[Federal Register: April 10, 2009 (Volume 74, Number 68)]
[Notices]
[Page 16411-16412]
[DOCID:fr10ap09-90]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2008-1177]

Collection of Information Under Review by Office of Management
and Budget: OMB Control Numbers: 1625-0097 and 1625-0099

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, this
request for comments announces that the U.S. Coast Guard is forwarding
two Information Collection Requests (ICRs), abstracted below, to the
Office of Information and Regulatory Affairs (OIRA), Office of
Management and Budget (OMB) requesting an extension of its approval for
the following collections of information: (1) 1625-0097, Plan Approval
and Records for Marine Engineering Systems--46 CFR Subchapter F; and
(2) 1625-0099, Requirements for the Use of Liquefied Petroleum Gas and
Compressed Natural Gas as Cooking Fuel on Passenger Vessels. Our ICRs
describe the information we seek to collect from the public. Review and
comments by OIRA ensure we only impose paperwork burdens commensurate
with our performance of duties.

DATES: Please submit comments on or before May 11, 2009.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2008-1177] to the Docket Management Facility (DMF) at the
U.S. Department of Transportation (DOT) or to OIRA. To avoid
duplication, please submit your comments by only one of the following
means:
    (1) Electronic submission. (a) To Coast Guard docket at http://
www.regulation.gov. (b) To OIRA by e-mail via: oira_
<EMAIL_ADDRESS>    (2) Mail or Hand delivery. (a) DMF (M-30), DOT, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC
20590-0001. Hand deliver between the hours of 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays. The telephone number is 202-
366-9329. (b) To OIRA, 725 17th Street, NW., Washington, DC 20503,
attention Desk Officer for the Coast Guard.
    (3) Fax. (a) To DMF,<PHONE_NUMBER>. (b) To OIRA at<PHONE_NUMBER>. To
ensure your comments are received in time, mark the fax, attention Desk
Officer for the Coast Guard.
    The DMF maintains the public docket for this Notice. Comments and
material received from the public, as well as documents mentioned in
this Notice as being available in the docket, will become part of the
docket and will be available for inspection or copying at room W12-140
on the West Building Ground Floor, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. You may also find the docket on the Internet
at http://www.regulations.gov.
    Copies of the ICRs are available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from
Commandant (CG-611), U.S. Coast Guard Headquarters, (Attn: Mr. Arthur
Requina), 2100 2nd Street, SW., Washington, DC 20593-0001. The
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mr. Arthur Requina, Office of
Information Management, telephone<PHONE_NUMBER> or fax<PHONE_NUMBER>, for
questions on these documents. Contact Ms. Renee V. Wright, Program
Manager, Docket Operations,<PHONE_NUMBER>, for questions on the docket.

SUPPLEMENTARY INFORMATION: The Coast Guard invites comments on whether
these ICRs should be granted based on it being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
collections; (2) the accuracy of the estimated burden of the
collections; (3) ways to enhance the quality, utility, and clarity of
information subject to the collections; and (4) ways to minimize the
burden of collections on respondents, including the use of automated
collection techniques or other forms of information technology.
    Comments to Coast Guard or OIRA must contain the OMB Control Number
of the ICR. Comments to Coast Guard must contain the docket number of
this request, [USCG 2008-1177]. For your comments to OIRA to be
considered, it is best if they are received on or before the May 11,
2009.
    Public participation and request for comments: We encourage you to
respond to this request by submitting comments and related materials.
We will post all comments received, without change, to http://
www.regulations.gov. They will include any personal information you
provide. We have an agreement with DOT to use their DMF. Please see the
``Privacy Act'' paragraph below.
    Submitting comments: If you submit a comment, please include the
docket number [USCG-2008-1177], indicate the specific section of the
document to which each comment applies, providing a reason for each
comment. We recommend you include your name, mailing address, an e-mail
address, or other contact information in the body of your document so
that we can contact you if we have questions regarding your submission.
You may submit comments and material by electronic means, mail, fax, or
delivery to the DMF at the address under ADDRESSES; but please submit
them by only one means. If you submit them by mail or delivery, submit
them in an unbound format, no larger than 8-1/2 by 11 inches, suitable
for copying and electronic filing. If you submit them by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. In response to your comments, we
may revise the ICR or decide not to seek an extension of approval for
this collection. The Coast Guard and OIRA will consider all comments
and material received during the comment period.
    Viewing comments and documents: Go to http://www.regulations.gov to
view documents mentioned in this Notice as being available in the
docket. Enter the docket number [USCG-2008-1177] in the Search box, and
click, ``Go>>.'' You may also visit the DMF in room W12-140 on the West
Building Ground Floor, 1200 New Jersey Avenue, SE., Washington, DC,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.
    Privacy Act: Anyone can search the electronic form of all comments
received in dockets by the name of the individual submitting the
comment (or signing the comment, if submitted on behalf of an
association, business, labor union, etc.). You may review the Privacy
Act statement regarding our

