EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Biopesticides and Pollution Prevention Division contact: Alexandra Boukedes,<PHONE_NUMBER>

SUBMISSION: Email the completed template to<EMAIL_ADDRESS>

Danisco US Inc.

1F8927

	EPA has received a pesticide petition (1F8927) from Danisco US Inc, 925 Page Mill Road, Palo Alto, CA 94304 requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish exemptions from the requirement of a tolerance for the microbial pesticides Gluconobacter cerinus strain BC18B and Hanseniaspora uvarum strain BC18Y in or on all food commodities.

Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, Danisco US Inc. has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by Danisco US Inc. and EPA has not fully evaluated the merits of the pesticide petition. The summary may have been edited by EPA if the terminology used was unclear, the summary contained extraneous material, or the summary unintentionally made the reader conclude that the findings reflected EPA's position and not the position of the petitioner.

I. Danisco US Inc. Petition Summary        	1F8927     A. Product Name and Proposed Use Practices

	 Gluconobacter cerinus strain BC18B and Hanseniaspora uvarum strain BC18Y are proposed for use as seed treatment, soil application, foliar spray, chemigation or aerial application, and post-harvest use for the purposes of fungal, bacterial, and nematode plant disease suppression and prevention. Gluconobacter cerinus strain BC18B and Hanseniaspora uvarum strain BC18Y are beneficial microorganisms that are used to suppress or control plant diseases by improving plant health and via a combination of antibiosis, competition for niches and nutrients, as well as induction of the plant's resistance through systemic defense in plants.

B. Product Identity/Chemistry

 Identity of the pesticide and corresponding residues. Gluconobacter cerinus strain BC18B and Hanseniaspora uvarum strain BC18Y           	2. Magnitude of residues at the time of harvest and method used to determine the residue. A determination of the magnitude of residues at harvest is not required for residues that are exempt from tolerances.

	3. A statement of why an analytical method of detecting and measuring the levels of the pesticide residue are not needed. An analytical method for residues of this MPCA is not applicable. It is expected that, when used as proposed, Gluconobacter cerinus strain BC18B and Hanseniaspora uvarum strain BC18Y, would not result in residues that are of toxicological concern.

C. Mammalian Toxicological Profile

Acute Oral Toxicity (OCSPP 870.1100): An acute oral toxicity study was conducted with rats to evaluate the potential for a manufacturing-use product containing 4.66 x 10[10] CFU/ml Gluconobacter cerinus strain BC18B and 2.75 x 10[9] CFU/ml Hanseniaspora uvarum strain BC18Y to cause toxicity following a single oral dose (MRID #51496905). The study was performed using the up-and-down procedure. The median lethal dose (LD50) was determined to be greater than 5,000 mg/kg body weight (Toxicity Category IV).

Acute Dermal Toxicity (OCSPP 870.1200): The acute dermal toxicity study data requirement was satisfied based on the acute oral toxicity study described above. The acute dermal toxicity of a manufacturing-use product containing 4.66 x 10[10] CFU/ml Gluconobacter cerinus strain BC18B and 2.75 x 10[9] CFU/ml Hanseniaspora uvarum strain BC18Y extrapolated from the acute oral study resulted in an LD50 of greater than 5,000 mg/kg body weight (Toxicity Category IV).

Acute Inhalation Toxicity Study in Rats (OCSPP 870.1300): An acute inhalation toxicity study was conducted with a manufacturing-use product containing 4.66 x 10[10] CFU/ml Gluconobacter cerinus strain BC18B and 2.75 x 10[9] CFU/ml Hanseniaspora uvarum strain BC18Y to evaluate the potential effects of inhalation exposure (MRID #51496906). Under the conditions of the study, a single 4h exposure to acute inhalation of the test substance was greater than 2.13 mg/L in male and female rats (Toxicity Category IV).

Primary Eye Irritation (OCSPP 870.2400): A primary eye irritation study was conducted with rabbits to evaluate the potential for a manufacturing-use product containing 4.66 x 10[10] CFU/ml Gluconobacter cerinus strain BC18B and 2.75 x 10[9] CFU/ml Hanseniaspora uvarum strain BC18Y to cause irritation following a single ocular exposure (MRID #51496907). The study was performed by instillation of 0.1 ml of the test substance in the conjunctival sac of the right eye of each of 3 rabbits. There was no corneal opacity or iritis in any treated eye during the study. The treated eye of one rabbit had minimal conjunctivitis within 24 hours after exposure that cleared by 48 hours. All animals were free of ocular irritation by 48 hours after exposure. (Toxicity Category IV).

Primary Dermal Irritation (OCSPP 870.2500): A primary dermal irritation study was conducted with rabbits to evaluate the potential for a manufacturing-use product containing 4.66 x 10[10] CFU/ml Gluconobacter cerinus strain BC18B and 2.75 x 10[9] CFU/ml Hanseniaspora uvarum strain BC18Y, to cause irritation following a single dermal exposure (MRID #51496908). The study was performed by topical application of 0.5 ml of test substance to the skin of three healthy rabbits for 4 hours. After removal of the patches that covered the application sites, one treated site showed very slight erythema. All animals were free of irritation by 24 hours after exposure (Toxicity Category IV).

Acute Pulmonary Toxicity/Pathogenicity Study in Rats (OCSPP 885.3150): An acute pulmonary toxicity/pathogenicity study was conducted with a manufacturing-use product containing Gluconobacter cerinus strain BC18B and Hanseniaspora uvarum strain BC18Y to determine the potential for toxicity and pathogenicity of the microbial pest control agents (MRID #51496909). The test substance was administered to 34 rats (17 male and 17 female) by intratracheal injection in a single high dose of 2.9 x 10[9] viable cells of Gluconobacter cerinus strain BC18B and 2.62 x 10[8] viable cells of Hanseniaspora uvarum strain BC18Y in 0.1 mL. A second group of four rats (2 male and 2 female) remained untreated as controls, and a third group of six rats (3 male and 3 female) received inactivated (autoclaved) test substance. The animals were observed frequently on the day of dosing for mortality and signs of pharmacologic and/or toxicologic effects and once daily thereafter for 23 days. Control groups (untreated and inactive test substance) were conducted concurrently. A gross necropsy of all animals was performed and recorded. Samples of brain, liver, lung, spleen, kidney, lymph nodes, blood and cecum contents were collected from treated rats necropsied on Days 1 (lungs only), 3, 9, 15, and 22/23. Lung samples were collected on the same days as other samples and on day 1. All samples collected were analyzed for viable Gluconobacter cerinus strain BC18B and Hanseniaspora uvarum strain BC18Y CFU content. There were no mortalities attributed to the test substance throughout the study. Clinical observations of irregular respiration were noted for males and females in the inactivated control and for some animals in the active test substance group, which were contributed to the route of administration of the test substance and transient. In all animals, respiration returned to normal by the end of the study. Except for one female in the inactivated control group, which showed mottled lungs on day 23, no findings on gross necropsy were noted for any other animal in any other group. Overall, mean body weights and mean body weight gain for the male and female test group animals were comparable to the control group animals. Gluconobacter cerinus strain BC18B as well as Hanseniaspora uvarum strain BC18Y were either not present or below the limit of detection for all male and female blood, brain, liver, spleen, kidney, and cecum content samples. Both strains were initially detected on day 1 in lung samples and on day 3 in lymph node samples. Clearance was achieved for both strains in lung and lymph node samples by Day 9. Under the conditions of this study, the acute pulmonary administration of Gluconobacter cerinus strain BC18-B and Hanseniaspora uvarum strain BC18Y, at a dose level of 2.9 x 10[9] and 2.62 x 108 viable CFU/animal, respectively, produced no clinical signs of persistent infection or pathogenicity in treated animals.

