[Federal Register Volume 77, Number 130 (Friday, July 6, 2012)]
[Notices]
[Pages 40033-40036]
[FR Doc No: 2012-16453]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2012-0437; FRL-9352-3]

Certain New Chemicals; Receipt and Status Information

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Section 5 of the Toxic Substances Control Act (TSCA) requires
any person who intends to manufacture (defined by statute to include
import) a new chemical (i.e., a chemical not on the TSCA Chemical
Substances Inventory (TSCA Inventory)) to notify EPA and comply with
the statutory provisions pertaining to the manufacture of new
chemicals. 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 premanufacture
notice (PMN) or an application for a test marketing exemption (TME),
and to publish in the Federal Register periodic status reports on the
new chemicals under review and the receipt of notices of commencement
(NOC) to manufacture those chemicals. This document, which covers the
period from May 1, 2012 to May 25, 2012, and provides the required
notice and status report, consists of the PMNs pending or expired, and
the NOC to manufacture a new chemical that the Agency has received
under TSCA section 5 during this time period.

DATES: Comments identified by the specific PMN number or TME number,
must be received on or before August 6, 2012.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2012-0437, 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 on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. The
DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the DCO is<PHONE_NUMBER>.
Such deliveries are only accepted during the DCO's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: EPA's policy is that all comments received will be
included in the docket without change and may be made available on-line
at http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or
email. The 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 regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is<PHONE_NUMBER>, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Bernice Mudd, Information Management Division (7407M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-8951; fax number:<PHONE_NUMBER>; 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 submitter of the PMNs addressed in this action.
If you have any questions regarding the applicability of this action to
a particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. 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 submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a

Code of Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Why is EPA taking this action?

    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/opt/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 status
reports on the new chemicals under review and the receipt of NOCs to
manufacture those chemicals. This status report, which covers the
period from May 1, 2012 to May 25, 2012, consists of the PMNs pending
or expired, and the NOCs to manufacture a new chemical that the Agency
has received under TSCA section 5 during this time period.

III. Receipt and Status Reports

    In Table I. of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the PMNs
received by EPA during this period: The EPA case number assigned to the
PMN, the date the PMN was received by EPA, the projected end date for
EPA's review of the PMN, the submitting manufacturer/importer, the
potential uses identified by the manufacturer/importer in the PMN, and
the chemical identity.

                               Table I--34 PMNs Received From 05/01/12 to 05/25/12
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                                          Projected
       Case No.         Received date    notice end      Manufacturer/          Use               Chemical
                                            date           importer
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P-12-0337............      05/02/2012      07/30/2012  CBI.............  (G) Coating       (G) Acid anhydride,
                                                                          additive.         polymer with
                                                                                aromatic isocyanate
                                                                                and
                                                                                polyalkyleneglycol,
                                                                                alkanol and
                                                                                hydroxyalkyl
                                                                                acrylate diazole
                                                                                reaction products
                                                                                and lactone
                                                                                homopolymer alkyl
                                                                                ester-blocked.
P-12-0338............      05/03/2012      07/31/2012  3M Company......  (S) Matrix resin  (G) Modified epoxy
                                                                          for carbon        resin.
                                                                          fiber
                                                                          composites.
P-12-0339............      05/04/2012      08/01/2012  Gelest, Inc.....  (S) Converted to  (S)
                                                                          silyl esters      Trichloro(3,3,4,4,5,
                                                                          used in the       5,6,6,7,7,8,8,8-
                                                                          hydrophization    tridecafluorooctyl)s
                                                                          of inorganic      ilane.
                                                                          surfaces;
                                                                          treatment of
                                                                          glass and
                                                                          inorganic
                                                                          surfaces to
                                                                          make them
                                                                          hydrophobic and
                                                                          oleophobic;
                                                                          research.
P-12-0340............      05/04/2012      08/01/2012  Huntsman          (G) Curing agent  (G) Reaction product
                                                        Corporation.                        of bisphenol a
                                                                                diglycidyl ether and
                                                                                an amineterminated
                                                                                cycloaliphatic
                                                                                propoxylate.
P-12-0341............      05/04/2012      08/01/2012  CBI.............  (G) Dispersant    (G) Octadecanoic
                                                                          for ink           acid, 12-hydroxy-,
                                                                          formulations.     polymer with
                                                                                formaldehyde-
                                                                                aromatic amine
                                                                                reaction products.
P-12-0342............      05/04/2012      08/01/2012  International     (S) Fragrance     (S) 3-[trans-4-(2-
                                                        flavors &         ingredient for    methylpropyl)cyclohe
                                                        fragrances, Inc.  use in            xyl]propanal 3[cis-4-
                                                                          fragrances for    (2-
                                                                          soaps,            methylpropyl)cyclohe
                                                                          detergents,       xyl]propanal.
                                                                          cleaners and
                                                                          other household
                                                                          products.
P-12-0343............      05/08/2012      08/05/2012  3M Company......  (G) Monomer.....  (G) Polyether
                                                                                diacrylate.
P-12-0344............      05/08/2012      08/05/2012  CBI.............  (G)               (G) Complex calcium
                                                                          Photoluminescen   aluminate, rare
                                                                          t pigment.        earth doped.
P-12-0345............      05/09/2012      08/06/2012  CBI.............  (G) Coating for   (G) Ultra violet-
                                                                          open non-         curable urethane
                                                                          descriptive use.  acrylate.

