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. 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 have been tobacco free since February 17,2013. I haven't smoked since the day I bought my e-cig, I no longer suffer from throat infections, sinus infections or bronchitis. Before I began vaping I would get sick three or four times a year. I tried other methods to quit. gum, patches, pills etc. Nothing took away the cravings! I feel so much better since I quit using analog cigarettes and I smoked for 27 years. 75 days isn't enough time for the companies to respond. Ecigs are saving lives!

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


[Federal Register: June 12, 2009 (Volume 74, Number 112)]
[Rules and Regulations]
[Page 27938-27940]
[DOCID:fr12jn09-13]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2009-0070]
RIN 1625-AA00

Safety Zone; Rockets Over the River; Bullhead City, AZ

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a safety zone, on the
navigable waters of the lower Colorado River, Bullhead City, AZ, in
support of the Rockets Over the River fireworks display. This safety
zone is necessary to provide for the safety of the participants, crew,
spectators,

participating vessels, and other vessels and users of the waterway.
Persons and vessels are prohibited from entering into, transiting
through, or anchoring within this safety zone unless authorized by the
Captain of the Port, or his designated representative.

DATES: This rule is effective from 8:30 p.m. to 10:30 p.m. on July 4,
2009.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2009-0070 and are available online by going to
http://www.regulations.gov, selecting the Advanced Docket Search option
on the right side of the screen, inserting USCG-2009-0070 in the Docket
ID box, pressing Enter, and then clicking on the item in the Docket ID
column. This material is also available for inspection or copying at
the Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail Petty Officer Shane Jackson, Waterways
Management, Coast Guard; telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On April 20, 2009 we published a notice of proposed rulemaking
(NPRM) entitled ``Safety zone; Rockets Over the River; Bullhead City,
Arizona,'' in the Federal Register (74 FR 17928). We received no
comments on the proposed rule. No public meeting was requested, and
none was held.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register because delaying the effective date
would be contrary to the public interest, since immediate action is
needed to ensure the public's safety.

Background and Purpose

    The Coast Guard is establishing a temporary safety zone on the
navigable waters of the Lower Colorado River, Bullhead City, AZ in
support of a fireworks show fired from the Arizona State Land Base near
the navigational channel of the Lower Colorado River, Bullhead City,
AZ. The fireworks show is being sponsored by The Laughlin Tourism
Committee. The safety zone is set at a 1200 foot radius around the
firing site. This temporary safety zone is necessary to provide for the
safety of the show's crew, spectators, participants of the event,
participating vessels, and other vessels and users of the waterway.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    This determination is based on the size and location of the safety
zone. Commercial vessels will not be hindered by the safety zone.
Recreational vessels will not be allowed to transit through the
designated safety zone during the specified times.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    This rule will affect the following entities, some of which may be
small entities: The owners or operators of vessels intending to transit
or anchor in a portion of the Colorado River from 8:30 p.m. to 10:30
p.m. on July 4, 2009.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons. The
safety zone will only be in effect for two hours late in the evening
when vessel traffic is low. Before the effective period, we will
publish a Local Notice to Mariners (LNM).

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to
assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g), of the Instruction. This rule involves establishment of a
safety zone.
    An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Public Law 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add new temporary zone Sec.  165.T11-169 to read as follows:

Sec.  165.T11-169  Safety zone; Rockets Over the River; Bullhead City,
Arizona

    (a) Location. The limits of the safety zone are as follows: all
navigable waters within 1200 feet of the Arizona State Land Base firing
site in approximate position 35[deg]09.15' N, 114[deg]34.07' W.
    (b) Enforcement Period. This section will be enforced from 8:30
p.m. to 10:30 p.m. on July 4, 2009. If the event concludes prior to the
scheduled termination time, the Captain of the Port will cease
enforcement of this safety zone and will announce that fact via
Broadcast Notice to Mariners.
    (c) Definitions. The following definition applies to this section:
designated representative, means any commissioned, warrant, and petty
officers of the Coast Guard on board Coast Guard, Coast Guard
Auxiliary, and local, state, and federal law enforcement vessels who
have been authorized to act on the behalf of the Captain of the Port.
    (d) Regulations. (1) Entry into, transit through or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port of San Diego or his designated on-scene representative.
    (2) Mariners requesting permission to transit through the safety
zone may request authorization to do so from the Patrol Commander
(PATCOM). The PATCOM may be contacted on VHF-FM Channel 16.
    (3) All persons and vessels shall comply with the instructions of
the Coast Guard Captain of the Port or the designated representative.
    (4) Upon being hailed by U.S. Coast Guard patrol personnel by
siren, radio, flashing light, or other means, the operator of a vessel
shall proceed as directed.
    (5) The Coast Guard may be assisted by other federal, state, or
local agencies.

    Dated: May 27, 2009.
T.H. Farris,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. E9-13774 Filed 6-11-09; 8:45 am]

BILLING CODE 4910-15-P


 1 Interim Guidance for Judging the Scientific Quality of Intentional Exposure Human Studies of Pesticide Toxicity March 17, 2006 U. S. Environmental Protection Agency Office of Pesticide Programs Health Effects Division PREFACE This guidance provides a general framework for reviewing a human toxicity study for scientific merit and for deciding how human data fit into the overall toxicity profile of a pesticide using a weight of evidence approach. The Office of Pesticide Programs ( OPP) has not issued guidance for the review of human toxicity studies before, and this initial effort should be considered as interim guidance for the evaluation of the scientific merit of already completed human toxicity studies considered for use in assessing potential pesticide health risks, and will be updated as experience is gained in evaluating human studies. The generic guidance provided here is based on informal guidance developed by the Office of Pesticide Program= s Health Effects Division in 2001 to evaluate human toxicity studies submitted in support of cholinesterase inhibiting pesticides.

Supplements will be developed as needed on other types of intentional exposure human studies such as dermal absorption studies, biomonitoring studies, etc.

This document does not attempt to address ethical issues related to the conduct of tests of pesticide toxicity on human subjects. Coinciding with the implementation ( April 7, 2006) of the Rule on Protections for Subjects in Human Research, EPA has developed separate guidance with respect to the review of the ethical conduct of intentional human exposure studies. In accor with the Human Studies Rule, whenever EPA conducts a scientific review of any such study, the Agency will also perform an ethical review of the study, and both the scientific and ethical reviews will be available to 2 risk assessors and risk managers before EPA decides to rely on such a study in any risk assessment or risk management action. 3 1. INTRODUCTION The goal of this document is to provide a general framework for Health Effects Division scientists in EPA= s Office of Pesticide Programs ( OPP) to judge the scientific adequacy and usefulness of intentional human dosing toxicity studies in assessing human health hazards and risks. The guidance is divided into two parts. First, it discusses key factors the reviewing toxicologist should consider in evaluating and documenting individual human studies. Second, it describes a weight of evidence process that scientists should use in judging the reliability of the body of human data and to decide how the human data fits in to the overall body of data relating to the toxicity of a pesticide.

The guidance is designed to promote clarity, consistency and transparency in the conclusions reached regarding the adequacy and usefulness of human studies in hazard and dose response assessment.

The topics described below should not be regarded as a checklist of requisite conditions, but rather factors a scientist should think about when evaluating a study ( as described in Section 2).

Furthermore, the weight of evidence approach described ( Section 3) is not a decision tree, but highlights information to be considered and questions to be addressed. It requires that the logic behind any judgements made be transparent.

The guidance is intended to be an analytical tool for evaluating human toxicity studies, and does not address directly how to conduct a human study.

2. EVALUATION OF HUMAN STUDIES The quality and reliability of human studies of pesticides should be evaluated according to sound scientific principles. The reviewer should pay particular attention to the following factors in reaching conclusions regarding the utility of such studies.

