[Federal Register Volume 86, Number 114 (Wednesday, June 16, 2021)]
[Notices]
[Pages 32034-32036]
[FR Doc No: 2021-12654]

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DEPARTMENT OF DEFENSE

DEPARTMENT OF ENERGY

ENVIRONMENTAL PROTECTION AGENCY

NUCLEAR REGULATORY COMMISSION

[EPA-HQ-OAR-2021-0276; FRL-10023-12-OAR]

Multi-Agency Radiation Survey and Site Investigation Manual,
Revision 2

AGENCY: Department of Defense, Department of Energy, Environmental
Protection Agency, and the Nuclear Regulatory Commission.

ACTION: Notice of availability with request for public comment.

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SUMMARY: The Department of Defense (DoD), Department of Energy (DOE),
Environmental Protection Agency (EPA) and the Nuclear Regulatory
Commission (NRC) are announcing for public comment the availability of
a draft revision document, entitled the ``Multi-Agency Radiation Survey
and Site Investigation Manual'' (MARSSIM). MARSSIM provides information
on planning, conducting, evaluating, and documenting environmental
radiological surveys of surface soil and building surfaces for
demonstrating compliance with regulations. MARSSIM, when finalized as
Revision 2, will be a multi-agency consensus document. The agencies are
seeking public comment in order to receive feedback from the widest
range of interested parties and to ensure that all information relevant
to developing the document is received. The agencies will review public
comments received on the draft MARSSIM Revision 2 as well as comments
from a concurrent, independent, scientific peer review. The Agencies
will review comments received during the public comment period and make
revisions to the document as appropriate.

DATES: Comments must be received on or before September 14, 2021.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2021-0276, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or withdrawn. The
EPA may publish any comment received to its public docket. Do not
electronically submit any information you consider to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Multimedia submissions (audio, video, etc.) must
be accompanied by a written comment. The written comment is considered
the official comment and should include discussion of all points you
wish to make. The EPA will generally not consider comments or comment
contents located outside of the primary submission (i.e., on the web,
cloud or other file sharing system). For additional submission methods,
the full EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit: http://www2.epa.gov/dockets/commenting-epa-dockets.
    You may obtain publicly-available information related to this
action, including copies of the MARSSIM

Revision 2, by any of the following methods:
    NRC's Agencywide Documents Access Management System (ADAMS): You
may obtain publicly-available documents online in the ADAMS Public
Documents collection at https://www.nrc.gov/reading-rm/adams.html. To
begin the search, select ``Begin Web-based ADAMS Search.'' Please refer
to ML21008A572 when contacting the NRC about the availability of the
MARSSIM Rev. 2 draft. For problems with ADAMS, please contact the NRC's
Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-
4737, or by email to<EMAIL_ADDRESS>Attention: The PDR, where
you may have previously examined and ordered copies of public documents
is currently closed for in-person document review.
    You may submit your request to the PDR via email at
<EMAIL_ADDRESS>or call 1-800-397-4209 between 8:00 a.m. and 4:00
p.m. (EST), Monday through Friday, except Federal holidays. The DOE,
EPA, and NRC each have a publication number for MARSSIM. They are: For
the DOE, DOE/AU-0002; for the EPA, EPA 402-P-20-001; for the NRC,
NUREG-1575, Rev. 2. A free single copy of the draft MARSSIM Revision 2
may be requested by email to<EMAIL_ADDRESS>    The MARSSIM Revision 2 document is also available for download at:
https://www.epa.gov/radiation/multi-agency-radiation-survey-and-site-investigation-manual-marssim.
    Instructions: All submissions received must include the Docket ID
No. EPA-HQ-OAR-2021-0276 for this rulemaking. Comments received may be
posted without change to https://www.regulations.gov/, including any
personal information provided. For detailed instructions and additional
information on submitting comments, see the SUPPLEMENTARY INFORMATION
section of this document.

FOR FURTHER INFORMATION CONTACT: Any of the following points of contact
for each agency for technical information (See ADDRESSES section above
for directions on obtaining a copy of the draft MARSSIM Revision 2.):
DoD: Erik Abkemeier, Phone:<PHONE_NUMBER><EMAIL_ADDRESS>
U.S. Navy, NAVSEADET RASO, 160 Main Road, Yorktown, VA 23691-5105; DOE:
Derek Favret (AU-22), Phone:<PHONE_NUMBER><EMAIL_ADDRESS>
or Amanda Anderson (EM-3.11), Phone:<PHONE_NUMBER>,
<EMAIL_ADDRESS>U.S. Department of Energy, 1000
Independence Avenue SW, Washington, DC 20585; EPA: Kathryn Snead;
Phone:<PHONE_NUMBER><EMAIL_ADDRESS>U.S. Environmental
Protection Agency, Mail Stop 6608T, 1200 Pennsylvania Avenue NW,
Washington, DC 20460-1000; NRC: Mark Fuhrmann, Phone:<PHONE_NUMBER>,
<EMAIL_ADDRESS>U.S. Nuclear Regulatory Commission, Mail Stop
TWF 10 A-12 11555 Rockville Pike, Rockville, MD 20852-2738. Questions
concerning the multi-agency document development project should be
addressed to Kathryn Snead, U.S. Environmental Protection Agency, 1200
Pennsylvania Ave. NW, MC 6608T, Washington, DC 20460,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

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

    1. Submitting Confidential Business Information (CBI). The EPA may
publish any comment received to its public docket. Do not submit CBI
information to the EPA through www.regulations.gov or email. Clearly
mark the part or all of the information that you claim to be CBI. For
CBI information in a disk or CD ROM that you mail to the EPA, mark the
outside of the disk or CD ROM as CBI and then identify electronically
within the files on 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:
     Identify the rulemaking by docket number EPA-HQ-OAR-2021-
0276 and other identifying information (subject heading, Federal
Register date and page number).
     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.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

