[Federal Register Volume 85, Number 76 (Monday, April 20, 2020)]
[Rules and Regulations]
[Pages 21783-21785]
[FR Doc No: 2020-07579]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2020-0005; Internal Agency Docket No. FEMA-8625]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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SUMMARY: This rule identifies communities where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP) that are scheduled for suspension on the effective dates
listed within this rule because of noncompliance with the floodplain
management requirements of the program. If the Federal Emergency
Management Agency (FEMA) receives documentation that the community has
adopted the required floodplain management measures prior to the
effective suspension date given in this rule, the suspension will not
occur and a notice of this will be provided by publication in the
Federal Register on a subsequent date. Also, information identifying
the current participation status of a community can be obtained from
FEMA's Community Status Book (CSB). The CSB is available at https://www.fema.gov/national-flood-insurance-program-community-status-book.

DATES: Effective Dates: The effective date of each community's
scheduled suspension is the third date (``Susp.'') listed in the third
column of the following tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact Adrienne L. Sheldon, PE, CFM, Federal
Insurance and Mitigation Administration, Federal Emergency Management
Agency, 400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
Federal flood insurance that is not otherwise generally available from
private insurers. In return, communities agree to adopt and administer
local floodplain management measures aimed at protecting lives and new
construction from future flooding. Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale
of NFIP flood insurance unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed in this document no longer meet that
statutory requirement for compliance with program regulations, 44 CFR
part 59. Accordingly, the communities will be suspended on the
effective date in the third column. As of that date, flood insurance
will no longer be available in the community. We recognize that some of
these communities may adopt and submit the required documentation of

legally enforceable floodplain management measures after this rule is
published but prior to the actual suspension date. These communities
will not be suspended and will continue to be eligible for the sale of
NFIP flood insurance. A notice withdrawing the suspension of such
communities will be published in the Federal Register.
    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
The date of the FIRM, if one has been published, is indicated in the
fourth column of the table. No direct Federal financial assistance
(except assistance pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act not in connection with a flood) may be
provided for construction or acquisition of buildings in identified
SFHAs for communities not participating in the NFIP and identified for
more than a year on FEMA's initial FIRM for the community as having
flood-prone areas (section 202(a) of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against
certain types of Federal assistance becomes effective for the
communities listed on the date shown in the last column. The
Administrator finds that notice and public comment procedures under 5
U.S.C. 553(b), are impracticable and unnecessary because communities
listed in this final rule have been adequately notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. FEMA has determined that the
community suspension(s) included in this rule is a non-discretionary
action and therefore the National Environmental Policy Act of 1969 (42
U.S.C. 4321 et seq.) does not apply.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended,
Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless
an appropriate public body adopts adequate floodplain management
measures with effective enforcement measures. The communities listed no
longer comply with the statutory requirements, and after the effective
date, flood insurance will no longer be available in the communities
unless remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for Part 64 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

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                                                Effective date
                                                authorization/
                                  Community     cancellation of    Current effective map   Date certain federal
      State and location             No.         sale of flood             date            assistance no longer
                                                 insurance in                               available in SFHAs
                                                   community
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           Region II

New Jersey:
    Haledon, Borough of,              340399  May 13, 1975,       April 17, 2020........  April 17, 2020.
     Passaic County.                           Emerg; March 16,
                                               1981, Reg; April
                                               17, 2020, Susp.
    Little Falls, Township of,        340401  July 6, 1973,       ......do*.............   Do.
     Passaic County.                           Emerg; August 17,
                                               1981, Reg; April
                                               17, 2020, Susp.
Pompton Lakes, Borough of,            345528  June 5, 1970,       ......do..............   Do.
 Passaic County.                               Emerg; September
                                               4, 1970, Reg;
                                               April 17, 2020,
                                               Susp.
Totowa, Borough of, Passaic           340408  May 23, 1975,       ......do..............   Do.
 County.                                       Emerg; August 5,
                                               1985, Reg; April
                                               17, 2020, Susp.

          Region VII

Iowa:
    Emerson, City of, Mills           190202  July 28, 1975,      ......do..............   Do.
     County.                                   Emerg; April 3,
                                               1984, Reg; April
                                               17, 2020, Susp.
    Glenwood, City of, Mills          190203  December 5, 1974,   ......do..............   Do.
     County.                                   Emerg; May 17,
                                               1982, Reg; April
                                               17, 2020, Susp.
    Hastings, City of, Mills          190204  October 14, 1982,   ......do..............   Do.
     County.                                   Emerg; October
                                               14, 1982, Reg;
                                               April 17, 2020,
                                               Susp.
    Malvern, City of, Mills           190205  August 4, 1975,     ......do..............   Do.
     County.                                   Emerg; September
                                               16, 1982, Reg;
                                               April 17, 2020,
                                               Susp.
    Mills County,                     190891  October 14, 1982,   ......do..............   Do.
     Unincorporated Areas.                     Emerg; October
                                               14, 1982, Reg;
                                               April 17, 2020,
                                               Susp.
    Pacific Junction, City of,        190206  December 23, 1974,  ......do..............   Do.
     Mills County.                             Emerg; April 4,
                                               1983, Reg; April
                                               17, 2020, Susp.
    Silver City, City of,             190207  January 2, 1976,    ......do..............   Do.
     Mills County.                             Emerg; September
                                               4, 1985, Reg;
                                               April 17, 2020,
                                               Susp.
Nebraska:
    Dodge County,                     310068  April 18, 1975,     ......do..............   Do.
     Unincorporated Areas.                     Emerg; August 17,
                                               1981, Reg; April
                                               17, 2020, Susp.
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*-do- =Ditto.
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp.--Suspension.

Katherine B. Fox,
Assistant Administrator for Mitigation, Federal Insurance and
Mitigation Administration--FEMA Resilience, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2020-07579 Filed 4-15-20; 4:15 pm]
BILLING CODE 9110-12-P


[Federal Register Volume 76, Number 110 (Wednesday, June 8, 2011)]
[Proposed Rules]
[Pages 33184-33188]
[FR Doc No: 2011-14211]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0360; FRL-8874-7]

Tetrachlorvinphos; Proposed Extension of Time-Limited Interim
Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes the extension of time-limited interim
tolerances for the combined residues of the insecticide
tetrachlorvinphos (Z)-2-chloro-1-(2,4,5-trichlorophenyl) vinyl dimethyl
phosphate, including its metabolites, 1-(2,4,5-trichlorophenyl)-ethanol
(free and conjugated forms), 2,4,5-trichloroacetophenone, and 1-(2,4,5-
trichlorophenyl)-ethanediol, in or on multiple commodities which will
be identified later in this document, under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: Comments, identified by docket identification (ID) number EPA-
HQ-OPP-2011-0360, must be received on or before August 8, 2011.

