1-?(isocyanatomethyl)?-
                                                                       ?1,?3,?3-?trimethylcyclohexane and
                                                                       1,?2,?3-?propanetriol, 2-?hydroxyethyl
                                                                       acrylate-?blocked.
P-15-0623...........................       4/18/2016       4/14/2016  (G) Fatty acids, polymers with bisphenol
                                                                       a, nutshell liq., epichlorohydrin,
                                                                       alkylenediamine, formaldehyde and
                                                                       polyalkylenepolyamine.
P-15-0733...........................        4/4/2016       3/13/2016  (G) Alkane carboxylic acid, hydroxy,
                                                                       hydroxyalkyl-alkyl, polymer with .alpha.-
                                                                       hydro-.omega.-hydroxypoly(oxy-1,2-
                                                                       ethanediyl) ether with alkyl-
                                                                       (hydroxyalkyl)-alkanediol (x:1), .alpha.-
                                                                       hydro-.omega.-hydroxypoly[oxy(alkyl-
                                                                       alkyldiyl)] and alkylenebis
                                                                       [isocyanatoalkane],-blocked.
P-15-0737...........................       4/12/2016        4/7/2016  (G) Diammonium salt of phosphate
                                                                       methacrylate.
P-15-0737...........................       4/12/2016        4/7/2016  (G) Monoammonium salt of phosphate
                                                                       methacrylate.
P-15-0769...........................       4/14/2016        4/4/2016  (G) Polyurethane silane.
P-16-0009...........................        4/1/2016        3/9/2016  (S) Fatty acids, castor-oil, esters with
                                                                       polyethylene glycol ether with glycerol
                                                                       (3:1).
P-16-0026...........................       4/11/2016        4/3/2016  (G) Amine functional epoxy, organic acid
                                                                       salt.
P-16-0100...........................        4/5/2016       3/23/2016  (G) Substituted heteropolycyclic derivs.
P-16-0107...........................       4/14/2016       3/27/2016  (G) Aromatic polycarboxylic acid, polymer
                                                                       with alkyldiol, alkylidioic acid,
                                                                       aromatic polyisocyanate, substituted
                                                                       alkyldiol, compd. with alkylamine.
P-16-0108...........................       4/28/2016       3/17/2016  (G) Carbonic acid, polymer with, 5-
                                                                       isocyanato-1-(isocyanatomethyl)- 1,3,3-
                                                                       trimethylcyclohexane, 2-hydroxyethyl
                                                                       acrylate-blocked.
P-16-0115...........................        4/6/2016       3/27/2016  (G) 2-propanediol, polymer with 2-
                                                                       ethyloxirane, oxirane and cycloaliphatic
                                                                       anhydride, polymer with 2,2???-[(1-
                                                                       methylethylidene)bis(4,1-
                                                                       phenyleneoxymethylene)]bis[oxirane].
P-16-0121...........................       4/18/2016       4/13/2016  (G) Acrylic acid polymer with polyethylene
                                                                       glycol.
P-16-0142...........................       4/26/2016       4/20/2016  (G) Amine salted polyacrylate.
P-16-0149...........................       4/18/2016       4/15/2016  (G) 2-alkenoic acid, alkyl ester, polymer
                                                                       with ethenyl benzene, alkyl 2-alky
                                                                       alkenoate and alkene carboxylic acid.
P-16-0159...........................       4/25/2016       3/31/2016  (G) Hexasodium 5-{4-[3-(8-benzoylamino-1-
                                                                       hydroxy-3,6-disulfonatonaphthalene-2-
                                                                       yldiazenyl)-4-sulfonatoanilino]-6-(2-
                                                                       sulfonatoethylamino)-1,3,5-triazine-2-
                                                                       ylamino{time} benzene-1,3-dicarboxylate.
P-16-0174...........................       4/29/2016       4/19/2016  (S) Butanedioic acid, 2-methylene-,
                                                                       telomer with phosphinic acid and sodium 4-
                                                                       ethenylbenzenesulfonate (1:1), sodium
                                                                       salt.
P-16-0175...........................       4/28/2016       4/18/2016  (S) Naphthalene, eicosyl-.
----------------------------------------------------------------------------------------------------------------

    Authority: 15 U.S.C. 2601 et seq.

    Dated: May 25, 2016.
Pamela Myrick,
Acting Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2016-13028 Filed 6-1-16; 8:45 am]
 BILLING CODE 6560-50-P


