Ms. Sonja Pascatore 3059 Garfield Road Jamestown, New York 14701 Dear Ms. Pascatore,

Thank you for your letter regarding the reregistration of endothall. Public comments that the Agency receives during public comment periods are an integral part of the reregistration process. It is my understanding that a reply letter was already sent to you from Administrator Johnson's office. However, I wanted to specifically address several of your comments, as well as the documents that you provided to the Agency. Below you will find responses to several of your direct comments. In addition, formal responses from the Environmental Fate and Effects Division and Health Effects Division are available in the endothall docket ( OPP 2004 0370) that includes responses to several of your comments.

After considering your comments which raise concerns about endothall concentrations increasing in aquatic environments ( a and i), we reexamined the report cited and found that it reported a 160% increase in dissipation, not concentration. The study that is referenced ( Yeo, 1970. Dissipation of Endothall and Effects on Aquatic Weeds and Fish. Weed Science, 18( 2): 282 284) indicates an overall decrease in endothall concentrations over time. Initial concentrations of 3 ppm decreased to 1.15 over 12 days ( Table 3).

In response to comment b, pertaining to the possibility of a small child ingesting endothall at doses that would result in adverse health effects: The Agency is concerned with children being exposed to pesticides in ways that would result in health risks. However, as part of the reregistration process, health risks resulting from labeled use patterns are assessed. For endothall, a risk assessment was conducted to assess risks to children and adults swimming in endothall treated water. Incidental oral exposure estimates for adults and children are below the Agency's level of concern. The swimming exposure scenario relies on very conservative assumptions, including an UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES exposure time of 3 hours a day for approximately 70 days for children and 300 days for adults. The Agency also expects exposure to swimmers from the dermal route to be extremely low.

Regarding comment c, concerning eye irritation: the active ingredient endothall is an eye irritant and can cause eye damage if it comes in contact with the eyes. There is a precautionary statement on all products with endothall as its active ingredient. The precautionary statement is directed towards mixers, loaders, and applicators, which come in direct contact with the undiluted product. Labels currently require the use of eyewear for occupational handlers. Because children are not anticipated to participate in applications or other handler activities, the Agency did not assess such risks to children. In addition, because of typical use patterns, the Agency does not believe that swimmers ( children or adults) will be exposed to endothall at concentrations that would result in eye irritation.

In response to comment e, pertaining to toxicity of endothall to fish: the Agency is concerned that application of endothall to water bodies may lead to fish kills, and this risk is addressed in the ecological risk assessment as well as on the product label. For most applications to public water bodies, proper permitting must be acquired before endothall can be applied. If a permit is required, the applicator must inform the municipality in the jurisdiction of the risks associated with the chemical that is to be applied. In addition, it is not the goal of endothall applicators to kill fish, and applicators take precautions to minimize risks to fish.

After considering your comments regarding endothall labels lacking a skull and crossbones warning sign ( f), we re examined current labels. Technical grade endothall is characterized as toxicity category I for acute oral toxicity, acute eye irritation, and acute dermal irritation. However, some label language ( i. e., skull and crossbones) is based on the acute toxicity characteristics of the end use products. Endothall end use products do not contain 100% active ingredient. Therefore, end use products usually have different toxicity than the active ingredient. As part of product reregistration, which follows active ingredient reregistration, the registrant is required to submit toxicity studies that use enduse formulations. After the end use product toxicity studies are reviewed, appropriate label language will be added to end use labels ( i. e., goggles, gloves, etc.). In addition, in response to comment g, the Pesticide Applicators Manual likely categorizes endothall technical as toxicity category I for handler and applicator purposes. Further, the numerous incident databases that the Agency consults during the reregistration process contained relatively few incidents of illness due to endothall. No endothall related hospitalizations have been reported due to endothall use.

In response to comment h, regarding endothall's carcinogenic potential: the submitted pages are taken from the paper " Health Effects of Using 2,4 D or Endothall is Lakes" by Ruth W. Shearer, Ph. D, dated May 21, 1984. Only two pre 1980 published mutagenicity studies were positive. Prior to this article, the only available oncogenicity studies sponsored by the registrant were a rat study by Industrial Biotest Laboratories ( IBT) and an unidentified mouse test. IBT was subsequently convicted of supplying fraudulent data and IBT studies are not used in EPA evaluations. Neither of these studies were used in the evaluation of endothall because they were performed prior to 1970, and the Federal Insecticide, Fungicide, and Rodenticide Act of 1988 forbids using studies for pesticide reregistration that were performed prior to 1970. The Agency has a complete set of valid oncogenicity tests ( rat and mouse) performed in the 80s and 90s which are negative for oncogenic response.

Again, thank you for your comments. The Agency appreciates carefully thought through comments such as yours because they serve as a way for us to assure that our evaluation is correct. I hope that the answers to your comments are helpful. If you have any further questions, feel free to contact me at 703 308 0041 or via email at hunter. mika@ epa. gov.

Sincerely,

Mika J. Hunter Chemical Review Manager Cc: Anne Overstreet Robert McNally Debbie Edwards


[Federal Register: September 17, 2009 (Volume 74, Number 179)]
[Notices]
[Page 47851-47855]
[DOCID:fr17se09-89]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Privacy Act of 1974: Systems of Records

AGENCY: Maritime Administration (MARAD), DOT.

ACTION: Notice to establish systems of records.

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

SUMMARY: DOT intends to establish systems of records under the Privacy
Act of 1974.

DATES: Effective Date: October 27, 2009. If no comments are received,
the proposal will become effective on the above date. If comments are
received, the comments will be considered and, where adopted, the
documents will be republished with changes.

ADDRESSES: Send comments to: Habib Azarsina, Departmental Privacy
Officer, S-80, United States Department of Transportation, Office of
the Secretary of Transportation, 1200 New Jersey Ave., SE., Washington,
DC 20590, or<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Habib Azarsina, Departmental Privacy
Officer, S-80, United States Department of Transportation, Office of
the Secretary of Transportation, 1200 New Jersey Ave., SE., Washington,
DC 20590, telephone<PHONE_NUMBER> or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Department of Transportation system of
records notice subject to the Privacy Act of 1974 (5 U.S.C. 552a), as
amended, has been published in the Federal Register and is available
from the above mentioned address.
System Number:
    DOT/MARAD 31

SYSTEM NAME:
    Mariner Outreach System (MOS).

