[Federal Register Volume 81, Number 157 (Monday, August 15, 2016)]
[Rules and Regulations]
[Pages 53931-53935]
[FR Doc No: 2016-19115]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0719; FRL-9949-49]

n-Butyl 3-hydroxybutyrate and Isopropyl 3-hydroxybutyrate;
Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of n-butyl 3-hydroxybutyrate (CAS Reg. No.
53605-94-0) and isopropyl 3-hydroxybutyrate (CAS Reg. No. 54074-94-1)
when used as inert ingredients (solvents) in pesticide formulations
applied to growing crops or raw agricultural commodities after harvest;
to animals; and to food contact surfaces in public eating places,
dairy-processing equipment, and food-processing equipment and utensils.
Steptoe and Johnson, on behalf of Eastman Chemical Company, submitted a
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting establishment of these exemptions from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of n-butyl 3-hydroxybutyrate and
isopropyl 3-hydroxybutyrate when applied or used under these
conditions.

DATES: This regulation is effective August 15, 2016. Objections and
requests for hearings must be received on or before October 14, 2016,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2015-0719, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The 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 Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2015-0719 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 14, 2016. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2015-0719, 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 CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 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.

II. Petition for Exemption

    In the Federal Register of November 23, 2015 (80 FR 72941) (FRL-
9936-73), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
10841) by Steptoe and Johnson LLP (1330 Connecticut Avenue NW.,
Washington, DC 20036-1795) on behalf of the Eastman Chemical Company
(200 South Wilcox Drive, Kingsport, TN 37660-5280). The petition
requested that 40 CFR 180.910, 180.930, and 180.940 be amended to
establish exemptions from the requirement of a tolerance for residues
of n-butyl 3-hydroxybutyrate (CAS Reg. No. 53605-94-0); and isopropyl
3-hydroxybutyrate (CAS Reg. No. 54074-94-1) when used as inert
ingredients (solvents) in pesticide formulations applied to pre- and
post-harvest crops under 40 CFR 180.910; to animals under 40 CFR
180.930; and to food contact surface sanitizing solutions under 40 CFR
180.940(a). That document referenced a summary of the petition prepared
by Steptoe and Johnson on behalf of Eastman Chemical Company, the
petitioner, which is available in the docket, http://www.regulations.gov.

Comments were received on the notice of filing. EPA's response to these
comments is discussed in Unit V.B.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for n-butyl 3-hydroxybutyrate and
isopropyl 3-hydroxybutyrate including exposure resulting from the
exemption established by this action. EPA's assessment of exposures and
risks associated with n-butyl 3-hydroxybutyrate and isopropyl 3-
hydroxybutyrate follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by n-butyl 3-hydroxybutyrate and
isopropyl 3-hydroxybutyrate as well as the no-observed-adverse-effect-
level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from
the toxicity studies are discussed in this unit.
    n-Butyl-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate are
structurally similar chemical entities differing only in one methyl
group (CH3). Therefore the toxicity of these two chemicals
is expected to be similar. Since there are no adequate data available
for each one individually, the Agency utilizes read-across data to fill
data gaps.
    n-Butyl-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate both
exhibit very low levels of acute oral, dermal and inhalation toxicity
each with LD50 values >5,000 mg/kg. n-Butyl-3-
hydroxybutyrate is moderately irritating to the rabbit eye and is
slightly irritating to rabbit skin. Isopropyl-3-hydroxybutyrate is not
irritating to rabbit skin. n-Butyl-3-hydroxybutyrate and isopropyl-3-
hydroxybutyrate are not dermal sensitizers.
    In a 28-day subchronic feeding study in rats which included a
reproduction/developmental screening assessment, exposure to isopropyl-
3-hydroxybutyrate resulted in no adverse test item-related
toxicological effects on clinical observations, no adverse effects seen
in FOB assessments, no adverse effects on motor activity evaluations,
no adverse effects seen in gross necropsy observations, male or female
reproductive performance, or neurobehavioral parameters. The no-
observed-adverse-effect-level (NOAEL) for reproductive toxicity was
1,000 mg/kg/day. The NOAEL for systemic toxicity was 1,000 mg/kg/day.
In the absence of effects on the general physical condition of
F1 pups, the NOAEL for neonatal toxicity was 1,000 mg/kg/
day.
    n-Butyl-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate were
negative in reverse gene mutation assays. Isopropyl-3-hydroxybutyrate
was negative in a chromosome aberration assay and a gene mutation
assay.
    There were no neurotoxicity or immunotoxicity studies available.
However, there was no evidence of adverse neurotoxic effects noted
during the FOB evaluations and the motor activity evaluations. There
was no evidence of immunotoxicity in the available database.
    Based on the negative responses seen in the genotoxicity and lack
of systemic toxicity in the reproductive and developmental screening
study, n-butyl-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate are
considered unlikely to be carcinogenic.
    n-Butyl-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate both have
a low solubility; therefore, it is unlikely that either material will
be absorbed by the body and become systemically bioavailable. Both
compounds are expected to hydrolyze quickly and completely in vivo, and
the resulting hydrolysis products are very close in structure or are
the same, depending on the specific hydrolysis product. The available
in vitro data suggests that isopropyl-3-hydroxybutyrate can undergo
fast hydrolysis by enzymes in the plasma and liver to produce n-butyl-
3-hydroxybutyrate, which is perhaps further metabolized. Isopropyl-3-
hydroxybutyrate concentration decreased from approximately 70 [mu]M to
below the limit of detection (<6.68 [mu]M) in plasma within 2 hours and
in rat liver S9 fraction within 30 minutes. Although stable in
phosphate buffer, isopropyl-3-