II. Background

    MARSSIM provides information on planning, conducting, evaluating,
and documenting environmental radiological surveys of surface soil and
building surfaces for demonstrating compliance with regulations.
MARSSIM, when finalized as Revision 2, will update this multi-agency
consensus document.
    MARSSIM was originally developed by the technical staffs of the
four Federal agencies having authority for control of radioactive
materials: DoD, DOE, EPA and NRC (60 FR 12555; March 7, 1995). The four
agencies issued Revision 1 to MARSSIM in August 2000, and additional
edits to Revision 1 in June 2001. MARSSIM has not been updated since
2001; updates prior to 2001 primarily consisted of minor non-technical
edits. Revision 2 updates the science, clarifies methods, and
implements lessons learned from over 20 years of the document's use in
industry.
    A summary of changes in MARSSIM Revision 2 includes the following:
(1) Added measurement quality objectives (MQOs) and measurement
uncertainty, (2) expanded measurement methods to include scan-only
surveys, (3) updated survey instrumentation information, (4) added
Scenario B (``assumed to meet the criteria until proven otherwise''),
(5) increased emphasis on regulator interface during survey design, (6)
improved description of the lower bound of the gray region (LBGR), (7)
updated references, (8) changed English units to International System
of Units (SI), (9) avoided using the term ``Area Factor,'' (10)
included additional examples in Chapter 5 and (11) reorganized Chapter
4.
    The public review is a necessary step in the development of a final
multi-agency consensus document. The document will also undergo
concurrent, independent, scientific peer review. The draft has not been
approved by the participating agencies for use, in part or in whole,
and should not be used, cited, or quoted, except for the purposes of
providing comments as requested.
    Commenters are requested to focus on technical accuracy and
understandability. Commenters are also

requested to address five questions while reviewing MARSSIM Revision 2:
    (1) Do the revisions to MARSSIM provide greater clarity while
maintaining a practical and implementable approach to performing
environmental radiological surveys of surface soil and building
surfaces?
    (2) Are the revisions to MARSSIM technically accurate?
    (3) Does MARSSIM Revision 2 provide useful examples and
descriptions of approaches to implementing surveys and the statistics
by which they are interpreted?
    (4) Is the information in MARSSIM Revision 2 understandable and
presented in a logical sequence? How can the presentation of material
be modified to improve the understandability of the manual?
    Comments may be submitted as proposed modified text, or as a
discussion. Comments should be accompanied by supporting bases,
rationale, or data. To ensure efficient and complete comment
resolution, commenters are requested to reference the page number and
the line number of MARSSIM Revision 2 to which the comment applies.
Enter only the beginning page and line number, even if your comment
applies to several pages or lines to follow.
    Comments corresponding to an entire chapter, an entire section, or
an entire table should be referenced to the line number for the title
of the chapter section, or table. Comments on footnotes should be
referenced to the line in the main text where the footnote is
indicated. Comments on figures should be referenced to the page on
which the figure appears. Figures do not have line numbers. The figure
number should be included in the text of the comment. Comments on the
entire manual should be referenced to the title page.
    Title: Draft Multi-Agency Radiation Survey and Site Investigation
Manual, Revision 2.

Laura Macaluso,
Director, Force Safety and Occupational Health, Deputy Assistant
Secretary of Defense Safety and Occupational Health, Office of the
Under Secretary for Personnel and Readiness, Department of Defense.
Michael J. Silverman,
Director, Office of Environmental Protection and ES&H Reporting, Office
of Environment, Health, Safety and Security, Department of Energy.
Jonathan Edwards,
Director, Office of Radiation and Indoor Air, Environmental Protection
Agency.
Raymond V. Furstenau,
Director, Office of Nuclear Regulatory Research, Nuclear Regulatory
Commission.
[FR Doc. 2021-12654 Filed 6-15-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: July 29, 2009 (Volume 74, Number 144)]
[Rules and Regulations]
[Page 37605-37612]
[DOCID:fr29jy09-18]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0710; FRL-8425-7]

Ethylene oxide adducts of 2,4,7,9-tetramethyl-5-decynediol, the
ethylene oxide content averages 3.5, 10, or 30 moles; Exemption from
the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY:  This regulation establishes an exemption from the requirement
of a tolerance for residues of ethylene oxide adducts of 2,4,7,9-
tetramethyl-5-decynediol, the ethylene oxide content averages 3.5, 10,
or 30 moles, herein referred to in this document as ethoxylated
acetylenic diols, when used as inert ingredients in pesticide
formulations for pre-harvest and post-harvest uses under 40 CFR
180.910, as well as for application to animals under 40 CFR 180.930.
The Joint Inerts Task Force (JITF), Cluster Support Team Number 19,
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of the ethoxylated acetylenic diols.

DATES: This regulation is effective July 29, 2009. Objections and
requests for hearings must be received on or before September 28, 2009,
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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0710. 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., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available 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 Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Kerry Leifer, Registration Division
(7505P), Office of Pesticide Programs, 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?

    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 those
engaged in the following activities:
     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 to
provide 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. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2008-0710 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before September 28, 2009.
    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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2008-0710, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: 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>.