SECURITY CLASSIFICATION:
    Unclassified, Sensitive.

SYSTEM LOCATION:
    NCCIPS Data Center Loading Dock, Cypress Loop Road, Building 9323,
Stennis Space Center, MS 39529.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM OF RECORDS:
    The Mariner Outreach System (MOS) contains information about U.S.
Coast Guard (USCG) mariners. MOS provides a systematic way to monitor
the adequacy of our nation's merchant mariner pool and to track and
maintain contact information and qualifications of mariners. Therefore,
there is the potential for the following categories of individual's
information to be covered by this system:
     Data about mariners who hold or previously held a USCG
credential.

CATEGORIES OF RECORDS IN THE SYSTEM:
    MOS contains the following types of information:
     Information from the Merchant Mariner License and
Documentation (MMLD) including personal data such as last 4 digits of
SSN, date of birth (DOB), place of birth (POB).
     Mariners updated contact information, e.g., address, e-
mail(s), and phone number(s).

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    National Security Directive 28 (October 5, 1989), Merchant
Marine Act of 1936; Maritime Security Act of 2003 (Pub. L. 108-136).

PURPOSES:
    MOS is an invaluable tool for MARAD and its partners to make valid
vessel and human resources projections; identify potential mariner
shortfalls; allow mariners to provide up-to-date/

accurate contact information; and to facilitate crewing of vessels
should a mariner shortage occur.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
    The Office of Maritime Workforce Development's routine use of
information is for resource projection, maintain contact information
and facilitate filling shortages. The merchant mariners who hold or
previously held a USCG credential can self-register and update his/her
own contact information after registration.

DISCLOSURE TO CONSUMER REPORTING AGENCIES:
    None.

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
    Data is stored in this system on a dedicated server.

RETRIEVABILITY:
    Registered mariners can only view their own personal records by
user ID, obtained from initial self-registration, and password.
    Authorized administrator at Maritime Workforce Development can
retrieve data for analysis, resource protection, and facilitation of
crewing of vessels, as necessary, by last name, first name and last 4-
digits of social security number.

SAFEGUARDS:
    The production environment is located in a secure zone behind a
firewall, called a Demilitarized Zone (DMZ) that enables secure
connections from the Internet.
    DOT Crisis and Security Management Center (CSMC) monitors all
traffic within the department looking for any possible attacks. CSMC
works with the modes during possible attacks. MARAD has Cisco ASA
devices to monitor events on the system, detect attacks, and provide
identification of unauthorized use of the system.
    The Stennis Data Center in Mississippi hosting MOS is occupied by
the Department of Navy contractor personnel and is not open to the
general public. The Data Center is uniquely constructed. It was
formerly an ammunition manufacturing facility and as such, its external
walls are constructed completely of steel reinforced concrete that is
12 to 48 inches thick. It has no windows. The construction materials as
well as its location inside of the Stennis Space Center significantly
reduce its vulnerability to most conventional types of external threats
i.e. vehicle born improvised explosive devices (VBIEDs), burglary,
trespassing, and unauthorized entry.
    The facility operates in a secure closed manner. Outside personnel
do not have unescorted access to the facility. Mail deliveries are
received by facility personnel who screen all material before being
brought into the facility. All equipment is delivered and sent through
a secure loading dock. All equipment is installed either by or under
the supervision of facility personnel.
    The test and development environments are available only to local
personnel and selected users connecting via a Virtual Private Network.
    System data is protected by daily backups to Linear Tape Open
(LTO3) tape. In addition, daily backups of data to a local server hard
drive, which are kept for a period of 14 days to safeguard the data.

RETENTION AND DISPOSAL:
    The files are retained and disposed of according to the MARAD
Records Schedule, according to the National Archives and Records
Administration, and DOT policy.

SYSTEM OWNER(S) AND ADDRESS:
    Director, Office of Maritime Workforce Development, Maritime
Administration, 1200 New Jersey Ave., SE., Washington, DC 20590. 202-
366-5469.

NOTIFICATION PROCEDURE:
    Individuals wishing to know if their records appear in this system
may make a request in writing to the FOIA/Privacy Act Officer, Maritime
Administration, 1200 New Jersey Ave, SE., W26-499, Washington, DC
20590. The request must include the requester's name, mailing address,
telephone number and/or e-mail address, a description and, if possible,
the location of the records requested, and verification of identity
(such as, a statement under penalty or perjury that the requester is
the individual who he or she claims to be).

RECORD ACCESS PROCEDURES:
    Individuals seeking access to information about them in this system
should apply to the FOIA/Privacy Act Officer, following the same
procedure as indicated under ``Notification procedure.'' Mariners can
log into the system to view their documents.

CONTESTING RECORD PROCEDURES:
    Individuals seeking to contest the content of information about
them in this system should apply to the FOIA/Privacy Act Officer,
following the same procedure as indicated under ``Notification
procedure.''

RECORD SOURCE CATEGORIES:
    Information in MOS is obtained from U.S. Coast Guard (USCG) and
registered merchant mariners.
    The data from USCG include: (a) MMLD data which contain credentials
information, e.g., merchant mariners credentials (MMC), merchant
mariners document (MMD), merchant mariners' standards, training
certification, and watch keeping (STCW), merchant mariners' license,
certificate of registry (COR); (b) Personal info: Name (e.g., first
name, middle name, last name, e-mail addresses, resident address,
citizenship, personal contact information); (c) merchant mariners' sea
service records.
    Registered merchant mariners data source: During self-registration,
the merchant mariner enters into MOS his/her last 4 digits of SSN,
first name, last name, place of birth, date of birth, and the password
of his/her choice. A registered mariner can use the user id and
password to update his/her own information later on.

EXEMPTIONS CLAIMED FOR THE SYSTEM:
    None.
System Number:
    DOT/MARAD 32

SYSTEM NAME:
    Maritime Service Compliance System (MSCS).

SECURITY CLASSIFICATION:
    Unclassified, Sensitive.