D. Aggregate Exposure

	1. Dietary exposure. Dietary exposure from use of Gluconobacter cerinus strain BC18-B and Hanseniaspora uvarum strain BC18Y, as proposed according to pre-harvest label directions, is expected to be minimal. The intended use of Gluconobacter cerinus strain BC18-B and Hanseniaspora uvarum strain BC18Y is application via seed and soil treatment or spray on growing plants for the purpose of disease control and suppression. In addition, both strains are intended to be for disease control or suppression post-harvest. Data in published literature demonstrate that Gluconobacter cerinus is a bacteria and is ubiquitous in soil and on plants and is found in grape musts. This species, together with acetic acid bacteria is used in the food industry for production of food and beverages. Hanseniaspora uvarum is a widespread yeast species frequently isolated from soil, various fruits, and musts. Hanseniaspora uvarum is a predominant yeast species during fermentations of fruit juices and is used in winemaking (see MRID 51496901).

	i. Food. Exposure of Gluconobacter cerinus strain BC18-B and/or Hanseniaspora uvarum strain BC18Y to humans is possible via consumption of food that has been treated post-harvest with these strains. As mentioned above, the species Gluconobacter cerinus strain and Hanseniaspora uvarum are present in or on food and therefore already widely consumed with fruits and beverages. In addition, the results of toxicity testing identify no risk to human health from Gluconobacter cerinus strain BC18-B and Hanseniaspora uvarum strain BC18Y and both strains do not produce recognized toxins, enzymes, or virulence factors normally associated with mammalian invasiveness or toxicity.

	ii. Drinking water. Exposure to humans from residues of Gluconobacter cerinus strain BC18-B and Hanseniaspora uvarum strain BC18Y in consumed drinking water would be unlikely. Both strains are not considered for application to surface or ground water. Gluconobacter cerinus strain BC18-B and Hanseniaspora uvarum strain BC18Y both prefer nutrient-rich environments to grow, which are not expected in drinking water, so significant levels in surface water or ground water are considered improbable. Additionally, the strains are not likely to tolerate the conditions water is subjected to in a drinking water facility. Chlorination, pH adjustments, high temperatures and/or anaerobic conditions of water treatment are expected to inactivate residues of the MPCAs. Significant exposure to Gluconobacter cerinus strain BC18-B and Hanseniaspora uvarum strain BC18Y from any drinking water source above background is not expected.

	2. Non-dietary exposure. The potential for non-dietary exposure of the general population, including infants and children to Gluconobacter cerinus strain BC18-B and Hanseniaspora uvarum strain BC18Y is reasonably low given the primary uses are for agricultural and ornamental treatments, and no residential uses per proposed product label. Personal Protective Equipment (PPE) mitigates the potential for exposure to applicators and handlers of the proposed product when used in agricultural settings.  Label mitigation measures are included on packaging to minimize exposures to the general population including infants and children.

E. Cumulative Effects

	There is no indication that the microorganisms, Gluconobacter cerinus strain BC18-B and Hanseniaspora uvarum strain BC18Y, act by a common mechanism of toxicity with other substances to result in any cumulative effects.

F. Safety Determination

	1. U.S. population. Toxicity studies have shown that Gluconobacter cerinus strain BC18-B and Hanseniaspora uvarum strain BC18Y are not toxic, pathogenic, infective or irritating to mammals following acute exposure. These results indicate the product is not of toxicological concern for the general population when used as proposed on the label.  Further, Gluconobacter cerinus strain BC18-B and Hanseniaspora uvarum strain BC18Y were not toxic or pathogenic following intratracheal injection, indicating these strains are not of concern for pathogenicity when used as proposed. Based on the data available, there is a reasonable certainty of no harm to the general US population from exposure to Gluconobacter cerinus strain BC18-B and Hanseniaspora uvarum strain BC18Y.

	2. Infants and children. It is not expected that, when used as proposed, Gluconobacter cerinus strain BC18-B and Hanseniaspora uvarum strain BC18Y would result in residues that are of toxicological concern. There is a reasonable certainty of no harm for infants and children from exposure to Gluconobacter cerinus strain BC18-B and Hanseniaspora uvarum strain BC18Y from the proposed uses. Retention of the Food Quality Protection Act (FQPA) safety factor is not necessary as part of the qualitative safety assessment for Gluconobacter cerinus strain BC18-B and Hanseniaspora uvarum strain BC18Y.

G. Effects on the Immune and Endocrine Systems

	To date there is no evidence to suggest that Gluconobacter cerinus strain BC18-B and Hanseniaspora uvarum strain BC18Y function in a manner similar to any known hormone, or that it acts as an endocrine disrupter.

H. Existing Tolerances

	There is no US EPA tolerance or tolerance exemption for Gluconobacter cerinus strain BC18-B or Hanseniaspora uvarum strain BC18Y.

I. International Tolerances

	A Codex Alimentarium Commission Maximum Residue Level (MRL) is not established for Gluconobacter cerinus strain BC18-B and Hanseniaspora uvarum strain BC18Y.


August 4, 2009

Karl Simon

Acting Division Director

Compliance and Innovative Strategies Division

1200 Pennsylvania Avenue, N. W.

Mail Code: 6406J

Washington, DC 20460

RE:	CAA Section 211(b) Fuels and Fuel Additives Health Effects Testing
Regulation:  Second Draft Final Report Gasoline ETBE Vapor Condensate -
A 13-Week Whole-Body Inhalation Study in Rats with Neurotoxicity
Assessment and 4-Week In Vivo Genotoxicity and Immunotoxicity
Assessments (Study No. 00-6129)

Dear Mr. Karl Simon:

The American Petroleum Institute (API), on behalf of the Section 211(b)
Research Group (RG), is submitting the following information for EPA
review and approval as partial fulfillment of the CAA Section 211(b)
Alternative Tier 2 requirements of the testing regulation:

Second Draft Final Report: Gasoline ETBE Vapor Condensate A 13-Week
Whole-Body Inhalation Study in Rats with Neurotoxicity Assessment and
4-Week In Vivo Genotoxicity and Immunotoxicity  Assessments (Study No.
00-6129)

 Reviewer Checklist

The Second Draft Final Report addresses all EPA and independent reviewer
comments as indicated, with page citation, in the Reviewer Checklist.