2.1. Study Design The reviewer should use sound scientific judgement to evaluate the study design which should have been described clearly and in sufficient detail to permit effective review and evaluation1. Seeking 1 The report may contain statements indicating whether the study was conducted under Good Clinical 4 advice from other toxicologists, or from experts in other disciplines such as statistics or epidemiology is advisable if the reviewer lacks knowledge in certain technical areas. Specific parameters to be considered in the study design include the following:

2.1.1. Test Material The test material for human pesticide toxicity studies is usually the technical grade of the active ingredient or, occasionally a formulated product. If the test material is the technical grade of the active ingredient, it is important to report not only the concentration of the active ingredient, but also the identity and concentration of impurities associated with the manufacture of the technical material, and any other ingredient chemicals such as diluents or stabilizers added to the technical material. If the test material is a formulation, identification of all inert ingredients is important for determining whether components other than the active ingredient may contribute to or influence the reported effects ( this information may not be reported in the study, but will be available in EPA= s files under the Registration Number). Also, such information is important to judge whether the active ingredient in a formulation was administered at a concentration sufficient to produce a response. The reviewer should also consider potential effects of a vehicle, if it is used in the study. Information should be included on whether potential vehicle induced effects were evaluated with a vehicle control group. If not, the reviewer should seek out information in the published literature from other human studies and animal testing on the toxicity of the vehicle.

2.1.2. Subject Selection Practice ( GCP) regulations ( i. e., 21 CFR 314.126, 21 CFR 50, or 40 CFR 26). Some old human studies might not have such statements; however, it does not necessarily suggest that these studies did not follow the GCP. These human toxicity studies may still have value for hazard assessment. 5 Studies should use healthy adult volunteers. Although it is preferable to collect data on both sexes, this may not be an issue if other information indicates that males and females are likely to respond similarly to the test material. The reviewer should note whether the study identified persons whose work history involved exposure to other agents that may confound study results ( for example,

pesticide applicators or agricultural workers). The reviewer should indicate whether the investigators evaluated the health status of subjects by physical examinations, clinical tests, and documented health histories to identify individuals with medically significant conditions which might compromise the study. The reviewer should indicate whether researchers attempted to identify confounding factors such as alcohol consumption, smoking, pharmaceutical drug use, or other exposures. Lastly, the reviewer should note any information gathered during the health screen of each subject that may explain unusual results.

2.1.3 Treatment and Control Groups Of critical importance to the study is the inclusion of appropriate control groups to insure that observed responses are associated with treatment and not due to biases or factors unrelated to treatment. The reviewer should indicate how subjects were assigned to treatment groups, in other words, whether assignment was random or based on attempts to match for confounding variables ( e. g., age, sex, smoking). The reviewer should indicate the types and adequacy of control groups used in the study  including whether concurrent untreated or placebo controls were used, and whether there were baseline measurements of subjects prior to initiation of dosing. The reviewer should note whether the investigators, subjects or both were unaware ( blind) as to the nature of the treatment that subjects received.

2.1.4. Number of Subjects per Group The number of subjects for each group should be large enough to allow adequate statistical power for a reliable analysis of the response. The number of subjects in a human study is usually based on considerations of the magnitude of the treatment effect and the number of dose groups evaluated, and sometimes determined by the number of subjects available. There are no strict criteria for number of subjects, and thus this is determined on a case by case basis. Studies with few subjects 6 may still be of value in a weight of evidence analysis in identifying doses that produce an effect.

Consultation with a statistician familiar with the design of human studies is recommended.

2.1.5. Dose Selection The reviewer should briefly describe the rationale and approach used for dose selection.

Depending on the objective of the study, there are various potentially valid dosing designs. For example, some studies may employ multiple doses and other studies may use a single dose with a multiple rising dose design which provides an assessment of effects, if any, at each dose level before proceeding to the next higher dose level.