public dockets in the January 17, 2008 issue of the Federal Register
(73 FR 3316).

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard has published the 60-day notice (74 FR 452, January 6,
2009) required by 44 U.S.C. 3506(c)(2). That notice elicited no
comments.

Information Collection Request

    1. Title: Plan Approval and Records for Marine Engineering
Systems--46 CFR Subchapter F.
    OMB Control Number: 1625-0097.
    Type of Request: Extension of a currently approved collection.
    Respondents: Owners and builders of commercial vessels.
    Abstract: This collection of information requires an owner or
builder of a commercial vessel to submit to the U.S. Coast Guard for
review and approval, plans pertaining to marine engineering systems to
ensure the vessel will meet regulatory standards.
    Forms: None.
    Burden Estimate: The estimated burden has decreased from 3,567
hours to 3,312 hours a year.
    2. Title: Requirements for the Use of Liquefied Petroleum Gas and
Compressed Natural Gas as Cooking Fuel on Passenger Vessels.
    OMB Control Number: 1625-0099.
    Type Of Request: Extension of a currently approved collection.
    Respondents: Owners and operators of passenger vessels.
    Abstract: The collection of information requires passenger vessels
to post two placards which contain safety and operating instructions on
the use of cooking appliances using liquefied or compressed natural
gas.
    Forms: None
    Burden Estimate: The estimated burden has increased from 2,547
hours to 5,288 hours a year.

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

    Dated: April 3, 2009.
D.T. Glenn,
Rear Admiral, U.S. Coast Guard, Assistant Commandant for Command,
Control, Communications, Computers and Information Technology.
[FR Doc. E9-8150 Filed 4-9-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register: September 19, 2007 (Volume 72, Number 181)]
[Rules and Regulations]
[Page 53445-53449]
[DOCID:fr19se07-13]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

EPA-HQ-OPP-2006-0297; FRL-8146-8]

Desmedipham; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
desmedipham in or on beet, garden, roots; beet, garden, tops and
spinach. The Interregional Research Project No. 4 (IR-4) requested this
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 19, 2007. Objections and
requests for hearings must be received on or before November 19, 2007,
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-2006-0297. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in 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<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, 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), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
    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 an electronic copy of this Federal
Register document through the electronic docket 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 pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, 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-2006-0297 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 November 19, 2007.
    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-2006-0297, 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'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. Petition for Tolerance

    In the Federal Register of April 21, 2006 (71 FR 20666) (FRL-8064-
7), 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
6E7027) by the Interregional Research Group (IR-4), 500 College Road
East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40
CFR 180.353 be amended by establishing a tolerance for residues of the
herbicide, desmedipham, (ethyl-m-hydroxycarbanilate carbanilate) in or
on the raw agricultural commodities: Beet, garden, roots at 0.05 parts
per million (ppm), beet, garden, tops at 1.0 ppm, and spinach at 6.0
ppm. That notice referenced a summary of the petition prepared by Bayer
CropScience, the registrant, 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.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish 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 the 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 the 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....'' These provisions were added to the FFDCA by the Food
Quality Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 tolerance
for residues of beet, garden, roots at 0.05 ppm, beet, garden, tops at
1.0 ppm, and spinach at 6.0 ppm. EPA's assessment of exposures and
risks associated with establishing the tolerance 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. Specific information on the studies received and the nature
of the adverse effects caused by desmedipham 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 in the
Reregistration Eligibility Decision (RED) for desmedipham and FQPA
Tolerance Reassessment Progress Report (TRED) for desmedipham (http://www.epa.gov/pesticides/reregistration/desmedipham/
) and at