hydroxybutyrate concentration levels decreased from 70 [mu]M to below
the LOD within 30 minutes with ONLY slight increases in beta-
hydroxybutyate levels indicating that either it is formed in small
quantity (minor pathway) and/or rapidly metabolized and removed from
the circulation.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    An acute effect was not found in the database therefore an acute
dietary assessment is not necessary. In the 28-day subchronic oral
toxicity study in rats with neurotoxicity measurements, no toxicity was
observed at doses up to 1,000 mg/kg/day. Therefore, the Agency
concluded that it is not necessary to conduct a quantitative risk
assessment.

C. Exposure Assessment

    1. Dietary exposure from food, feed uses and drinking water. In
evaluating dietary exposure to n-butyl-3-hydroxybutyrate and isopropyl-
3-hydroxybutyrate, EPA considered exposure under the proposed exemption
from the requirement of a tolerance. EPA assessed dietary exposures
from n-butyl-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate in food
and drinking water as follows: Dietary exposure can occur from eating
foods or ingesting drinking water containing residues of n-butyl-3-
hydroxybutyrate and isopropyl-3-hydroxybutyrate. Because no hazard
endpoint of concern was identified for the acute and chronic dietary
assessment (food, feed and drinking water uses, a quantitative dietary
exposure risk assessment was not conducted
    2. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
    n-Butyl-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate may be
used in inert ingredients in products that are registered for specific
uses that may result in residential exposure, such as pesticides used
in and round the home. However, since no endpoint of concern identified
in the available database, it is not necessary to conduct a
quantitative residential exposure assessment.
    3. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found n-butyl-3-hydroxybutyrate and isopropyl-3-
hydroxybutyrate to share a common mechanism of toxicity with any other
substances, and n-butyl-3-hydroxybutyrate and isopropyl-3-
hydroxybutyrate does not appear to produce a toxic metabolite produced
by other substances. For the purposes of this tolerance action,
therefore, EPA has assumed that n-butyl-3-hydroxybutyrate and
isopropyl-3-hydroxybutyrate does not have a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's Web site
at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    As part of its qualitative assessment, EPA evaluated the available
toxicity and exposure data on n-butyl-3-hydroxybutyrate and isopropyl-
3-hydroxybutyrate and considered its validity, completeness, and
reliability, as well as the relationship of this information to human
risk. EPA considers the toxicity database to be sufficient to evaluate
risk and has identified no residual uncertainty with regard to prenatal
and postnatal toxicity or exposure. No hazard was identified based on
the available studies; therefore, EPA concludes that there are no
threshold effects of concern to infants, children, or adults from n-
butyl-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate. As a result,
EPA concludes that no additional margin of exposure (safety) is
necessary.