SYSTEM LOCATION:
    NCCIPS Data Center Loading Dock, Cypress Loop Road, Building 9323,
Stennis Space Center, MS 39529.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM OF RECORDS:
    The following categories of individuals are covered by this system:
     Current and former students of the U.S. Merchant Marine
Academy (USMMA) at Kings Point, NY.
     Current and former students enrolled in the Student
Incentive Payment (SIP) program at the six (6) State Maritime Academies
(SMAs).

CATEGORIES OF RECORDS IN THE SYSTEM:
    MSCS contains the following types of information:
     Current SMA SIP and USMMA students' name, address, SSN,
date of birth (DOB) and graduation date.
     Former SMA SIP and USMMA students' name, address, SSN,
DOB.
     Data to determine former student compliance with
obligation requirements.

     Data to determine SIP funding provided to SMA (SIP)
cadets.
     Data to determine if a graduate from the SMA or the USMMA
has received a deferment or waiver from MARAD of their service
obligation.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    Merchant Marine Act of 1936; Maritime Security Act of 2003 (Pub. L.
108-136).

PURPOSES:
    MSCS provides an online method for students and graduates of the
maritime academies to report their compliance with post-graduation
national service obligation requirements. The system also assists MARAD
in monitoring and documenting student's enrollment status while
attending the maritime academies, making subsidy payments to SMA SIP
students, and maintaining a record of the maritime academy graduates
fulfillment of their service obligations. The MSCS also contains the
graduate's employment determination waivers, and graduate school
deferments.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
    MSCS is used by current students and graduates to report their
compliance with service obligation requirements. MSCS is used by the
Office of Maritime Workforce Development at MARAD to monitor student's
enrollment status. MSCS is used by the USMMA to enter service
obligation information on the USMMA graduates.

DISCLOSURE TO CONSUMER REPORTING AGENCIES:
    None.

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
    Data is stored in this system on a dedicated server.

RETRIEVABILITY:
    Records are retrievable by name or social security number.

ACCESSIBILITY/SAFEGUARDS:
    The production environment is located in a secure zone behind a
firewall, called a Demilitarized Zone (DMZ) that enables secure
connections from the Internet.
    DOT Crisis and Security Management Center (CSMC) monitors all
traffic within the department looking for any possible attacks. CSMC
works with the modes during possible attacks. MARAD has Cisco ASA
devices to monitor events on the system, detect attacks, and provide
identification of unauthorized use of the system.
    The Stennis Data Center in Mississippi hosting MSCS is occupied by
the Department of Navy contractor personnel and is not open to the
general public. The Data Center is uniquely constructed. It was
formerly an ammunition manufacturing facility and as such, its external
walls are constructed completely of steel reinforced concrete that is
12 to 48 inches thick. It has no windows. The construction materials as
well as its location inside of the Stennis Space Center significantly
reduce its vulnerability to most conventional types of external threats
i.e. vehicle born improvised explosive devices (VBIEDs), burglary,
trespassing, and unauthorized entry.
    The facility operates in a secure closed manner. Outside personnel
do not have unescorted access to the facility. Mail deliveries are
received by facility personnel who screen all material before being
brought into the facility. All equipment is delivered and sent through
a secure loading dock. All equipment is installed either by or under
the supervision of facility personnel. The test and development
environments are available only to local personnel and selected users
connecting via a Virtual Private Network.
    System data is protected by daily backups to Linear Tape Open
(LTO3) tape. In addition, daily backups of data to a local server hard
drive, which are kept for a period of 14 days to safeguard the data.

RETENTION AND DISPOSAL:
    The files are retained and disposed of according to the MARAD
Records Schedule, according to the National Archives and Records
Administration, and DOT policy.

SYSTEM OWNER(S) AND ADDRESS:
    Academies Program Officer, Maritime Administration, U.S. Department
of Transportation, 1200 New Jersey Avenue, SE., Washington, DC 20590.
202-366-0284.

NOTIFICATION PROCEDURE:
    Individuals wishing to know if their records appear in this system
may make a request in writing to the FOIA/Privacy Act Officer, Maritime
Administration, 1200 New Jersey Ave., SE., W26-499, Washington, DC
20590. The request must include the requester's name, mailing address,
telephone number and/or e-mail address, a description and, if possible,
the location of the records requested, and verification of identity
(such as, a statement under penalty or perjury that the requester is
the individual who he or she claims to be).

RECORD ACCESS PROCEDURES:
    Individuals seeking access to information about them in this system
should apply to the FOIA/Privacy Act Officer, following the same
procedure as indicated under ``Notification procedure.'' Mariners can
log into the system to view their documents.

CONTESTING RECORD PROCEDURES:
    Individuals seeking to contest the content of information about
them in this system should apply to the FOIA/Privacy Act Officer,
following the same procedure as indicated under ``Notification
procedure.''

RECORD SOURCE CATEGORIES:
    Information in MSCS is obtained from the USMMA and the SMA, and
both current and former students of the USMMA and current and former
students enrolled in the SIP program at the six (6) SMAs.
    Information includes students' names (first, middle initial, and
last), addresses, SSNs, date of birth, enrollment status while
attending the Academies, subsidy payments to SMA SIP students, records
of the graduates' fulfillment of service obligations, graduates'
employment determination waivers, and graduate school deferments.

EXEMPTIONS CLAIMED FOR THE SYSTEM:
    None.
System Number:
    DOT/MARAD 33

SYSTEM NAME:
    Payroll Labor Distribution System (PLDS).

SECURITY CLASSIFICATION:
    Unclassified, Sensitive.

SYSTEM LOCATION:
    NCCIPS Data Center Loading Dock, Cypress Loop Road, Building 9323,
Stennis Space Center, MS 39529.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM OF RECORDS:
    The Payroll Labor Distribution System is a system, which creates
Accounting Transaction files based on Payroll information from IR Labor
Cost File and the Reserve Fleet Files. This system has a biweekly
processing cycle, which performs by the Federal users in the MARAD
office of accounting through a menu processor, the processing programs,
and data entry programs.
    Therefore, there is the potential for the following categories of
individuals'

information to be covered by this system:
     Data about MARAD personnel (officials and employees).