ADDRESSES: Submit your comments, identified by docket ID number EPA-HQ-
OPP-2011-0360, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Tetrachlorvinphos; Proposed Extension of Time-
Limited Interim Pesticides, Office of Pesticide Programs (OPP)
Regulatory Public Docket (7502P), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2011-0360. 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 Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an 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.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Carmen Rodia, Registration Division
(7504P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail 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.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. 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 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. Background

    Following the enactment of the Food Quality Protection Act of 1996
(FQPA), EPA reviewed and assessed under the new FQPA aggregate risk
standard, the existing tolerances of 31 organophosphates (OPs),
including tetrachlorvinphos (TCVP). In late December 2002, EPA reported
the results of its assessment of TCVP tolerances in its Tolerance
Reassessment Eligibility Decision (TRED) document, (67 FR 77491,
December 18, 2002) (FRL-7279-2).
    The TCVP TRED concluded that the TCVP livestock residue studies
were not adequate, and recommended that the Agency require the
registrant to conduct and submit new magnitude of residue (MOR) studies
to support permanent TCVP tolerances. The TCVP TRED also recommended
the Agency revoke 4 existing tolerances in commodities supporting TCVP
uses that were no longer registered. Finally, the TRED recommended that
the Agency use existing TCVP metabolism studies to modify 5 existing
livestock tolerances (fat of cattle, hogs and poultry as well as eggs
and milk fat) and establish 11 tolerances for additional tissues of
cattle, hogs and poultry (such as meat, meat byproducts and kidney and
liver). Specifically, the TRED recommended that EPA establish 16 TCVP
tolerances as ``time-limited for a period of 18 months * * * to permit
sufficient time for the registrant to submit the required MOR
studies.'' TCVP TRED at 41. On February 6, 2004, EPA issued a Generic
Data Call-In Notice requiring the registrant to conduct and submit new
livestock MOR studies for meat, milk, poultry, and eggs.
    On February 6, 2008, pursuant to section 408(e) of the FFDCA, EPA
proposed to revoke, modify and establish tolerances for 10 pesticides,
including TCVP (73 FR 6867) (FRL-8345-2). EPA explained that the
proposed tolerance actions were a ``follow-up to the Agency
reregistration program under Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), and tolerance reassessment program under FFDCA
section 408(q).'' Id. As such, EPA proposed to implement the tolerance
recommendations made in the TCVP TRED by:
    (1) Revising the tolerance expression in 40 CFR 180.252 to regulate
the residues of TCVP and its metabolites;
    (2) Revise and establish 16 time-limited TCVP livestock tolerances
to reflect levels of TCVP and its metabolites in various metabolism
studies; and
    (3) Revoke tolerances for residues of TCVP for goat fat and horse
fat. Specifically, EPA proposed to establish the 16 TCVP tolerances for
``18 months to permit time for the submission of additional MOR data to
support permanent tolerances.'' (73 FR 6867, February 6, 2008). Because
the Agency was taking action to establish tolerances in/on beef cattle,
hog and poultry commodities, EPA determined that the exception that
permitted the use of TCVP as an additive to beef cattle, dairy cattle,
horse and swine feed at certain rates was no longer necessary. On
September 17, 2008, EPA finalized the rule as proposed, establishing,
among other things, 16 time-limited tolerances for TCVP with an
expiration date of March 17, 2010 (73 FR 53732) (FRL-8375-2). For both
the proposal and the final rule, EPA determined that the ``increased
tolerances and new tolerances to be established are safe; i.e., there
is a reasonable certainty that no harm will result from aggregate
exposure to the pesticide chemical residue.'' (73 FR 53732, September
17, 2008).
    It was EPA's intention that upon submission of the required TCVP
MOR studies, the time-limited tolerances would be extended to allow EPA
sufficient time to review the data with the expectation that the data
would support the establishment of permanent tolerances. Prior to March
17, 2010, the registrant did in fact submit MOR data in cattle (MRID
47193001), MOR data in poultry (MRID 47589301), and the livestock
validation methodology (MRID 47369201). However, due to a mistake on
the part of EPA, the data were not reviewed in a timely manner.
Compounding this error, EPA also failed to extend the time-limited
tolerances to allow for the Agency to review the data and make a
determination with respect to converting the time-limited tolerances
into permanent tolerances.
    Accordingly, in order to remedy the Agency's mistake and to be
consistent with its original proposal and final rule establishing the
TCVP time-limited tolerances, EPA is proposing to extend the expired
time-limited tolerances for another 18 months to allow EPA to review
the livestock MOR data submitted by the registrant as well as
subsequent submissions, including storage stability data (MRID
47589301) to support the previously submitted MOR data in poultry,
storage stability data (MRID 48378101) to support the previously
submitted MOR data in cattle, and a waiver request for MOR data in
swine.
    In the TCVP TRED, EPA ``found that, apart from consideration of the
potential cumulative risks from all of the OPs, each of the tolerances
would meet the FFDCA safety standard. EPA has not considered the impact
of these cumulative risks in the reassessment of these tolerances and
has determined that these tolerances make, at most, only a negligible
contribution to the overall risks from OPs. Therefore, these tolerances
can be maintained regardless of the outcome of the OP cumulative
assessment and any potential regulatory action taken as a result of
that assessment. Accordingly, EPA ``believes it is appropriate to
consider these tolerances reassessed for the purposes of section 408(q)
of FQPA as of July 23, 2002.'' (67 FR 52985, August 14, 2002) (FRL-
7192-4).
    Among the factors EPA considered in making the decision to reassess
these tolerances were extensive livestock feeding/metabolism studies as
well as extensive monitoring data that was in agreement with the
livestock feeding/metabolisms studies. In sum, there were very few
detectable residues in the OP monitoring data for animal commodities.
EPA relied upon extensive monitoring data from the U.S. Department of
Agriculture's (USDA) Pesticide Data Program (PDP) and U.S. Food and
Drug Administration's (FDA) Total Diet Study (TDS) covering residues of
multiple OPs in meats and poultry. The residue monitoring data showed
infrequent detections, and those residues were detected at low levels.
Out of approximately 400 meat samples analyzed by the TDS for multiple
OPs from 1991-1999, only 9 samples detected any OP residues (the
residues ranged between 0.002 ppm and 0.009 ppm). Out of the
approximately 500 poultry samples analyzed by PDP for multiple OPs from
1997-2000, only 1 sample detected an OP residue (0.01 ppm) for a
pesticide that currently has a tolerance. Id. For milk and eggs,
extensive monitoring data were available from USDA's PDP and FDA's TDS.
The residue monitoring data showed no detectable OP residues in milk
(there was only 1 trace sample detected out of approximately 1,800
samples analyzed by PDP for multiple OPs from 1996-1998). The residue
monitoring for eggs also showed no detectable OP residues (only 1 trace
sample was detected out of approximately 1,300 samples analyzed by TDS
for multiple OPs from 1992-1998). Id.
    In July of 2006, EPA completed the OP cumulative risk assessment
(CRA), using the best available monitoring data. The updated USDA PDP
data indicated that OP residues would not be expected to occur in
significant amounts in meat