http://www.regulations.gov in document ``Desmedipham: Human Health Risk

Assessment for Petition 6E7027 dated February 1, 2007'' in Docket ID
EPA-HQ-OPP-2006-0297.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from 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) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the LOC 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
risks by comparing aggregate 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 LOC by all
applicable UFs. Short-term, intermediate-term, and long-term risks are
evaluated by comparing aggregate exposure to the LOC to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    A summary of the toxicological endpoints for desmedipham used for
human risk assessment can be found at http://www.regulations.gov in

document ``Desmedipham: Human Health Risk Assessment for Petition
6E7027 dated February 1, 2007'' at page number 6 in docket ID number
EPA-HQ-OPP-2007-0297.
    Subsequent to completion of the February 1, 2007 risk assessment,
EPA reevaluated the cancer classification of desmedipham. Previously,
desmedipham was ``tentatively'' classified as a Group E carcinogen
(evidence of non-carcinogenicity for humans) under the classification
scheme in effect at the time. The classification was ``tentative''
pending submission of historical control data on the incidence of
mammary gland fibroadenomas and information to address the number of
animals examined at the low and mid-doses for histopathology in the
chronic/carcinogenicity study in Wistar rats. To date, historical
control data for the Wistar rat cancer study have not been submitted to
the Agency. However, the need for this historical control data is
alleviated by the submission of a new chronic/carcinogenicity study in
Sprague Dawley rats. The new Sprague

Dawley rat study examined doses comparable to those examined in the
Wistar rat study. In this new cancer rat study, there was no treatment
related increase in the incidence of mammary gland fibroadenomas and no
increase in any other tumor type or in the total number of tumors. EPA
has concluded that desmedipham should now be classified as ``Not likely
to be Carcinogenic to Humans'' based on the lack of carcinogenic
potential noted in the available studies. EPA's re-evaluation of the
cancer classification can be found at http://www.regulations.gov in document

``Desmedipham: Re-evaluation of Cancer Classification'' in Docket ID
EPA-HQ-OPP-2006-0297.
    To assess acute dietary exposure, an endpoint and dose were
selected from a developmental study in the rat. The maternal NOAEL was
10 milligrams/kilogram (mg/kg)/day based on increased methemoglobin at
100 mg/kg/day (LOAEL). An UF of 100 was applied to the acute toxicity
endpoint resulting in an aPAD of 0.1 mg/kg bodyweight (bw)/day. The
FQPA safety factor was reduced from 10x to 1x.
    To assess chronic dietary exposure, an endpoint and dose were
selected from a two-generation reproduction study in rats. The NOAEL
from this study was 4 mg/kg bw/day and the LOAEL was 20 mg/kg/day based
on parental systemic toxicity of hemolytic anemia accompanied by
significant increases in splenic weights and compensatory functioning
of the thyroid. An UF of 100 (10x for interspecies extrapolation and
10x for intraspecies variability) was applied to the chronic toxicity
endpoint resulting in a cPAD of 0.04 mg/kg bw/day. The FQPA Safety
Factor (SF) was reduced from 10x to 1x.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to desmedipham, EPA considered exposure under the petitioned-
for tolerances as well as all existing desmedipham tolerances in (40
CFR 180.353). EPA assessed dietary exposures from desmedipham in food
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. In estimating acute dietary
exposure, EPA used food consumption information from the U.S.
Department of Agriculture (USDA) 1994-1996, and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, EPA assumed all foods for which there are existing and
proposed tolerances were treated and contain tolerance-level residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996,
and 1998 Nationwide CSFII. As to residue levels in food, EPA assumed
all foods for which there are tolerances existing and proposed were
treated and contain tolerance-level residues.
    iii. Cancer. Desmedipham has been classified as ``Not Likely to be
Carcinogenic to Humans''. Therefore, the Agency concluded that
desmedipham is not expected to pose a carcinogenic risk and
quantification of exposure for the purpose of assessing cancer risk is
not necessary.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for desmedipham in drinking water. Because
the Agency does not have comprehensive monitoring data, drinking water
concentration estimates are made by reliance on simulation or modeling
taking into account data on the environmental fate characteristics of
desmedipham. 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
.