II. Background

    In the Federal Register of December 3, 2008 (73 FR 73640) (FRL-
8390-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8E7374) by The Joint Inerts Task Force, Cluster Support Team 19 (CST
19), c/o CropLife America, 1156 15th Street, NW., Suite 400,
Washington, DC 20005. The petition requested that 40 CFR 180.910 and 40
CFR 180.930 be amended by establishing exemptions from the requirement
of a tolerance for residues of the inert ingredients ethoxylated
acetylenic diols. That notice referenced a summary of the petition
prepared by the Joint Inerts Task Force (JITF), Cluster Support Team
Number 19 (CST 19), the petitioner, which is available to the public in
the docket, http://www.regulations.gov. There were no comments received
in response to the notice of filing.
    This petition was submitted in response to a final rule of August
9, 2006, (71 FR 45415) (FRL-8084-1), in which the Agency revoked, under
section 408(e)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA),
the existing exemptions from the requirement of a tolerance for
residues of certain inert ingredients because of insufficient data to
make the determination of safety required by FFDCA section 408(b)(2).
The expiration date for the tolerance exemptions subject to revocation
was August 9, 2008, which was later extended to August 9, 2009 (73 FR
45312) (FRL-8372-7), to allow for data to be submitted to support the
establishment of tolerance exemptions for these inert ingredients prior
to the effective date of the tolerance exemption revocation.

 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(b)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of 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 performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 the petitioned-for
exemption from the requirement of a tolerance for residues of the
ethoxylated acetylenic diols when used as inert ingredients in
pesticide formulations for pre-harvest and post-harvest uses, as well
as for application to animals. EPA's assessment of exposures and risks
associated with establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
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.
    The available mammalian toxicology database includes acute,
subchronic (rat and dog) repeat dose, and reproductive toxicity studies
(rat) via the oral route for a representative ethoxylated compound for
the series of polyethoxylated 2,4,7,9-tetramethyl-5-decyne-4,7-diols
and the proposed major unethoxylated metabolite, and mutagenicity data
for the unethoxylated compound. The available toxicology data are
adequate to support the requested exemption from the requirement of
tolerance when used in pesticide formulations for these ethoxylated
acetylenic diols. In addition to concern for the parent compounds, the
Agency has identified the unethoxylated metabolite, 2,4,7,9-
tetramethyl-5-decyne-4,7-diol, to be of concern. Unethoxylated and
ethoxylated acetylenic diols are expected to follow a similar metabolic
pathway. This would include hydrolytic or oxidative removal of the
polyethoxylate chain to generate a common acetylenic diol primary
metabolite and polyethoxylated moieties, which would vary in size
depending on the extent of ethoxylation in the parent molecule. The
primary acetylenic diol metabolite would be analogous to a related
surfactant (CAS Reg. No. 126-86-3). Both the diol and polyethoxylate
moieties would undergo rapid oxidative degradation and excretion likely
as conjugates. The unethoxylated diol metabolite is of concern in food
and water only. The Agency has concluded that the available data on the
ethoxylated compound and unethoxylated metabolite (CAS Reg. Nos. 9014-
85-1 and 126-86-3) are representative of the chemicals in the
polyethoxylated 2,4,7,9-tetramethyl-5-decyne-4,7-diols cluster.
Further, the Agency has concluded that the currently available toxicity
dataset is adequate to apply to the cluster and to characterize the
potential toxic effects of these surfactants.
    The ethoxylated compounds are not acutely toxic by the oral, dermal
and inhalation routes of exposure, but are slight to severe eye and
mild skin irritants. The unethoxylated metabolite demonstrates low to
medium acute toxicity by the oral and dermal routes of exposure, with
the greatest concerns being eye and skin irritation. There is no
evidence that the unethoxylated metabolite is mutagenic, and no
increases in polyploidy or chromosome aberrations were observed in the
presence and absence of metabolic activation.
    There is no clear target organ identified for the ethoxylated
compound or the unethoxylated metabolite, although increased liver
weight (without histopathology) was a consistent finding. Following
subchronic exposure to the ethoxylated compound, no specific target
organ toxicity or neurotoxicity was observed in rats and dogs. In a 1-
generation reproduction study, decreased pup body weights were observed
at weaning following exposure to the ethoxylated and unethoxylated
compounds at dose levels at and greater than the limit dose. Following
subchronic exposure to the unethoxylated metabolite, compound-related
neurological disturbances (convulsions and tremors) were observed in
the dog. However, the concern for this finding is low based on the
following considerations:
    1. The clinical signs were sporadic.
    2. There was no neuropathology at any dose.
    3. No neurotoxic clinical signs were seen following subchronic
exposures to the parent compound.
    4. This endpoint is used as the point of departure in conjunction
with highly conservative exposure inputs for assessing chronic dietary
risks for the diol metabolite.
    5. There was no evidence with either the parent or metabolite of
neurotoxicity in rats, the species of choice for conducting
neurotoxicity studies.
    There was evidence of increased susceptibility following pre- and
post-natal exposures to rats for 1-generation where decreases in body
weights of the offspring were seen at high doses (1,000 or 2,000
milligrams/kilogram/day (mg/kg/day)) that did not cause any parental/
systemic toxicity. It should be noted that the offspring effects were
seen at and above the limit dose. Similarly, following exposure to the
unethoxylated compound, there was a decrease in pup body weight at dose
levels of 1,000 and 2,000 mg/kg/day, whereas the parental animals
displayed body-weight effects only at the 2,000 mg/kg/day dose level.
Based on the fact that the effect (decreased body weight) was observed
only at the limit dose and above and there is a clear NOAEL, there is
no residual concern for this finding.
     There are no chronic toxicity studies available for this series of
nonionic surfactants. The Agency used a qualitative structure activity
relationship (SAR) database, DEREK Version 11, to determine if there
were structural alerts suggestive of carcinogenicity. No structural
alerts were identified. Based on the negative response for
mutagenicity, the fact that no specific target organs have been
identified in the rat and dog subchronic studies at the limit dose, the
lack of any alerts in model predictions, and SAR analysis, the Agency
concluded that the ethoxylated acetylenic diol inerts or their
unethoxylated diol metabolite are not likely to be carcinogenic.
    Specific information on the studies received and the nature of the
adverse effects caused by ethoxylated acetylenic diols or the
unethoxylated diol metabolite as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in document ``Ethoxylated Acetylenic Diols (JITF
CST 19 Inert Ingredients). Human Health Risk Assessment to Support
Proposed Exemption from the Requirement of a Tolerance When Used as
Inert Ingredients in Pesticide Formulations'', pages 10-15 and pages
50-57 in docket ID number EPA-HQ-OPP-2008-0710.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-term,
intermediate-term, and chronic-term risks are evaluated by comparing
food, water, and residential