When the RG receives EPA’s approval of the second draft report, the
final study report will be submitted to you at the EPA Office of
Transportation and Air Quality, Transportation and Regional Programs
Division, as part of the requirements of Clean Air Act Section 211(b)(2)
and 211(e) (Docket No. A-90-07). If you require further information,
please contact Tom Gray by mail at this address.

Regards,

Thomas M. Gray

Encl (2):

Second Draft Final Report: Gasoline ETBE Vapor Condensate A 13-Week
Whole-Body Inhalation Study in Rats with Neurotoxicity Assessment and
4-Week In Vivo Genotoxicity and Immunotoxicity  Assessments (Study No.
00-6129)

	Reviewer Checklist

Cc:	Joe Sopata, EPA (via email)

		An equal opportunity employer

Thomas M. Gray

211(b) Technical Manager

1220 L Street, Northwest

Washington, DC  20005-4070

Tel<PHONE_NUMBER>

Fax<PHONE_NUMBER>

E-mail<EMAIL_ADDRESS>


[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Notices]
[Pages 60512-60513]
[FR Doc No: 2011-25133]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3328-EM; Docket ID FEMA-2011-0001]

New York; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of New York (FEMA-3328-EM), dated August 26,
2011, and related determinations.

DATES: Effective Date: August 26, 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: Notice is hereby given that, in a letter
dated August 26, 2011, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5208 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in certain areas
of the State of New York resulting from Hurricane Irene beginning on
August 25, 2011, and continuing, are of sufficient severity and
magnitude to warrant an emergency declaration under the Robert T.
Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121 et seq. (``the Stafford Act''). Therefore, I declare that such
an emergency exists in the State of New York.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), including direct Federal assistance, under the Public
Assistance program. This assistance excludes regular time costs for
subgrantees' regular employees.
    Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, Philip
E. Parr, of FEMA is appointed to act as the Federal Coordinating
Officer for this declared emergency.
    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Philip E. Parr, of FEMA is appointed
to act as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of New York have been designated
as adversely affected by this declared emergency:

    Bronx, Kings, New York, Queens, Richmond, Nassau, and Suffolk
Counties for emergency protective measures (Category B), including
Federal direct assistance, under the Public assistance program at 75
percent federal funding.

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.

    Dated: September 23, 2011.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-25133 Filed 9-28-11; 8:45 am]
BILLING CODE 9111-23-P


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

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life, although it was too late for many of my family members, including my father who died from lung cancer caused by combustible cigarettes.  I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.

Sincerely,

Kevin S. Tully


    	U.S. Environmental Protection Agency
                    stratospheric ozone protection program
                         class i controlled substance
                                methyl bromide
                     sales of critical use methyl bromide
                   to end users annual report (40 CFR 82.13)
note: form must be completed by any company that provided methyl bromide gas or fumigations to critical users.  form must be completed by a central office on behalf of their divisions; one form per company.
SECTION 1   COMPANY IDENTIFICATION
1.1  Date of Submission

  1.2  Year to Which This Report Applies

1.3   Original Submittal     Re-submittal
1.4 Company Information
Company Name
Street Address
City
State
Zip Code
1.5 Company Contact Identification
Reporting Company Contact Person
E-mail Address
Phone Number
Fax Number
1.6  Company Type
   (check all that apply)
                                   Distributor
                             Third Party Applicator
                                    Producer
                                    Importer
1.7 Signature of Reporting Company Representative
I certify under penalty of law that I have personally examined and am familiar with the information submitted in this and all attached documents, and that based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the submitted information is true, accurate, and complete.  I am aware that there are significant penalties for submitting false information, including the possibility of fine and imprisonment.
Name
Title
Signature
Date
SEND COMPLETED FORMS TO:
For U.S. Postal Service:
U.S. EPA
Stratospheric Protection Division
Office of Atmospheric Programs
Mail Code: 6205T
1200 Pennsylvania Avenue, NW
Washington, D.C. 20460
For Private Courier:
U.S. EPA
Stratospheric Protection Division
Office of Atmospheric Programs
Room 4355CC
1201 Constitution Avenue, NW
Washington, D.C. 20004

A company may assert a claim of confidentiality for information submitted in this form by clearly marking that information as confidential. Such information shall be treated in accordance with EPA's procedures for information claimed as confidential at 40 CFR Part 2, Subpart B, and will only be disclosed by the means set forth in the subpart. If no claim of confidentiality accompanies the report when it is received by EPA, it may be made public without further notice to the company (40 CFR 2.203).

The public reporting and recordkeeping burden for this collection of information is estimated to average 1.0 hours per response. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U.S. Environmental Protection Agency (2822T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address.

     	U.S. Environmental Protection Agency
                    stratospheric ozone protection program
                         class i controlled substance
                                methyl bromide
                     sales of critical use methyl bromide
                   to end users annual report (40 CFR 82.13)
SECTION 2   SALES DATA
2.1  Company Name

2.2  Critical Use Methyl Bromide (newly produced or imported) sold (active ingredient only)*
Pre-Plant (kg)
Post-Harvest (kg)
Year-End Inventory Calculation
  2.3.A  Beginning Inventory of Critical Use Methyl Bromide from Prior Control Periods, if any (NOT pre-phaseout stocks).  Note: This is the same amount as the previous control period's ending inventory.*
Pre-Plant (kg)
Post-Harvest (kg)
  2.3.B  Critical Use Methyl Bromide Bought this Year (only new production/import, NOT pre-phaseout stocks)*
Pre-Plant (kg)
Post-Harvest (kg)
  2.4  Critical Use Methyl Bromide Sold to an Entity Other than a Critical User (e.g., Distributor, Third Party Applicator)*
Pre-Plant (kg)
Post-Harvest (kg)
  2.5  Year-End Inventory  -  Critical Use Methyl Bromide Not Sold In Reporting Year (2.3.A + 2.3.B  -  2.2  -  2.4)*
Pre-Plant not sold by year end (kg)

Post-Harvest not sold by year end (kg)
2.6  Name(s) of Company(ies) for which Newly Produced Critical Use Methyl Bromide is Being Held and Associated Amount (kg) Held for Each (excluding end-users)
Company Name:
Pre-Plant (kg):
Post-Harvest (kg):
Company Name:
Pre-Plant (kg):
Post-Harvest (kg):
Company Name:
Pre-Plant (kg):
Post-Harvest (kg):
note: complete the pre-2005 methyl bromide stocks report for quantities of methyl bromide owned that was produced/imported before january 1, 2005.
*If none, enter 0.  Do not leave blank.