or milk. The analysis in the OP CRA indicated that animal commodities
do not significantly contribute to OP dietary exposure and total OP
dietary risk. This characterization was supported by additional
information, including the updated TDS data. On July 31, 2006, EPA
finalized the TCVP reregistration eligibility determination by
concluding that the pesticide tolerances covered by the IREDs and TREDs
that were pending the result of the OP CRA--including TCVP tolerances,
meet the safety standard under section 408(b)(2) of the FFDCA.
    In 2008, EPA confirmed that USDA PDP analyses of livestock
commodities, including milk, poultry, pork, and beef, through 2005
showed virtually no detectable residues of TCVP (except for 2 lone milk
samples detected at levels just above the LOQ (less than one part per
billion), detected out of approximately 5,200 samples analyzed by PDP
for multiple OPs from 2001-2005. Furthermore, the USDA Food Safety and
Inspection Service (FSIS) monitors meat for residues of
tetrachlorvinphos, and there have been no detections of
tetrachlorvinphos from 2000-2009.

III. Proposal

    EPA on its own initiative, under section 408(e) of the FFDCA, 21
U.S.C. 346a(e), is proposing to extend the dates of expiration/
revocation for the time-limited interim tolerances for the combined
residues of the insecticide tetrachlorvinphos (Z)-2-chloro-1-(2,4,5-
trichlorophenyl) vinyl dimethyl phosphate, including its metabolites,
1-(2,4,5-trichlorophenyl)-ethanol (free and conjugated forms), 2,4,5-
trichloroacetophenone, and 1-(2,4,5-trichlorophenyl)-ethanediol, in or
on cattle, fat (of which no more than 0.1 ppm is tetrachlorvinphos per
se) at 0.2 parts per million (ppm); cattle, kidney (of which no more
than 0.05 ppm is tetrachlorvinphos per se) at 1.0 ppm; cattle, liver
(of which no more than 0.05 ppm is tetrachlorvinphos per se) at 0.5
ppm; cattle, meat (of which no more than 2.0 ppm is tetrachlorvinphos
per se) at 2.0 ppm; cattle, meat byproducts, except kidney and liver at
1.0 ppm; egg (of which no more than 0.05 ppm is tetrachlorvinphos per
se) at 0.2 ppm; hog, fat (of which no more than 0.1 ppm is
tetrachlorvinphos per se) at 0.2 ppm; hog, kidney (of which no more
than 0.05 ppm is tetrachlorvinphos per se) at 1.0 ppm; hog, liver (of
which no more than 0.05 ppm is tetrachlorvinphos per se) at 0.5 ppm;
hog, meat (of which no more than 2.0 ppm is tetrachlorvinphos per se)
at 2.0 ppm; hog, meat byproducts, except kidney and liver at 1.0 ppm;
milk, fat (reflecting negligible residues in whole milk and of which no
more than 0.05 ppm is tetrachlorvinphos per se) at 0.05 ppm; poultry,
fat (of which no more than 7.0 ppm is tetrachlorvinphos per se) at 7.0
ppm; poultry, liver (of which no more than 0.05 ppm is
tetrachlorvinphos per se) at 2.0 ppm; poultry, meat (of which no more
than 3.0 ppm is tetrachlorvinphos per se) at 3.0 ppm; and poultry, meat
byproducts, except liver at 2.0 ppm, for a period of 18 months
following the date of publication of the final rule in the Federal
Register, in order to provide the Agency with additional time to
complete the reviews of the submitted livestock MOR data, storage
stability data, and the waiver request for the swine MOR data.

IV. Statutory and Executive Order Reviews

    This proposed rule establishes a tolerance under section 408(e) of
FFDCA. 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 proposed rule has been exempted from review under Executive Order
12866 due to its lack of significance, this proposed rule 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). This proposed rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). 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),
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). 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 of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances are being established under section 408(e) of the FFDCA,
such as the tolerance in this proposed 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. The Agency
hereby certifies that this proposed action will not have significant
negative economic impact on a substantial number of small entities. In
addition, the Agency has determined that this action will not have a
substantial direct effect on States, on the relationship between the
national government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This proposed rule directly regulates growers, food
processors, food handlers, and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this proposed rule does not have any ``Tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000). Executive Order 3175 requires EPA to develop
an accountable process to ensure ``meaningful and timely input by
Tribal officials in the development of regulatory policies that have
Tribal implications.'' ``Policies that have Tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian Tribes, on the
relationship between the Federal Government and the Indian Tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian Tribes.'' This proposed rule will not have
substantial direct effects on Tribal governments, on the relationship
between the Federal Government and Indian Tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian Tribes, as

specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this proposed rule.

List of Subjects in 40 CFR Part 180

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

    Dated: May 26, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR chapter I be amended as
follows:

PART 180--[AMENDED]

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

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

    2. Section 180.252 is revised to read as follows:

Sec.  180.252  Tetrachlorvinphos; tolerances for residues.