    In the environment, at neutral to alkaline pH, desmedipham is
rapidly hydrolyzed to EHPC (ethyl-(3-hydroxyphenyl) carbamate). Given
that EHPC has a sub-structure that has been associated with
methemoglobin effects, the endpoint of concern for the parent
desmedipham for acute and chronic exposures, EHPC has been included in
the dietary risk assessment for drinking water.
    The Agency calculated Tier 1 (upper-bound) Drinking Water
Concentrations (EDWCs) for the combined residues of parent desmedipham
plus EHPC. EDWCs for desmedipham plus EHPC were calculated using the
FQPA Index Reservoir Screening Tool (FIRST) (surface water) and
Screening Concentration In - Ground Water (SCI-GROW) (ground water)
drinking water models. Both models provide estimates suitable for
screening purposes. Modeled EDWCs for peak and average concentrations
of desmedipham plus EHPC in surface water are 130 parts per billion
(ppb) and 71 ppb, respectively. The modeled peak and average EDWCs for
ground water are 0.04 ppb.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 130 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 71 ppb was used to assess
the contribution to drinking water.
    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).
    Desmedipham is not registered for use in or on any sites that would
result in residential exposure.
    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 determined that desmedipham does not have a common
mechanism of toxicity with the other N-methyl carbamate pesticides.
Unlike other pesticides for which EPA has followed a cumulative risk
approach based on a common mechanism of toxicity, EPA has not made a
common mechanism of toxicity finding as to desmedipham and any other
substances and desmedipham does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that desmedipham has 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 of the FFDCA provides that EPA shall
apply an additional (``10X'') tenfold 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. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not

support the choice of a different factor, or, if reliable data are
available, EPA uses a different additional FQPA safety factor value
based on the use of traditional UFs and/or special FQPA safety factors,
as appropriate.
    2. Prenatal and postnatal sensitivity. Desmedipham is not
considered a developmental toxicant or a mutagen. Developmental
toxicity studies show no increased sensitivity in fetuses as compared
to maternal animals following in utero exposures in rats and rabbits. A
two-generation reproduction toxicity study in rats showed no increased
susceptibility in pups when compared to adults, There was no evidence
of abnormalities in the development of the fetal nervous system in the
pre/post natal studies. Neither brain weight nor histopathology of the
nervous system was affected in the subchronic and chronic toxicity
studies.
    3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
    The toxicology database is complete and there are no data gaps.
There are no residual concerns regarding pre- or post-natal toxicity.
There is no evidence requiring a developmental neurotoxicity study, and
    i. The toxicology database is complete and there are no data gaps.
    ii. There are no residual concerns regarding pre- or post-natal
toxicity.
    iii. There is no evidence requiring a developmental neurotoxicity
study, and
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% crop treated (CT) and tolerance-level residues. Conservative
ground and surfacewater modeling estimates were used. These assessments
will not underestimate the exposure and risks posed by desmedipham.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-term, intermediate-term,
and long-term risks are evaluated by comparing aggregate exposure to
the LOC to ensure that the MOE called for by the product of all
applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to desmedipham will occupy 26% of the aPAD for the population group
(all infants less than 1 yr old) receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
desmedipham from food and water will utilize 13% of the cPAD for the
population group all infants less than 1 yr old.
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Desmedipham is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Desmedipham is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
    5. Aggregate cancer risk for U.S. population. Desmedipham is
classified as ``Not Likely to be Carcinogenic to Humans'' and is not
expected to pose a cancer risk.
    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 desmedipham residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Liquid Chromatography/Mass
Spectrometry/Mass Spectrometry (LC/MS/MS) method AL/01/02) is available
to enforce the tolerance expression. The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>;
e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    There are no established or proposed Codex, Canadian or Mexican
MRLs for desmedipham.

V. Conclusion

    Therefore, the tolerance is established for residues of the
herbicide, desmedipham (ethyl-m-hydroxycarbanilate carbanilate) in or
on the raw agricultural commodities: Beet, garden, roots at 0.05 ppm,
beets, garden, tops at 1.0 ppm, and spinach at 6.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, 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 the 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 the 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 6, 2000) do not apply to this rule. In addition,
This 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).

VII. 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: September 7, 2007.
Lois Rossi,
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.  180.353, paragraph (a) is revised to read as follows:

Sec.  180.353  Desmedipham; tolerances for residues.