1 TABLE OF CONTENTS FOR ICR SUPPORTING STATEMENT PART A OF SUPPORTING STATEMENT PAGE 2 PART B OF SUPPORTING STATEMENT PAGE 9 APPENDIX A: MATERNAL QUESTIONNAIRE PAGE 12 APPENDIX B: FIRST FEDERAL REGISTER NOTICE PDF FILE 2 PART A OF ICR SUPPORTING STATEMENT 1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title of the Information Collection: Seven County Study of Air Quality and Birth Defects: Computer Assisted Telephone Questionnaire for Subset of Study Population 1( b) Short Characterization/ Abstract: The computer assisted telephone interview ( CATI) is one component of a larger study based on a linked records case control analysis that will examine the association between exposure to five criteria air pollutants ( carbon monoxide, nitrogen oxides, ozone, sulfur dioxide, and PM 10) and the risk of selected congenital cardiac defects and oral clefts in seven counties ( Bexar, Dallas, El Paso, Harris, Hidalgo, Tarrant, Travis) in Texas between 1997 and 1999. The computer assisted telephone interview is a sub study designed to help improve exposure assignment and understand better the relationship between certain individual behaviors and ambient air pollution exposure, and ultimately how those behaviors may modify the risks of birth defects associated with exposure to air pollutants. The questionnaire contains a maximum of 28 questions categorized into 6 sections: Residential History, Work History, Time Spent Outside the Home ( Weekdays), Time Spent Outside the Home ( Weekends), Multivitamin Use, and Tobacco Use. Participants in the telephone interview will be the mothers of babies born with and without birth defects in 1999 in seven Texas counties and will be randomly selected from the larger case control study of air pollution and birth defects in the state. Potential participants will be first contacted by mail to provide basic information about the questionnaire. Within two weeks of receipt of the letter, they will be telephoned and invited to complete the questionnaire over the telephone.

2. NEED FOR AND USE OF THE INFORMATION COLLECTION 2( a) Need/ Authority for the Collection: Previous U. S. studies examining the relationship between air pollution and birth defects or other adverse reproductive outcomes have not used data beyond the Environmental Protection Agency's stationary ambient monitors to estimate exposure. This questionnaire will provide necessary data to refine the exposure assessment. Maternal residence at conception ( rather than relying on the assumption that the mother was lived at the residence reported at delivery, when she conceived) will allow us to more precisely estimate her exposure during the critical window for the birth defects under study, weeks three through eight. Maternal work history will allow us to divide women by whether they were employed or not, the assumption being that their exposure to air pollution may be greater if they worked outside the home ( and were therefore commuters) than if they did not work outside the home. The sections on time spent outside the home on weekdays and weekends try to estimate the amount of time ( and intensity of activity) spent out of doors, as well as the time spent traveling in vehicles. Both types of activities will likely increase one's exposure to air pollution and can help refine the assessment. The sections on maternal vitamin use and smoking during pregnancy will provide relevant data on potential confounders of the association between air pollution and birth defects. 3 2( b) Practical Utility/ Users of the Data: This data will be used by the study investigators, to help estimate the association between air pollution exposure and risk of selected birth defects. This will be the first study in this research area to collect this type of data, and if it proves useful, will indicate a need for such supplemental data collection in future studies. In addition, it may lead to the recommendation of certain traffic or outdoor activity related preventive measures to reduce exposure to air pollution during pregnancy, and thereby reduce the risk of selected birth defects.

3. NON DUPLICATION, CONSULTATIONS AND OTHER COLLECTION CRITERIA 3( a) Non duplication: We know of no other effort at this time to study the effects of air pollution exposure on the risk of birth defects that employs a supplemental questionnaire to gather this level of data. There is no existing database or repository of this type of information that we could access.

3( b) Public Notice Required Prior to ICR submission to OMB: The first Federal Register notice was published on December 23, 2002 ( see Appendix B). We received no public comment. 3( c) Consultations: Not applicable 3( d) Effects of Less Frequent Collection: The information will be collected once. This factor, therefore, does not apply to this study.

3( e) General Guidelines: We have adhered to all of OMB's general guidelines. Potential participants will be contacted by mail and provided with basic information about the study. They will be given a phone number to call if they are not interested in being contacted to participate in the interview. Potential participants who do not call to express their lack of interest will be contacted by telephone approximately 2 weeks after receiving the mailed information. They will be read a standard script requesting informed consent, and if elicited, will be invited to complete the telephone interview.

3( f) Confidentiality: We will adhere to all standard steps to maintain confidentiality. These include the exclusion of unique identifiers from the database following completion of the telephone interviews and storage of hard copies in locked files. Contractor involvement will be monitored by requiring hard and/ or electronic copies to be stored at EPA after the contractor has completed data processing. The contractor will agree to observe the rules of confidentiality regarding the health information provided by individuals. Any electronic copies of data containing personal information will be kept in password protected computers or CDs in a locked filing cabinet. No reports will contain any uniquely identifying information about the participants.

3( g) Sensitive Questions: Mothers of cases or controls who were stillborn, electively terminated or died in utero may be particularly sensitive to any questions about their pregnancies. 4 In order to ensure that these mothers are treated with the utmost sensitivity, the interviewers will not be blinded to their status. If the interviewer detects that the mother is becoming emotionally distressed during the interview, he or she will be trained to offer to stop the interview. Before beginning the questionnaire, all participants will be reminded of their right to not answer any question or stop the interview at any time. Arguably, the questions about vitamin use and cigarette smoking may be more sensitive, in that there are socially acceptable responses based on what may be more commonly known about their role in relation to the risk of birth defects. No questions about very sensitive issues such as sexual behaviors, income and illness, are asked.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents: Respondents of the computer assisted telephone questionnaire will be mothers of birth defect cases and healthy controls participating in a larger case control study of how air pollution may affect the risk of birth defects. They will have all given birth in 1999 in one of the seven counties under investigation. We expect between 700 and 1000 respondents.