CATEGORIES OF RECORDS IN THE SYSTEM:
    The input of information into PLDS is not discretionary. Utilizing
information from Department of Interior (DOI) Payroll system and the
Reserve Fleet files, PLDS performs accounting, reconciliation and cost
assignment using data from both sources. PLDS contains the following
types of information:
     DOI (Labor Cost File) which includes MARAD personnel's
personal information, e.g., SSN, first name, middle name, last name,
pay grade and step, salary data.
     Reserve Fleet files contain MARAD personnel's personal
information, e.g., SSN, first name, middle name, last name, hours
worked during a pay period.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    Maritime Domain Awareness (MDA) program and the Maritime Security
Act of 2003 (Pub. L. 108-136).

PURPOSES:
    The Payroll Labor Distribution System allows for the utilization of
payroll information, received from DOI (Labor Cost File), in performing
the routine accounting functions for the Maritime Administration
(MARAD) officials and employees. These functions include the comparison
and reconciliation of data from the Labor Cost Distribution File
against data on the Reserve Fleet Files. These functions also include
the assignment of costs to project numbers based on information taken
from the Reserve Fleet files, and the creation of accounting
transactions for input into the Departmental Accounting Financial
Information System (Dafis) Accounting System.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
    The routine use of the information is for payroll accounting
procedures, including reconciliation with the DOI Payroll system.

DISCLOSURE TO CONSUMER REPORTING AGENCIES:
    None.

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
    Data is stored in this system on a dedicated server.

RETRIEVABILITY:
    Only authorized staff in the Chief Financial Officer (CFO) office
can retrieve records by searching name, SSN and/or project.

ACCESSIBILITY/SAFEGUARDS:
    The production environment is located in a secure zone behind a
firewall, called a Demilitarized Zone (DMZ) that enables secure
connections from the Internet.
    DOT Crisis and Security Management Center (CSMC) monitors all
traffic within the department looking for any possible attacks. CSMC
works with the modes during possible attacks. MARAD has Cisco ASA
devices to monitor events on the system, detect attacks, and provide
identification of unauthorized use of the system.
    The Stennis Data Center in Mississippi hosting PLDS is occupied by
the Department of Navy contractor personnel and is not open to the
general public. The Data Center is uniquely constructed. It was
formerly an ammunition manufacturing facility and as such, its external
walls are constructed completely of steel reinforced concrete that is
12 to 48 inches thick. It has no windows. The construction materials as
well as its location inside of the Stennis Space Center significantly
reduce its vulnerability to most conventional types of external threats
i.e. vehicle born improvised explosive devices (VBIEDs), burglary,
trespassing, and unauthorized entry.
    The facility operates in a secure closed manner. Outside personnel
do not have unescorted access to the facility. Mail deliveries are
received by facility personnel who screen all material before being
brought into the facility. All equipment is delivered and sent through
a secure loading dock. All equipment is installed either by or under
the supervision of facility personnel.
    The test and development environments are available only to local
personnel and selected users connecting via a Virtual Private Network.
    System data is protected by daily backups to Linear Tape Open
(LTO3) tape. In addition, daily backups of data to a local server hard
drive, which are kept for a period of 14 days to safeguard the data.

RETENTION AND DISPOSAL:
    The files are retained and disposed of according to the MARAD
Records Schedule, according to the National Archives and Records
Administration, and DOT policy. Currently PLDS records are retained for
12 years. Records older than 12 years will be purged by system owner.

SYSTEM OWNER(S) AND ADDRESS:
    John Hoban, Deputy Chief Financial Officer (CFO), Maritime
Administration, 1200 New Jersey Ave., SE., Washington, DC 20590.
<EMAIL_ADDRESS>202-366-5110.

NOTIFICATION PROCEDURE:
    Individuals wishing to know if their records appear in this system
may make a request in writing to the FOIA/Privacy Act Officer. (DOT
employees may make the request in person or in writing). The request
must include the requester's name, mailing address, telephone number
and/or e-mail address, a description and, if possible, the location of
the records requested, and verification of identity (such as, a
statement under penalty or perjury that the requester is the individual
who he or she claims to be).

RECORD ACCESS PROCEDURES:
    Individuals seeking access to information about them in this system
should apply to the FOIA/Privacy Act Officer, following the same
procedure as indicated under ``Notification procedure.''

CONTESTING RECORD PROCEDURES:
    Individuals seeking to contest the content of information about
them in this system should apply to the FOIA/Privacy Act Officer,
following the same procedure as indicated under ``Notification
procedure.''

RECORD SOURCE CATEGORIES:
    Information in PLDS is obtained from DOI and Reserve Fleet files.
    The records retrieved from DOI's Labor Cost File per pay period
(via secured ftp) contain personal information such as SSN, name (last,
middle, first), pay grade and step, and salary.
    The data in Reserve Fleet File include SSN, name (last, middle,
first), hours worked during a pay period.

EXEMPTIONS CLAIMED FOR THE SYSTEM:
    None.
System Number:
    DOT/MARAD 34

SYSTEM NAME:
    Personnel Management Information System (PMIS).

SECURITY CLASSIFICATION:
    Unclassified, Sensitive.

SYSTEM LOCATION:
    NCCIPS Data Center Loading Dock, Cypress Loop Road, Building 9323,
Stennis Space Center, MS 39529.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM OF RECORDS:
    The following categories of individuals are covered by PMIS:
    1. All active MARAD employees, which include U.S. Merchant Marine
Academy (USMMA) Federal employees.
    2. All inactive MARAD and USMMA employees, which include retirees.

CATEGORIES OF RECORDS IN THE SYSTEM:
    PMIS contains the following types of records:
     Payroll information such as pay grade, salary, awards,
thrift savings data (TSP), reduction in force (RIF) Personnel data
include SSN, name (first, middle, last), security clearance level,
employment status, organization, etc.
     Project labor charges has the labor rate information for
each MARAD mission project.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    Merchant Marine Act of 1936.

PURPOSES:
    PMIS is used for personnel management, which includes name, labor
charges, approved project codes. The information is utilized for
project management and forecasting labor charges.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
    PMIS provides MARAD managers with timely Personnel Compensation &
Benefit (PC&B) information to allow informed decision-making, which can
be the cost effects of current and future staffing and the financial
position of their organizations. PMIS is also used to generate bi-
weekly, monthly, and ad hoc management reports, e.g., a within grade
increase (WGI) projection report for the employees' pay increase and
budget cost within an organization.