2.1.6. Dose Preparation and Administration The reviewer should determine the adequacy of administration of the test material. How was the concentration of the active material determined? For multiple dose studies were dosing solutions prepared each day? A description of how and when the test material was administered should be provided, for example, when were doses administered in relation to food consumption? The reviewer should evaluate whether the method of administration is appropriate to insure absorption of the test material and should determine whether the administered doses were correctly calculated. The duration of dosing may range from a single dose on one day to multiple doses over many weeks,

depending on the objective of the study. Although researchers often employ multiple dose levels to establish a point of departure such as a No Observed Adverse Effect Level ( NOAEL), or to establish differences in interspecies sensitivity, a single dose human study in conjunction with animal studies may be useful in establishing a point of departure.

<IP_ADDRESS>. Sample Handling Given the potential for the instability or reversibility of some toxic effects, for example,

acetylcholinesterase inhibition by carbamates, the reviewer needs to pay close attention to biological sample collection, processing, storage, and assay procedures described in the study report. Use of improper or sub optimal procedures can result in data inaccuracies or increase data variability.

Proper handling of biological samples in human studies will vary case by case, and may be informed 7 by studies on laboratory animals, as well as other sources such as the published literature on a specific toxicity.

2.1.8. Clinical Observations and Symptoms Clinical signs or symptoms are important parameters to be considered in assessing hazard.

Based, in part, on responses observed in animal dosing studies, the human subjects are likely to have been observed for clinical signs following administration of the test material. Clinical data should be tabulated based on number of individuals per dose group exhibiting signs of a particular type, as well as the intensity, time of onset, and duration of the responses, in order to gain an understanding of a dose response relationship, if possible. Baseline data for clinical observations should be reported,

particularly for the more quantifiable measures ( e. g., heart rate, blood pressure). Adverse clinical signs noted during the exposure period can be used as evidence for dose related toxicity and can play an important role in determining a point of departure.

2.1.9. Clinical Chemistry Clinical chemistry tests including hematology and urinalysis can serve to monitor the safety and well being of test subjects, as well as providing valuable information regarding systemic effects of the test material. The magnitude of clinical chemistry parameters should be compared with pretreatment and control values for detection of biologically relevant shifts. When using pretreatment control data, it must be kept in mind that normal values in hematologic and clinical chemistry measurements depend on the specific methods used to generate the data. Therefore, only values produced by the identical methods in the same period of time from the same laboratory are valid in such comparisons. Sometimes measurements of test substance in the urine or feces are added in the study report. This information is helpful in understanding the absorption and elimination of the test material and can serve as a confirmation for the administration of test material for each subject.

2.2. Evaluation of Data 8 The findings from a human study must be interpreted in the context of the study conduct and quality ( as discussed above, e. g., appropriate subject selection, number of subjects, dosing regimen,

sample collection/ preparation, methodology), as well as the statistical and biological significance.

2.2.1. Statistical Analysis All statistical methods used in the study should be identified, described and referenced.

Careful scrutiny of the author= s statistical methods and results, and when necessary, re analysis of the author= s data should be done to corroborate reported results. Treatment and pretreatment values for each subject should be compared statistically, as well as a comparison with the concurrent control and/ or placebo group and treatment groups as a whole. The pattern of individual responses ( pretreatment versus treatment results) should be addressed as well as mean responses of subjects in the treatment group. It is important to keep in mind that a statistically significant response may or may not be biologically important, for example, a response may be statistically significant yet be within the range of normal human response. When outliers are removed for statistical reasons, the reasons for removing them should be specified. The selection of a significance level is a judgement choice based on consideration of the potential for false positive and false negative outcomes. Typical significance levels are 5% ( p# 0.05) or 1% ( p# 0.01). In the case of non positive results, it is important that a statistical analysis be performed to determine the power of the test to detect a positive response considering such factors as number of subjects, variability in baseline values, and characteristics of the response being analyzed. For example, data on cholinesterase inhibition may be analyzed for power of the study to detect a negative finding, whereas data on signs and symptoms are less amenable to standard tests for power and should be subjected to alternative statistical analyses depending on the nature of the response being analyzed or questions raised concerning the data. The reviewers are encouraged to seek advice from statisticians regarding the appropriateness and accuracy of the statistical analysis.