    (a) General. Tolerances are established for residues of the
herbicide desmedipham, (ethyl-m-hydroxycarbanilate carbanilate) in or
on the following raw agricultural commodities in the table that
follows:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Beet, garden, roots..................................               0.05
Beet, garden, tops...................................                1.0
Beet, sugar, roots...................................                0.2
Beet, sugar, tops....................................                0.2
Spinach..............................................                6.0
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-18373 Filed 9-18-07; 8:45 am]

BILLING CODE 6560-50-S


TABLE 2 AVERAGE ANNUAL EPA RESOURCE REQUIREMENTS NESHAP SUBPART II  SHIP BUILDING AND REPAIR FACILITIES REPORTING/ RECORDKEEPING REQUIREMENT EPA Hours/

Occurence ( A ) Occurences/

Plant/ Year ( B) EPA Hours/

Year ( C= A* B)

( C) Plants/ Year ( D) EPA Hours/

Year ( E= C* D)

( E)

INITIAL PERFORMANCE TESTS N/ A REPEAT PERFORMANCE TEST N/ A REPORT REVIEW Notification of Construction 2 1 2 2 4 Notification of Operational Changes 2 1 2 2 4 Notification of Anticipated Startup 2 0 0 0 0 Notification of Actual Startup 2 0 0 0 0 Review of initial notification and implementation plan 2 0 0 24 0 Review of semi annual notification of compliance status 2 2 4 45 180 TOTAL ANNUAL HOURS 188 SALARY BURDEN ( per year) $ 6,711.60 ( 188 X $ 35.70)

Note:

EPA labor rate ( GS 10 Step 1 + 110% overhead) $ 35.70


5/ 25/ 06 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY HUMAN STUDIES REVIEW BOARD ( HSRB) PUBLIC TELECONFERENCE MEETING JUNE 8, 2006 1: 30 pm  4: 00 pm ( Eastern Time)

HSRB MEETING FOR REVIEW AND APPROVAL OF APRIL 4 6, 2006 HSRB MEETING REPORT *

Meeting location via telephone only Members of the public may obtain the call in number at 202 564 8381 C 1: 30 PM Introduction and Identification of Board Members   Celia Fisher, Ph. D. ( HSRB Chair)

C 1: 45 PM Welcome and Introduction   William Farland, Ph. D. ( Chief Scientist, Office of the Science Advisor [ OSA], EPA)

C 1: 50 AM Meeting Administrative Procedures  Paul Lewis, Ph. D. ( Designated Federal Officer, HSRB, OSA, EPA)

C 1: 55 PM Meeting Process   Celia Fisher, Ph. D. ( HSRB Chair)

C 2: 05 AM Public Comments C 2: 35 PM Board Discussion and Decision on Report  Celia Fisher, Ph. D. ( HSRB Chair)

Aldicarb Methomyl Oxamyl Azinphos methyl DDVP Ethephon Hydrogen Cyanide Amitraz General Board Discussion/ Decision C 3: 50 PM Summary and Next Steps  Celia Fisher, Ph. D. ( HSRB Chair) and Paul Lewis, Ph. D. ( Designated Federal Officer, HSRB, EPA)

C 4: 00 PM Adjournment * Please be advised that agenda times are approximate. For further information, including teleconference number, please contact the HSRB Designated Federal Officer, Paul Lewis, via telephone: 202 564 8381 or email: lewis. paul@ epa. gov


[Federal Register: December 12, 2006 (Volume 71, Number 238)]
[Notices]
[Page 74499]
[DOCID:fr12de06-53]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP98-18-026]

Iroquois Gas Transmission System, L.P.; Notice of Negotiated Rate

December 6, 2006.
    Take notice that on December 1, 2006, Iroquois Gas Transmission
System, L.P. (Iroquois) tendered for filing the following revised
sheets to its FERC Gas Tariff, First Revised Volume No. 1, to be
effective on December 1, 2006:

Original Sheet No. 6K
Original Sheet No. 6L

    Iroquois states that copies of its filing were served on all
jurisdictional customers and interested state regulatory agencies.
    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 and 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 in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not 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 14 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 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 e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-21092 Filed 12-11-06; 8:45 am]

BILLING CODE 6717-01-P