4( b) Information Requested ( i) Data items, including record keeping requirements a. Section 1: Residential History ( 4 questions): Our database will contain an address from the Texas Birth Defects Registry ( for the mothers of birth defect cases) or the birth certificate ( for the mothers of non malformed controls). However, in order to more accurately determine the air pollution exposure during the early part of pregnancy, we need to be able to place the participants in geographical space and time, to link them with an ambient air pollution monitor. We will be recording all residences in which the mothers lived for at least one month between the estimated date of conception and the date of birth of the case or control child. It is helpful to know where the mother resided when she found out she was pregnant ( as opposed to simply knowing residence at delivery as available in the birth defects registry or vital records database) and whether she moved during the course of her pregnancy. If a mother states that the address in our database is the same as her address when she found out she was pregnant, the remaining questions in that section are skipped. If a mother cannot recall or does not wish to reveal the exact address, we will probe to ask for the street intersection. The structure of this section is derived from that of the National Birth Defects Prevention Study ( a Centers for Disease Control funded initiative). b. Section 2: Work History ( 1 question): In order to categorize participants by whether they worked outside the home during the early part of their pregnancy, we ask one question. Women who did not work outside the home may have been more likely to be near their homes during the day; the air pollution exposure estimates for these women may be more accurate than for women who worked outside the home. 5 c. Section 3: Time Spent Outside the Home on Weekdays ( 5 questions): This section, perhaps the most important section for improving the assessment of air pollution exposure, asks women to recall the amount of time they typically spent outdoors on a given weekday during the first three months of pregnancy. They are then asked to estimate how much of this time was spent as a driver or passenger in a vehicle, and the type of road where most of the driving took place. They are then asked to estimate how much of the time was spent in outside activities and how much of the activity was vigorous enough to work up a sweat. Mobile sources of air pollution are a large component of total air pollution, and an attempt to estimate the intensity of exposure to air pollution via a crude quantification of traffic related exposures will be helpful. Women engaging in outdoor activities in which they break a sweat will indicate an increased respiration rate and a greater likelihood of absorbing potentially harmful air pollutants. d. Section 4: Time Spent Outside the Home on Weekends ( 5 questions): These are the same set of five questions, except that they ask women to focus more on their weekend activities. e. Section 5: Multivitamin Use: ( 2 questions minimum; 7 questions maximum): Respondents are asked to recall whether they took any kind of vitamin, supplement or vitamin complex from the three months before conception through the first trimester of pregnancy. They are asked to recall when they started and stopped taking the vitamin, or if they cannot remember the dates, approximately how long they took the vitamin in total. They are also asked how frequently they took it. They are allowed up to four responses. This set of questions is validated and in use in a national study of birth defects. The protective role of folic acid in the prevention of neural tube defects is wellestablished and there is some suggestive data that some vitamins may protect against other birth defects as well. It is an important confounder in this analysis, and may also serve as an important source of effect modification, if the vitamin consumption increases the mother's ability to fight the adverse effects of air pollution. The structure of this section is derived from the National Birth Defects Prevention Study ( a Centers for Disease Control funded initiative). f. Section 6: Cigarette Smoking: ( 3 questions minimum; 6 questions maximum): Respondents are asked to report on their cigarette consumption ever, and specifically during the first trimester of pregnancy. Cigarette smoking may be a confounder of the association between air pollution and birth defects, and may also be an important effect measure modifier. The questions are validated and used in a number of population based surveys including NHANES and the Pregnancy Risk Assessment Monitoring System ( a Centers for Disease Control funded study). The last two questions ask about environmental tobacco smoke exposure, which may also be an important confounder of the effects of ambient air pollution. 6 ( ii) Respondent activities: Potential respondents will be mailed an introductory letter and informational brochure about the study about two weeks prior to receiving a call. The interviewer will elicit verbal informed consent when calling to conduct the interview. The respondents need only reply to the questions asked in the telephone interview. The risks associated with this activity do not extend beyond those of daily living.

5. THE INFORMATION COLLECTED   AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) Agency Activities: The Agency has a support contract in place with a private research organization whose scope of work includes the ability to conduct all aspects of this project. The contractor's workplan will include the production of the final brochure, the mailing of the introductory letter and brochure, the tracking of phone numbers, the conversion of the interview script into a computer assisted telephone questionnaire, the finalization of an interviewer's guide, the conduct of the interviews, and the assembly of the results into a SAS dataset. The Agency will administer the contract and perform quality assurance procedures for the data collection.

5( b) Collection Methodology and Management: All mothers of cases and controls from 1999 will be sent an introductory letter and study fact sheet in the mail. Approximately two weeks later, a trained interviewer will telephone the mother to follow up on the mailing. After introducing him or herself, the interviewer will inquire as to whether the woman received the mailed materials. If she did, the interviewer will ask if she is interested in participating, and if so, will gather her verbal informed consent and proceed with the interview. If at any point in time, the participant has any questions, the interviewer will respond to them. If the woman does not wish to continue with the interview at any point in time, the interviewer will end the interview, only probing as to why the woman would not like to continue. The contractor will assemble the data into a SAS dataset, using only an identifying code to link with the already established dataset assembled from the records linkage. The electronic questionnaires with unique identifiers will be turned over to the EPA and kept on CD in the principal investigator's office. Quality assurance measures will be taken; the principal investigators may call a sample of participants to ask them about the quality of the interview experience. Also, a subset of the interviews will be conducted by one of the principal investigators, a US EPA pre doctoral trainee.