[Federal Register: October 13, 2005 (Volume 70, Number 197)]
[Notices]
[Page 59742]
[DOCID:fr13oc05-80]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP05-688-000]

Northern Natural Gas Company; Notice of Proposed Changes in FERC
Gas Tariff

October 5, 2005.

    Take notice that on September 30, 2005, Northern Natural Gas
Company (Northern) tendered for filing to become part of its FERC Gas
Tariff, Fifth Revised Volume No. 1, the following tariff sheets
proposed to be effective on November 1, 2005 as follows:

1 Revised 72 Revised Sheet No. 50,
1 Revised 73 Revised Sheet No. 51,
1 Revised 36 Revised Sheet No. 52,
1 Revised 72 Revised Sheet No. 53,
1 Revised 20 Revised Sheet No. 56,
1 Revised 28 Revised Sheet No. 59,
1 Revised Twelfth Revised Sheet No. 59A,
1 Revised 31 Revised Sheet No. 60,
1 Revised Eleventh Revised Sheet No. 60A.

    Northern states that the above tariff sheets are being filed to
update and effectuate the November 1, 2005 tariff sheets containing the
settlement rates approved in Docket Nos. RP03-398-000 and RP04-155-000
to reflect the interim rate changes for the electric compression
charge, the Waterville storage point rate treatment and the ACA.
    Northern further states that copies of the filing have been mailed
to each of its customers and interested state commissions.
    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. E5-5627 Filed 10-12-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 239 (Thursday, December 12, 2013)]
[Rules and Regulations]
[Pages 75451-75452]
[FR Doc No: 2013-29684]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2013-1036; Special Conditions No. 25-510-SC]

Special Conditions: Cessna Model 750 Series Airplanes; Aircraft
Electronic System Security Protection From Unauthorized External Access

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special condition; request for comments.

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

SUMMARY: These special conditions are issued for the Cessna Model 750
Series airplanes. These airplanes will have a novel or unusual design
feature associated with the architecture and connectivity capabilities
of the airplanes' computer systems and networks. Connectivity to, or
access by, external systems and networks may result in security
vulnerabilities to the airplanes' systems.

DATES: The effective date of these special conditions is December 12,
2013. We must receive your comments by January 27, 2014.

ADDRESSES: Send comments identified by docket number [FAA-2013-XXXX]
using any of the following methods:
     Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending
your comments electronically.
    Mail: Send comments to Docket Operations, M-30, U.S. Department of
Transportation (DOT), 1200 New Jersey Avenue SE., Room W12-140, West
Building Ground Floor, Washington, DC, 20590-0001.
    Hand Delivery or Courier: Take comments to Docket Operations in
Room W12-140 of the West Building Ground Floor at 1200 New Jersey
Avenue SE., Washington, DC, between 8 a.m. and 5 p.m., Monday through
Friday, except federal holidays.
    Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov/, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA docket, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov/.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov/ at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except federal holidays.

FOR FURTHER INFORMATION CONTACT: Varun Khanna, FAA, Airplane and Flight
Crew Interface Branch, ANM-111, Transport Airplane Directorate,
Aircraft Certification Service, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The proposed network architecture includes
the following connectivity between systems:
    1. Airplane control, communication, display, monitoring and
navigation systems,
    2. Operator business and administrative support systems, and
    3. Passenger entertainment systems, and access by systems external
to the airplane.
    The applicable airworthiness regulations do not contain adequate or
appropriate safety standards for this design feature. These special
conditions contain the additional safety standards that the
Administrator considers necessary to establish a level of safety
equivalent to that established by the existing airworthiness standards.
    The FAA has determined that notice of, and opportunity for prior
public comment on, these special conditions are impracticable because
these procedures would significantly delay issuance of the design
approval and thus delivery of the affected aircraft. The FAA has also
determined that notice of these special conditions is unnecessary
because the substance of these special conditions has been subject to
the public comment process in several prior instances with no
substantive comments received. The FAA therefore finds that good cause
exists for making these special conditions effective upon publication
in the Federal Register.

Comments Invited

    We invite interested people to take part in this rulemaking by
sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    We will consider all comments we receive by the closing date for
comments. We may change these special conditions based on the comments
we receive.

Background

    On September 10, 2010, Cessna Aircraft Company applied for an
amendment to the Model 750 Type Certificate No. T00007WI.
    The Model 750 is a twin-engine pressurized executive jet airplane
with standard seating provisions for 14 passenger/crew. This airplane
will have a maximum takeoff weight of 36,600 pounds with a wingspan of
69.2 feet, a maximum operating altitude of 51,000 feet, and will have
two aft-mounted Rolls-Royce AE3007C2 engines.
    The proposed Cessna Model 750 avionics architecture is novel or
unusual for executive jet airplanes by allowing connection to airplane
electronic systems and networks, and access from aircraft external
sources (e.g., wireless devices, Internet connectivity) to the
previously isolated airplane electronic assets. Cessna's proposed
design is considered by the FAA to be an architecture which introduces
potential security risks and vulnerabilities not addressed in current
regulations and aircraft-level or system-level safety assessment
methods. Consequently, this special condition has been produced to
address security and safety issues arising from the use of this type of
architecture, and foreseeable flight and maintenance applications
impacted by these interconnected data networks and the addition of
external access points.

Type Certification Basis

    Under Title 14, Code of Federal Regulations (14 CFR) 21.17, Cessna
must show that the Model 750 series meets the applicable provisions of
14 CFR part 25, as amended by Amendments 25-1 through 25-128. The

certification basis for the 750 (S/N -000501 and on) is documented and
agreed to within the Cessna Aircraft Company Model 750 Block Point
Change G-1 Issue Paper.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the Model 750 series because of a
novel or unusual design feature, special conditions are prescribed
under Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same novel or
unusual design feature, the proposed special conditions would also
apply to the other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and
proposed special conditions, the Cessna Model 750 series airplane must
comply with the fuel vent and exhaust emission requirements of 14 CFR
part 34 and the noise certification requirements of 14 CFR part 36 and
the FAA must issue a finding of regulatory adequacy under Sec.  611 of
Public Law 92-574, the ``Noise Control Act of 1972.''
    The FAA issues special conditions, as defined in 14 CFR 11.19,
under Sec.  11.38, and they become part of the type-certification basis
under Sec.  21.17(a)(2).

Novel or Unusual Design Features

    The Cessna Model 750 will incorporate the following novel or
unusual design features: digital systems architecture composed of
several connected networks. The proposed architecture and network
configuration may be used for, or interfaced with, a diverse set of
functions, including:
    1. Flight-safety related control, communication, display,
monitoring, and navigation systems (aircraft control functions);
    2. Operator business and administrative support (operator
information services);
    3. Passenger information and entertainment systems (passenger
entertainment services); and,
    4. The capability to allow access to or by systems external to the
airplane.