    (a) General. Tolerances are established for the combined residues
of the insecticide tetrachlorvinphos (Z)-2-chloro-1-(2,4,5-
trichlorophenyl) vinyl dimethyl phosphate, including its metabolites,
1-(2,4,5-trichlorophenyl)-ethanol (free and conjugated forms), 2,4,5-
trichloroacetophenone, and 1-(2,4,5-trichlorophenyl)-ethanediol, in or
on the following commodities:

------------------------------------------------------------------------
                                    Parts per     Expiration/revocation
            Commodity                million              date
------------------------------------------------------------------------
Cattle, fat (of which no more             0.2   [date 18 months from the
 than 0.1 ppm is                                 date of Final tolerance
 tetrachlorvinphos per se).                      publication].
Cattle, kidney (of which no more          1.0   [date 18 months from the
 than 0.05 ppm is                                date of Final tolerance
 tetrachlorvinphos per se).                      publication].
Cattle, liver (of which no more           0.5   [date 18 months from the
 than 0.05 ppm is                                date of Final tolerance
 tetrachlorvinphos per se).                      publication].
Cattle, meat (of which no more            2.0   [date 18 months from the
 than 2.0 ppm is                                 date of Final tolerance
 tetrachlorvinphos per se).                      publication].
Cattle, meat byproducts, except           1.0   [date 18 months from the
 kidney and liver.                               date of Final tolerance
                                                 publication].
Egg (of which no more than 0.05           0.2   [date 18 months from the
 ppm is tetrachlorvinphos per                    date of Final tolerance
 se).                                            publication].
Hog, fat (of which no more than           0.2   [date 18 months from the
 0.1 ppm is tetrachlorvinphos                    date of Final tolerance
 per se).                                        publication].
Hog, kidney (of which no more             1.0   [date 18 months from the
 than 0.05 ppm is                                date of Final tolerance
 tetrachlorvinphos per se).                      publication].
Hog, liver (of which no more              0.5   [date 18 months from the
 than 0.05 ppm is                                date of Final tolerance
 tetrachlorvinphos per se).                      publication].
Hog, meat (of which no more than          2.0   [date 18 months from the
 2.0 ppm is tetrachlorvinphos                    date of Final tolerance
 per se).                                        publication].
Hog, meat byproducts, except              1.0   [date 18 months from the
 kidney and liver.                               date of Final tolerance
                                                 publication].
Milk, fat (reflecting negligible          0.05  [date 18 months from the
 residues in whole milk and of                   date of Final tolerance
 which no more than 0.05 ppm is                  publication].
 tetrachlorvinphos per se).
Poultry, fat (of which no more            7.0   [date 18 months from the
 than 7.0 ppm is                                 date of Final tolerance
 tetrachlorvinphos per se).                      publication].
Poultry, liver (of which no more          2.0   [date 18 months from the
 than 0.05 ppm is                                date of Final tolerance
 tetrachlorvinphos per se).                      publication].
Poultry, meat (of which no more           3.0   [date 18 months from the
 than 3.0 ppm is                                 date of Final tolerance
 tetrachlorvinphos per se).                      publication].
Poultry, meat byproducts, except          2.0   [date 18 months from the
 liver.                                          date of Final tolerance
                                                 publication].
------------------------------------------------------------------------

     (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2011-14211 Filed 6-7-11; 8:45 am]
BILLING CODE 6560-50-P


Significant New Alternatives Policy Program

Refrigeration and Air Conditioning Sector

Risk Screen on Substitutes for CFC-12, HCFC-22, and R-502 in Retail Food
Refrigeration.

Substitute: Propane

This risk screen contains no Clean Air Act (CAA) Confidential Business
Information (CBI) and, therefore, may be disclosed to the public.

INTRODUCTION

Ozone-depleting substances (ODS) are being phased out of production in
response to a series of diplomatic and legislative efforts that have
taken place over the past decade, including the Montreal Protocol and
the Clean Air Act Amendments of 1990 (CAAA).  The U.S. Environmental
Protection Agency (EPA), as authorized by Section 612 of the CAAA, is
developing a program to evaluate the human health and environmental
risks posed by alternatives to ODS.  The main purpose of EPA's program,
called the Significant New Alternatives Policy (SNAP) Program, is to
identify acceptable and unacceptable substitutes for ODS in specific end
uses.

EPA’s decision on the acceptability of a substitute is based largely
on the findings of a screening assessment of potential human health and
environmental risks posed by the substitute in specific applications.
EPA has already screened a large number of substitutes in many end uses
within all of the major ODS-using sectors, including refrigeration and
air conditioning, solvent cleaning, foam blowing, aerosols, fire
suppression, adhesives, coatings and inks, and sterilization. The
results of these risk screens are presented in a series of Background
Documents that are available in EPA's docket.

The purpose of this report is to supplement EPA’s Background Document
on the refrigeration and air conditioning sector (EPA 1994) (hereinafter
referred to as the Background Document) by adding to the list of
potential substitutes for specific end-uses of CFC-12, HCFC-22 and R-502
in this sector.  The proposed end-use application considered in this
analysis is retail food refrigeration, specifically ice cream cabinets.
The specific proposed CFC-12, HCFC-22 and R-502 substitute examined in
this report is propane (R-290).  The substitute would only be used in
new equipment, not in retrofitted equipment.

The proposed substitute, propane, may contain minute quantities of
impurities.   Table 1 details the impurities which may be present in the
substitute and notes the maximum estimated concentrations of these
impurities.

Table   SEQ Table \* ARABIC  1 . Composition of the Substitute.

Substitute	Percent by Weight

Propane	(99.5%

Potential Impurities	Maximum Concentration (ppm v/v)

Ethane	1700

Propylene	300

n-Butane	1000

Sulphur	1

Water	12

The potential risks associated with use of substitutes in retail food
refrigeration have been examined at length in the Background Document.
The reader is referred to this reference for a detailed discussion of
the methodologies used to conduct this risk screen.  Presently, EPA’s
SNAP Program has not approved any hydrocarbons as a substitute in retail
food refrigeration end uses.  Of particular concern are the flammability
risks associated with hydrocarbons during manufacturing, use, servicing,
and disposal of retail food refrigeration appliances.  Occupational
exposure modeling was performed to ensure that use of the proposed
substitute in the application listed above did not pose unacceptable
risk to workers during equipment manufacture.  Modeling was performed at
the end-use to ensure that potential catastrophic releases of the
substitute did not pose unacceptable risk to store employees and
customers in locations where the ice cream cabinets are in use.  Lastly,
general population exposure modeling was performed to ensure that the
proposed substitute would not pose unacceptable risk to the population
at large.