2.2.2. Presentation and Discussion of Results In reaching a conclusion as to whether the data allow one to identify endpoints and points of departure and other important information ( e. g., time of peak effects, duration and reversibility of 9 effect, time to reach steady state) for use in risk assessment, the reviewer must look at the biological and statistical significance of the response, and the pattern of effects. The reviewer should prepare a series of tables, plots or charts of the responses and provide a discussion of the data that addresses the following questions: what effects ( if any) were observed and at what dose( s), was there a dose response, the magnitude or severity of the response, onset and duration of the effects, and the incidence ( i. e., how many subjects responded). Such comparisons of the patterns or trends in the response data aid in the interpretation of biological relevance, significance, and overall usefulness of the study. In tabulating the response data, the reviewer should include both the individual data for each subject, as well as the mean values. Furthermore, if data are available from multiple studies or from acute and subchronic dosing phases of a study, these multiple data sets should be tabulated in a comparative manner in order to evaluate consistency and response trends across different studies and across different durations of exposure.

Responses may or may not be statistically significant. Even if an effect is not statistically significant, if the pattern of onset, duration, and nature of effects appears consistent with what is generally understood about the toxic properties of the test material and its class, then this provides greater confidence that the effects are treatment related. For example, if unusual time course data are encountered, the reviewer should determine if the results can be reconciled with what is understood about the metabolism and toxicology of the test agent. In studies where no effects are found, the reviewer needs to note the quality of the study and how well the study design allowed for the potential to detect an effect ( e. g., power of study), and therefore how much confidence one can place on lack of an observed effect.

2.2.3. Summary In preparing the Data Evaluation Record, the reviewer should provide a summary that highlights the key conclusions/ recommendations regarding whether a point of departure or other information about the biological and kinetic characteristics of the test material can be identified from the study. The summary should also clearly lay out the rationale supporting the conclusions, as well 10 as, the confidence in the identified value( s), by describing the strengths and weaknesses of the study.

It should be recognized that results of humans studies will span a broad continuum that can not be easily capsulized in guidance, ranging from a seriously flawed study that can not be used to a robust study that provides a wealth of information that could be incorporated in the risk assessment.

Evidence that falls within this continuum may still have some utility in the risk assessment and will require case by case judgements.

3. WEIGHT OF EVIDENCE ANALYSIS The intent of a weight of evidence analysis with respect to human toxicity of pesticides is to determine how the human data should be integrated into the overall toxicity database of a pesticide including information on kinetics and mode of action as well as toxicity studies. The analysis is a two step process. First, the body of human data should be evaluated for scientific quality and weighed in the context of scientific reliability and relevance, and then the strengths and weaknesses of the key data identified from all available human and animal studies should be considered together in an integrative manner. This is followed by a narrative description which includes the rationale used for selecting the critical study or studies used to establish reference values. The weight of evidence narrative should clearly convey to an individual unfamiliar with the toxicology of a chemical the logic and decision path followed in reaching decisions on the selection of critical studies for use in establishing a point of departure such as a NOAEL or Benchmark Dose, evaluating interspecies differences in toxicological response or on other toxicological information for use in risk assessments.

Previous sections of this document highlighted factors that should be addressed in preparing Data Evaluation Records for studies on a chemical of interest. The weight of evidence analysis should be prepared by the risk assessment team prior to selection of key studies for assessment of health risks,

and should be included in the risk assessment or made available as a stand alone document to the Health Effects Division= s Risk Assessment Review Committee or any other decision making body that needs to know the basis for the points of departure chosen for risk assessment.