Discussion

    The architecture and network configuration in the Cessna Model 750
Series airplanes may allow increased connectivity to, or access by,
external airplane sources, airline operations, and maintenance systems
to the aircraft control functions and airline information services. The
aircraft control functions and airline information services perform
functions required for the safe operation and maintenance of the
airplane. Previously these functions and services had very limited
connectivity with external sources. The architecture and network
configuration may allow the exploitation of network security
vulnerabilities resulting in intentional or unintentional destruction,
disruption, degradation, or exploitation of data, systems, and networks
critical to the safety and maintenance of the airplane. This
configuration may also include the electronic transmission of field-
loadable software (and hardware) applications and databases to the
airplane, which would subsequently be loaded into the safety-related
equipment and systems. The existing regulations and guidance material
did not anticipate these types of airplane system architectures.
Furthermore, 14 CFR regulations and current system safety assessment
policy and techniques do not address potential security
vulnerabilities, which could be exploited by unauthorized access to
airplane systems, data buses, and servers. Therefore, these special
conditions are issued to ensure that the security (i.e.,
confidentiality, integrity, and availability) of airplane systems is
not compromised by unauthorized wired or wireless electronic
connections.
    For the reasons discussed above, these special conditions contain
the additional safety standards that the Administrator considers
necessary to establish a level of safety equivalent to that established
by the existing airworthiness standards.

Applicability

    As discussed above, these special conditions are applicable to the
Cessna Model 750 Series airplanes. Should Cessna apply at a later date
for a change to the type certificate to include another model
incorporating the same novel or unusual design feature, the special
conditions would apply to that model as well.

Conclusion

    This action affects only certain novel or unusual design features
on one model series of airplanes. It is not a rule of general
applicability.
    The substance of these special conditions has been subjected to the
notice and comment period in several prior instances and has been
derived without substantive change from those previously issued. It is
unlikely that prior public comment would result in a significant change
from the substance contained herein. Therefore, the FAA has determined
that prior public notice and comment are unnecessary, and good cause
exists for adopting these special conditions upon publication in the
Federal Register. The FAA is requesting comments to allow interested
persons to submit views that may not have been submitted in response to
the prior opportunities for comment described above.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Cessna Model 750 Series airplanes.

System Security Protection for Aircraft Control Domain and Information
Services Domain From External Access

    1. The applicant must ensure airplane electronic system security
protection from access by unauthorized sources external to the
airplane, including those possibly caused by maintenance activity.
    2. The applicant must ensure that electronic system security
threats are identified and assessed, and that effective electronic
system security protection strategies are implemented to protect the
airplane from all adverse impacts on safety, functionality, and
continued airworthiness.
    3. The applicant must establish appropriate procedures to allow the
operator to ensure that continued airworthiness of the aircraft is
maintained, including all post-type-certification modifications that
may have an impact on the approved electronic system security
safeguards.

    Issued in Renton, Washington, on December 4, 2013.
John P. Piccola, Jr.,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-29684 Filed 12-11-13; 8:45 am]
BILLING CODE 4910-13-P


Hazardous Waste for Solvent-Contaminated Wipes.'' A copy of the
analysis is available in the docket for this action and the analysis is
briefly summarized here.
    Entities that may be affected by the final rule include facilities
that use reusable and/or disposable wipes in conjunction with solvents
that are hazardous wastes when discarded. EPA identified approximately
90,549 facilities in 13 economic sub-sectors (based on five- or six-
digit North American Industry Classification System (NAICS) codes) \45\
that generate solvent-contaminated wipes and, therefore, will be
affected by the final rule. This estimate includes 576 large quantity
generators (LQGs) and 89,973 small quantity generators (SQGs).
Collectively, these LQGs and SQGs generate approximately 2.2 billion
solvent-contaminated wipes each year. Note that conditionally exempt
small quantity generators (CESQGs) are conditionally exempt from 40 CFR
parts 262 through 270 provided they comply with the requirements at 40
CFR 261.5. Therefore, we have assumed that they are not affected by the
final rule.
---------------------------------------------------------------------------

    \45\ NAICS is the standard used by Federal statistical agencies
in classifying business establishments for the purpose of
collecting, analyzing, and publishing statistical data related to
the U.S. business economy.
---------------------------------------------------------------------------

    Handlers of solvent-contaminated wipes are also affected by today's
rule. These include solid waste management facilities that manage
solvent-contaminated disposable wipes once they have been discarded
(i.e., hazardous and non-hazardous landfills/combustors), and
industrial laundries and dry cleaners that clean solvent-contaminated
reusable wipes. EPA identified eight industries (based on five- or six-
digit NAICS codes) with facilities that handle solvent-contaminated
wipes and, therefore, will be affected by the final rule. In
particular, EPA estimates that approximately 3,730 solid waste
management facilities and 359 industrial laundries and dry cleaners
will be affected by the final rule.
    Excluding non-monetary benefits, EPA estimates that the final rule
will result in a net savings of approximately $18.0 million per year
(2011 dollars). The net savings of $18.0 million per year factored in
the annualized total one-time cost of the final rule across all
facilities of approximately $123,000 to $164,000 in the first-year
after promulgation of the final rule, total annual costs of
approximately $6.4 million and total annual savings of approximately
$24.4 million across all affected entities. EPA evaluated these costs
and savings over a 10-year period.
    The primary benefit of the final rule is the annual savings
associated with RCRA regulatory compliance. However, EPA also
anticipates that the final rule will result in other expected benefits,
including (1) pollution prevention and waste minimization benefits, (2)
fire safety benefits, and (3) potential benefits to industrial
laundries and dry cleaners by excluding solvent-contaminated reusable
wipes from the definition of solid waste--that is, removing the
``waste'' label. The other expected benefits of the final rule are
estimated at between $3.7 million and $9.9 million per year (2011
dollars).
    Pollution prevention and waste minimization benefits of the final
rule take the form of avoided future purchases of virgin solvents if
captured spent solvent ``free liquids'' are recycled.\46\ The final
rule excludes disposable wipes from hazardous waste requirements,
provided the solvent-contaminated wipes contain no free liquids.
Therefore, the final rule provides a strong economic incentive for
generators to remove free liquid spent solvent, which is then made
available to be recycled. Furthermore, under the hazardous waste
regulations, LQGs may have had only 90 days to accumulate solvent-
contaminated wipes. However, under the final rule, generators may
accumulate solvent-contaminated wipes, along with free liquids, for up
to 180 days. Longer accumulation periods increase the potential for a
generator to accumulate sufficient amounts of spent solvent to make
recycling more economically feasible. The total annual pollution
prevention and waste minimization benefits are estimated to be between
$0.21 million and $0.96 million.
---------------------------------------------------------------------------

    \46\ EPA only estimates this benefit for disposable wipes,
because reusable wipes are already required to contain no free
liquids under most existing state programs.
---------------------------------------------------------------------------