5( c) Small Entity Flexibility: The procedures for the CATI have been designed to minimize the burden to the mothers who agree to participate in the study.

5( d) Collection Schedule: The entire questionnaire, including the gathering of informed consent, should last approximately 10 minutes. The completion of all interviews should take approximately 3 months. Preliminary data sets will be extensively reviewed for quality assurance prior to any analysis. 7 6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION 6( a) Estimating Respondent Burden:

The burden will be approximately 10 minutes per respondent including the gathering of informed consent and the conduct of the CATI.

TABLE 1. ESTIMATED ANNUAL RESPONDENT BURDEN Type of Respondent Respondent Activities Estimated Number of Respondents Burden Hours Frequency Annual Reporting Burden Annual Cost X 14.72 Mother CATI 1000 .167 1 167 $ 2,458.24*

*$ 14.72/ hour ( average hourly wage)

Annual Reporting Burden: 167 hours Annual Respondent Cost: $ 2,458.24 No Annual Record Keeping Burden 6( b) Estimating Respondent Costs ( i) Estimating Labor Costs ( CATI): The wage estimate for the parental respondent is based on the average salary for women who work full time reported by the US Bureau of Labor and Statistics Employment Cost Trends ( March 1999) at $ 14.72/ hour. Given the .17 hour burden, the respondent cost for each family is $ 2.50. ( ii) Estimating Capital and Operations and Maintenance Costs: No capital costs are involved. ( iii) Capital/ Start Up Operating and Maintenance ( O& M) Costs: No capital/ startup costs are involved. ( iv) Annualizing Capital Costs: Not applicable 6( c) Estimating Agency Burden and Cost:

The Agency already has a support contract in place with a private research organization whose scope of work includes the ability to conduct all aspects of this project.

TABLE 2. AGENCY COST ANNUAL BURDEN Burden Hours Costs ($)

AGENCY ACTIVITIES Contractor EPA Freq Total Hours Contractor $ 66/ hour EPA $ 49/ hour Prepare and format questionnaires 60 80 1 140 3,960 3,920 8 Prepare computers 120 8 1 128 7,920 392 Plan logistics and coordination 40 40 1 80 2,640 2,640 Participant Tracing ( including mailing) 160 0 1 160 10,560 0 Interviewer Training 40 0 1 40 2,640 0 Telephone Interview ( allowing multiple attempts at contacting individual and documentation) 1000 0 1 1000 66,000 0 Prepare statistical datasets and reports 80 0 1 80 5,280 0 Quality Assurance and Quality Control 40 10 1 50 2,640 490 Convert Data to Electronic Form 10 0 1 10 660 0 Perform Statistical Analysis* 0 20 1 20 0 980 TOTAL 1708 102,300 8,422 * The statistical analyses will be largely conducted by a stipended predoctoral fellow at the EPA.

Agency Total Annual Burden: 1,708 hours Agency Total Annual Cost: $ 102,300 + $ 8,422 = $ 110,722 These agency burden estimates were based on our prior experience in developing and gathering information for research purposes. The agency costs are based on a GS 13( 6) for the primary investigator and include benefits. The majority of the data analysis will be conducted by a doctoral student who is not a paid EPA employee. The contractor costs are based on a composite cost given the people needed to conduct this study.

6( d) Estimating the Respondent Universe and Total Burden and Costs:

Assuming a 100% response rate, we could have up to 1,000 respondents to the telephone questionnaire. This would be a 10,000 minute ( 167hours) time burden. Operating under this assumption the total estimated respondent costs would be $ 2,458.24. A more realistic assumption is a 70% response rate resulting in the conduct of 700 interviews and a total burden of 7000 minutes, or approximately 117 hours. This would result in a total cost of $ 1722.24.

6( e) Bottom Line Burden Hours and Cost Tables ( i) Respondent Tally: 167 hours at a cost of $ 2458.24. ( ii) The Agency Tally: 1708 hours at a cost of $ 110,722. ( iii) Variations in the Annual Bottom Line: This project will last less than one year, therefore this factor is not applicable. 9 6( f) Reasons for a Change in Burden: There is no change in the burden, therefore this factor is not applicable.

6( g) Burden Statement:

The annual public reporting and record keeping burden for this collection of information is estimated to average 10 minutes per respondent. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. ORD 2003 0001, which is available for public viewing at the Office of Environmental Information Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the Environmental Information Docket is ( 202) 566 1753. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. ( ORD 2003 0001) and ICR number ( 2109.01) in any correspondence.

PART B OF ICR SUPPORTING STATEMENT 1) Introduction The results of this computer assisted telephone interview will help refine the exposure assessment to air pollution, and provide data on probable confounders of the association between air pollution and the risk of birth defects. In Part B of this supporting statement, the survey 10 objectives, design and key variables will be explained. In addition, the methods of data collection and analysis will be outlined.