exposure to the POD to ensure that the margin of exposure (MOE) called
for by the product of all applicable UFs is not exceeded. This latter
value is referred to as the Level of Concern (LOC).
    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
greater than that 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.
    A summary of the toxicological endpoints for ethoxylated acetylenic
diols used for human health risk assessment is shown in Table 1 of this
unit.

 Table 1.--Summary of Toxicological Doses and Endpoints for ethoxylated acetylenic diols for Use in Human Health
                                                 Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations)             No appropriate endpoints were identified for acute dietary risk
 Parent and Diol Metabolite                                            assessment.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL= 500 mg inert/kg/  Chronic RfD = 5 mg/kg/   1-generation
 Parent Compound                        day UFA = 10x UFH =      daycPAD = 5 mg/kg/day    reproduction/
                                        10x FQPA SF = 1x                                  subchronic oral
                                                                                toxicity study - rat
                                                                                (CAS Reg. No. 9014-85-
                                                                                1) Offspring LOAEL =
                                                                                1,000 mg/kg/day, based
                                                                                on decreased pup body
                                                                                weight (11% lower than
                                                                                control) at weaning
                                                                                (only time assessed);
                                                                                BW decreased 21-22%
                                                                                lower than control at
                                                                                2,000 mg/dg/day.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (all populations)      NOAEL = 200 mg/kg/day    Chronic RfD = 2 mg/kg/   Subchronic oral
 Diol Metabolite                        UFA = 10x UFH = 10x      daycPAD = 2 mg/kg/day    toxicity study - dog
                                        FQPA SF = 1x                                      (CAS Reg. No. 126-86-
                                                                                3) LOAEL = 250 mg/kg/
                                                                                day, based on sporadic
                                                                                compound-related
                                                                                neurological
                                                                                disturbances
                                                                                (convulsions and
                                                                                tremors; time of
                                                                                occurrence unknown)
----------------------------------------------------------------------------------------------------------------
Incidental Oral Short- and             NOAEL= 500 mg/kg/day     Residential/             1-generation
 Intermediate Term Dermal and           UFA = 10 x UFH = 10 x    Occupational LOC for     reproduction/
 Inhalation (All Durations) Parent      FQPA SF = 1x (20%        MOE = 100                subchronic oral
 Compound                               Dermal absorption;                                toxicity study - rat
                                        inhalation and oral                               (CAS Reg. No. 9014-85-
                                        toxicity assumed                                  1) Offspring LOAEL =
                                        equivalent)                                       1,000 mg/kg/day, based
                                                                                on decreased pup body
                                                                                weight (11% lower than
                                                                                control) at weaning
                                                                                (only time assessed);
                                                                                BW decreased 21-22%
                                                                                lower than control at
                                                                                2,000 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Classification: No animal toxicitydata available for an assessment. Based
 Parent and Diol Metabolite                  on SAR analysis, the ethoxylated acetylenic diols and the diol
                                                     metabolite are not expected to be carcinogenic.
----------------------------------------------------------------------------------------------------------------
 Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). PAD = population adjusted dose
  (a=acute, c=chronic). FQPA SF = FQPA Safety Factor. RfD = reference dose. MOE = margin of exposure. LOC =
  level of concern. N/A = not applicable.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to the ethoxylated acetylenic diols and the unethoxylated diol
metabolite, EPA considered exposure under the petitioned-for exemptions
from the requirement of a tolerance. EPA assessed dietary exposures
from ethoxylated acetylenic diols in food as follows:
     i. Acute exposure. No adverse effects attributable to a single
exposure of ether the parent ethoxylated acetylenic diol inerts or the
unethoxylated diol metabolite were seen in the toxicity databases;
Therefore, acute dietary risk assessments for the parent compound and
the unethoxylated diol metabolite are not necessary.
     ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used food consumption information from the United
States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, no residue data were submitted for the ethoxylated
acetylenic diol inert ingredients or the unethoxylated diol metabolite.
In the absence of specific residue data, EPA has developed an approach
which uses surrogate information to derive upper bound exposure
estimates for the subject inert ingredients. Upper bound exposure
estimates are based on the highest tolerance for a given commodity from
a list of high-use insecticides, herbicides, and fungicides. A complete
description of the general approach taken to assess inert ingredient
risks in the absence of residue data is contained in the memorandum
entitled ``Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic
Aggregate (Food and Drinking Water) Dietary Exposure and Risk
Assessments for the Inerts.'' (D361707, S. Piper, 2/25/09) and can be
found at http://www.regulations.gov in