E. Aggregate Risks and Determination of Safety

    Because no toxicological endpoints of concern were identified, EPA
concludes that aggregate exposure to residues of n-butyl-3-
hydroxybutyrate and isopropyl-3-hydroxybutyrate will not pose a risk to
the U.S. population, including infants and children, and that there is
a reasonable certainty that no harm will result to the general
population, or to infants and children from aggregate exposure to n-
butyl-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of n-
butyl-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate in or on any
food commodities. EPA is not establishing a limitation on the amount of
n-butyl-3-hydroxybutyrate and isopropyl-3-hydroxybutyrate that may be
used in pesticide formulations applied to growing crops.

B. Comments

    Two generic comments objecting to the use of chemicals in food were
submitted to the docket for this action.

Neither of the comments contained any specific information bearing on
the Agency's safety finding for these chemicals. The Agency understands
the commenters' concerns and recognizes that some individuals believe
that pesticides should be banned on agricultural crops. However, the
existing legal framework provided by section 408 of the Federal Food,
Drug and Cosmetic Act (FFDCA) states that tolerances may be set when
persons seeking such tolerances or exemptions have demonstrated that
the pesticide meets the safety standard imposed by that statute. The
comment appears to be directed at the underlying statute and not EPA's
implementation of it; the citizen has made no contention that EPA has
acted in violation of the statutory framework.

VI. Conclusions

    Therefore, exemptions from the requirement of a tolerance are
established under 40 CFR 180.910, 40 CFR 180.930, and 40 CFR 180.940(a)
for n-butyl-3-hydroxybutyrate (CAS Reg. No. 53605-94-0) and isopropyl-
3-hydroxybutyrate (CAS Reg. No. 54074-94-1) when used as inert
ingredients (solvents) in pesticide formulations applied to growing
crops or raw agricultural commodities after harvest (40 CFR 180.910);
to animals (40 CFR 180.930); or to food contact surfaces in public
eating places, dairy-processing equipment, and food-processing
equipment and utensils (40 CFR 180.940(a)).

VII. Statutory and Executive Order Reviews

    This action establishes exemptions from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemptions in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: July 25, 2016.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.910, add alphabetically the inert ingredients to the
table to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
         Inert ingredients              Limits              Uses
------------------------------------------------------------------------

                              * * * * * * *
n-Butyl-3-hydroxybutyrate (CAS      ..............  Solvent.
 Reg. No. 53605-94-0).

                              * * * * * * *
Isopropyl-3-hydroxybutyrate (CAS    ..............  Solvent.
 Reg. No. 54074-94-1).

                              * * * * * * *
------------------------------------------------------------------------

0
3. In Sec.  180.930, add alphabetically the inert ingredients to the
table to read as follows:

Sec.  180.930  Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
         Inert ingredients              Limits              Uses
------------------------------------------------------------------------

                              * * * * * * *
n-Butyl-3-hydroxybutyrate (CAS      ..............  Solvent.
 Reg. No. 53605-94-0).

                              * * * * * * *
Isopropyl-3-hydroxybutyrate (CAS    ..............  Solvent.
 Reg. No. 54074-94-1).

                              * * * * * * *
------------------------------------------------------------------------

0
4. In Sec.  180.940(a), add alphabetically the inert ingredients to the
table in paragraph (a) to read as follows:

Sec.  180.940  Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).

* * * * *
    (a) * * *

------------------------------------------------------------------------
        Pesticide chemical           CAS Reg. No.          Limits
------------------------------------------------------------------------

                              * * * * * * *
n-Butyl-3-hydroxybutyrate.........      53605-94-0  Solvent.

                              * * * * * * *
Isopropyl-3-hydroxybutyrate.......      54074-94-1  Solvent.

                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-19115 Filed 8-12-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 76 (Friday, April 19, 2013)]
[Notices]
[Page 23568]
[FR Doc No: 2013-09176]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0018]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Health Care Professional Survey of
Prescription Drug Promotion

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Health Care Professional Survey of
Prescription Drug Promotion'' has been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On October 12, 2012, the Agency submitted a
proposed collection of information entitled ``Health Care Professional
Survey of Prescription Drug Promotion'' to OMB for review and clearance
under 44 U.S.C. 3507. 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. OMB has now
approved the information collection and has assigned OMB control number
0910-0730. The approval expires on February 29, 2016. A copy of the
supporting statement for this information collection is available on
the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: April 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-09176 Filed 4-18-13; 8:45 am]
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[Federal Register: August 20, 2008 (Volume 73, Number 162)]
[Notices]
[Page 49189-49194]
[DOCID:fr20au08-52]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2008-0628; FRL-8379-7]