P-12-0346............      05/09/2012      08/06/2012  Henkel            (S) Crosslinker   (S) 2-propenone,
                                                        Corporation.      in moisture       o,o',o-
                                                                          cure sealant      (ethylsilylidyne)
                                                                          formulation.      trioxime''.
P-12-0347............      05/09/2012      08/06/2012  CBI.............  (G) Pigment       (G) Tall-oil, esters
                                                                          dispersant.       with maleated
                                                                                polyalkene glycol,
                                                                                compounds with
                                                                                amides from
                                                                                substituted amine
                                                                                and tall-oil acids.
P-12-0348............      05/09/2012      08/06/2012  CBI.............  (S) Tin catalyst  (S) Hexanoic acid,
                                                                          for               3,5,5-trimethyl-,
                                                                          polyurethane      tin(2+) salt (2:1).
                                                                          foam.
P-12-0351............      05/10/2012      08/07/2012  CBI.............  (G) Coating       (G) Siloxanes and
                                                                          additive.         silicones, alkyl,
                                                                                alkyl propoxy ethyl,
                                                                                methyl octyl, alkyl
                                                                                polyfluorooctyl.
P-12-0352............      05/14/2012      08/11/2012  CBI.............  (G) Site limited  (G) Styrenated
                                                                          raw material      salicylic acid.
                                                                          for industry.
P-12-0353............      05/15/2012      08/12/2012  CBI.............  (S) Extrusion     (G) Polymer of
                                                                          tubing systems;   aromatic
                                                                          injection         dicarboxylic acid
                                                                          molding of        and alkane diamine.
                                                                          special
                                                                          applications.
P-12-0354............      05/15/2012      08/12/2012  CBI.............  (G) Open, non-    (G) Blocked aliphatic
                                                                          dispersive use.   polyisocyanate.
P-12-0355............      05/16/2012      08/13/2012  CBI.............  (G) Chemical      (G) Aromatic
                                                                          intermediate.     polyester.
P-12-0356............      05/16/2012      08/13/2012  CBI.............  (G) Destructive   (G) Intermediate for
                                                                          use.              catalyst.
P-12-0357............      05/16/2012      08/13/2012  Trinity           (S) Flame         (S) Alkanes, C14	16,
                                                        manufacturing,    retardant in      chloro.
                                                        Inc..             rubber
                                                                          products;
                                                                          extreme
                                                                          pressure
                                                                          additive in
                                                                          lubricants.
P-12-0358............      05/17/2012      08/14/2012  CBI.............  (S) Wood          (S) Hexanedioic acid,
                                                                          coatings.         polymer with 2,2-
                                                                                dimethyl-1,3-
                                                                                propanediol, 2-ethyl-
                                                                                2-(hydroxymethyl)1,3-
                                                                                propanediol, 1,6-
                                                                                hexanediol, 3-
                                                                                hydroxy-2-
                                                                                (hydroxymethyl)-2-
                                                                                methylpropanoic acid
                                                                                and 5-isocyanato-1-
                                                                                (isocyanatomethyl)-
                                                                                1,3,3-
                                                                                trimethylcyclohexane
                                                                                , compd. with N,N-
                                                                                diethylethanamine.
P-12-0359............      05/17/2012      08/14/2012  CBI.............  (G) Component in  (G) Chlorosilane
                                                                          electronic        mixture.
                                                                          manufacturing.
P-12-0360............      05/21/2012      08/18/2012  CBI.............  (G) Polymer       (G) Alkylsilane.
                                                                          reinforcemnt.
P-12-0361............      05/22/2012      08/19/2012  CBI.............  (G) Pigment       (G) Benzene, 2,4-
                                                                          formulation       diisocyanato-1-alkyl-
                                                                          additive.         , homopolymer, 1-
                                                                                alkanol- and 1H-
                                                                                imidazole-1-
                                                                                propanamine- and 2-
                                                                                oxepanone-tetrahydro-
                                                                                2H-pyran-2-one
                                                                                polymer [2-(2-
                                                                                butoxymethylethoxy)m
                                                                                ethylethoxy]methylet
                                                                                hyl ester-blocked.
P-12-0362............      05/22/2012      08/19/2012  Scott Bader, Inc  (G) Fabrication   (G) Unsaturated
                                                                          of composite      urethane
                                                                          articles.         methacrylate.
P-12-0363............      05/22/2012      08/19/2012  CBI.............  (G) Polymer       (G)
                                                                          admixture for     Alkylcarboxyalkenyl
                                                                          cements.          polymer with
                                                                                carboxyalkenyl
                                                                                dihydroxyalkylate,
                                                                                carboxyalkenyl and
                                                                                alkylalkenyl
                                                                                sulfonate sodium
                                                                                salt.
P-12-0364............      05/22/2012      08/19/2012  Lubrigreen        (G) Biobased      (S) Fatty acids,
                                                        Biosynthetics.    lubricant base    C8	18 and C18
                                                                          oil.              unsaturated,
                                                                                reaction products
                                                                                with isomerized
                                                                                oleic acid
                                                                                homopolymer,
                                                                                hydrogenated.
P-12-0365............      05/22/2012      08/19/2012  Lubrigreen        (G) Biobased      (S) Fatty acids,
                                                        Biosynthetics.    lubricant base    coco, reaction
                                                                          oil.              products with
                                                                                isomerized oleic
                                                                                acid homopolymer,
                                                                                hydrogenated.
P-12-0366............      05/22/2012      08/19/2012  Lubrigreen        (G) Lubricant     (S) Fatty acids,
                                                        Biosynthetics.    base oil.         C8	18 and C18
                                                                                unsaturated,
                                                                                reaction products
                                                                                with isomerized
                                                                                oleic acid
                                                                                homopolymer iso-bu
                                                                                ester, hydrogenated.
P-12-0367............      05/22/2012      08/19/2012  Lubrigreen        (G) Lubricant     (S) Fatty acids,
                                                        Biosynthetics.    base oil.         coco, reaction
                                                                                products with
                                                                                isomerized oleic
                                                                                acid homopolymer iso-
                                                                                bu ester,
                                                                                hydrogenated.