docket ID number EPA-HQ-OPP-2008-0738.
    In the dietary exposure assessment, the Agency assumed that the
residue level of the inert ingredient would be no higher than the
highest tolerance for a given commodity. Implicit in this assumption is
that there would be similar rates of degradation (if any) between the
active and inert ingredient and that the concentration of inert
ingredient in the scenarios leading to these highest of tolerances
would be no higher than the concentration of the active ingredient.
    The Agency believes the assumptions used to estimate dietary
exposures lead to an extremely conservative assessment of dietary risk
due to a series of compounded conservatisms. First, assuming that the
level of residue for an inert ingredient is equal to the level of
residue for the active ingredient will overstate exposure. The
concentrations of active ingredient in agricultural products is
generally at least 50 percent of the product and often can be much
higher. Further, pesticide products rarely have a single inert
ingredient; rather there is generally a combination of different inert
ingredients used which additionally reduces the concentration of any
single inert ingredient in the pesticide product in relation to that of
the active ingredient. In the case of ethoxylated acetylenic diols, a
conservative screening level chronic dietary (food and water)
assessment was conducted for both the parent ethoxylated acetylenic
diol inerts and for the 2,4,7,9-tetramethyl-5-decyne-4,7-diol
metabolite.
    Second, the conservatism of this methodology is compounded by EPA's
decision to assume that, for each commodity, the active ingredient
which will serve as a guide to the potential level of inert ingredient
residues is the active ingredient with the highest tolerance level.
This assumption overstates residue values because it would be highly
unlikely, given the high number of inert ingredients, that a single
inert ingredient or class of ingredients would be present at the level
of the active ingredient in the highest tolerance for every commodity.
Finally, a third compounding conservatism is EPA's assumption that all
foods contain the inert ingredient at the highest tolerance level. In
other words, EPA assumed 100 percent of all foods are treated with the
inert ingredient at the rate and manner necessary to produce the
highest residue legally possible for an active ingredient. In summary,
EPA chose a very conservative method for estimating what level of inert
residue could be on food, then used this methodology to choose the
highest possible residue that could be found on food and assumed that
all food contained this residue. No consideration was given to
potential degradation between harvest and consumption even though
monitoring data shows that tolerance level residues are typically one
to two orders of magnitude higher than actual residues in food when
distributed in commerce.
    Accordingly, although sufficient information to quantify actual
residue levels in food is not available, the compounding of these
conservative assumptions will lead to a significant exaggeration of
actual exposures. EPA does not believe that this approach
underestimates exposure in the absence of residue data.
    iii. Cancer. The Agency used a qualitative structure activity
relationship (SAR) database, DEREK11, to determine if there were
structural alerts suggestive of carcinogenicity. No structural alerts
for carcinogenicity were identified. Based on the negative response for
mutagenicity, the fact that no specific target organs have been
identified in the rat and dog subchronic studies at the limit dose, the
lack of any alerts in model predictions, and SAR analysis, the Agency
concluded that the ethoxylated acetylenic diol inerts or their
unethoxylated diol metabolite are not likely to be carcinogenic. Since
the Agency has not identified any concerns for carcinogenicity relating
to the ethoxylated acetylenic diol inerts or their unethoxylated diol
metabolite, a cancer dietary exposure assessment was not performed.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for the ethoxylated acetylenic diols or their
unethoxylated diol metabolite. Tolerance level residues and/or 100 PCT
were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for the ethoxylated acetylenic diols and unethoxylated diol
metabolite in drinking water. These simulation models take into account
data on the physical, chemical, and fate/transport characteristics of
the ethoxylated acetylenic diols and unethoxylated diol metabolite.
Further information regarding EPA drinking water models used in
pesticide exposure assessment can be found at http://www.epa.gov/
oppefed1/models/water/index.htm.
    A screening level drinking water analysis, based on the Pesticide
Root Zone Model /Exposure Analysis Modeling System (PRZM/EXAMS) was
performed to calculate the estimated drinking water concentrations
(EDWCs) of the ethoxylated acetylenic diols and unethoxylated diol
metabolite. Modeling runs on four surrogate inert ingredients using a
range of physical chemical properties that would bracket those of the
the ethoxylated acetylenic diols and unethoxylated diol metabolite were
conducted. Modeled acute drinking water values ranged from 0.001 parts
per billion (ppb) to 41 ppb. Modeled chronic drinking water values
ranged from 0.0002 ppb to 19 ppb. Further details of this drinking
water analysis can be found at http://www.regulations.gov in document
``Ethoxylated Acetylenic Diols (JITF CST 19 Inert Ingredients). Human
Health Risk Assessment to Support Proposed Exemption from the
Requirement of a Tolerance When Used as Inert Ingredients in
Pesticide'', at pages 15-16 and 59-61 in docket ID number EPA-HQ-OPP-
2008-0710.
    For the purpose of the screening level dietary risk assessment to
support this request for an exemption from the requirement of a
tolerance for the ethoxylated acetylenic diols and unethoxylated diol
metabolite, a conservative drinking water concentration value of 100
ppb based on screening level modeling was used to assess the
contribution to drinking water for the chronic dietary risk assessments
for the parent compounds and for the metabolite of concern. These
values were directly entered into the dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). The ethoxylated
acetylenic diols may be used in inert ingredients in pesticide products
that are registered for specific uses that may result in both indoor
and outdoor residential exposures. The ethoxylated acetylenic diol
inerts are used in pesticide formulations that may be used around the
home. In addition, these inerts may be used in pesticide products
applied to pets as dust formulations and aerosol sprays intended for
flea control on carpeted surfaces and bedding. Lastly, these inert
surfactants may be present in home cleaning products. The ethoxylated
acetylenic diols inerts do not have utility in personal care products.
A screening level residential exposure and risk assessment was
completed for products containing ethoxylated acetylenic diols as inert
ingredients. In