Certain New Chemicals; Receipt and Status Information

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Section 5 of the Toxic Substances Control Act (TSCA) requires
any person who intends to manufacture (defined by statute to include
import) a new chemical (i.e., a chemical not on the TSCA Inventory) to
notify EPA and comply with the statutory provisions pertaining to the
manufacture of new chemicals. Under sections 5(d)(2) and 5(d)(3) of
TSCA, EPA is required to publish a notice of receipt of a
premanufacture notice (PMN) or an application for a test marketing
exemption (TME), and to publish periodic status reports on the
chemicals under review and the receipt of notices of commencement to
manufacture those chemicals. This status report, which covers the
period from July 28, 2008 through August 1, 2008, consists of the PMNs
and TME, both pending or expired, and the notices of commencement to
manufacture a new chemical that the Agency has received under TSCA
section 5 during this time period.

DATES: Comments identified by the specific PMN number or TME number,
must be received on or before September 19, 2008.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2008-0628, 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.
Attention: Docket ID Number EPA-HQ-OPPT-2008-0628. 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: Direct your comments to docket ID number EPA-HQ-OPPT-

2008-0628. 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 e-
mail. The regulations.gov website 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 e-
mail comment directly to EPA without going through regulations.gov,
your e-mail 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. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
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 Federal holidays. The telephone
number of the EPA/DC Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OPPT Docket is<PHONE_NUMBER>. 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: Colby Lintner, Regulatory Coordinator,
Environmental Assistance Division, Office of Pollution Prevention and
Toxics (7408M), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>;
e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. As such, the
Agency has not attempted to describe the specific entities that this
action may apply to. Although others may be affected, this action
applies directly to the submitter of the premanufacture notices
addressed in the action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. 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 e-mail. 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
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?

    Section 5 of TSCA requires any person who intends to manufacture
(defined by statute to include import) a new chemical (i.e., a chemical
not on the TSCA Inventory to notify EPA and comply with the statutory
provisions pertaining to the manufacture of new chemicals. Under
sections 5(d)(2) and 5(d)(3) of TSCA, EPA is required to publish a
notice of receipt of a PMN or an application for a TME and to publish
periodic status reports on the chemicals under review and the receipt
of notices of commencement to manufacture those chemicals. This status
report, which covers the period from July 28, 2008 through August 1,
2008, consists of the PMNs and TME, both pending or expired, and the
notices of commencement to manufacture a new chemical that the Agency
has received under TSCA section 5 during this time period.

III. Receipt and Status Report for PMNs

    This status report identifies the PMNs and TME, both pending or
expired, and the notices of commencement to manufacture a new chemical
that the Agency has received under TSCA section 5 during this time
period. If you are interested in information that is not included in
the following tables, you may contact EPA as described in Unit II. to
access additional non-CBI information that may be available.
    In Table I of this unit, EPA provides the following information (to
the extent that such information is not claimed as CBI) on the PMNs
received by EPA during this period: the EPA case number

assigned to the PMN; the date the PMN was received by EPA; the
projected end date for EPA's review of the PMN; the submitting
manufacturer; the potential uses identified by the manufacturer in the
PMN; and the chemical identity.