P-12-0368............      05/22/2012      08/19/2012  Lubrigreen        (G) Lubricant     (S) Fatty acids,
                                                        Biosynthetics.    base oil.         C8	18 and C18
                                                                                unsaturated,
                                                                                reaction products
                                                                                with isomerized
                                                                                oleic acid
                                                                                homopolymer 2-
                                                                                ethylhexyl ester,
                                                                                hydrogenated.
P-12-0369............      05/22/2012      08/19/2012  Lubrigreen        (G) Lubricant     (S) Fatty acids,
                                                        Biosynthetics.    base oil.         coco, reaction
                                                                                products with
                                                                                isomerized oleic
                                                                                acid homopolymer 2-
                                                                                ethylhexyl ester,
                                                                                hydrogenated.
P-12-0370............      05/23/2012      08/20/2012  CBI.............  (G) Additive for  (G) Phenyl
                                                                          electronics.      silsesquioxane
                                                                                copolymer.
P-12-0371............      05/23/2012      08/20/2012  Cytec             (G) Mineral       (G) Modified
                                                        Industries, Inc.  reagent           isothiocyanate
                                                                          intermediate.     compound.
P-12-0372............      05/23/2012      08/20/2012  CBI.............  (G) Open, non-    (G) Brominated
                                                                          dispersive use.   stryene polymer.
----------------------------------------------------------------------------------------------------------------

    In Table II of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the NOCs
received by EPA during this period: The EPA case number assigned to the
NOC, the date the NOC was received by EPA, the projected end date for
EPA's review of the NOC, and chemical identity.

                              Table II--22 NOCs Received From 05/01/12 to 05/25/12
----------------------------------------------------------------------------------------------------------------
                                                           Commencement
               Case No.                  Received date    notice end date                 Chemical
----------------------------------------------------------------------------------------------------------------
P-09-0024............................        05/11/2012        05/07/2012  (G) Polymer of alkanedioic acid and
                                                                            alkanediamine.
P-09-0042............................        05/15/2012        01/29/2009  (G) Alkoxy phosphate ester salt.
P-09-0528............................        05/22/2012        05/10/2012  (G) Vinylsilane.
P-10-0135............................        05/25/2012        05/23/2012  (G) Fluoroketone.
P-10-0245............................        05/18/2012        04/04/2012  (G) Linseed oil, ester with
                                                                            pentaerythritol, polymer with 5-
                                                                            isocyanato-1-(isocyanatomethyl)-
                                                                            alkylcyclohexane.
P-10-0378............................        05/03/2012        04/30/2012  (G) Metal oxide modified with alkyl
                                                                            and vinyl-terminated polysiloxanes.
P-11-0020............................        05/10/2012        04/16/2012  (G) Acylated alkenyl succinimide.
P-11-0453............................        05/18/2012        05/15/2012  (G) Polyurethane prepolymer.
P-11-0589............................        05/10/2012        04/06/2012  (G) Copolymer of vinyl alkanoates and
                                                                            alkene sulfonic acid sodium salt.
P-12-0059............................        05/17/2012        04/27/2012  (G) Epoxy urethane.
P-12-0087............................        05/16/2012        04/22/2012  (G) Acrylate manufacture byproduct
                                                                            distillation residues.
P-12-0095............................        05/10/2012        05/07/2012  (G) Polyacrylate.
P-12-0103............................        05/25/2012        04/30/2012  (G) Alkene-substituted fatty acid
                                                                            methyl ester polymer.
P-12-0127............................        05/07/2012        04/10/2012  (G) Benzoic acid, bis(alkyl)-hydroxy-
                                                                            substituted phenyl ester.
P-12-0133............................        05/03/2012        04/08/2012  (S) 2-oxepanone, polymer with 1,6-
                                                                            diisocyanatohexane, 2,2-dimethyl-1,3-
                                                                            propanediol and 2,2'-
                                                                            oxybis[ethanol].
P-12-0153............................        05/23/2012        04/26/2012  (G) Acrylic copolymer.
P-12-0161............................        05/07/2012        04/26/2012  (G) Mdi modified polyester with 1,4
                                                                            butanediol, iso-pr alcohol-blocked.
P-12-0163............................        05/04/2012        05/03/2012  (G) Organoazo cuprate sulfate sodium
                                                                            salts.
P-12-0164............................        05/04/2012        05/03/2012  (G) Aromatic diazo compound.
P-12-0166............................        05/23/2012        04/26/2012  (G) 1,2,3-propanetriol, homopolymer
                                                                            with cyclic ether.
P-12-0177............................        05/18/2012        05/15/2012  (G) 2-propenoic acid, 2-methyl-,
                                                                            telomer with 2-substituted alkyl
                                                                            alkenoate, 2-mercaptoethanol and
                                                                            sodium 2-methyl-2-[(1-substituted
                                                                            alken-1-yl)nitrogen containing
                                                                            derivative]-amino]-1-substituted
                                                                            alkane (1:1), sodium salt,
                                                                            peroxydisulfuric acid
                                                                            ([(ho)s(o)2]2o2) sodium salt (1:2)-
                                                                            initiated.
P-98-0149............................        05/16/2012        03/20/1998  (G) Epoxy acrylate.
----------------------------------------------------------------------------------------------------------------

    If you are interested in information that is not included in these
tables, you may contact EPA as described in Unit II. to access
additional non-CBI information that may be available.

List of Subjects

    Environmental protection, Chemicals, Hazardous substances, Imports,
Notice of commencement, Premanufacturer, Reporting and recordkeeping
requirements, Test marketing exemptions.