Section 2 of this report summarizes the results of the risk screen for
the proposed substitute.  The remainder of the report is organized into
the following sections:

Section 3: Atmospheric Assessment

Section 4: Flammability Assessment

Section 5: Asphyxiation Assessment

Section 6: Toxicity Assessment

Section 7: Volatile Organic Compound Assessment

Section 8: References

SUMMARY OF RESULTS

Propane is recommended for SNAP approval for retail ice cream cabinets.
EPA's risk screen indicates that the use of the proposed substitute will
be less harmful to the atmosphere than the continued use of CFC-12,
HCFC-22 and R-502.   No significant toxicity risks to workers,
consumers, or the general population are expected according to
occupational and end-use exposure modeling.  Flammability models
indicate that risks of explosions are not a concern for store employees
or customers.  To further protect against the limited risk of explosion,
it is recommended that the cabinets not be used in small, poorly
ventilated spaces (see Section 4).  Caution must be used in
manufacturing facilities and by refrigeration technicians to minimize
explosion risk while in the presence of large quantities of the
substitute.  This includes installation of proper safety equipment
during manufacturing, transportation, and storage and providing proper
training and certification to technicians.  EPA recommends that American
Society of Heating, Refrigerating and Air-Conditioning Engineers
(ASHRAE) Standards 15 and 34 be followed.

ATMOSPHERIC ASSESSMENT

This section presents an assessment of the potential risks to
atmospheric integrity posed by the use of propane in the retail food
refrigeration sector.  The ODP, GWP, and atmospheric lifetime (ALT) of
the proposed substitute are presented in Table 2.

The environmental impacts resulting from use of propane are generally in
the range of those predicted for other substitutes examined in the
Background Document.  The substitute is substantially less harmful to
the ozone layer, has less climate impact, and a shorter atmospheric
lifetime compared to CFC-12, HCFC-22 and R-502.

Table   SEQ Table \* ARABIC  2 .  Atmospheric Impacts of Propane
Compared to CFC-12, HCFC-22 and R-502.

Refrigerant	Ozone Depleting Potential (ODP)	Global Warming Potential
(GWP)	Atmospheric Lifetime years (ALT)

Propane	0a	(3a	<1b

CFC-12	1c	8,100d	100c

HCFC-22	0.055 c	1,500 d	12 c

R-502 e 	0.33	5,478	NA

NA = Not Available

a Propane SNAP Submission (Ben and Jerry’s/Unilever 2008).

b Atmospheric lifetime (ALT) not provided in SNAP submission.  Wuebbles
(2003) indicates that propane has an ALT of 5 – 21 days.

c Available at: http://www.epa.gov/ozone/ods.html.

d IPCC, Second Assessment Report (1996).

e R-502 is a blend consisting of HCFC-22 (49%) and CFC-115 (51%).  The
ODP and GWP presented for this blend were calculated using values from
http://www.epa.gov/ozone/ods.html and IPCC’s Second Assessment Report
(1996), respectively.

FLAMMABILITY ASSESSMENT

Propane is flammable when its concentration in air is in the range of
2.1%-9.5% by volume (this is equal to 21,000 ppm to 95,000 ppm).  In the
presence of an ignition source (e.g., static electricity, a spark
resulting from a closing door, or a cigarette), an explosion or a fire
could occur when the concentration of propane is within these
flammability limits.  The remainder of this section addresses the
potential for flammability risks at the end-use, and during manufacture
and servicing and provides a discussion of measures to be taken to
ensure safe use.

The proposed use of this substitute is in ice cream cabinets which could
reasonably be expected to be located either in the main area of a store,
or in a storage room.  Because a storage room could be much smaller than
the main area of a store, a reasonable worst-case scenario analysis was
performed to model catastrophic release of the refrigerant in a storage
room.  For the analysis, a storage room with a volume of 42 m3 was
assumed.  In the analysis, the full charge of the unit is assumed to be
emitted over the course of one minute and the model conservatively
assumes 2.5 air exchanges occur per hour.  Horizontal stratification is
also assumed since propane is denser than air and will settle in higher
concentrations closer to the ground.  In order to simulate the
horizontal concentration gradient that will occur because of the weight
differential between the refrigerant and air, it is assumed that 95
percent of the leaked refrigerant mixes evenly into the bottom 0.4 meter
of the room, and the rest of the refrigerant mixes evenly in the
remaining volume (Kataoka 1999).

Under catastrophic release scenarios, the maximum instantaneous
concentration of propane in the lower stratum of the room would be
approximately 66 percent of its lower flammability limit (LFL) for the
room size assumed, as shown in Table 3.  The maximum instantaneous
concentration is lower in the upper stratum of the room, as only five
percent of the leaked refrigerant is present in this stratum, and this
stratum has a greater volume than the lower stratum.  For flammability
to be of concern under the conservative (protective) assumptions
described above, the volume of the storage room would have to be 28.5 m3
(1,006.5 ft3).  Assuming a square room with a ceiling height of 3 m (9.8
ft), this equates to a 3.1 x 3.1 m (10.1 x 10.1 ft) storage room.  As
storage rooms can be of varying size, and because boxes and other
equipment in the room may reduce the effective volume of the room, it is
therefore recommended that propane cabinets not be installed in small,
poorly ventilated spaces, to avoid the risk of fire and explosion.
However, for average sized rooms the risk of explosion is minimal.
Cutting a hole in the bottom of storage room doors (to act as a vent and
increase air circulation) and the installation of leak prevention
devices would further protect against the limited risk of explosion.
For example, in commercial refrigeration end-uses, refrigerant leak
prevention systems can be used to capture leaked refrigerant in a
receiving tank during over pressure events, rather than venting the
refrigerant to the atmosphere.  Additionally, in motor vehicle
air-conditioning, an outflow prevention device can be used to prevent
leakage events when the heat exchanger of a unit is damaged.    ICF
recommends that similar safety devices be installed within units
containing propane to further reduce the risk of explosion.

Table   SEQ Table \* ARABIC  3 . Flammability Assessment

Room Type/Appliance Type	Reasonable Worst-Case Scenario	Flammability
Threshold Scenario

	Room Size (m3)	Maximum Instantaneous Concentration

(ppm) a,b	Room Size (m3)	Maximum Instantaneous Concentration

(ppm) a,b

Storage Room/Ice Cream Cabinet	42 (1,483 ft3)	13,780	28.5 (1,006.5 ft3)
20,308

a Lower Flammability Limit of propane is equal to 21,000 ppm

b Values provided in these columns refer to the concentration in the
lower stratum of the room.