this assessment, representative scenarios, based on end-use product
application methods and labeled application rates, were selected. The
Agency conducted an assessment to represent worst-case residential
exposure by assessing ethoxylated acetylenic diols in pesticide
formulations (Outdoor Scenarios); ethoxylated acetylenic diols in
disinfectant-type uses; (Indoor Scenarios) and ethoxylated acetylenic
diols in pet products; (Pet Product Scenarios). Further details of this
residential exposure and risk analysis can be found at http://
www.regulations.gov in the memorandum entitled ``JITF Inert
Ingredients. Residential and Occupational Exposure Assessment
Algorithms and Assumptions Appendix for the Human Health Risk
Assessments to Support Proposed Exemption from the Requirement of a
Tolerance When Used as Inert Ingredients in Pesticide Formulations'',
(D364751, 5/7/09, Lloyd/LaMay in docket ID number EPA-HQ-OPP-2008-0710.
    4. 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 ethoxylated acetylenic diols to share a common
mechanism of toxicity with any other substances, and ethoxylated
acetylenic diols do not appear to produce a toxic metabolite produced
by other substances. For the purposes of this tolerance action,
therefore, EPA has assumed that ethoxylated acetylenic diols do 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 website 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.
    2. Prenatal and postnatal sensitivity. The toxicity database
consists of a 1-generation reproductive toxicity study on the
ethoxylated compound and a 1-generation reproductive toxicity study on
the unethoxylated compound.
    The Agency performed a Degree of Concern Analysis because the rat
reproduction studies provided evidence of increased susceptibility in
the offspring relative to the parents. The purpose of the Degree of
Concern analysis was:
    i. To determine the level of concern for the effects observed when
considered in the context of all available toxicity data; and
    ii. Identify any residual uncertainties after establishing toxicity
endpoints and traditional uncertainty factors to be used in the risk
assessment.
    In the case of the ethoxylated acetylenic diols and unethoxylated
diol metabolite, there was evidence of increased susceptibility in the
1-generation reproduction toxicity studies in rats. Although there is
some increased susceptibility in the rat reproductive toxicity studies
(where the offspring NOAEL of 500 mg/kg/day was lower than the paternal
NOAELs of 1,000 and 2,000 mg/kg/day), the effects (decreased body
weight) were observed only at the limit and twice the limit dose. The
dose-response for this effect has been adequately characterized, and
the NOAEL selected as a point of departure for the chronic dietary,
dermal and inhalation risk assessment is protective of the adverse
offspring effects. Thus, there are no residual concerns.
    There was some evidence of clinical signs indicative of
neurotoxicity following subchronic exposures to the diol metabolite in
dogs. However, the concern for this finding is low based on the
following considerations:
    a. The clinical signs were sporadic;
    b. There was no neuropathology at any dose;
    c. No neurotoxic clinical signs were seen following subchronic
exposures to the parent compound;
    d. This endpoint is used as the point of departure in conjunction
with highly conservative exposure inputs for assessing chronic dietary
risks for the diol metabolite; and
    e. There was no evidence with either the parent or metabolite of
neurotoxicity in rats, the species of choice for conducting
neurotoxicity studies. Therefore, additional neurotoxicity data,
including developmental neurotoxicity studies are not required.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for the ethoxylated acetylenic diols and
unethoxylated diol metabolite is considered adequate for assessing the
risks to infants and children (the available studies are described in
Unit IV.D.2.).
    ii. There are no concerns or residual uncertainties concerning pre-
and postnatal toxicity for the reasons given in this Unit.
    iii. No additional neurotoxicity data are required.
    iv. While there is no chronic toxicity study, the Agency has
concluded that based on the very conservative exposure assessment and
the fact that the toxicity endpoint is also very conservative (effects
were only seen at and above the limit dose), the 10X interspecies and
10X intraspecies uncertainty factor would be adequately protective, and
no additional uncertainty factor is needed for extrapolating from
subchronic to chronic exposure.
     v. There are no residual uncertainties identified in the exposure
databases. The food and drinking water assessment is not likely to
underestimate exposure to any subpopulation, including those comprised
of infants and children. The food exposure assessments are considered
to be highly conservative as they are based on the use of the highest
tolerance level from the surrogate pesticides for every food and 100
PCT is assumed for all crops. EPA also made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to the ethoxylated acetylenic diols or their diol metabolite
in drinking water. EPA used similarly conservative assumptions to
assess post-application exposure of children as well as incidental oral
exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by the ethoxylated acetylenic diols.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all

appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD
by all applicable UFs. For linear cancer risks, EPA calculates the
probability of additional cancer cases given the estimated aggregate
exposure. Short-term, intermediate-term, and chronic-term risks are
evaluated by comparing the estimated aggregate food, water, and
residential exposure to the POD to ensure that the MOE called for by
the product of all applicable UFs is not exceeded.
    The Agency has conducted aggregate risk assessments to support the
proposed uses of the ethoxylated acetylenic diols as inert ingredients
in pesticide formulations. As noted previously, the ethoxylated
acetylenic diols assessment includes not only parent compounds, but
also 2,4,7,9-tetramethyl-5-decyne-4,7-diol. The Agency notes that
concern for this degradate is for residues in food and water only.
Additionally, the Agency has selected endpoints and doses for risk
assessment separately for the parent compound and diol metabolite.
Therefore, separate parent compound and diol metabolite aggregate risk
assessments are appropriate. The aggregate risk assessment for the diol
metabolite includes residues in food and water only.
    1. Acute risk. There was no hazard attributable to a single dietary
exposure seen in the toxicity database for the parent ethoxylated
acetylenic diols or the unethoxylated diol metabolite. Therefore, the
parent ethoxylated acetylenic diols or the unethoxylated diol
metabolite are not expected to pose an acute risk.
    2. Chronic risk. A chronic aggregate risk assessment takes into
account exposure estimates from chronic dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for chronic exposure, the chronic dietary exposure from food and water
to the parent ethoxylated acetylenic diol is 4% of the cPAD for the
U.S. population and 13% of the cPAD for children 1-2 yrs old, the most
highly exposed population subgroup. The chronic dietary (food and
water) exposure for the unethoxylated diol metabolite resulted in a
risk estimate of 10% of the cPAD for the U.S. population and 31% of the
cPAD for children 1-2 yrs old, the most highly exposured population
subgroup.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Ethoxylated acetylenic diol inerts are used as inert ingredients in
pesticide products that are currently registered for uses that could
result in short-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with short-term residential exposures to the ethoxylated
acetylenic diols. Using the exposure assumptions described in this
unit, EPA has concluded that the combined short-term aggregated food,
water, and residential exposures result in aggregate MOEs of 670, for
both adult males and females, respectively. Adult residential exposure
combines high end dermal and inhalation handler exposure from indoor
hand wiping with a high end post application dermal exposure from
contact with treated lawns. EPA has concluded the combined short-term
aggregated food, water, and residential exposures result in an
aggregate MOE of 600 for children. Children's residential exposure
includes total exposures associated with contact with treated lawns
(dermal and hand-to-mouth exposures). As the LOC is for MOEs that are
lower than 100, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    Ethoxylated acetylenic diol inerts are used as inert ingredients in
pesticide products that are currently registered for uses that could
result in intermediate -term residential exposure and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with intermediate-term residential exposures to
ethoxylated acetylenic diols. Using the exposure assumptions described
in this unit, EPA has concluded that the combined intermediate-term
aggregated food, water, and residential exposures result in aggregate
MOEs of 2,500 for both adult males and females respectively. Adult
residential exposure includes high end post application dermal exposure
from contact with treated lawns. EPA has concluded that the combined
intermediate-term aggregated food, water, and residential exposures
result in an aggregate MOE of 690 for children. Children's residential
exposure includes total exposures associated with contact with treated
lawns (dermal and hand-to-mouth exposures). As the LOC is for MOEs that
are lower than 100, these MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. The Agency has not
identified any concerns for carcinogenicity relating to the parent
ethoxylated acetylenic diol inerts or the degradate of concern.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to residues of the ethoxylated acetylenic diol inerts.

V. Other Considerations

A. Analytical Enforcement Methodology

     An analytical method is not required for enforcement purposes
since the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Residue Limits

    The Agency is not aware of any country requiring a tolerance for
the ethoxylated acetylenic diol inerts nor have any CODEX Maximum
Residue Levels been established for any food crops at this time.

VI. Conclusion

    Therefore, an exemption from the requirement of a tolerance is
established for residues of Ethylene oxide adducts of 2,4,7,9-
tetramethyl-5-decynediol, the ethylene oxide content averages 3.5, 10,
or 30 moles, when used as inert ingredients applied to crops pre-
harvest and post-harvest, or to animals.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA 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 final rule has been
exempted from review under Executive Order 12866, this final 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) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule 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 section 408(d) of FFDCA, such as the tolerance 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 final rule 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 section 408(n)(4) of FFDCA. 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    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).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule 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 21, 2009.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.

0
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, the table is amended by adding alphabetically the
following inert ingredients to read as follows:

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

* * * * *

------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
Ethylene oxide adducts of         ..................  Surfactants,
 2,4,7,9-tetramethyl-5-                                related adjuvants
 decynediol, the ethylene oxide                        of surfactants
 content averages 3.5, 10 or 30
 moles (CAS Reg. No. 9014-85-1)
                              * * * * * * *
------------------------------------------------------------------------

* * * * *

0
3. In Sec. 180.930, the table is amended by adding alphabetically the
following inert ingredients to read as follows:

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

* * * * *

------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
Ethylene oxide adducts of         ..................  Surfactants,
 2,4,7,9-tetramethyl-5-                                related adjuvants
 decynediol, the ethylene oxide                        of surfactants
 content averages 3.5, 10 or 30
 moles (CAS Reg. No. 9014-85-1)
                              * * * * * * *
------------------------------------------------------------------------

* * * * *

I40[FR Doc. E9-17958 Filed 7-28-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 87, Number 226 (Friday, November 25, 2022)]
[Notices]
[Page 72475]
[FR Doc No: 2022-25713]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER23-452-000]

EEC Skyhawk Lessee LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
EEC Skyhawk Lessee LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is December 8, 2022.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: November 18, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-25713 Filed 11-23-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: November 16, 2007 (Volume 72, Number 221)]
[Notices]
[Page 64605-64606]
[DOCID:fr16no07-54]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12892-000]

BPUS Generation Development, LLC; Notice of Application Accepted
for Filing and Soliciting Motions To Intervene, Protests, and Comments