2) Survey Objectives, Key Variables The objective of this telephone questionnaire is to gather some supplemental data to help refine the assessment of exposure to air pollution during early pregnancy ( See Appendix A). The survey also hopes to collect data on probable confounders of the association between air pollution and the risk of selected birth defects. The survey is divided into six sections: Residential History, Work History, Time Spent Outside the Home on Weekdays, Time Spent Outside the Home on Weekends, Vitamin Use, and Cigarette Smoking. Key variables from each section are as follows:

Section 1: all addresses lived at for at least one month from conception through the first three months of pregnancy Section 2: participant work outside the home ( yes/ no) during early pregnancy Section 3: on average weekday, time spent outside the home; time spent as driver or passenger of vehicle; time spent outside in activities such as walking, running, gardening; time spent vigorously engaged in these activities Section 4: the same set of questions as Section 3, except pertaining to outdoor activities on weekends Section 5: any vitamin use from three months before conception through first trimester; type, duration and frequency of vitamin use Section 6: any lifetime cigarette smoking ( more than 100 cigarettes); any cigarette smoking during early pregnancy; amount of cigarettes smoked; environmental tobacco exposure at work or school 3) Survey Design 3( a) Target Population and Coverage The target population for this computer assisted telephone interview study will be mothers delivering an infant with or without a birth defect in seven Texas counties in 1999. 3( b) Sample Design ( i) Sampling Frame The sampling frame will be mothers already under analysis in the linked records component of the Seven County Study of Air Quality and Birth Defects. ( ii) Sample Size The sample size will be constrained by the ability to ascertain the correct contact information for mothers whose last recorded address was in 1999. The record linkage component of the study will have approximately 1500 cases and 1500 controls. We do not expect to have the statistical power that we have for the record linkage analyses, and expect a maximum of 1000 cases and controls combined. A more realistic estimate is 700 respondents.

4) Pretests, Pilot Tests, Collection Methods and Analyzing Survey Results 11 The survey has been informally pretested, yet there have not been any formal pilots. As indicated above, three sections of the questionnaire have been validated by use in well established telephone and in person interviews. The data collection will be via a computer assisted telephone interview and will be conducted in a large part, by an EPA contractor with expertise in this area.

The data will be compiled into a SAS dataset for analysis by the principal investigators. Data analysis will explore the statistical associations between measurements of air quality ( based on EPA ambient monitoring data) and the risk of selected birth defects, accounting for factors such as vitamin use ( which decreases the risk of some birth defects) and cigarette smoking ( which increases the risk of some birth defects). The questionnaire asks about residential history in order to estimate exposure more accurately early in gestation by using residence at conception instead of residence at delivery. The analysis will compare the exposure estimates at the different address locations and ultimately quantify the misclassification of exposure based on using address at delivery. In addition, the study will compare estimates of the association between air quality and risk of birth defects using the two different addresses to estimate exposure. The questions about commuting patterns and outdoor activities during pregnancy will help us understand how exposure to ambient air pollution may change with changes in individual behaviors. First, the analysis will measure the association between these individual activities and exposure to ambient air pollution, and will ultimately examine the statistical interaction between these activities and ambient exposure. 12 APPENDIX A: MATERNAL QUESTIONNAIRE IF LIVE BORN INFANT: The first set of questions is about where you were living when you were pregnant with [ NAME OF INDEX CHILD ( NOIC)] that you delivered on [ DATE OF INDEX BIRTH ( DOIB)].

IF TERMINATION OR FETAL DEATH: The first set of questions is about where you were living during the pregnancy that ended on [ DATE OF PREGNANCY TERMINATION ( DOPT)].

Residential History A1. From [ ESTIMATED DATE OF CONCEPTION ( EDC)] to DOIB/ DOPT, how many different residences did you live in for more than one month? NUMBER OF DIFFERENT RESIDENCES ______ RF DK A2. What was your complete address on [ EDC]? LIST ALL IN CHART. What was your address after that? PROBE IF NEEDED: It is important for the study that we get at least a general location of your household. Would you please identify the intersection of roads that was closest to your home? A3. What month and year did you start living there? A4. What month and year did you stop living there? Do you still live there?

A. STREET CITY COUNTY STATE ZIP Or STREET 1 STREET 2 MONTH ____ YEAR ______ MONTH _____ YEAR ______

CURRENTLY LIVING THERE = DATE OF INTERVIEW B. STREET CITY COUNTY STATE MONTH ____ YEAR ______ MONTH _____ YEAR ______

CURRENTLY LIVING 13 ZIP Or STREET 1 STREET 2 THERE = DATE OF INTERVIEW C. STREET CITY COUNTY STATE ZIP Or STREET 1 STREET 2 MONTH ____ YEAR ______ MONTH _____ YEAR ______

CURRENTLY LIVING THERE = DATE OF INTERVIEW D. STREET CITY COUNTY STATE ZIP Or STREET 1 STREET 2 MONTH ____ YEAR ______ MONTH _____ YEAR ______

CURRENTLY LIVING THERE = DATE OF INTERVIEW Work History B1. Were you working at a job outside your home between [ EDC] and [+ 3]? YES NO RF DK Time Spent Outside the Home ( Weekdays)