DISCLOSURE TO CONSUMER REPORTING AGENCIES:
    None.

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING,
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
    Data is stored in this system on a dedicated server.

RETRIEVABILITY:
    Records are retrievable by last name, organization code and pay
period.

SAFEGUARDS:
    The production environment is located in a secure zone behind a
firewall, called a Demilitarized Zone (DMZ) that enables secure
connections from the Internet.
    DOT Crisis and Security Management Center (CSMC) monitors all
traffic within the department looking for any possible attacks. CSMC
works with the modes during possible attacks. MARAD has Cisco ASA
devices to monitor events on the system, detect attacks, and provide
identification of unauthorized use of the system.
    The Stennis Data Center in Mississippi hosting PMIS is occupied by
the Department of Navy contractor personnel and is not open to the
general public. The Data Center is uniquely constructed. It was
formerly an ammunition manufacturing facility and as such, its external
walls are constructed completely of steel reinforced concrete that is
12 to 48 inches thick. It has no windows. The construction materials as
well as its location inside of the Stennis Space Center significantly
reduces its vulnerability to most conventional types of external
threats i.e. vehicle born improvised explosive devices (VBIEDs),
burglary, trespassing, and unauthorized entry.
    The facility operates in a secure closed manner. Outside personnel
do not have unescorted access to the facility. Mail deliveries are
received by facility personnel who screen all material before being
brought into the facility. All equipment is delivered and sent through
a secure loading dock. All equipment is installed either by or under
the supervision of facility personnel.
    The test and development environments are available only to local
personnel and selected users connecting via a Virtual Private Network.
    System data is protected by daily backups to Linear Tape Open
(LTO3) tape. In addition, daily backups of data to a local server hard
drive, which are kept for a period of 14 days to safeguard the data.

RETENTION AND DISPOSAL:
    The files are retained and disposed of according to the MARAD
Records Schedule, according to the National Archives and Records
Administration, and DOT policy. Schedule No. 232 (Dispose of when
superseded by master file processing updates.)

SYSTEM OWNER(S) AND ADDRESS:
    Deputy Chief Financial Officer (CFO), Maritime Administration, 1200
New Jersey Ave, SE., Washington, DC 20590.<PHONE_NUMBER>.

NOTIFICATION PROCEDURE:
    Individuals wishing to know if their records appear in this system
may make a request in writing to the FOIA/Privacy Act Officer, Maritime
Administration 1200 New Jersey Ave, SE., W26-499, Washington, DC 20590.
The request must include the requester's name, mailing address,
telephone number and/or e-mail address, a description and, if possible,
the location of the records requested, and verification of identity
(such as, a statement under penalty or perjury that the requester is
the individual who he or she claims to be).

RECORD ACCESS PROCEDURES:
    Individuals seeking access to information about them in this system
should apply to the FOIA/Privacy Act Officer, following the same
procedure as indicated under ``Notification procedure.'' Mariners can
log into the system to view their documents.

CONTESTING RECORD PROCEDURES:
    Individuals seeking to contest the content of information about
them in this system should apply to the FOIA/Privacy Act Officer,
following the same procedure as indicated under ``Notification
procedure.''

RECORD SOURCE CATEGORIES:
    Information in PMIS is obtained from U.S. Department of Interior
(DOI) and DOT/FAA Federal Personnel and Payroll System (FPPS).
    The data from DOI includes employees' payroll data such as SSN,
name (first, middle, last), hours worked, and salary.
    The information from FPPS contains number of employees for each
organization, SSN, name (first, middle, last), salary, type of pay
plan, and leave balance.

EXEMPTIONS CLAIMED FOR THE SYSTEM:
    None.

    Dated: September 10, 2009.
Habib Azarsina,
Departmental Privacy Officer.
[FR Doc. E9-22388 Filed 9-16-09; 8:45 am]

BILLING CODE 4910-9X-P


[Federal Register Volume 84, Number 29 (Tuesday, February 12, 2019)]
[Notices]
[Pages 3470-3471]
[FR Doc No: 2019-02036]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-E-6739]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ZEJULA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for ZEJULA and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
15, 2019. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by August 12, 2019.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 15, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 15, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-E-6739 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; ZEJULA.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management

Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, ZEJULA
(niraparib) indicated for maintenance treatment of adult patients with
recurrent epithelial ovarian, fallopian tube, or primary peritoneal
cancer who are in a complete or partial response to platinum-based
chemotherapy. Subsequent to this approval, the USPTO received a patent
term restoration application for ZEJULA (U.S. Patent No. 8,071,623)
from MSD Italia S.R.l., and the USPTO requested FDA's assistance in
determining the patent's eligibility for patent term restoration. In a
letter dated January 9, 2018, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of ZEJULA represented the first permitted commercial marketing
or use of the product. Thereafter, the USPTO requested that FDA
determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
ZEJULA is 3,234 days. Of this time, 3,086 days occurred during the
testing phase of the regulatory review period, while 148 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
May 21, 2008. The applicant claims May 22, 2008, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was May 21, 2008,
which was the first date after receipt of the IND that the
investigational studies were allowed to proceed.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: October
31, 2016. FDA has verified the applicant's claim that the new drug
application (NDA) for ZEJULA (NDA 208447) was initially submitted on
October 31, 2016.
    3. The date the application was approved: March 27, 2017. FDA has
verified the applicant's claim that NDA 208447 was approved on March
27, 2017.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 370 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 7, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02036 Filed 2-11-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 206 (Wednesday, October 24, 2012)]
[Rules and Regulations]
[Pages 64911-64915]
[FR Doc No: 2012-26086]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0677; FRL-9365-7]

Fluoxastrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of fluoxastrobin and its Z-isomer in or on poultry, liver; hog, fat;
hog, meat byproducts; and rice, grain. Arysta LifeScience, North
America, LLC, requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 24, 2012. Objections and
requests for hearings must be received on or before December 24, 2012,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2009-0677, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Heather Garvie, Registration Division
(7504P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0677 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
December 24, 2012. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2009-0677, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.