    Fire safety benefits of the final rule are attributed to several
specific rule conditions, including (1) wipes must be stored in
non[hyphen]leaking, closed containers, which ensures that the wipes are
contained and are not exposed to the environment and potential ignition
sources; (2) wipes must be labeled ``Excluded
Solvent[hyphen]Contaminated Wipes,'' which ensures that the generators,
handlers, as well as other personnel, such as state and EPA
enforcement, are aware of the contents of the containers and can handle
them appropriately (e.g., not store the wipes next to an open flame);
and (3) wipes must not contain free liquids, which reduces the
likelihood of fire ignition. The total annual fire safety benefits from
reusable wipes are estimated to be between $0.23 million and $2.31
million.\47\
---------------------------------------------------------------------------

    \47\ Solvent-contaminated disposable wipes are currently subject
to the hazardous waste requirements, including the hazardous waste
container standards in 40 CFR 265 Subpart I. Therefore, EPA expects
there would be no incremental fire safety benefits associated with
solvent-contaminated disposable wipes from this rule.
---------------------------------------------------------------------------

    Excluding reusable wipes from the definition of solid waste--that
is, removing the label of ``waste,'' may increase the economic value of
a product. The total annual benefits from these impacts are estimated
to be between $3.3 million and $6.6 million per year.
    Adding the net savings to the other expected benefits, the net
benefits of the final rule are estimated at between $21.7 million and
$27.8 million per year (2011 dollars).

B. Paperwork Reduction Act (Information Collection Request)

    The information collection requirements in this rule will be
submitted for approval to OMB under the Paperwork Reduction Act, 44
U.S.C.

3501 et seq. The information collection requirements are not
enforceable until OMB approves them. The information collection request
has been updated since the November 2003 proposed rule to reflect the
final rule requirements and to respond to public comments.
    The information requirements established for this action are
voluntary to the extent that the conditional exclusions being finalized
today are voluntary and represent an overall reduction in burden, as
compared with the alternative information requirements associated with
managing the solvent-contaminated wipes as hazardous waste. The
information requirements help ensure that (1) entities operating under
today's rule are held accountable to the applicable requirements; and
(2) inspectors can verify compliance with the conditions of today's
rule when needed.
    For the information collection requirements applicable to
conditionally excluded solvent-contaminated wipes, the aggregate annual
burden to respondents over the three-year period covered by this ICR is
estimated to be 65,064 hours, with a cost to affected entities of
$3,384,436. This cost includes an estimated labor cost of $1,604,680
and an operation and maintenance cost of $1,779,756, which includes the
purchase of container labels. EPA estimates that the burden savings
under today's rule as compared to the existing hazardous waste
requirements will be 14,497 hours and $557,706 per year. Thus, the net
impacts under the final rule are estimated to be 50,567 hours and
$2,826,730 per year. There are no capital/startup costs and no costs
for purchases of services. There are no reporting requirements
associated with today's rule. EPA estimates that 67,851 respondents
will be required to keep records. The average annual recordkeeping
burden is estimated to be almost one hour per respondent. This estimate
includes time for reading the regulations, affixing labels to
containers, and maintaining at the site specified documentation that
the excluded solvent-contaminated wipes are being managed in accordance
with today's final rule. There are no administrative costs to the
Agency. Burden is defined at 5 CFR 1320.3(b).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9. When this ICR is
approved by OMB, the Agency will publish a technical amendment to 40
CFR part 9 in the Federal Register to display the OMB control number
for the approved information collection requirements contained in this
final rule.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of today's rule on small
entities, small entity is defined as (1) a small business as defined by
the Small Business Administration's (SBA) regulations at 13 CFR
121.201; (2) a small governmental jurisdiction that is a government of
a city, county, town, school district or special district with a
population of less than 50,000; and, (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field.
    After considering the economic impacts of today's final rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. The small
entities that are affected by this final rule include entities that use
or handle solvent-contaminated reusable and disposable wipes. EPA's
analysis estimates that 57,786 small entities are located in states
that are expected to adopt the final rule, which includes 55,327
generators and 2,459 handlers. We have determined in our ``Regulatory
Impact Analysis for Conditional Exclusions from Solid and Hazardous
Waste for Solvent-Contaminated Wipes'' that the economic impacts of the
final rule on the smallest of the small entities, firms with only one
employee, range from only 0.01 percent to 0.54 percent of total annual
revenue. These results are well below the one percent screening
criterion used to identify firms that might experience significant
economic impacts. Furthermore, all affected entities generating or
handling solvent-contaminated disposable wipes are expected to incur
savings as a result of the final rule.
    Although this final rule will not have a significant economic
impact on a substantial number of small entities, EPA nonetheless has
tried to reduce the impact of this rule on small entities. Today's rule
establishes consistent regulations for reusable wipes with the
intention that these requirements complement existing industry
practices and thus minimize any additional burden on small entities.
Additionally, EPA plans to develop and/or support user-friendly
compliance assistance tools, such as the summary chart available in the
docket for today's rule, which provides an overview of the exclusion
for reusable wipes and disposable wipes.

D. Unfunded Mandates Reform Act

    This action contains no federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for state, local, or tribal governments or the private
sector. The action imposes no enforceable duty on any State, local or
tribal governments or the private sector. Therefore, this action is not
subject to the requirements of sections 202 or 205 of the UMRA.
    This action is also not subject to the requirements of section 203
of UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. Under the final
rule, EPA is modifying its hazardous waste management regulations under
RCRA to (1) conditionally exclude from the definition of hazardous
waste solvent-contaminated disposable wipes and (2) conditionally
exclude from the definition of solid waste solvent-contaminated
reusable wipes. The conditional exclusions are considered less
stringent than the current Federal regulations because they exclude
certain materials now regulated by RCRA Subtitle C. Thus, authorized
states are not required to adopt the final rule, provided their program
is at least as stringent as the federal program. In addition, even if
the final rule is adopted by their state, generators of solvent-
contaminated wipes may opt to continue to manage such wipes under the
current federal hazardous waste regulations rather than under the
conditional exclusions.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132. RCRA, (42 U.S.C. 6901 to 6992k)
establishes the relationship between states and the federal government
with respect to