November 8, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12892-000.
    c. Date filed: July 30, 2007.
    d. Applicant: BPUS Generation Development, LLC.
    e. Name of Project: Columbia Lock & Dam Hydroelectric Project.
    f. Location: Ouachita River in Caldwell County, Louisiana. It would
use the U.S. Army Corps of Engineers' Columbia Lock & Dam.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Jeffrey M. Auser, P.E., BPUS Generation
Development, LLC, 225 Greenfield Parkway, Suite 201, Liverpool, NY
13088,<PHONE_NUMBER>.
    i. FERC Contact: Robert Bell,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Kimberly, D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Comments, protests, and
interventions may be filed electronically via the Internet in lieu of
paper; see 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's web site under the ``e-Filing'' link. The Commission
strongly encourages electronic filings. Please include the project
number (P-12892-000) on any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project using the U.S. Army
Corps of Engineers' Columbia Lock & Dam and operated in a run-of-river
mode would consist of: (1) A new 55-foot long, 100-foot wide, 35-foot
high concrete powerhouse; (2) a new intake channel and tailrace channel
on the west side of the river; (3) two turbine/generator units with a
combined installed capacity of 6 megawatts; (4) a new 12,000-foot long
above ground transmission line extending from the switchyard near the
powerhouse to an interconnection point with an existing transmission
line northwest of the powerhouse; and (5) appurtenant facilities. The
proposed Columbia Lock & Dam Project would have an average annual
generation of 47 gigawatt-hours.
    l. This filing is available for review at the Commission in the
Public Reference Room or may be viewed on the Commission's Web site at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket

number excluding the last three digits in the docket number field to
access the document. For assistance, call toll-free 1-866-208-3676 or
e-mail<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy
is also available for inspection and

reproduction at the address in item h above.
    m. Competing Preliminary Permit: Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR 4.30
and 4.36.
    n. Competing Development Application: Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30 and 4.36.
    o. Notice of Intent: A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    p. Proposed Scope of Studies Under Permit: A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    q. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    r. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``NOTICE OF INTENT
TO FILE COMPETING APPLICATION'', ``COMPETING APPLICATION'',
``PROTEST'', and ``MOTION TO INTERVENE'', as applicable, and the
Project Number of the particular application to which the filing
refers. Any of the above-named documents must be filed by providing the
original and the number of copies provided by the Commission's
regulations to: The Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. An additional copy must be
sent to Director, Division of Hydropower Administration and Compliance,
Federal Energy Regulatory Commission, at the above-mentioned address. A
copy of any notice of intent, competing application or motion to
intervene must also be served upon each representative of the Applicant
specified in the particular application.
    s. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
 Secretary.
 [FR Doc. E7-22398 Filed 11-15-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 56 (Friday, March 24, 2017)]
[Notices]
[Page 15054]
[FR Doc No: 2017-05824]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Filing

------------------------------------------------------------------------
                                                   Docket Nos.
------------------------------------------------------------------------
Savage, Jeffrey S......................  ID-6679-001
Van Abel, Brian J......................  ID-7433-001
Mahling, Wendy B.......................  ID-7213-001
------------------------------------------------------------------------

    Take notice that on March 10, 2017, Jeffrey S. Savage, Brian J. Van
Abel, and Wendy B. Mahling filed a supplement to application for
authorization to hold interlocking positions, pursuant to section
305(b) of the Federal Power Act, 16 U.S.C. 825d(b), and Part 45 of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedure, 18 CFR part 45.8 (2016).
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
``eSubscription'' link on the Web site that enables subscribers to
receive email notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on March 31, 2017.

    Dated: March 14, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-05824 Filed 3-23-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 48 (Monday, March 15, 2021)]
[Notices]
[Pages 14333-14334]
[FR Doc No: 2021-05259]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2021-0178]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625-0020

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting an extension of
its approval for the following collection of information:

1625-0020, Security Zones, Regulated Navigation Areas, and Safety
Zones; without change.
    Our ICR describes the information we seek to collect from the
public. Before submitting this ICR to OIRA, the Coast Guard is inviting
comments as described below.

DATES: Comments must reach the Coast Guard on or before May 14, 2021.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2021-0178] to the Coast Guard using the Federal
eRulemaking Portal at https://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.
    A copy of the ICR is available through the docket on the internet
at https://www.regulations.gov. Additionally, copies are available
from: Commandant (CG-6P), ATTN: Paperwork Reduction Act Manager, U.S.
Coast Guard, 2703 Martin Luther King Jr. Ave. SE, Stop 7710,
Washington, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: A.L. Craig, Office of Privacy
Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>, for questions
on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology.
    In response to your comments, we may revise this ICR or decide not
to seek an extension of approval for the Collection. We will consider
all comments and material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2021-0178], and
must be received by May 14, 2021.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at https://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to https://www.regulations.gov and will include any
personal information you have provided. For more about privacy and
submissions in response to this document, see DHS's eRulemaking System
of Records notice (85 FR 14226, March 11, 2020).

Information Collection Request

    Title: Security Zones, Regulated Navigation Areas, and Safety
Zones.
    OMB Control Number: 1625-0020.
    Summary: The Coast Guard collects this information only when
someone seeks a security zone, regulated navigation area, or safety
zone. It uses the information to assess the need to establish one of
these areas.
    Need: Section 70034 and 70051 of 46 U.S.C., and parts 6 and 165 of
33 CFR give the Coast Guard Captain of the Port (COTP) the authority to
designate security zones in the U.S. for as long as the COTP deems
necessary to prevent damage or injury. Section 70001 of 46 U.S.C.
authorizes the Coast Guard to prescribe rules to control vessel traffic
in areas he or she deems hazardous because of reduced visibility,
adverse weather, or vessel congestion. Section 70011 of 46 U.S.C.
authorizes the Coast Guard to establish rules to allow the designation
of safety zones where access is limited to authorized persons,
vehicles, or vessels to protect the public from hazardous situations.
    Forms: None.
    Respondents: Federal, State, and local government agencies, owners
and operators of vessels and facilities.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has increased from 224
hours to 928 hours a year, due to an increase in the estimated annual
number of respondents.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
chapter 35, as amended.

    Dated: March 9, 2021.
Kathleen Claffie,
Chief, Office of Privacy Management, U.S. Coast Guard.
[FR Doc. 2021-05259 Filed 3-12-21; 8:45 am]
BILLING CODE 9110-04-P