The next few questions are about the time spent outside your home on a typical weekday between [ EDC] and [+ 3] 14 C1. About how much time per day did you spend outside of your home or another building, including time spent outdoors or traveling in a vehicle? MINUTES __ HOURS __ RF DK C2. About how much of this [ RESPONSE TO C1] was spent in a car, truck or bus as a driver or passenger? MINUTES __ HOURS __ RF DK C3. On what type of road did you mostly travel during this [ RESPONSE TO C2]? [ READ LIST] Major highways or freeways City streets with stoplights City streets without stoplights Paved country roads Unpaved roads RF DK C4. About how much of this [ RESPONSE TO C1] was spent outside, in activities such as walking, gardening, exercising or job related outdoor activities? MINUTES __ HOURS __ RF DK C5. About how much of this [ RESPONSE TO C4] were you active enough to work up a sweat? MINUTES ___ HOURS ___ RF DK Time Spent Outside the Home ( Weekends)

The next few questions are about your time spent outside your home on a typical weekend between [ EDC] and [+ 3].

D1. About how much time per day did you spend outside of your home or another building, including time spent outdoors or traveling in a vehicle? 15 MINUTES __ HOURS ___ RF DK D2. About how much of this [ RESPONSE TO D1] was spent in a car, truck or bus as a driver or passenger? MINUTES __ HOURS __ RF DK D3 On what type of road did you mostly travel during this [ RESPONSE TO D2]? Major highways or freeways City streets with stoplights City streets without stoplights Paved country roads Unpaved roads RF DK D4. About how much of this [ RESPONSE TO D1] was spent outside, in activities such as walking, gardening, exercising or job related outdoor activities? MINUTES __ HOURS__ RF DK D5. About how much of this [ RESPONSE TO D4] were you active enough to work up a sweat? MINUTES ___ HOURS ___ RF DK Multivitamin use E1. Did you take any kind of vitamin, multivitamin or vitamin complex between [   3] and [ EDC]? YES NO RF DK 16 E2. Did you take any kind of prenatal vitamin, multivitamin, or vitamin complex between [ EDC] and [ DOIB/ DOPT]? YES NO RF DK FOR EACH VITAMIN ASK E3 THROUGH E5. IF YOU GET EXACT DATES IN E4 and E5, SKIP E6. E3. What vitamin did you take? PROBE: Anything else? Do you remember what it was called? E4. When did you start using ( VITAMIN)? E5. When did you stop using ( VITAMIN)?

OR E6. How long did you take it? E7. How often did you use the vitamin?

A. _________ DK _ _ / _ _/ _ _ _ _ _ _ / _ _/ _ _ _ _ Day( s) ___ Week( s) ___ Months( s) ___ Year( s) ____ RF DK Per day ___ Per week ___ Per month ___ Per year ____ RF DK B. _________ DK _ _ / _ _/ _ _ _ _ _ _ / _ _/ _ _ _ _ Day( s) ___ Week( s) ___ Months( s) ___ Year( s) ____ RF DK Per day ___ Per week ___ Per month ___ Per year ____ RF DK C. _________ DK _ _ / _ _/ _ _ _ _ _ _ / _ _/ _ _ _ _ Day( s) ___ Week( s) ___ Months( s) ___ Year( s) ____ RF DK Per day ___ Per week ___ Per month ___ Per year ____ RF DK D. _________ DK _ _ / _ _/ _ _ _ _ _ _ / _ _/ _ _ _ _ Day( s) ___ Week( s) ___ Months( s) ___ Year( s) ____ RF DK Per day ___ Per week ___ Per month ___ Per year ____ RF DK 17 Cigarette Smoking The next questions are about tobacco use.

F1. Have you smoked at least 100 cigarettes in your entire life? YES NO, GO TO F5 RF DK The following questions ask about tobacco use only between [ EDC] and [+ 3].

F2. Were you smoking at all? YES NO, GO TO F5 RF DK F3. Were you smoking cigarettes every day? YES NO, GO TO F5. RF DK F4. How many cigarettes did you smoke per day? SPECIFY: RF DK IF SKIPPED F2 F4 SAY: The next two questions are about your exposure to cigarette smoke between [ EDC] and [+ 3].

F5. Did anyone in your household smoke cigarettes? YES NO RF DK F6. Did anyone smoke cigarettes near you at a workplace or school? YES NO RF DK 18 Conclusion of Questionnaire Thank you very much for participating in this study. We believe that your responses will help us to better understand how the quality of the air we breathe may be related to birth defects. Thanks again and have a great day. 19 APPENDIX B: FIRST FEDERAL REGISTER NOTICE


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request USEPA/ Office of Enforcement and Compliance Assurance 2. OMB control number b. G None a. 2060 0451 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title Emission Guidelines for Commercial and Industrial Solid Waste Incineration Units ( 40 CFR part 60, subpart DDDD)