hazardous waste management, including provisions for authorized state
hazardous waste programs (42 U.S.C. 6926, section 3006) and retention
of state authority (42 U.S.C. 6929, section 3009). Under section 3009
of RCRA, states and their political subdivisions may not impose
requirements less stringent for hazardous waste management than the
federal government. Therefore, although the final rule prevents state
and local laws that are less stringent with respect to management of
solvent-contaminated wipes, the final rule does not have federalism
implications beyond those already established by RCRA. Thus, Executive
Order 13132 does not apply to this action.
    In the spirit of Executive Order 13132, and consistent with EPA
policy to promote communications between EPA and State and local
governments, EPA specifically solicited comment on the proposed action
from State and local officials.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    Subject to the Executive Order 13175 (65 FR 67249, November 9,
2000) EPA may not issue a regulation that has tribal implications, that
imposes substantial direct compliance costs, and that is not required
by statute, unless the federal government provides the funds necessary
to pay the direct compliance costs incurred by tribal governments, or
EPA consults with tribal officials early in the process of developing
the proposed regulation and develops a tribal summary impact statement.
    EPA has concluded that this action may have tribal implications.
However, it will neither impose substantial direct compliance costs on
tribal governments, nor preempt tribal law. This action may have tribal
implications to the extent that generating facilities on tribal lands
use solvents on wipes or handling facilities located on tribal lands
may receive solvent-contaminated wipes.
    EPA did not consult directly with representatives of tribal
governments early in the process of developing this regulation;
however, EPA did conduct extensive outreach with the public, which
included two public comment periods and a public meeting. Additionally,
we specifically solicited comment on the November 2003 proposed rule
from tribal officials.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    This action is not subject to EO 13045 (62 FR 19885, April 23,
1997) because it is not economically significant as defined in EO
12866, and because the Agency does not believe the environmental health
or safety risks addressed by this action present a disproportionate
risk to children. This action's health and risk assessments are
contained in section III.D.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy. Further, we have concluded that this
rule is not likely to have any adverse energy effects because the rule
addresses management of solvent-contaminated wipes under RCRA and will
not have significant impacts on energy supply, distribution, or use.

I. National Technology Transfer and Advancement Act of 1995

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.
    This rulemaking includes environmental monitoring or measurement
consistent with the Agency's Performance Based Measurement System
(``PBMS''). For certain conditions, such as today's container standard,
EPA has decided not to require the use of specific, prescribed
technical standards. Rather, the rule will allow the use of any method
that meets the prescribed performance criteria. The PBMS approach is
intended to be more flexible and cost-effective for the regulated
community; it is also intended to encourage innovation and improved
data quality. EPA is not precluding the use of any method, whether it
constitutes a voluntary consensus standard or not, as long as it meets
the performance criteria specified.
    The rulemaking does involve a technical standard for one condition
of today's exclusions. For the definition of ``no free liquids,'' EPA
has determined that the Paint Filter Liquids Test, (SW-846, Method
9095B) is most appropriate to determine whether solvent-contaminated
wipes contain no free liquids (although the no free liquids standard
may also be determined using another standard or test method as defined
by an authorized state). This test is included in EPA's official
compendium of analytical and sampling methods entitled ``Test Methods
for Evaluating Solid Waste, Physical/Chemical Methods'' (EPA
Publication SW-846), which have been evaluated and approved for use in
complying with the RCRA regulations.\48\ The Paint Filter Liquids Test
was specifically chosen because it is currently being used by the
majority of states to determine whether solvent-contaminated wipes
contain free liquids and is also the test used to implement the
restrictions on disposal of free liquids in the MSWLF regulations (40
CFR 258.28). The Paint Filter Liquids Test is also simple and
inexpensive to perform and typically produces clear results.
---------------------------------------------------------------------------

    \48\ http://www.epa.gov/epawaste/hazard/testmethods/sw846/index.htm.
---------------------------------------------------------------------------

J. Executive Order 12898: Environmental Justice

    Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of protection provided for human health or the
environment. Specifically, EPA has concluded that today's action will
not result in disproportionate adverse impacts to the communities of
concern because (1) the results of the 2012 final risk analysis
demonstrate that solvent-contaminated wipes and sludge from laundries
and dry cleaners disposed in MSWLFs do not pose significant risk to
human health and the environment; (2) the conditions of the rule (such
as

ensuring that solvent-contaminated wipes are stored in non-leaking,
closed containers and that such wipes contain no free liquids at the
point of being sent for disposal or cleaning) address potential hazards
during accumulation, storage, transportation, and handling; and (3) we
do not anticipate any increased affects from transportation as, to the
extent this rule changes the destination of solvent-contaminated wipes,
they would likely be disposed with other solid wastes and thus,
transported along well established solid waste hauler routes.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
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 the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective January 31, 2014.

List of Subjects

40 CFR Part 260

    Environmental protection, Hazardous waste.

40 CFR Part 261

    Environmental protection, Hazardous waste, Solid waste.

    Dated: July 22, 2013.
Gina McCarthy,
Administrator.

    For the reasons set out in the preamble, parts 260 and 261 of title
40, Chapter I of the Code of Federal Regulations, are amended as
follows:

PART 260--HAZARDOUS WASTE MANAGEMENT SYSTEM: GENERAL

0
1. The authority citation for part 260 continues to read as follows:

    Authority: 42 U.S.C. 6905, 6912(a), 6921-6927, 6930, 6934, 6935,
6937, 6938, 6939, and 6974.

Subpart B--Definitions

0
2. Section 260.10 is amended by adding in alphabetical order the
definitions of ``No free liquids,'' ``Solvent-contaminated wipe,'' and
``Wipe'' to read as follows:

Sec.  260.10  Definitions.

* * * * *
    No free liquids, as used in 40 CFR 261.4(a)(26) and 40 CFR
261.4(b)(18), means that solvent-contaminated wipes may not contain
free liquids as determined by Method 9095B (Paint Filter Liquids Test),
included in ``Test Methods for Evaluating Solid Waste, Physical/
Chemical Methods'' (EPA Publication SW-846), which is incorporated by
reference, and that there is no free liquid in the container holding
the wipes. No free liquids may also be determined using another
standard or test method as defined by an authorized state.
* * * * *
    Solvent-contaminated wipe means--
    (1) A wipe that, after use or after cleaning up a spill, either:
    (i) Contains one or more of the F001 through F005 solvents listed
in 40 CFR 261.31 or the corresponding P- or U- listed solvents found in
40 CFR 261.33;
    (ii) Exhibits a hazardous characteristic found in 40 CFR part 261
subpart C when that characteristic results from a solvent listed in 40
CFR part 261; and/or
    (iii) Exhibits only the hazardous waste characteristic of
ignitability found in 40 CFR 261.21 due to the presence of one or more
solvents that are not listed in 40 CFR part 261.
    (2) Solvent-contaminated wipes that contain listed hazardous waste
other than solvents, or exhibit the characteristic of toxicity,
corrosivity, or reactivity due to contaminants other than solvents, are
not eligible for the exclusions at 40 CFR 261.4(a)(26) and 40 CFR
261.4(b)(18).
* * * * *
    Wipe means a woven or non-woven shop towel, rag, pad, or swab made
of wood pulp, fabric, cotton, polyester blends, or other material.
* * * * *

PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE

0
3. The authority citation for part 261 continues to read as follows:

    Authority: 42 U.S.C. 6905, 6912(a), 6921, 6922, 6924(y), and
6838.

Subpart A--General

0
4. Section 261.4 is amended by adding paragraphs (a)(26) and (b)(18) to
read as follows:

Sec.  261.4  Exclusions.