Catastrophic releases of large quantities of refrigerant during
servicing and manufacturing, especially in areas where large amounts of
refrigerant are stored, could cause an explosion.  For this reason, it
is important that only properly trained and certified refrigerant
technicians handle propane.  The submitter has provided information
regarding their training program for service technicians.  The program
includes detailed information covering important topics such as
potential ignition sources, proper tools to use with flammable
refrigerants, safe workplace behavior and service procedures.  At the
end of the training, technicians must pass a multiple choice assessment
(Ben and Jerry’s/Unilever 2008).  All technicians who will be
servicing cabinets using propane should receive this training and be
required to pass the assessment.  As a further precaution, propane
storage and transport equipment should be installed with safety devices
that minimize the likelihood of catastrophic releases.  For example,
NFPA 58 Liquefied Petroleum Gas Code (NFPA 2008) requires the use of
overfill protection devices (OPD) on cylinders to minimize the
likelihood of leaks.  The NPFA 58 Code also contains storage and
transportation requirements/guidelines.  Similar equipment safety and
procedural requirements should be implemented for this substitute.

It is important that the strictest standards be followed during the
manufacture of these ice cream cabinets.  It is recommended that
refrigerants be properly stored and caution used within manufacturing
facilities to minimize explosion risk and that workers adhere to the
requirements set by OSHA under 29 CFR 1910.  OSHA requirements include
proper ventilation and storage practices within manufacturing facilities
to prevent fire and explosion.  Proper ventilation should be maintained
at all times during the manufacture of equipment containing propane
through adherence to good manufacturing practices. If refrigerant levels
in the air surrounding the equipment rise above one-fourth of the lower
flammability limit, the space should be evacuated and re-entry should
only occur after the space has been properly ventilated.  Ventilation is
also of the utmost importance to mitigate the risk of fire or explosion
when servicing equipment using propane.  During servicing operations,
technicians should ensure that proper ventilation is in place through
the use of fans (or other mechanical ventilation devices) and portable
refrigerant detectors should be used to alert technicians to the
presence of flammable gases in the area.

ASPHYXIATION ASSESSMENT

The risk of asphyxiation for a reasonable “worst-case” scenario was
investigated for propane.  This analysis considers the same small
storage room as in Section 4. This analysis does not consider conditions
that are likely to occur that would reduce the levels to which
individuals would be exposed, such as open doors or windows, fans
operating, conditioned airflow (either heated or cooled), or even
seepage between the door and door frame.

The maximum charge of propane necessary to reduce the oxygen levels to
12 percent in air, in a storage room of volume 42 m3 (1,483 ft3), was
calculated, assuming horizontal stratification of the refrigerant and
the air.  Horizontal stratification is assumed since propane is denser
than air and will settle in higher concentrations closer to the ground.
Assuming that nitrogen and oxygen retain the same relative volumes in
the rooms with the balance composed entirely of propane, and that the
pressure of the room does not increase significantly with the addition
of the refrigerant, a charge of approximately 904 g would be necessary
to reach 12 percent oxygen in the lower stratum.  This amount represents
more than six times the maximum intended charge of approximately 150 g
for a single propane ice cream cabinet.  Charge requirements to reach
the same effect in the upper strata would be even higher because of the
stratum’s larger volume.  For asphyxiation to be of concern with the
proposed charge size, under the conservative (protective) assumptions
described above, the volume of the storage room would have to be about
6.96 m3 (245.8 ft3).  Assuming a square room with a ceiling height of 3
m (9.8 ft), this equates to a 1.5 x 1.5

 m (5 x 5 ft) storage room.

The results of the asphyxiation assessment are summarized in Table 4
below.  EPA does not believe that the use of propane in this end-use
poses a significant risk of asphyxiation or impaired coordination to
store employees or customers.

Table   SEQ Table \* ARABIC  4 .  Asphyxiation Assessment

Room Type/Appliance Type	Appliance Charge (g)	Reasonable Worst-Case
Scenario	Asphyxiation Threshold Scenario

Room Size (m3)	Charge Causing Impairment (g)a	Room Size (m3)	Charge
Causing Impairment (g)a

Storage Room/ Ice Cream Cabinet	150	42 (1,483 ft3)	904	6.96 (245.8 ft3)
150

a Values provided in these columns refer to the charge required to cause
impairment in the lower stratum of the room.

TOXICITY ASSESSMENT

6.1 	TOXICITY REFERENCE VALUES

To assess potential health risks from exposure to this substitute in the
retail food refrigeration sector, EPA identified the relevant toxicity
threshold values for comparison to modeled exposure concentrations for
different scenarios.  For the occupational exposure analysis, potential
risks from chronic and acute worker exposure were evaluated by comparing
exposure concentrations to available occupational exposure limits.
Occupational exposure limits are typically established for either an
eight-hour or ten-hour time period for long-term exposure, such as the
Workplace Guidance Levels (WGLs), or for a 10 to 30-minute period for
short-term exposure, such as the Emergency Guidance Levels (EGLs), as
shown in Table 5.  Because they are designed to assess risks from acute
exposure, emergency guidance levels are used to assess risks from
short-term consumer exposures.  Reference concentrations (RfCs) are used
to assess risks to the general population from exposure to ambient air
releases and to assess potential risks associated with chronic consumer
exposures.  A list of the relevant toxicity limits is shown in Table 5.
Table 6 provides definitions for acronyms used in Table 5.  EPA’s
approach for identifying or developing these values is discussed in
Chapter 3 of the Background Document.

Table   SEQ Table \* ARABIC  5 .  Toxicity Levels of Propane and
Potential Impurities

	Long-term Exposure

ppm	Short-term Exposure

ppm	Reference Concentration (RfC)

mg/m3

Substitute

Propane	1000 a

(OSHA PEL/NIOSH REL)	2100 a (IDLH)	0.9 b

Potential Impurities

Ethane	NA c	NA c	NA

Propylene	NA d	NA d	NA

n-Butane	800 e (NIOSH REL)	NA	0.95 b

Sulphur	NA	NA	NA

NA  = Not Available

a "Based on acute inhalation toxicity data in humans (ACGIH 1991; Braker
1980), a value much greater than 10,000 ppm would have been appropriate.
However, the revised IDLH for propane is 2,100 ppm based strictly on
safety considerations (i.e., being 10% of the lower explosive limit of
2.1%)."  (NIOSH 1996)

b SNAP Refrigerant Background Document (EPA 1994).

c Ethane is a "simple asphyxiant."
http://www.osha.gov/dts/chemicalsampling/data/CH_238900.html

d Propylene is a "simple asphyxiant."
http://www.osha.gov/dts/chemicalsampling/data/CH_264442.html

e http://www.cdc.gov/niosh/npg/npgd0068.html

Table   SEQ Table \* ARABIC  6 .  Explanation of Toxicity-Related
Acronymsa

Organization 	Definition

OSHA	Occupational Safety and Health Administration

NIOSH	National Institute for Occupational Safety and Health

Exposure Limit	Definition	Explanation

IDLH	Immediately Dangerous to Life and Health	If exposed to this
concentration, room occupants are expected to be able to escape the room
within 30 minutes without experiencing escape-impairing or irreversible
health effects.