    Dated: June 18, 2012.
Chandler Sirmons,
Acting Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2012-16453 Filed 7-5-12; 8:45 am]
BILLING CODE 6560-50-P


% Predict blood CPY and urine TCPY levels
% Drinking water concentrations from Orestimba Creek Site 3 120 days.xlsx
% Adults
% Cecilia Tan
% Jan 21, 2016

% Setting model parameters
use human_parameters_MRP
use preg_female_parameters
BWSW=1;			% Set BW to a fixed value
BWST=72.9;	 % Set BW to 72.9 kg
PREG=0;			% Not pregnant
DT(1) = 0.0;
DORAL(1) = 0.0;
TSTOP=2880; 	% Exposure duration in hrs

%TO READ IN DOSES FROM AN EXCEL SPREADSHEET. must be saved as .xls
VOLUME=1.71062  % Water consumption volume in L/DAY
EVENTS=4        % Drinking frequency per day
DT = xlsRead("Drinkingwater.xls", "Creek", "A2:A482") ; % Dosing Times
AMTCDOSE=xlsRead("Drinkingwater.xls", "Creek", "B2:B482")*VOLUME/EVENTS; % Dose in ug/l
prepare time rbcce cv urinetcpy cvo
start@nocallback

% Output RBC AChE, venous blood conc for cpf, urine TCPY conc, venous blood conc for oxon
mytable = [_time _rbcce _urinetcpy _cv*350.6 _cvo*334.5]; % Output unit ug/L for concentrations
save mytable @file='orestimba_adult_01222016.txt' @format=ascii


[Federal Register: December 17, 2009 (Volume 74, Number 241)]
[Notices]
[Page 66980-66981]
[DOCID:fr17de09-52]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0573]

International Conference on Harmonisation; Draft Guidance on
Addendum to International Conference on Harmonisation S6; Preclinical
Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1);
Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Addendum to ICH S6:
Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
S6(R1).'' The draft guidance was prepared under the auspices of the
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH). The draft guidance
provides recommendations on nonclinical studies to support the safety
of clinical trials and marketing applications for biotechnology-derived
pharmaceuticals. The draft guidance is intended to clarify and provide
greater detail to the nonclinical recommendations in the ICH guidance
entitled ``S6 Preclinical Safety Evaluation of Biotechnology-Derived
Pharmaceuticals'' (ICH S6) published in the Federal Register of
November 18, 1997 (62 FR 61515).

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit electronic or written comments on the draft guidance
by February 1, 2010.

ADDRESSES:  Submit electronic comments on the draft guidance to http://
www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm.
2201, Silver Spring, MD 20993-0002; or the Office of Communication,
Outreach and Development (HFM-40), Center for Biologics Evaluation and
Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448. The guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. Send two self-addressed
adhesive labels to assist the office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Anne M. Pilaro, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, rm. 2324, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Mercedes A. Serabian, Center for Biologics Evaluation and Research
(HFM-760), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852,<PHONE_NUMBER>.
    Regarding the ICH: Michelle Limoli, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics

Evaluation and Research, FDA; and the Pharmaceutical Research and
Manufacturers of America. The ICH Secretariat, which coordinates the
preparation of documentation, is provided by the International
Federation of Pharmaceutical Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In October 2009, the ICH Steering Committee agreed that a draft
guidance entitled ``Addendum to ICH S6: Preclinical Safety Evaluation
of Biotechnology-Derived Pharmaceuticals S6(R1)'' should be made
available for public comment. The draft guidance is the product of the
Safety (S6) Expert Working Group of the ICH. Comments about this draft
will be considered by FDA and the ICH S6 Safety Expert Working Group.
    The draft document provides guidance on nonclinical studies to
support the safety of clinical trials and marketing applications for
biotechnology-derived pharmaceuticals. Biotechnology-derived
pharmaceuticals include protein therapeutic, diagnostic, and
prophylactic products derived from cell-culture systems such as
bacteria, yeast, and eukaryotic cells, including organisms produced by
recombinant DNA technology. The draft guidance specifically provides
clarification of and greater detail to the nonclinical recommendations
in ICH S6 regarding the topics of species selection, study design, and
recommendations for immunogenicity, carcinogenicity, and reproductive
and developmental toxicity testing of biotechnology-derived
pharmaceuticals. ICH S6 was published more than 10 years ago and much
knowledge relevant to the safety evaluation of biopharmaceuticals has
been gained since that original publication. This draft guidance seeks
to incorporate this new knowledge within the established framework of
ICH S6 and is intended to enable the development of safe and effective
biopharmaceuticals. In addition, this draft guidance harmonizes
approaches given in both ICH S6 and the ICH guidance ``M3(R2)
Nonclinical Safety Studies for the Conduct of Human Clinical Trials and
Marketing Authorization for Pharmaceuticals.''
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments on the draft guidance.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.regulations.gov, http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: December 11, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-29991 Filed 12-16-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 87, Number 105 (Wednesday, June 1, 2022)]
[Rules and Regulations]
[Pages 32973-32975]
[FR Doc No: 2022-11557]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0281; Project Identifier MCAI-2021-01315-R;
Amendment 39-22056; AD 2022-11-06]
RIN 2120-AA64

Airworthiness Directives; Leonardo S.p.a. Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Leonardo S.p.a. Model A109S and AW109SP helicopters. This AD
was prompted by a report of a protective sheath, installed around a
fixed flight control rod, which should have been removed during
assembly. This AD requires borescope inspecting certain parts, and
removing any foreign object if detected, as specified in a European
Union Aviation Safety Agency (EASA) AD, which is incorporated by
reference. The FAA is issuing this AD to address the unsafe condition
on these products.

DATES: This AD is effective July 6, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of July 6,
2022.