                                            I. 65 Premanufacture Notices Received From: 07/28/08 to 08/01/08
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Projected Notice End
              Case No.                    Received Date               Date           Manufacturer/Importer           Use                  Chemical
--------------------------------------------------------------------------------------------------------------------------------------------------------
P-08-0547                            07/21/08                10/18/08                CBI                    (G) Additive, open,    (G) Polyether
                                                                                non-dispersive use     urethane block
                                                                                copolymer compound
                                                                                with unsaturated
                                                                                fatty acids
P-08-0548                            07/21/08                10/18/08                CBI                    (G) Additive, open,    (G) Polyether
                                                                                non-dispersive use     modified
                                                                                polyurethane
P-08-0549                            07/21/08                10/18/08                CBI                    (G) Additive, open,    (G) Polyether
                                                                                non-dispersive use     modified
                                                                                polydimethylsiloxane
P-08-0550                            07/21/08                10/18/08                Honeywell Specialty    (G) Foam additive      (S) 1-propene,
                                                                                Materials                                     1,3,3,3-tetrafluoro-
                                                                                , (1E)-
P-08-0551                            07/21/08                10/18/08                Honeywell Specialty    (S) Chemical           (S) 1-propene,
                                                                                Materials              intermediate (as CIS-  1,3,3,3-tetrafluoro-
                                                                                isomer)                , (1Z)-
P-08-0552                            07/21/08                10/18/08                CBI                    (G) Industrial wood    (G) Multifunctional
                                                                                coating                acrylate
P-08-0553                            07/21/08                10/18/08                CBI                    (G) industrial wood    (G) Polycarbonate
                                                                                applications           polyurethane
                                                                                acrylate oligomer
P-08-0554                            07/22/08                10/19/08                CBI                    (G) Aqueous            (G) Aqueous
                                                                                polyurethane rubber    polyurethane
                                                                                coating resin for      dispersion
                                                                                open, non-dispersive
                                                                                use
P-08-0555                            07/24/08                10/21/08                CBI                    (G) Polymer used in    (G) Polymer of
                                                                                electronics            aromatic
                                                                                manufacture            dianhydride,
                                                                                aromatic diamine and
                                                                                polysiloxanediamine.
P-08-0556                            07/28/08                10/25/08                CBI                    (G) Open non-          (G) Aromatic
                                                                                dispersive             prepolymer based on
                                                                                TDI
P-08-0557                            07/25/08                10/22/08                Cytec Industries Inc.  (G) Coatings resin     (G) Acrylated
                                                                                aliphatic
                                                                                polyurethane
P-08-0558                            07/28/08                10/25/08                CBI                    (S) Polyurethane       (G) Polyurethane
                                                                                acrylate used in the   acrylate
                                                                                manufacture of ultra
                                                                                violet curable
                                                                                coatings
P-08-0559                            07/28/08                10/25/08                CBI                    (G) Chemical           (G) Aliphatic
                                                                                intermediate           ketoxime
P-08-0560                            07/29/08                10/26/08                DIC International,     (G) Additive for       (G) Modified
                                                                                LLC.                   lubricants             polyalkyldiene
                                                                                polymer
P-08-0561                            07/29/08                10/26/08                CBI                    (S) Ingredient in      (G) Cycloaklyl
                                                                                fragrance compound     piperonyl ether
P-08-0562                            07/29/08                10/26/08                CBI                    (G) Mining aid         (S) Tall oil,
                                                                                maleated, oxidized,
                                                                                sodium salts
P-08-0563                            07/29/08                10/26/08                CBI                    (G) Mining aid         (S) Tall oil,
                                                                                maleated, oxidized,
                                                                                potassium salts
P-08-0564                            07/29/08                10/26/08                CBI                    (G) Mining aid         (S) Tall oil,
                                                                                maleated, oxidized,
                                                                                calcium salts
P-08-0565                            07/29/08                10/26/08                CBI                    (G) Mining aid         (S) Tall oil,
                                                                                maleated, oxidized,
                                                                                ammonium salts
P-08-0566                            07/29/08                10/26/08                CBI                    (G) Mining aid         (S) Fatty acids, tall
                                                                                oil, maleated,
                                                                                oxidized, sodium
                                                                                salts
P-08-0567                            07/29/08                10/26/08                CBI                    (G) Mining aid         (S) Fatty acids, tall
                                                                                oil, maleated,
                                                                                oxidized, potassium
                                                                                salts
P-08-0568                            07/29/08                10/26/08                CBI                    (G) Mining aid         (S) Fatty acids, tall
                                                                                oil, maleated,
                                                                                oxidized, calcium
                                                                                salts
P-08-0569                            07/29/08                10/26/08                CBI                    (G) Mining aid         (S) Fatty acids, tall
                                                                                oil, maleated,
                                                                                oxidized, ammonium
                                                                                salts
P-08-0570                            07/29/08                10/26/08                CBI                    (G) Mining aid         (S) Fatty acids, tall
                                                                                oil, polymd.,
                                                                                oxidized, sodium
                                                                                salts
P-08-0571                            07/31/08                10/28/08                CBI                    (G) Ink binder         (G) Acrylate, polymer
                                                                                with acrylate,
                                                                                ketoacrylamide,
                                                                                styrene and acrylate
P-08-0572                            07/31/08                10/28/08                CBI                    (G) Ink binder         (G) Acrylate, polymer
                                                                                with acrylate,
                                                                                ketoacrylamide,
                                                                                styrene and
                                                                                acrylate, ammonium
                                                                                salt
P-08-0573                            07/31/08                10/28/08                CBI                    (G) Ink binder         (G) Acrylate, polymer
                                                                                with acrylate,
                                                                                ketoacrylamide,
                                                                                styrene and
                                                                                acrylate, sodium
                                                                                salt
P-08-0574                            07/31/08                10/28/08                CBI                    (G) Ink binder         (G) Acrylate, polymer
                                                                                with acrylate,
                                                                                ketoacrylamide,
                                                                                styrene and
                                                                                acrylate, potassium
                                                                                salt
P-08-0575                            07/31/08                10/28/08                CBI                    (G) Ink binder         (G) Acrylate, polymer
                                                                                with acrylate,
                                                                                ketoacrylamide,
                                                                                styrene and
                                                                                acrylate, compound
                                                                                with amino alcohol
P-08-0576                            07/31/08                10/28/08                CBI                    (G) Ink binder         (G) Acrylate, polymer
                                                                                with acrylate,
                                                                                ketoacrylamide,
                                                                                styrene and
                                                                                acrylate, compound
                                                                                with amino alcohol