     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http:[sol][sol]www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at
http:[sol][sol]www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register issue of October 5, 2011 (76 FR 61647)
(FRL-8890-5), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 1F7897) by Arysta LifeScience, North America, LLC, 15401
Weston Pkwy., Suite 150, Cary, NC 27513. The petition requested that 40
CFR 180.609 be amended by establishing tolerances for combined residues
of the fungicide fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-
4-pyrimydinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime, and its Z-isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-
4-pyrimydinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime, in or on rice, grain at 6.0 parts per million (ppm). That
document referenced a summary of the petition prepared by Arysta
LifeScience, North America LLC, the registrant, which is available in
the docket, http:[sol][sol]www.regulations.gov. A comment was received
on the notice of filing. EPA's response to this comment is discussed in
Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
revised the proposed tolerance on rice, grain to 4.0 ppm and
established additional tolerances for hog, fat; hog, meat byproducts;
and poultry, liver. The reason for these changes are explained in Unit
IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of 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 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 * *
*.''
    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 fluoxastrobin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with fluoxastrobin
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 most recent human health risk assessment for fluoxastrobin was
conducted for use on the squash/cucumber crop subgroup 9B. Since that
time, an adequate functional immunotoxicity study has been submitted
and reviewed. In accordance with 40 CFR part 158--Data Requirements for
Pesticides, a subchronic inhalation study is also required for
fluoxastrobin. However, the Agency has waived the inhalation toxicity
study data requirement at this time. The hazard characterization and
toxicity endpoints for risk assessment remain unchanged.
    Fluoxastrobin and its major metabolites were evaluated in a battery
of genotoxicity tests and results were negative. The carcinogenic
potential of fluoxastrobin was adequately tested in rats and mice of
both sexes. The results demonstrated a lack of treatment-related
increase in tumor incidence in rats or mice. There was no mutagenicity
concern and no structure activity relationship alert. It was concluded
that there was no incidence of carcinogenicity for fluoxastrobin.
Specific information on the studies received and the nature of the
adverse effects caused by fluoxastrobin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule
that established a tolerance for residues of fluoxastrobin in or on
squash/cucumber subgroup 9B. That rule was published in the Federal
Register issue of August 17, 2011 (76 FR 50893) (FRL-8884-4).

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty factors (UFs)/safety factors (SFs) are used in
conjunction with the POD to calculate a safe exposure level--generally
referred to as a population-adjusted dose (PAD) or a reference dose
(RfD)--and a safe margin of exposure (MOE). For non-threshold risks,
the Agency assumes that any amount of exposure will lead to some degree
of risk. Thus, the Agency estimates risk in terms of the probability of
an occurrence of the adverse effect expected in a lifetime. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for fluoxastrobin used for
human risk assessment is shown in Table 1 of the final rule published
in the Federal Register issue of August 17, 2011, p. 50895.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluoxastrobin, EPA considered exposure under the
petitioned-for tolerances as well as all existing fluoxastrobin
tolerances in 40 CFR 180.609. EPA assessed dietary exposures from
fluoxastrobin 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. No such effects were

identified in the toxicological studies for fluoxastrobin; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data 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, EPA conducted a conservative dietary exposure
assessment for fluoxastrobin. The assumptions of this dietary
assessment included tolerance level residues and 100 percent crop
treated (PCT). The Dietary Exposure Evaluation Model (DEEM) software
version 7.81 default processing factors were assumed except for where
tolerances were established for processed commodities or when
processing studies showed no concentration. Based on processing
studies, the processing factors for dried potato (granules/flakes),
potato chips, potato flour, and tomato puree were reduced to 1.
Separate tolerances were set for peanut oil, tomato paste, and wheat
bran; therefore, the processing factors for these commodities were set
at 1.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fluoxastrobin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for fluoxastrobin. Tolerance level residues and/or
100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. Based on laboratory
studies, fluoxastrobin persists in soils for several months to several
years and is slightly to moderately mobile in soil. The Agency used
screening level water exposure models in the dietary exposure analysis
and risk assessment for fluoxastrobin in drinking water. These
simulation models take into account data on the physical, chemical, and
fate/transport characteristics of fluoxastrobin. 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.
    Based on the Tier 1 Rice Model and Screening Concentration in
Ground Water (SCI-GROW) models, the estimated drinking water
concentrations (EDWCs) of fluoxastrobin for chronic exposures for non-
cancer assessments are estimated to be 93 parts per billion (ppb) for
surface water and 0.038 ppb for ground water. Modeled estimates of
drinking water concentrations were directly entered into the dietary
exposure model. For chronic dietary risk assessment, the water
concentration value of 93 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).
    Fluoxastrobin is currently registered for the following uses that
could result in residential exposures: Spot treatment and/or broadcast
control of diseases on turf, including lawns and golf courses. EPA
assessed residential exposure using the following assumptions:
Residential handler exposure for adults is expected to be short-term
only. Intermediate-term and chronic exposures are not likely because of
the intermittent nature of applications by homeowners. Since there are
no toxicity findings for the short-term dermal route of exposure up to
the limit dose, the residential handler assessment only includes the
inhalation route of exposure.
    There is also potential for homeowners and their families (of
varying ages) to be exposed as a result of entering areas that have
previously been treated with fluoxastrobin. Exposure might occur on
areas such as lawns used by children or recreational areas such as golf
courses used by adults and youths. Potential routes of exposure include
dermal (adults and children) and incidental oral ingestion (children).
Since no acute hazard has been identified, an assessment of episodic
granular ingestion was not conducted. Further information regarding EPA
standard assumptions and generic inputs for residential exposures may
be found at: http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    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 fluoxastrobin to share a common mechanism of
toxicity with any other substances, and fluoxastrobin does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
fluoxastrobin does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at  http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA (Food
Quality Protection Act) SF. In applying this provision, EPA either
retains the default value of 10X, or uses a different additional SF
when reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. The available studies used
to evaluate pre- and postnatal exposure susceptibility do not indicate
increased susceptibility of rats or rabbits to fluoxastrobin. These
studies include the following:
    i. Developmental toxicity studies in rats.
    ii. Developmental toxicity studies in rabbits.
    iii. A 2-generation reproduction study in rats.
    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 fluoxastrobin is complete.
    ii. There is no indication that fluoxastrobin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that fluoxastrobin results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. The exposure databases are estimated based on data that
reasonably account for potential exposures. The