ADDRESSES: For EASA material incorporated by reference (IBR) in this
final rule, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne,
Germany; telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. For Leonardo S.p.a. service information identified
in this final rule, contact Leonardo S.p.A. Helicopters, Emanuele
Bufano, Head of Airworthiness, Viale G.Agusta 520, 21017 C.Costa di
Samarate (Va) Italy; telephone (+39) 0331-225074; fax (+39) 0331-
229046; or at https://customerportal.leonardocompany.com/en-US/. You
may find the EASA material on the EASA website at https://ad.easa.europa.eu. You may view this material at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321,
Fort Worth, TX 76177. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. Service information that is
IBRed is also available in the AD docket at https://www.regulations.gov
by searching for and locating Docket No. FAA-2022-0281.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0281; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, the
EASA AD, any comments received, and other information. The address for
Docket Operations is U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Andrea Jimenez, Aerospace Engineer,
COS Program Management Section, Operational Safety Branch, Compliance &
Airworthiness Division, FAA, 1600 Stewart Ave., Suite 410, Westbury, NY
11590; telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0255, dated November 15, 2021,
and corrected November 24, 2021 (EASA AD 2021-0255), to correct an
unsafe condition for Leonardo S.p.A. Helicopters Model A109S
helicopters, serial number (S/N) 22735, 22736, and 22737, and equipped
with Trekker Kit; and Model AW109SP helicopters, S/N 22407, 22408,
22409, 22412, 22414 to 22427 inclusive, and 22429.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to Leonardo S.p.a. Model
A109S helicopters, S/N 22735, 22736, and 22737, and equipped with
Trekker Kit; and Model AW109SP helicopters S/N 22407, 22408, 22409,
22412, 22414 through 22427 inclusive, and 22429. The NPRM published in
the Federal Register on March 22, 2022 (87 FR 16120). The NPRM was
prompted by a report of a protective sheath, installed around a fixed
flight control rod, which should have been removed during assembly. The
NPRM proposed to require borescope inspecting certain parts, and
removing any foreign object if detected, as specified in EASA AD 2021-
0255.
    The FAA is issuing this AD to detect any foreign object
contamination, which if not addressed, could affect the free movement
of the flight controls and result in subsequent reduced control of the
helicopter. See EASA AD 2021-0255 for additional background
information.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the costs.

Conclusion

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA reviewed the relevant
data and determined that air safety requires adopting this AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these helicopters. This AD is adopted as proposed in the
NPRM.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0255 specifies procedures for borescope inspecting
certain part-numbered parts installed on the control rods and levers of
the rotors flight controls, and removing any foreign object if
detected.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Other Related Service Information

    The FAA reviewed Leonardo Helicopters Alert Service Bulletin No.

109SP-148, dated October 26, 2021 (ASB 109SP-148). This service
information specifies instructions for borescope inspecting certain
part-numbered parts installed on the control rods and levers of the
rotors flight controls of the left-hand and right-hand forward struts
and removing foreign objects.
    The FAA also reviewed Leonardo Helicopters Alert Service Bulletin
No.109S-104, dated October 26, 2021, which specifies the same
instructions as ASB 109SP-148 but only applies to Model A109S
helicopters with certain Trekker Kits installed.

Costs of Compliance

    The FAA estimates that this AD affects 1 helicopter of U.S.
Registry. Labor rates are estimated at $85 per work-hour. Based on
these numbers, the FAA estimates the following costs to comply with
this AD.
    Borescope inspecting the control rods and levers of the rotor
flight controls for any foreign object takes about 4 work-hours for an
estimated cost of $340 per inspection and $340 for the U.S. fleet.
    The FAA estimates the following costs to do any necessary on-
condition corrective actions that are required based on the results of
the inspection:
    Removing any foreign object would take a minimal amount of time
with a minimal parts cost.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect 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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2022-11-06 Leonardo S.p.a.: Amendment 39-22056; Docket No. FAA-2022-
0281; Project Identifier MCAI-2021-01315-R.

(a) Effective Date

    This airworthiness directive (AD) is effective July 6, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Leonardo S.p.a. Model A109S helicopters,
serial number (S/N) 22735, 22736, and 22737, and equipped with
Trekker Kit; and Model AW109SP helicopters S/N 22407, 22408, 22409,
22412, 22414 through 22427 inclusive, and 22429, certificated in any
category.

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 6700, rotorcraft
Flight Control.

(e) Unsafe Condition

    This AD was prompted by a report of a protective sheath,
installed around a fixed flight control rod, which should have been
removed during assembly. The FAA is issuing this AD to detect any
foreign object contamination, which if not addressed, could affect
the free movement of the flight controls and result in subsequent
reduced control of the helicopter.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2021-0255, dated November 15, 2021, and corrected November 24, 2021
(EASA AD 2021-0255).

(h) Exceptions to EASA AD 2021-0255

    (1) Where EASA AD 2021-0255 requires compliance in terms of
flight hours, this AD requires using hours time-in-service.
    (2) Where EASA AD 2021-0255 refers to its effective date, this
AD requires using the effective date of this AD.
    (3) Where paragraph (1) of EASA AD 2021-0255 specifies ``inspect
each affected part in accordance with the instructions of the
applicable ASB,'' for this AD replace ``in accordance with the
instructions of the applicable ASB'' with ``in accordance with the
Accomplishment Instructions, Section 3, paragraph 5. of the
applicable ASB.''
    (4) Where paragraph (2) of EASA AD 2021-0255 specifies ``if,
during the inspection as required by paragraph (1) this AD, any
foreign object is found on an affected part, before next flight,
remove that foreign object in accordance with the applicable ASB,''
this AD requires if any foreign object is found, before further
flight, remove the foreign object. The instructions in the
``applicable ASB'' are for reference only and are not required for
the actions in paragraph (2) of EASA AD 2021-0255.
    (5) This AD does not mandate compliance with the ``Remarks''
section of EASA AD 2021-0255.