PEL	Permissible Exposure Limit	This is an 8-hour time-weighted average
exposure limit set by OSHA.

REL	Recommended Exposure Limit	This is a 10-hour time-weighted average
exposure limit set by NIOSH.

RfC	Reference Concentration	A concentration “designed to protect the
general population against adverse systemic (i.e., noncancer)
effects.”

aAll information in this table taken from EPA (1994).

6.2	OCCUPATIONAL EXPOSURE

Occupational exposure modeling was performed for the proposed substitute
to ensure that use of the substitute does not pose an unacceptable risk
to workers.  The methodology used for this screening assessment is based
on the one used in the occupational exposure and hazard analysis
described in Chapter 5 of the Background Document. A box-model approach
was used to evaluate potential worker exposure to alternative
refrigerants.   This approach has been widely used for many years to
estimate probable exposures of workers to hazardous airborne materials,
and has been described in detail by the National Institute for
Occupational Safety and Health (NIOSH).  This model takes into
consideration the duration and magnitude of the resulting exposure which
is influenced by 1) duration and intensity of the release, 2) rate at
which contaminated air is diluted with uncontaminated air, 3) proximity
of the worker to the source of the release, and 4) the length of time
the worker remains in the affected space.

Estimates of refrigerant release per event for various release scenarios
and data on number of events were obtained from the Vintaging Model.
The release per event was conservatively assumed to be 1 percent of the
equipment charge during manufacturing and 3 percent of the equipment
charge during disposal.  The release rate per event was multiplied by
the number of events estimated to occur over a workday.  For equipment
manufacturing, the number of events per workday was assumed to equal the
number of units containing the substitute produced per plant per year
divided by 365 workdays per year.  For the purposes of this model, it is
assumed that propane will have a market penetration rate of 23% and that
one production facility will be in operation.  These assumptions result
in approximately 274 events/manufacturing facility/workday.  For
disposal, it was conservatively assumed that 100 units are disposed
during an 8-hour work day nationwide.

The maximum time weighted average (TWA) exposure was estimated for each
exposure scenario, and this value compared to the Workplace Guidance
Levels (WGLs) for propane and the potential impurities in the
substitute.  The modeling results indicate that the short-term
(15-minute and 30-minute) and long-term (8-hour) worker exposure
concentrations are at a maximum, about 50 percent of the WGLs.  Table 7
displays the maximum estimated 15-minute TWA occupational exposure
levels of propane and the potential impurities in the substitute.   Even
these maximum estimated short-term occupational levels are significantly
lower than the 8-hour or 10-hour long-term WGLs, and therefore
occupational exposure to propane and the potential impurities is not
considered a toxicity threat.

Table 7.  Occupational Risk Assessment

	Maximum 15-minute TWA Occupational Exposure Levels (ppm)	Workplace
Guidance Levels (ppm) a	Workplace Guidance Levels Time Period

Substitute

Propane	502	1000	10-hour TWAb

Potential Impurities

Ethane	0.9	NA	NA

Propylene	0.2	NA	NA

n-Butane	0.5	800	10-hour TWA

Sulphur	5.4 x 10-4	NA	NA

NA = Not Available

a. See Table 5 for more information.

b. The WGL for Propane is set as a 1000 ppm 8-hr TWA by OSHA and a 10-hr
TWA by NIOSH.

6.3	END-USE EXPOSURE

This section presents estimates of potential store employee and customer
exposures to propane in ice cream cabinets.  An exposure analysis was
performed to examine potential catastrophic release of the substitute in
a small storage room (as in Sections   REF _Ref222646985 \r \h  \*
MERGEFORMAT  4  and   REF _Ref222646989 \r \h  \* MERGEFORMAT  5 ) under
a reasonable “worst-case” scenario.  The analysis was undertaken to
determine the 15- and 30-minute TWA exposures for the substitute, which
were then compared to the standard toxicity limits presented in Table 5
to assess the risk to consumers.  However, the TWA values are fairly
conservative as the analysis does not consider opened windows, fans
operating, conditioned airflow (either heated or cooled) and other
variables that would reduce the levels to which individuals would be
exposed.

The model involves a refrigerant leak from an ice cream cabinet into an
enclosed storage room of volume 42 m3 (1,483 ft3). The model assumes
that the individual is present at the start of the leak and the
individual remains in the room while the refrigerant is released. It is
also assumed that horizontal stratification causes most of the
refrigerant to settle in higher concentrations closer to the ground.  In
order to simulate the horizontal concentration gradient that will occur
because of the weight differential between the refrigerant and air, it
is assumed that 95 percent of the leaked refrigerant mixes evenly into
the bottom 0.4 meter of the room, and the rest of the refrigerant mixes
evenly in the remaining volume (Kataoka 1999).  Exposure concentrations
were calculated using the box model described in the Background
Document, which was adapted to estimate concentrations on a
minute-by-minute basis. In the analysis, the full charge of the unit is
assumed to be emitted over the course of one minute and the model
conservatively assumes 2.5 air exchanges occur per hour.

The highest expected levels of exposure at the end-use based on this
analysis occur in the lower stratum of the room.  The results of the
assessment are presented in Table 8.

Table 8.  End-Use Exposure Assessment

	15-minute TWA Exposure (ppm)	30-minute TWA Exposure (ppm)

Substitute

Propane	10,414	7,963

Potential Impurities

Ethane	19	15

Propylene	3.4	2.6

n-Butane	11	8.6

Sulphur	0.01	0.009

TWA = Time Weighted Average

While the IDLH for propane is 2,100 ppm, NIOSH (1996) notes that "based
on acute inhalation toxicity data in humans (ACGIH 1991; Braker 1980), a
value much greater than 10,000 ppm would have been appropriate. However,
the revised IDLH for propane is 2,100 ppm based strictly on safety
considerations (i.e., being 10% of the lower explosive limit of 2.1%)."
Therefore, it is believed that even under the very conservative
assumptions used in this model, exposures to propane should not pose a
toxicity threat.  Steps to protect against fire or explosion in the
space should be taken, as detailed in Section   REF _Ref222646985 \r \h
\* MERGEFORMAT  4 .  Exposure to the minute quantities of the impurities
detailed in Table 8 is also not expected to pose a toxicity threat,
given the low toxicity of these substances.  Should catastrophic release
from a cabinet located in the main area of a store occur, exposure
levels are not expected to pose a toxicity threat as the room volumes in
the store would be larger than those used in this model.  Thus, exposure
concentrations would be even lower in the main area of the store.