chronic dietary food exposure assessment was conservatively based on
100 PCT assumptions, tolerance-level residues, and conservative ground
and surface drinking water modeling estimates. New 2012 Residential
Standard Operating Procedures (SOPs) were used to assess post-
application exposure to children including incidental oral exposure.
The residential post-application assessment assumes maximum application
rates and conservative day zero hand-to-mouth activities. All of the
exposure estimates for fluoxastrobin are based on conservative high-end
assumptions and are not likely to result in underestimated risk.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
fluoxastrobin is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fluoxastrobin from food and water will utilize 36% of the cPAD for the
general population, and 75% of the cPAD for children 1-2 years old, the
population group receiving the greatest exposure. Based on the
explanation in Unit III.C.3., regarding residential use patterns,
chronic residential exposure to residues of fluoxastrobin is not
expected.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short-term residential exposure
plus chronic exposure to food and water (considered to be a background
exposure level).
    Fluoxastrobin is 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 fluoxastrobin. Because all
short- and intermediate-term quantitative hazard assessments (via the
dermal and incidental oral routes) for fluoxastrobin are based on the
same endpoint, a screening-level, conservative aggregate risk
assessment was conducted that combined the short-term incidental oral
and intermediate-term exposure estimates (i.e., the highest exposure
estimates) in the risk assessments for adults. The Agency believes that
most residential exposure will be short-term, based on the use pattern.
    There is potential short- and intermediate-term exposure to
fluoxastrobin via the dietary (which is considered background exposure)
and residential (which is considered primary) pathways. For adults,
these pathways lead to exposure via the oral (background), and dermal
and inhalation (primary) routes. For children, these pathways lead to
exposure via the oral (background), and incidental oral and dermal
(primary) routes.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 920 for adults
and 220 for children (1-2 years old). Because EPA's level of concern
for fluoxastrobin is a MOE of 100 or below, these MOEs are not of
concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, fluoxastrobin is not expected to pose a cancer risk to humans.
    5. 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 fluoxastrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/mass
spectrometry/mass spectrometry) is available to enforce the tolerance
expression. Method No. 00604 is available for plant commodities and
Method No. 00691 is available for animal commodities. 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>; email address<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. There are currently no
established Mexican, Canadian, or Codex MRLs or tolerances for
fluoxastrobin.

C. Response to Comment

    One comment was received to the docket from the City of Sacramento,
CA. The comment was a request that the EPA thoroughly review the
request to register fluoxastrobin for use on rice with regard to its
potential to affect drinking water quality. The Agency has determined
that dietary risks for fluoxastrobin are below the Agency's concern for
dietary exposure and risk.

D. Revisions to Petitioned-For Tolerances

    The petitioner requested a tolerance level of 6.0 ppm for rice,
grain in the notice of filing. The Agency has revised the tolerance
level from 6.0 ppm to 4.0 ppm for rice, grain based on the data used to
support the risk assessment. The petitioner has subsequently submitted
a revised notice of filing to the Agency requesting a tolerance level
of 4.0 ppm for rice, grain.
    The use of fluoxastrobin on rice, grain will result in a slight
increase in the dietary burden to ruminants; however secondary residues
in rumiant commodities are not expected to exceed the established
tolerances for milk and ruminant tissues. The increased dietary burden
to swine and poultry results in the need for tolerances for hog, fat at
0.03 ppm; hog meat, byproducts at 0.06 ppm; and poultry, liver at 0.06
ppm.

V. Conclusion

    Therefore, tolerances are established for combined residues of
fluoxastrobin and its Z-isomer, in or on rice, grain at 4.0 ppm; hog,
fat at 0.03 ppm; hog, meat

byproducts at 0.06 ppm; and poultry, liver at 0.06 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this 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) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: October 15, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.609:
0
i. Add alphabetically the commodity ``Rice, grain'' to the table in
paragraph (a)(1).
0
ii. Add alphabetically the following commodities to the table in
paragraph (a)(2). The additions read as follows:

Sec.  180.609  Fluoxastrobin; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Rice, grain................................................          4.0

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

    (2) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Hog, fat...................................................         0.03
Hog, meat byproducts.......................................         0.06

                                * * * * *
Poultry, liver.............................................         0.06

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

* * * * *
[FR Doc. 2012-26086 Filed 10-23-12; 8:45 am]
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[Federal Register Volume 83, Number 243 (Wednesday, December 19, 2018)]
[Proposed Rules]
[Pages 65117-65118]
[FR Doc No: 2018-27421]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 281

[EPA-R08-UST-2018-0728; FRL-9986-99--Region 8]

North Dakota: Authorization of State Underground Storage Tank
Program Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: Pursuant to the Resource Conservation and Recovery Act (RCRA
or Act), the Environmental Protection Agency (EPA) is proposing to
approve revisions to the State of North Dakota's Underground Storage
Tank (UST) program submitted by the State. This action is based on the
EPA's determination that the State's revisions satisfy all requirements
for UST program approval. The State's federally-authorized UST program,
as revised pursuant to this action, will remain subject to the EPA's
inspection and enforcement authorities under sections 9005 and 9006 of
RCRA subtitle I and other applicable statutory and regulatory
provisions. All revisions to the State of North Dakota's UST program
would be federally approved as of the effective date of this action.

DATES: Send written comments by January 18, 2019.