8. Agency form number( s) ( If applicable) EPA ICR Number 1927.03 9. Keywords Incineration unit, solid waste, CISWI, Industrial Solid Waste Incineration Units 10. Abstract Respondents are owners or operators of CISWI units. All respondents would read the rule and are required to prepare a control plan and waste management plan to be kept on site. The information will be used to ensure that the emission guidelines for commercial and industrial solid waste incineration units are being achieved on a continuous basis. Initial, semiannual, and annual compliance reports are required.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. X Federal Government c. Not for profit institutions f. X State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 97 b. Total annual responses 276 1. Percentage of these responses collected electronically 10 ______ % c. Total hours requested 72,423 d. Current OMB inventory 9,145 e. Difference 63,278 f. Explanation of difference 1. Program Change 2. Adjustment 63,278 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs 87 b. Total annual costs ( O& M) 12 c. Total annualized cost requested 99 d. Current OMB inventory 0 e. Difference 99 f. Explanation of difference 1. Program change 2. Adjustment 99 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. Application for benefits e. Program planning or management b. Program evaluation f. Research c. General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. X Semi annually 6. X Annually 7. Q Biannually 8. X Other ( describe) Initially 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Learia A. Williams Phone: ( 202) 564 4113 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3):

( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Michael S. Alushin, Director Compliance Assessment and Media Programs Division Office of Compliance Office of Enforcement and Compliance Assurance Date Signature of Senior Official or designee Doreen Sterling, Acting Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95


[Federal Register Volume 79, Number 58 (Wednesday, March 26, 2014)]
[Proposed Rules]
[Pages 16749-16752]
[FR Doc No: 2014-05817]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2013-0600; FRL-9906-74-OAR]
RIN 2060-AR89

Protection of Stratospheric Ozone: Updates to HCFC Trade Language
As Applied to Article 5 Countries; Ratification Status of Parties to
the Montreal Protocol; and Harmonized Tariff Schedule Commodity Codes

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
update: regulations governing trade of HCFCs to reflect that HCFC
control measures have now taken effect for Parties operating under
Article 5 of the Montreal Protocol; references to Party ratification
status; tariff codes for ozone depleting substances to address changes
made in 2012 by the U.S. International Trade

Commission; and other minor provisions. In the ``Rules and
Regulations'' section of this Federal Register, we are making these
conforming edits as a direct final rule without a prior proposed rule.
If we receive no adverse comment, we will not take further action on
this proposed rule.

DATES: Comments must be received by April 25, 2014.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2013-0600, by one of the following methods:
     www.regulations.gov: Follow the online instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Mail: Docket  EPA-HQ-OAR-2013-0600, Air and
Radiation Docket and Information Center, U.S. Environmental Protection
Agency, Mail code: 6102T, 1200 Pennsylvania Avenue NW., Washington, DC
20460.
     Hand Delivery: Docket  EPA-HQ-OAR-2013-0600 Air
and Radiation Docket at EPA West, 1301 Constitution Avenue NW., Room
B108, Mail Code 6102T, Washington, DC 20004. Such deliveries are only
accepted during the Docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2013-0600. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. If
you want to submit confidential comments, please send them to the
individual listed in the FOR FURTHER INFORMATION CONTACT section. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of you
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at www.epa.gov/epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Jeremy Arling by telephone at (202)
343-9055 or by email at<EMAIL_ADDRESS>or by mail at U.S.
Environmental Protection Agency, Stratospheric Protection Division,
Stratospheric Program Implementation Branch (6205J), 1200 Pennsylvania
Ave. NW., Washington DC 20460. You may also visit the Ozone Protection
Web site of EPA's Stratospheric Protection Division at www.epa.gov/ozone/strathome.html for further information about EPA's Stratospheric
Ozone Protection regulations, the science of ozone layer depletion and
related topics.

SUPPLEMENTARY INFORMATION:

I. Why is EPA issuing this proposed rule?

    This document proposes to take action on ``Protection of
Stratospheric Ozone: Updates to HCFC Trade Language as Applied to
Article 5 Countries; Ratification Status of Parties to the Montreal
Protocol; and Harmonized Tariff Schedule Commodity Codes.'' We have
published a direct final rule in the ``Rules and Regulations'' section
of this Federal Register because we view this as a noncontroversial
action and anticipate no adverse comment. We have explained our reasons
for this action in the preamble to the direct final rule.
    If we receive no adverse comment, we will not take further action
on this proposed rule. If we receive adverse comment, we will withdraw
the direct final rule and it will not take effect. We would address all
public comments in any subsequent final rule based on this proposed
rule.
    We do not intend to institute a second comment period on this
action. Any parties interested in commenting must do so at this time.
For further information, please see the information provided in the
ADDRESSES section of this document.

II. Does this action apply to me?

    This rulemaking will affect the following categories: Industrial
Gas Manufacturing entities (NAICS code 325120), including fluorinated
hydrocarbon gas manufacturers and importers; Other Chemical and Allied
Products Merchant Wholesalers (NAICS code 424690), including chemical
gases and compressed gases merchant importers.
    This list is not intended to be exhaustive, but rather provides a
guide for readers regarding the types of entities that could
potentially be regulated by this action. Other types of entities not
listed in this table could also be affected. To determine whether your
facility, company, business organization, or other entity is regulated
by this action, you should carefully examine these regulations. If you
have questions regarding the applicability of this action to a
particular entity, consult the person listed in the FOR FURTHER
INFORMATION CONTACT section.
    For further information, please see the information provided in the
direct final action that is located in the ``Rules and Regulations''
section of this Federal Register publication.