P-08-0577                            07/31/08                10/28/08                CBI                    (G) Adhesive,          (G) Polyacrylate
                                                                                coating, ink           oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate and
                                                                                epoxy diacrylate
                                                                                with .beta.-
                                                                                diketone.
P-08-0578                            07/31/08                10/28/08                CBI                    (G) Adhesive,          (G) Polyacrylate
                                                                                coating, ink           oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate and
                                                                                epoxy diacrylate
                                                                                with .beta.-
                                                                                diketone.
P-08-0579                            07/31/08                10/28/08                CBI                    (G) Adhesive,          (G) Polyacrylate
                                                                                coating, ink           oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate and
                                                                                epoxy diacrylate
                                                                                with .beta.-
                                                                                diketone.
P-08-0580                            07/31/08                10/28/08                CBI                    (G) Adhesive,          (G) Polyacrylate
                                                                                coating, ink           oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate and
                                                                                epoxy diacrylate
                                                                                with .beta.-
                                                                                diketone.
P-08-0581                            07/31/08                10/28/08                CBI                    (G) Adhesive,          (G) Polyacrylate
                                                                                coating,ink            oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate and
                                                                                epoxy diacrylate
                                                                                with .beta.-
                                                                                diketone.
P-08-0582                            07/31/08                10/28/08                CBI                    (G) Adhesive,          (G) Polyacrylate
                                                                                coating, ink           oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate and
                                                                                epoxy diacrylate
                                                                                with .beta.-
                                                                                diketone.
P-08-0583                            07/31/08                10/28/08                CBI                    (G) Adhesive,          (G) Polyacrylate
                                                                                coating, ink           oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                triacrylate,
                                                                                diacrylate, .beta.-
                                                                                ketoester and
                                                                                dialkylmine.
P-08-0584                            07/31/08                10/28/08                CBI                    (G) Adhesive,          (G) Polyacrylate
                                                                                coating, ink           oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                triacrylate,
                                                                                diacrylate, .beta.-
                                                                                ketoester and
                                                                                dialkylmine.
P-08-0585                            07/31/08                10/28/08                CBI                    (G) Adhesive,          (G) Polyacrylate
                                                                                coating, ink           oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                triacrylate,
                                                                                diacrylate, .beta.-
                                                                                ketoester and
                                                                                dialkylmine.
P-08-0586                            07/31/08                10/28/08                CBI                    (G) Adhesive,          (G) Polyacrylate
                                                                                coating, ink           oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                triacrylate,
                                                                                diacrylate, .beta.-
                                                                                ketoester and
                                                                                dialkylmine.
P-08-0587                            07/31/08                10/28/08                CBI                    (G) Adhesive,          (G) Polyacrylate
                                                                                coating, ink           oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                triacrylate,
                                                                                diacrylate, .beta.-
                                                                                ketoester and
                                                                                dialkylmine.
P-08-0588                            07/31/08                10/28/08                CBI                    (G) Adhesive,          (G) Polyacrylate
                                                                                coating, ink           oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                triacrylate,
                                                                                diacrylate, .beta.-
                                                                                ketoester and
                                                                                dialkylmine.
P-08-0589                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Polyacrylate
                                                                                adhesive               oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate, epoxy
                                                                                diacrylate and
                                                                                .beta.-ketoester
P-08-0590                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Polyacrylate
                                                                                adhesive               oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate, epoxy
                                                                                diacrylate and
                                                                                .beta.-ketoester
P-08-0591                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Polyacrylate
                                                                                adhesive               oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate, epoxy
                                                                                diacrylate and
                                                                                .beta.-ketoester
P-08-0592                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Polyacrylate
                                                                                adhesive               oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate, epoxy
                                                                                diacrylate and
                                                                                .beta.-ketoester
P-08-0593                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Polyacrylate
                                                                                adhesive               oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate, epoxy
                                                                                diacrylate and
                                                                                .beta.-ketoester