(i) Special Flight Permit

    Special flight permits may be issued in accordance with 14 CFR
21.197 and 21.199, provided no passengers are onboard.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (k) of
this AD. Information may be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    For more information about this AD, contact Andrea Jimenez,
Aerospace Engineer, COS Program Management Section, Operational
Safety Branch, Compliance &

Airworthiness Division, FAA, 1600 Stewart Ave., Suite 410, Westbury,
NY 11590; telephone<PHONE_NUMBER>; email [email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2021-0255,
dated November 15, 2021, and corrected November 24, 2021.
    (ii) [Reserved]
    (3) For EASA AD 2021-0255, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; internet www.easa.europa.eu. You may find the
EASA material on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket at https://www.regulations.gov by searching
for and locating Docket No. FAA-2022-0281.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on May 16, 2022.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2022-11557 Filed 5-31-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 127 (Monday, July 2, 2012)]
[Rules and Regulations]
[Pages 39162-39164]
[FR Doc No: 2012-16001]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 774

[Docket No. 120112039-2176-03]
RIN 0694-AF45

Implementation of the Understandings Reached at the 2011
Australia Group (AG) Plenary Meeting and Other AG-Related
Clarifications to the EAR

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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

SUMMARY: The Bureau of Industry and Security (BIS) publishes this final
rule to amend the Export Administration Regulations (EAR) to implement
the understandings reached at the June 2011 plenary meeting of the
Australia Group (AG). This rule amends the Commerce Control List (CCL)
entry in the EAR that controls human and zoonotic pathogens and
``toxins'' and the entry that controls genetic elements and genetically
modified organisms to reflect changes to the AG ``List of Biological
Agents for Export Control'' that were made based on the understandings
adopted at the June 2011 AG plenary meeting. In addition, this rule
amends the CCL entries in the EAR that control chemical manufacturing
facilities and equipment, and equipment capable of use in handling
biological materials to reflect the June 2011 AG plenary changes to the
``Control List of Dual-Use Chemical Manufacturing Facilities and
Equipment and Related Technology and Software'' and the ``Control List
of Dual-Use Biological Equipment and Related Technology and Software,''
respectively.

DATES: This rule is effective July 2, 2012.

ADDRESSES: Send comments regarding this collection of information,
including suggestions for reducing the burden, to Jasmeet Seehra,
Office of Management and Budget (OMB), by email to<EMAIL_ADDRESS>or by fax to<PHONE_NUMBER>; and to the Regulatory
Policy Division, Bureau of Industry and Security, Department of
Commerce, 14th Street & Pennsylvania Avenue NW., Room 2705, Washington,
DC 20230.

FOR FURTHER INFORMATION CONTACT: Elizabeth Sangine, Director, Chemical
and Biological Controls Division, Office of Nonproliferation and Treaty
Compliance, Bureau of Industry and Security, Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    The Bureau of Industry and Security (BIS) is amending the Export
Administration Regulations (EAR) to implement the understandings
reached at the June 2011 plenary meeting of the Australia Group (AG).
The AG is a multilateral forum consisting of 40 participating countries
that maintain export controls on a list of chemicals, biological
agents, and related equipment and technology that could be used in a
chemical or biological weapons program. The AG periodically reviews
items on its control list to enhance the effectiveness of participating
governments' national controls and to achieve greater harmonization
among these controls.
    The June 2011 AG plenary meeting adopted understandings that
affected the AG ``List of Biological Agents for Export Control,'' the
AG ``Control List of Dual-Use Chemical Manufacturing Facilities and
Equipment and Related Technology and Software'' and the AG ``Control
List of Dual-Use Biological Equipment and Related Technology and
Software.''
    This rule amends Export Control Classification Numbers (ECCNs)
1C351 and 1C353 to reflect the AG changes to the ``List of Biological
Agents for Export Control.'' Specifically, ECCN 1C351 (Human and
zoonotic pathogens and ``toxins'') is amended by removing and reserving
paragraph .b (Rickettsiae), since these organisms are more
appropriately identified as bacteria. Coxiella burnetii and Rickettsia
prowasecki (a.k.a. Rickettsia prowazekii), which were previously
controlled under ECCN 1C351.b.2 and .b.3, respectively, are now
controlled as bacteria under ECCN 1C351.c.10 and .c.13, respectively.
Bartonella Quintana (Rochalimea Quintana, Rickettsia Quintana) and
Rickettsia rickettsii, which were previously controlled under ECCN
1C351.b.1 and .b.4, respectively, are removed from ECCN 1C351, since
they are no longer included on the AG ``List of Biological Agents.''
    ECCN 1C353 (Genetic elements and genetically modified organisms) is
amended by revising Technical Note 1 and adding a new Technical Note 4
to clarify that this ECCN controls certain de novo chemically
synthesized genetic material and artificially-produced organisms.
Specifically, Technical Note 1 to ECCN 1C353 is revised to indicate
that ``genetic elements'' also include chromosomes, genomes, plasmids,
transposons, and vectors that have been ``chemically synthesized in
whole or in part.'' New Technical Note 4 to ECCN 1C353 indicates that
``genetically modified organisms'' include ``organisms in which the
genetic material (nucleic acid sequences) has been altered in a way
that does not occur naturally by mating and/or natural recombination,
and encompasses those produced artificially in whole or in part.''
    This rule also amends ECCN 2B350 (Chemical manufacturing facilities
and equipment) by adding a new Technical Note 3, at the end of the
entry, to clarify that materials used for gaskets, packing, seals,
screws or washers, or other materials performing a sealing function, do
not determine the control status of the items listed in ECCN 2B350,
provided that such components are designed to be interchangeable.
    In addition, this rule amends ECCN 2B352 (Equipment capable of use
in handling biological materials) by revising the introductory text of
paragraph .d.1 to remove the phrase ``without propagation of
aerosols.'' Participating countries at the 2011 AG plenary agreed that
this phrase was redundant, as it applied to cross (tangential) flow
filtration equipment capable of separation of pathogenic
microorganisms, viruses, toxins or cell cultures.
    Finally, this rule amends ECCNs 2B350 and 2B352 to clarify certain
control parameters for pumps (i.e., multiple-seal and seal-less pumps
and vacuum pumps) and steam sterilizable freeze-drying (lyophilization)
equipment, respectively. Specifically, ECCN 2B350.i is amended by
adding two parenthetical phrases in the introductory text to specify
the maximum flow-rate of such pumps in liters of water per hour, as
follows: ``multiple-seal and seal-less pumps with manufacturer's
specified maximum flow-rate greater than 0.6 m\3\/hour (600 liters/
hour), or vacuum pumps with manufacturer's specified maximum flow-rate
greater than 5 m\3\/hour (5,000 liters/hour).'' ECCN 2B352.e is amended