III. What are the procedures for notice and comment on this rulemaking?

    The direct final rule that's publishing in the ``Rules and
Regulations'' section of this Federal Register will be effective on
June 24, 2014 without further notice unless we receive adverse comment
by April 25, 2014. If EPA receives adverse comment, we will publish a
timely withdrawal in the Federal Register informing the public that all
or part of the direct final rule will not take effect. EPA will address
all public comments in a subsequent final rule based on this proposed
rule. We will not institute a second public comment period on this
action. Any parties interested in commenting must do so at this time.
    You may claim that information in your comments is confidential
business information, as allowed by 40 CFR part 2. If you submit
comments and include information that you claim as confidential
business information, we request that you submit them directly to
Jeremy Arling in two versions: one clearly marked ``Public'' to be
filed in the public docket, and the other marked ``Confidential'' to be
reviewed by authorized government personnel only. For further
information, please see the ADDRESSES section of this document.

IV. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is
therefore not subject to review under Executive Orders 12866 and 13563
(76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act

    This action does not impose any new information collection burden.
EPA already requires recordkeeping and reporting for ozone-depleting
substances and this action does not amend those provisions. The Office
of Management and Budget (OMB) has previously approved the information
collection requirements contained in the existing regulations at 40 CFR
part 82, subpart A under the provisions of the Paperwork Reduction Act,
44 U.S.C. 3501 et seq. and has assigned OMB control number 2060-0498.
The OMB control numbers for EPA's regulations in 40 CFR are listed in
40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice-and-comment rulemaking requirements under the Administrative
Procedure Act or any other statute, unless the agency certifies that
the rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    We have considered the economic impacts of this rule on small
entities. For purposes of assessing the impacts of this rule on small
entities, a small entity is defined as: (1) A small business that is
primarily engaged in industrial gas manufacturing as defined by NAICS
codes 325120 with fewer than 1000 employees or engaged in wholesale of
those gases as defined by NAICS codes 424620 with fewer than 100
employees; (2) a small governmental jurisdiction that is a government
of a city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field.
    After considering the economic impacts of today's proposed rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. The only
provision of this proposed rule that has the potential to affect small
entities is the update to the HCFC trade ban prohibiting the import or
export of HCFCs to four countries. Based on data reported to EPA, there
are fewer than half a dozen companies that have exported to these
countries in the last few years and none are small businesses.
    Although this proposed rule will not have a significant economic
impact on a substantial number of small entities, EPA nonetheless has
tried to reduce the impact of this rule on small entities. In 2013 and
2014, EPA sent a letter to all importers and exporters notifying them
of the trade ban provisions in the Montreal Protocol. We continue to be
interested in the potential impacts of the proposed rule on small
entities and welcome comments on issues related to such impacts.

D. Unfunded Mandates Reform Act

    This action contains no Federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for State, local, or tribal governments or the private
sector. UMRA does not apply to rules that are necessary for the
national security or the ratification or implementation of
international treaty obligations. This rule updates the regulations to
reflect the provisions of the Montreal Protocol related to trade with
non-Parties. Other changes in this rule are to improve the accuracy and
consistency of the regulations and have no to little impact on the
regulated community. Therefore, this action is not subject to the
requirements of sections 202 or 205 of the UMRA.
    This action is also not subject to the requirements of section 203
of UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. Potentially
affected entities are not government entities but rather producers,
importers, and exporters of HCFCs.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It does not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132. Potentially affected entities are
not government entities but rather producers, importers, and exporters
of HCFCs. Thus, Executive Order 13132 does not apply to this action.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This action does
not significantly or uniquely affect the communities of Indian tribal
governments. It does not impose any enforceable duties on communities
of Indian tribal governments. Thus, Executive Order 13175 does not
apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying
only to those regulatory actions that concern health or safety risks,
such that the analysis required under section 5-501 of the EO has the
potential to influence the regulation. This action is not subject to EO
13045 because it implements specific trade provisions already agreed
upon and in effect under an international treaty.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355
(May 22, 2001)), because it is not a significant regulatory action
under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. The NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards. This proposed
rulemaking does not involve technical standards. Therefore, EPA is not
considering the use of any voluntary consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order (EO) 12898 (59 FR 7629, Feb. 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the U.S.
    EPA has determined that this action will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it increases the
level of environmental protection for all affected populations without
having any disproportionately high and adverse human health or
environmental effects on any population, including any minority or low-
income population. This action updates regulatory provisions related to
the HCFC trade ban: The effect is to prohibit export of HCFCs to a
small list of countries that are not Party to the Beijing Amendment to
the Montreal Protocol.

List of Subjects in 40 CFR Part 82

    Environmental protection, Administrative practice and procedure,
Air pollution control, Chemicals, Exports, Hydrochlorofluorocarbons,
Imports.

    Dated: March 7, 2014.
Gina McCarthy,
Administrator.
[FR Doc. 2014-05817 Filed 3-25-14; 8:45 am]
BILLING CODE 6560-50-P