P-08-0594                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Polyacrylate
                                                                                adhesive               oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate, epoxy
                                                                                diacrylate and
                                                                                .beta.-ketoester
P-08-0595                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Polyacrylate
                                                                                adhesive               oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate, epoxy
                                                                                diacrylate and
                                                                                .beta.-diketone.
P-08-0596                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Polyacrylate
                                                                                adhesive               oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate, epoxy
                                                                                diacrylate and
                                                                                .beta.-diketone.
P-08-0597                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Polyacrylate
                                                                                adhesive               oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate, epoxy
                                                                                diacrylate and
                                                                                .beta.-diketone.
P-08-0598                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Polyacrylate
                                                                                adhesive               oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate, epoxy
                                                                                diacrylate and
                                                                                .beta.-diketone.
P-08-0599                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Polyacrylate
                                                                                adhesive               oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate, epoxy
                                                                                diacrylate and
                                                                                .beta.-diketone.
P-08-0600                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Polyacrylate
                                                                                adhesive               oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate, epoxy
                                                                                diacrylate and
                                                                                .beta.-diketone.
P-08-0601                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Polyacrylate
                                                                                adhesive               oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate, epoxy
                                                                                diacrylate and
                                                                                .beta.-ketoester.
P-08-0602                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Polyacrylate
                                                                                adhesive               oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate, epoxy
                                                                                diacrylate and
                                                                                .beta.-ketoester.
P-08-0603                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Polyacrylate
                                                                                adhesive               oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate, epoxy
                                                                                diacrylate and
                                                                                .beta.-ketoester.
P-08-0604                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Polyacrylate
                                                                                adhesive               oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate, epoxy
                                                                                diacrylate and
                                                                                .beta.-ketoester.
P-08-0605                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Polyacrylate
                                                                                adhesive               oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate, epoxy
                                                                                diacrylate and
                                                                                .beta.-ketoester.
P-08-0606                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Polyacrylate
                                                                                adhesive               oligomer product
                                                                                from base-catalyzed
                                                                                reaction of
                                                                                tetraacrylate,
                                                                                triacrylate, epoxy
                                                                                diacrylate and
                                                                                .beta.-ketoester.
P-08-0607                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Aliphatic
                                                                                adhesive               urethane diacrylate
                                                                                monomer from
                                                                                diisocyanate and
                                                                                monoepoxide acrylate
                                                                                ester.
P-08-0608                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Aliphatic
                                                                                adhesive               urethane diacrylate
                                                                                monomer from
                                                                                diisocyanate and
                                                                                monoepoxide acrylate
                                                                                ester
P-08-0609                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Aliphatic
                                                                                adhesive               urethane diacrylate
                                                                                monomer from
                                                                                diisocyanate and
                                                                                monoepoxide acrylate
                                                                                ester
P-08-0610                            08/01/08                10/29/08                CBI                    (G) Ink, coating,      (G) Aliphatic
                                                                                adhesive               urethane diacrylate
                                                                                monomer from
                                                                                diisocyanate and
                                                                                monoepoxide acrylate
                                                                                ester
P-08-0611                            08/01/08                10/29/08                CBI                    (G) Rubber additive    (G) Isocyanate
                                                                                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 TMEs
received:

                                       II. 1 Test Marketing Exemption Notices Received From: 07/28/08 to 08/01/08
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Projected Notice End
              Case No.                    Received Date               Date           Manufacturer/Importer           Use                  Chemical
--------------------------------------------------------------------------------------------------------------------------------------------------------
T-08-0017                            07/25/08                09/07/08                Cytec Industries Inc.  (G) Coatings resin     (G) Acrylated
                                                                                aliphatic
                                                                                polyurethane
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