    (a) * * *
    (26) Solvent-contaminated wipes that are sent for cleaning and
reuse are not solid wastes from the point of generation, provided that
    (i) The solvent-contaminated wipes, when accumulated, stored, and
transported, are contained in non-leaking, closed containers that are
labeled ``Excluded Solvent-Contaminated Wipes.'' The containers must be
able to contain free liquids, should free liquids occur. During
accumulation, a container is considered closed when there is complete
contact between the fitted lid and the rim, except when it is necessary
to add or remove solvent-contaminated wipes. When the container is
full, or when the solvent-contaminated wipes are no longer being
accumulated, or when the container is being transported, the container
must be sealed with all lids properly and securely affixed to the
container and all openings tightly bound or closed sufficiently to
prevent leaks and emissions;
    (ii) The solvent-contaminated wipes may be accumulated by the
generator for up to 180 days from the start date of accumulation for
each container prior to being sent for cleaning;
    (iii) At the point of being sent for cleaning on-site or at the
point of being transported off-site for cleaning, the solvent-
contaminated wipes must contain no free liquids as defined in Sec.
260.10 of this chapter.
    (iv) Free liquids removed from the solvent-contaminated wipes or
from the container holding the wipes must be managed according to the
applicable regulations found in 40 CFR parts 260 through 273;
    (v) Generators must maintain at their site the following
documentation:
    (A) Name and address of the laundry or dry cleaner that is
receiving the solvent-contaminated wipes;
    (B) Documentation that the 180-day accumulation time limit in 40
CFR 261.4(a)(26)(ii) is being met;
    (C) Description of the process the generator is using to ensure the
solvent-contaminated wipes contain no free liquids at the point of
being laundered or dry cleaned on-site or at the point of being
transported off-site for laundering or dry cleaning;
    (vi) The solvent-contaminated wipes are sent to a laundry or dry
cleaner whose discharge, if any, is regulated under sections 301 and
402 or section 307 of the Clean Water Act.
    (b) * * *
    (18) Solvent-contaminated wipes, except for wipes that are
hazardous waste due to the presence of trichloroethylene, that are sent
for

disposal are not hazardous wastes from the point of generation provided
that
    (i) The solvent-contaminated wipes, when accumulated, stored, and
transported, are contained in non-leaking, closed containers that are
labeled ``Excluded Solvent-Contaminated Wipes.'' The containers must be
able to contain free liquids, should free liquids occur. During
accumulation, a container is considered closed when there is complete
contact between the fitted lid and the rim, except when it is necessary
to add or remove solvent-contaminated wipes. When the container is
full, or when the solvent-contaminated wipes are no longer being
accumulated, or when the container is being transported, the container
must be sealed with all lids properly and securely affixed to the
container and all openings tightly bound or closed sufficiently to
prevent leaks and emissions;
    (ii) The solvent-contaminated wipes may be accumulated by the
generator for up to 180 days from the start date of accumulation for
each container prior to being sent for disposal;
    (iii) At the point of being transported for disposal, the solvent-
contaminated wipes must contain no free liquids as defined in Sec.
260.10 of this chapter.
    (iv) Free liquids removed from the solvent-contaminated wipes or
from the container holding the wipes must be managed according to the
applicable regulations found in 40 CFR parts 260 through 273;
    (v) Generators must maintain at their site the following
documentation:
    (A) Name and address of the landfill or combustor that is receiving
the solvent-contaminated wipes;
    (B) Documentation that the 180 day accumulation time limit in 40
CFR 261.4(b)(18)(ii) is being met;
    (C) Description of the process the generator is using to ensure
solvent-contaminated wipes contain no free liquids at the point of
being transported for disposal;
    (vi) The solvent-contaminated wipes are sent for disposal
    (A) To a municipal solid waste landfill regulated under 40 CFR part
258, including 40 CFR 258.40, or to a hazardous waste landfill
regulated under 40 CFR parts 264 or 265; or
    (B) To a municipal waste combustor or other combustion facility
regulated under section 129 of the Clean Air Act or to a hazardous
waste combustor, boiler, or industrial furnace regulated under 40 CFR
parts 264, 265, or 266 subpart H.
* * * * *
[FR Doc. 2013-18285 Filed 7-30-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)]
[Rules and Regulations]
[Page 61616]
[FR Doc No: 2016-21476]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2016-0745]

Safety Zone; North Atlantic Ocean, Virginia Beach, VA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce safety zone regulations for a
fireworks display taking place offshore the Virginia Beach oceanfront
in the vicinity of the 20th Street, Virginia Beach, VA, on October 1,
2016. This action is necessary to ensure safety of life on navigable
waters during this event. Our regulation for Recurring Marine Events
within the Fifth Coast Guard District identifies the regulated area for
this fireworks display event. During the enforcement period, no person
or vessel may enter, transit through, anchor in, or remain within the
regulated area without approval from the Captain of the Port Hampton
Roads or a designated representative.

DATES: From 8:30 p.m. through 10 p.m. on October 1, 2016, the
regulations in 33 CFR 165.506 will be enforced for the safety zone
regulated area listed in row (c) 9 of the table to Sec.  165.506.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email ENS Chandra Saunders, U.S. Coast
Guard Sector Hampton Roads (WWM); telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
regulations in 33 CFR 165.506 from 8:30 p.m. until 10 p.m. on October
1, 2016, for the safety zone regulated area listed in row (c) 9 of the
table to Sec.  165.506. This enforcement is related to a fireworks
display that is part of the Virginia Beach Neptune Festival, on the
North Atlantic Ocean, Virginia Beach, VA. This action is being taken to
provide for the safety of life on navigable waterways during this
event.
    Our regulation for Recurring Marine Events within the Fifth Coast
Guard District, Sec.  165.506, specifies the location of the regulated
area for this safety zone within a 1000 yard radius of the center
located near the shoreline at approximate position latitude
36[deg]51'12'' N., longitude 075[deg]58'06'' W., located off Virginia
Beach, VA between 17th and 31st streets. As specified in Sec.  165.506
(d), during the enforcement period, no vessel may not enter, remain in,
or transit through the safety zone without approval from the Captain of
the Hampton Roads (COTP) or a COTP designated representative. The Coast
Guard may be assisted by other Federal, state or local law enforcement
agencies in enforcing this regulation.
    This notice of enforcement is issued under authority of 33 CFR
165.506(d) and 5 U.S.C. 552 (a). In addition to this notice of
enforcement in the Federal Register, the Coast Guard plans to provide
notification of this enforcement period via the Local Notice to
Mariners and marine information broadcasts.

    Dated: August 17, 2016.
Richard J. Wester,
Captain, U.S. Coast Guard, Captain of the Port, Hampton Roads, VA.
[FR Doc. 2016-21476 Filed 9-6-16; 8:45 am]
BILLING CODE 9110-04-P