by adding two parenthetical phrases that specify the condenser capacity
of such equipment in liters of water per 24 hours, as follows: ``10 kgs
of ice or greater in 24 hours (10 liters of water or greater in 24
hours), but less than 1,000 kgs of ice in 24 hours (less than 1,000
liters of water in 24 hours).'' These changes are being made by BIS in
order to indicate these AG control parameters in units of measure that
are more commonly used in the United States.
    None of the changes made by this rule increase the scope of the
controls in ECCNs 1C351, 1C353, 2B350 and 2B352. Except for the removal
of Bartonella Quintana and Rickettsia rickettsii from ECCN 1C351, the
items that are controlled under these ECCNs remain the same.
    Although the Export Administration Act expired on August 20, 2001,
the President, through Executive Order 13222 of August 17, 2001, 3 CFR,
2001 Comp., p. 783 (2002), as extended by the Notice of August 12,
2011, 76 FR 50661 (August 16, 2011), has continued the EAR in effect
under the International Emergency Economic Powers Act.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has been designated a ``significant regulatory
action'' although not economically significant, under section 3(f) of
Executive Order 12866. Accordingly, the rule has been reviewed by the
Office of Management and Budget.
    2. Notwithstanding any other provision of law, no person is
required to respond to, nor shall any person be subject to a penalty
for failure to comply with, a collection of information subject to the
requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.) (PRA), unless that collection of information displays a currently
valid Office of Management and Budget (OMB) Control Number. This rule
contains a collection of information subject to the requirements of the
PRA. This collection has been approved by OMB under Control Number
0694-0088 (Multi-Purpose Application), which carries a burden hour
estimate of 58 minutes to prepare and submit form BIS-748. Send
comments regarding this burden estimate or any other aspect of this
collection of information, including suggestions for reducing the
burden, to Jasmeet Seehra, Office of Management and Budget (OMB), and
to the Regulatory Policy Division, Bureau of Industry and Security,
Department of Commerce, as indicated in the ADDRESSES section of this
rule.
    3. This rule does not contain policies with Federalism implications
as that term is defined in Executive Order 13132.
    4. The provisions of the Administrative Procedure Act (5 U.S.C.
553) requiring notice of proposed rulemaking, the opportunity for
public participation, and a delay in effective date, are inapplicable
because this regulation involves a military and foreign affairs
function of the United States (See 5 U.S.C. 553(a)(1)). Immediate
implementation of these amendments is non-discretionary and fulfills
the United States' international obligation to the Australia Group
(AG). The AG contributes to international security and regional
stability through the harmonization of export controls and seeks to
ensure that exports do not contribute to the development of chemical
and biological weapons. The AG consists of 40 member countries that act
on a consensus basis and the amendments set forth in this rule
implement the understandings reached at the June 2011 AG plenary
meeting and other changes that are necessary to ensure consistency with
the controls maintained by the AG. Since the United States is a
significant exporter of the items in this rule, immediate
implementation of this provision is necessary for the AG to achieve its
purpose. Any delay in implementation will create a disruption in the
movement of affected items globally because of disharmony between
export control measures implemented by AG members, resulting in tension
between member countries. Export controls work best when all countries
implement the same export controls in a timely and coordinated manner.
    Further, no other law requires that a notice of proposed rulemaking
and an opportunity for public comment be given for this final rule.
Because a notice of proposed rulemaking and an opportunity for public
comment are not required to be given for this rule under the
Administrative Procedure Act or by any other law, the analytical
requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.)
are not applicable. Therefore, this regulation is issued in final form.

List of Subjects in 15 CFR Part 774

    Exports, Foreign trade, Reporting and recordkeeping requirements.

    Accordingly, part 774 of the Export Administration Regulations (15
CFR parts 730-774) is amended as follows:

PART 774--[AMENDED]

0
1. The authority citation for 15 CFR part 774 continues to read as
follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et
seq., 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42
U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C. 1824a; 50 U.S.C. app. 5; 22
U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 CFR,
1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p.
783; Notice of August 12, 2011, 76 FR 50661 (August 16, 2011).