                            III. 18 Notices of Commencement From: 07/28/08 to 08/1/08
----------------------------------------------------------------------------------------------------------------
                                                                Commencement Notice
              Case No.                     Received Date             End Date                  Chemical
----------------------------------------------------------------------------------------------------------------
P-06-0423                             07/31/08                07/18/08                (G) 2-Propenoic acid, 2-
                                                                                methyl-, 1,2-ethanediyl
                                                                                ester, telomer with alkyl
                                                                                2-
                                                                                [[(alkylthio)thioxomethyl
                                                                                ]thio]-2-methylalkanoate,
                                                                                alkyl methacrylate and me
                                                                                methacrylate, tert-bu 2-
                                                                                ethylhexaneperoxoate-
                                                                                initiated
P-07-0639                             07/30/08                07/18/08                (G) Ether carboxylic acid
                                                                                amide
P-07-0662                             07/18/08                06/30/08                (G) Substituted alkenyl-
                                                                                terminated siloxanes and
                                                                                silicones polymers with
                                                                                substituted acrylates,
                                                                                peroxide initiated
P-08-0105                             07/22/08                06/29/08                (G) Azo compound
P-08-0114                             07/29/08                06/25/08                (G) Alkanoic acid, ethenyl
                                                                                ester, polymer with
                                                                                ethenyl acetate and alkyl
                                                                                2-propenoate
P-08-0121                             08/01/08                07/10/08                (G) Acryloylisocyanate
P-08-0124                             07/30/08                07/18/08                (G) Quaternary ammonium
                                                                                compound
P-08-0209                             07/28/08                07/23/08                (G) Poly(oxy-1,2-
                                                                                ethanediyl), .alpha.-bis
                                                                                alkyl substituted
                                                                                hydroxyphenyl ester-
                                                                                .omega.-bis alkyl
                                                                                substituted hydroxyphenyl
                                                                                ester
P-08-0265                             08/01/08                07/08/08                (G) Polymer of isocyanic
                                                                                acid, polymethylene
                                                                                polyphenylene ester, with
                                                                                alkyl polyamine, .alpha.-
                                                                                hydro-.gamma.-
                                                                                hydroxypoly[(oxy(methyl-
                                                                                1,2-ethanediyl)) and
                                                                                methyloxirane
P-08-0275                             07/18/08                07/07/08                (S) Cesium tungsten oxide
P-08-0310                             07/24/08                07/19/08                (G) Heteromonocycle
                                                                                carboxylic acid, (3-
                                                                                chloro-2-pyridinyl)-oxo-,
                                                                                ethyl ester
P-08-0327                             07/23/08                07/14/08                (G) Halogenated aromatic
                                                                                ester derivatives
P-08-0333                             07/25/08                06/28/08                (G) Fatty acids, C18-
                                                                                unsaturated, dimers,
                                                                                polymer with alkyldioic
                                                                                acids, ethylenediamine,
                                                                                dialkylcyclicdiamine, and
                                                                                tall-oil fatty acid
P-08-0335                             07/25/08                06/28/08                (G) Fatty acids, C18-
                                                                                unsaturated, dimers,
                                                                                polymer with alkyldioic
                                                                                acid, ethylenediamine,
                                                                                dialkyloxydiamine, and
                                                                                tall-oil fatty acid
P-08-0344                             07/18/08                07/10/08                (S) 1,3-dioxepin, 4,7-
                                                                                dihydro-2-(1,1,4-
                                                                                trimethyl-3-pentenyl yl)-
P-08-0352                             07/28/08                07/17/08                (G) Alkyl acrylate polymer
                                                                                with inorganic acid and
                                                                                alkoxyethyl acrylate,
                                                                                alkyl ester
P-08-0384                             07/31/08                07/21/08                (G) Vegetable oils, esters
                                                                                with polyols
P-95-0231                             07/28/08                02/23/00                (G) Polyester resin
----------------------------------------------------------------------------------------------------------------

List of Subjects

    Environmental protection, Chemicals, Premanufacturer notices.

    Dated: Augut 13, 2008.
Chandler Sirmons,
Acting Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. E8-19304 Filed 8-19-08; 8:45 am]

BILLING CODE 6560-50-S


Comment Info: =================

General Comment:These documents concern pages 2342 through 2553 of BMI France response to an information collection request.