ADDRESSES: Submit your comments by one of the following methods:
    1. Federal eRulemaking Portal: http://www/regulations.gov. Follow
the online instructions for submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Mail: Benjamin Bents, Project Officer, UST, Solid Waste and PCB
Unit, Resource Conservation and Recovery Program, Office of
Partnerships and Regulatory Assistance (8P-R), EPA Region 8, 1595
Wynkoop Street, Denver, Colorado 80202-1129.
    4. Hand delivery or courier: Deliver your comments to Benjamin
Bents, Region 8, Project Officer, UST, Solid Waste and PCB Unit,
Resource Conservation and Recovery Program, Office of Partnerships and
Regulatory Assistance (8P-R), EPA Region 8, 1595 Wynkoop Street,
Denver, Colorado 80202-1129.
    Instructions: Direct your comments to Docket ID No. EPA-R08-UST-
2018-0728. The EPA's policy us that all comments received will be
included in the public docket without change and may be available
online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through http://www.regulations.gov, or email. The federal http://www.regulations.gov
website is an ``anonymous access'' system, which means the EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an email comment directly to the EPA
without going through http://www.regulations.gov, your email address
will be automatically captured and included as part of the comment that
is placed in the public docket and made available on the internet. If
you submit an electronic comment, the EPA recommends that you include
your name and other contact information in the body of your comment and
with any disk or CD-ROM you submit. If the EPA cannot read your comment
due to technical difficulties, and cannot contact you for
clarification, the EPA may not be able to consider your comment.
Electronic files should avoid the use of special characters, any form
of encryption, and be free of any defects or viruses.
    You can view and copy the documents that form the basis for this
action and associated publicly available materials from 8:30 a.m. to
4:00 p.m., Monday through Friday at the following location: EPA Region
8, 1595 Wynkoop Street, Denver, Colorado 80202-1129, phone number (303)
312-6435. Interested persons wanting to examine these documents should
make an appointment with the office at least 2 days in advance.

FOR FURTHER INFORMATION CONTACT: Benjamin Bents, Project Officer, UST,
Solid Waste and PCB Unit, Resource Conservation and Recovery Program,
Office of Partnerships and Regulatory Assistance (8P-R), EPA Region 8,
1595 Wynkoop Street, Denver, Colorado 80202-1129, phone number (303)
312-6435, email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The State of North Dakota adopted state
Senate Bill No. 2327 (S.L. 2017, ch. 199, Sec.  75) which separated the
Environmental Health Section from the North Dakota Department of Health
(NDDOH) to create a stand-alone North Dakota Department of
Environmental Quality (NDDEQ). Per S.L. 2017, ch. 199, Section 75, the
transfer of authority, power, and duties related to environmental
quality from NDDOH to NDDEQ will become effective upon the North Dakota
Legislative Council's receipt of the certification by the Chief of the
Environmental Health Section of the State Department of Health
attesting that all necessary federal approvals have been obtained and
all necessary federal and other agreements have been amended to ensure
the State will continue to meet the authorization requirements it
currently satisfies after the transfer of authority, powers, and duties
from the NDDOH to the NDDEQ. This rule constitutes the EPA approval of
the transfer of all duties and responsibilities of the State relating
to the existing federal UST program in North Dakota from the NDDOH to
the NDDEQ.
    The State plans to rely on the date when the EPA signs the final
rule for purposes of notifying the state legislature that the EPA has
approved these revisions, which will provide for the transfer of
authority to implement the federal UST program from the NDDOH to NDDEQ
to be effective under state law. The EPA understands that the State
intends to take the necessary

additional steps as specified in S.L. 2017, ch. 199, Section 75, to
ensure that NDDEQ comes into existence and that the NDDEQ rules are
effective as a matter of state law prior to the effective date of the
EPA's approval of these revisions. Unless and until the NDDEQ rules and
agency become fully effective under federal law, for purposes of
federal law the EPA recognizes the State's program as currently
approved. For additional information, see the direct final rule
published in the ``Rules and Regulations'' section of this issue of the
Federal Register.

    Authority: This rule is issued under the authority of Sections
2002(a), 7004(b), and 9004 of the Solid Waste Disposal Act, as
amended, 42 U.S.C. 6912(a), 6991c, 6991d, and 6991e.

List of Subjects in 40 CFR Part 281

    Environmental protection, Administrative practice and procedure,
Hazardous substances, State program approval, and Underground storage
tanks.

    Dated: December 13, 2018.
Douglas Benevento,
Regional Administrator, Region 8.
[FR Doc. 2018-27421 Filed 12-18-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 45 (Wednesday, March 7, 2012)]
[Notices]
[Page 13599]
[FR Doc No: 2012-5531]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9644-7]

Good Neighbor Environmental Board; Notification of Public
Advisory Committee Teleconference

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification of Public Advisory Committee Teleconference.

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SUMMARY: Pursuant to the Federal Advisory Committee Act, Public Law 92-
463, notice is hereby given that the Good Neighbor Environmental Board
(GNEB) will hold a public teleconference on March 22, 2012 from 12 p.m.
to 5 p.m. Eastern Standard Time. The meeting is open to the public. For
further information regarding the teleconference and background
materials, please contact Mark Joyce at the number listed below.
    Background: GNEB is a federal advisory committee chartered under
the Federal Advisory Committee Act, Public Law 92463. GNEB provides
advice and recommendations to the President and Congress on
environmental and infrastructure issues along the U.S. border with
Mexico.
    Purpose of Meeting: The purpose of this teleconference is to
discuss the Good Neighbor Environmental Board's Fifteenth Report. The
report will focus on water infrastructure issues in the U.S.-Mexico
border region.

SUPPLEMENTARY INFORMATION: If you wish to make oral comments or submit
written comments to the Board, please contact Mark Joyce at least five
days prior to the meeting.
    General Information: Additional information concerning the GNEB can
be found on its Web site at www.epa.gov/ofacmo/gneb.
    Meeting Access: For information on access or services for
individuals with disabilities, please contact Mark Joyce at (202) 564-
2130 or email at<EMAIL_ADDRESS>To request accommodation of a
disability, please contact Mark Joyce at least 10 days prior to the
meeting to give EPA as much time as possible to process your request.

    Dated: February 29, 2012.
Mark Joyce,
Acting Designated Federal Officer.
[FR Doc. 2012-5531 Filed 3-6-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 99 (Monday, May 23, 2011)]
[Notices]
[Page 29775]
[FR Doc No: 2011-12597]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1976-DR; Docket ID FEMA-2011-0001]

Kentucky; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the Commonwealth of Kentucky (FEMA-1976-DR), dated May 4, 2011, and
related determinations.

DATES: Effective Date: May 10, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the Commonwealth of Kentucky is hereby amended to include the
following areas among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of May 4, 2011.

    Bath, Green, Lewis, Mason, Pendleton, and Spencer Counties for
Public Assistance.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-12597 Filed 5-20-11; 8:45 am]
BILLING CODE 9111-23-P