6.4	GENERAL POPULATION EXPOSURE

In the SNAP Background document for refrigerants (EPA 1994), the RfC
value for propane is 0.9 m/m3.  We compared this RfC to estimated
factory releases and on-site releases.  This gives a ratio of exposure
concentration to RfC that varies between 1.9 x 10-4 to 3.5 x 10-1,
depending on the type of release scenario.  Ratios of exposure
concentration to RfC for the substitute’s impurities (for which RfCs
are available) were even lower.  Since the exposure concentrations for
the substances are lower than the RfC values, the substitute is not
expected to pose a toxicity threat to the general population.

VOLATILE ORGANIC COMPOUND (VOC) ASSESSMENT

Propane has not been exempted as a VOC under the CAA (40 CFR 51.000).
However, through regulations and standard industry practices, VOC
emissions should be controlled.  Chapter 8 of the Background Document
shows that potential emissions of VOCs from all substitutes for all end
uses in the refrigeration and air conditioning sector are likely to be
insignificant relative to VOCs from all other sources (i.e., other
industries, mobile sources, and biogenic sources).  Additional analysis
shows that even if all ice cream cabinets produced by Unilever/Ben and
Jerry’s in one year were to leak their entire charge over the course
of the year (extremely unlikely), the resulting annual VOC emissions
would be only about 8.5x10-5 percent of all annual anthropogenic VOC
emissions.  As these emissions of propane are several orders of
magnitude less than other anthropogenic emissions, the environmental
impacts of these VOCs are not considered a threat.

8.  	REFERENCES

ACGIH. 1991.  Propane. In: Documentation of the threshold limit values
and biological exposure indices. 6th ed. Cincinnati, OH: American
Conference of Governmental Industrial Hygienists, pp. 12861287.

Armines.  2008.  Inventory of Direct and Indirect GHG Emissions from
Stationary Air Conditioning and Refrigeration Sources, with Special
Emphasis on Retail Food Refrigeration and Unitary Air Conditioning.
Provisional Final Report.  June 2008.  Available at: <
http://www.arb.ca.gov/cc/commref/armines_report_03_625.pdf>.

Ben and Jerry’s/Unilever SNAP Submission. 2008. Significant New
Alternatives Policy Program Submission to the United States
Environmental Protection Agency, October 2008.

Braker W, Mossman AL. 1980. Matheson gas data book. 6th ed. Secaucus,
NJ: Matheson Gas Products, pp. 615623.

EPA 2008.  Volatile Organic Compounds – National Summary of VOC
Emissions.  Last updated 21 October 2008.  Accessed 4 March 2009.
Available at <http://www.epa.gov/air/emissions/voc.htm>.

EPA 1994.  Significant New Alternatives Policy Technical Background
Document:  Risk Screen on the Use of Substitutes for Class I
Ozone-depleting Substances: Refrigeration and Air Conditioning.
Stratospheric Protection Division.  March, 1994.

ICF. 1997. Physiological Effects of Alternative Fire Protection Agents -
Hypoxic Atmospheres Conference. Stephanie Skaggs prepared the
proceedings of the conference held May 22, 1997 in New London, CT.

Kataoka.  1999.  “Allowable Charge Limit of Flammable Refrigerants and
Ventilation Requirements.”  Draft Proposal.  O. Kataoka/Daikin/Japan,
June, 1999.

NFPA.  2008.  NFPA 58: Liquefied Petroleum Gas Code.  National Fire
Protection Agency.

NIOSH. 1996.  Propane: IDLH Documentation.  August 1996.  Accessed 17
Feburary 2009.  Available online at: <
http://www.cdc.gov/niosh/idlh/74986.html>.

Sheldon, L.S., et al.  1989. "An Investigation of Infiltration and
Indoor Air Quality."  New York State Energy Research & Development
Authority, Report 90-11.

Wuebbles 2003.  Personal communication with Don Wuebbles.  E-mail.  July
21, 2003.

 This room was considered a ‘high risk room’ due to its small size
and poor ventilation. (Ben and Jerry’s/Unilever 2008)

 The charge size used in all models in this analysis is 150g of propane.
 The submitter notes that the cabinets will have a charge size of about
90g; however the maximum charge will be 150g (Ben and Jerry’s/Unilever
2008).  To ensure all models address a reasonable “worst-case,” the
maximum charge size was chosen for use in the models.

 The submitter notes that “catastrophic leaks during operation have
not been recorded.”

 http://www.freepatentsonline.com/5259204.html

 http://www.freepatentsonline.com/6966365.html

 OSHA regulation 29 CFR 1910.110 considers ventilation adequate “when
the concentration of the gas in a gas-air mixture does not exceed 25
percent of the lower flammable limit.”

 Twelve percent oxygen in air is the NOAEL for hypoxia (ICF 1997).

 ICF International maintains the Vintaging Model for EPA in order to
simulate the aggregate impacts of the ODS phaseout on the use and
emissions of various fluorocarbons and their substitutes over a period
of several years across more than 40 different applications.  The model
tracks the use and emissions of various compounds for the annual
vintages of new equipment that enter service in each end-use.  The
vintage of each type of equipment determines such factors as leak rate,
charge size, number of units in operation, and the initial ODS substance
that the equipment contained.

 During disposal it is assumed that only 90 percent of the refrigerant
charge remains in the unit.

 This number conservatively assumes that all Unilever cabinets in North
America (a figure provided in the SNAP Submission) are in the US and
that all will be replaced with R290 cabinets by 2010.  This number of
cabinets was divided by the number of predicted new small retail
refrigeration units produced in 2010, from the Vintaging Model.

   An Armines (2008) study presents data from site visits to California
convenience stores, “minimarkets” and supermarkets during which the
minimum store area encountered was 100 m2.   Assuming a 3 m ceiling
height (as in the scenarios used in this risk screen), this is equal to
a volume of 300 m3, or more than seven times the volume of the store
room used in this analysis.

 Release scenarios include factory and on-site releases, with and
without recycling of the refrigerant.

 Conservatively assuming that all Unilever cabinets in North America (a
figure provided in the SNAP Submission) are in the US and that all will
be replaced with R290 cabinets.

 This figure was calculated using 2002 annual VOC emissions data from
EPA (2008).

	 				   May 26, 2009