0
2. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 1, ECCN 1C351 is amended under the ``Items'' paragraph in the
List of Items Controlled section by removing and reserving paragraph b.
and by revising paragraph c. to read as follows:

Supplement No. 1 to Part 774--The Commerce Control List

* * * * *
    1C351 Human and zoonotic pathogens and ``toxins'', as follows
(see List of Items Controlled).
* * * * *

List of Items Controlled

* * * * *
    Items:
* * * * *
    b. [Reserved]
    c. Bacteria, as follows:
    c.1. Bacillus anthracis;
    c.2. Brucella abortus;
    c.3. Brucella melitensis;
    c.4. Brucella suis;
    c.5. Burkholderia mallei (Pseudomonas mallei);
    c.6. Burkholderia pseudomallei (Pseudomonas pseudomallei);
    c.7. Chlamydophila psittaci (formerly known as Chlamydia
psittaci);
    c.8. Clostridium botulinum;
    c.9. Clostridium perfringens, epsilon toxin producing types;
    c.10. Coxiella burnetii;
    c.11. Enterohaemorrhagic Escherichia coli, serotype O157 and
other verotoxin producing serotypes;
    c.12. Francisella tularensis;
    c.13. Rickettsia prowasecki (a.k.a. Rickettsia prowazekii);
    c.14. Salmonella typhi;
    c.15. Shigella dysenteriae;
    c.16. Vibrio cholerae; or
    c.17. Yersinia pestis.
* * * * *

0
3. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 1,

ECCN 1C353 is amended under the ``Items'' paragraph in the List of
Items Controlled section by revising Technical Note 1 and by adding a
new Technical Note 4 in numerical order, to read as follows:

    1C353 Genetic elements and genetically modified organisms, as
follows (see List of Items Controlled).
* * * * *

List of Items Controlled

* * * * *
    Items:
* * * * *
    Technical Notes: 1. ``Genetic elements'' include, inter alia,
chromosomes, genomes, plasmids, transposons, and vectors, whether
genetically modified or unmodified, or chemically synthesized in
whole or in part.
* * * * *
    4. ``Genetically modified organisms'' include organisms in which
the genetic material (nucleic acid sequences) has been altered in a
way that does not occur naturally by mating and/or natural
recombination, and encompasses those produced artificially in whole
or in part.

0
4. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 2, ECCN 2B350 is amended under the ``Items'' paragraph in the
List of Items Controlled section by revising the introductory text of
paragraph i. and by adding a new ``Technical Note 3,'' in numerical
order, to read as follows:

    2B350 Chemical manufacturing facilities and equipment, except
valves controlled by 2A226 or 2A292, as follows (see List of Items
Controlled).
* * * * *
    List of Items Controlled
* * * * *
    Items:
* * * * *
    i. Multiple-seal and seal-less pumps with manufacturer's
specified maximum flow-rate greater than 0.6 m\3\/hour (600 liters/
hour), or vacuum pumps with manufacturer's specified maximum flow-
rate greater than 5 m\3\/hour (5,000 liters/hour) (under standard
temperature (273 K (0 [deg]C)) and pressure (101.3 kPa) conditions),
and casings (pump bodies), preformed casing liners, impellers,
rotors or jet pump nozzles designed for such pumps, in which all
surfaces that come into direct contact with the chemical(s) being
processed are made from any of the following materials:
* * * * *

    Technical Note 3:
     The materials used for gaskets, packing, seals, screws or
washers, or other materials performing a sealing function, do not
determine the control status of the items in this ECCN, provided
that such components are designed to be interchangeable.

0
5. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 2, ECCN 2B352 is amended under the ``Items'' paragraph in the
List of Items Controlled section by revising the introductory text of
paragraph d.1 and by revising paragraph e to read as follows:

    2B352 Equipment capable of use in handling biological materials,
as follows (see List of Items Controlled).
* * * * *

List of Items Controlled

* * * * *
    Items:
* * * * *
    d. * * *
    d.1. Cross (tangential) flow filtration equipment capable of
separation of pathogenic microorganisms, viruses, toxins or cell
cultures having all of the following characteristics:
* * * * *
    e. Steam sterilizable freeze-drying (lyophilization) equipment
with a condenser capacity of 10 kgs of ice or greater in 24 hours
(10 liters of water or greater in 24 hours), but less than 1,000 kgs
of ice in 24 hours (less than 1,000 liters of water in 24 hours).
* * * * *

    Dated: June 22, 2012.
Kevin J. Wolf
Assistant Secretary for Export Administration.
[FR Doc. 2012-16001 Filed 6-29-12; 8:45 am]
BILLING CODE 3510-33-P


[Federal Register Volume 81, Number 157 (Monday, August 15, 2016)]
[Proposed Rules]
[Page 53978]
[FR Doc No: 2016-19125]

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

40 CFR Part 52

[EPA-R01-OAR-2012-0865; A-1-FRL-9950-59-Region 1]

Air Plan Approval; NH; Control of Volatile Organic Compound
Emissions From Minor Core Activities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) revision submitted by the
State of New Hampshire on October 4, 2012. The revision clarifies
Reasonably Available Control Technology (RACT) requirements as they
apply to minor core activities of volatile organic compound (VOC)
sources. The intended effect of this action is to propose approval of
these requirements into the New Hampshire SIP. This action is being
taken in accordance with the Clean Air Act.

DATES: Written comments must be received on or before September 14,
2016.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R01-
OAR-2012-0865 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the ``For Further Information Contact'' section. For the
full EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: David L. Mackintosh, Air Quality
Planning Unit, U.S. Environmental Protection Agency, EPA New England
Regional Office, 5 Post Office Square--Suite 100, (Mail code OEP05-2),
Boston, MA 02109-3912, tel.<PHONE_NUMBER>, fax<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules Section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this action
rule, no further activity is contemplated. If EPA receives adverse
comments, the direct final rule will be withdrawn and all public
comments received will be addressed in a subsequent final rule based on
this proposed rule. EPA will not institute a second comment period. Any
parties interested in commenting on this action should do so at this
time. Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.
    For additional information, see the direct final rule which is
located in the Rules Section of this Federal Register.

    Dated: August 1, 2016.
H. Curtis Spalding,
Regional Administrator, EPA New England.
[FR Doc. 2016-19125 Filed 8-12-16; 8:45 am]
 BILLING CODE 6560-50-P