The weight of evidence analysis involves judgments about the conduct of studies and the quality of the dose response data, In examining the body of evidence, the consistency of responses among different human studies ( if several studies are available) as well as the consistency between human and experimental animal results should be considered, as well as the impact of data deficiencies and limitations. One should not only look at toxicity studies but consider all available information 11 including epidemiology studies, incident data, in vitro data, and comparative animal vs. human data on absorption, metabolism, distribution and excretion. For example, if animal studies indicate that there is a sex difference in response to the test material, the gender issue should be addressed in the review of the human study. In another example, if there is an indication that humans are more or less sensitive than animals, this species difference should be addressed.

In conducting a weight of evidence analysis, the factors to consider in integrating human data into the totality of the toxicity database will vary from study to study. Data that either support or reduce confidence in the use of human studies should be presented. Factors that increase confidence in the use of a human data to establish a point of departure, for example, might include ( 1) consistent observations in multiple independent human studies; ( 2) results consistent with animal data; ( 3)

demonstration of a dose response relationship, and ( 4) clinical signs correlated with a sensitive subclinical response. Examples of factors that might diminish the usefulness of a study and reduce the confidence for establishing a reference dose include ( 1) poor study design; ( 2) inconsistent results within the study and among different human studies; and ( 3) inconsistent results among human and animal studies. The reviewer should identify the strengths and weaknesses of the human studies. No single factor is determinative, and all information should be judged in context. For example,

availability of dose response information from a human study may enhance its usefulness, but absence of such data would not necessarily prevent consideration of the study in establishing a point of departure. Data from human studies, although presumed to be more relevant to the assessment of human hazard and risk, might be deemed unreliable because of limitations in study design or results ( e. g. small number of subjects, high variability in the data, uncertainties regarding the methodology).

In such a case, data from animal studies would be used exclusively for selection of points of departure2. Conversely, if a human study is robust ( e. g. adequate number of subjects, sound methodologies used and a consistent pattern in responses), the data may support use of the human data even if the results are inconsistent with those from animal testing.

2 Special mention should be made of the situation where humans appear to be more sensitive than laboratory animals to a pesticide. In this case, even weak human data should not be disregarded if they suggest that use of animal data are not health protective. 12 Even though a human study might not be considered sufficiently robust to serve as the critical study for assessment of hazard or risk, the study might be useful for a more limited purpose.

Depending on the quality of the human study, the human data may be used to corroborate the endpoints selected from key animal studies, or to identify adjustments that need to be made to uncertainty factors, particularly the interspecies uncertainty factor. In some cases, the human data may add credence to data from animal studies that indicate a steady state is attained following treatment after a defined period of dosing. The weight of evidence narrative should present all information from a human study that may supplement information from animal studies even if a human study is not selected as a point of departure for estimating risk.

4. CONCLUSIONS This document outlines the factors that should be considered in evaluating an intentional exposure study performed with human subjects. In assessing the scientific acceptability of a human study, the reviewer must answer several questions:

$ Is the study soundBwas it well designed, properly conducted, and did it answer the research question conclusively?

$ If the study is sound, how does it fit with other available published or unpublished human studies and with available incident data? Are the human data consistent with the toxicology data base in laboratory animals?

$ How should a human study be used in risk assessment? Is the study under consideration sufficiently robust that it defines a point of departure from which risk can be estimated? Can the human data be used as the basis for developing an alternative interspecies uncertainty factor?

The answers to these questions should be derived from a consideration of all available human and laboratory animal evidence as described above, and should be presented in a narrative which clearly articulates the strengths and limitations of the human studies, and indicates the appropriate role for the study in the hazard and dose response assessment. A detailed rationale should be provided for all conclusions. 13 REFERENCES Code of Federal Regulations ( 1997) Title 40, Vol. 1, Part 1 49.

Code of Federal Regulations ( 1998) Title 21, Vol. 1, Part 1 99.

Code of Federal Regulations ( 1998) Title 21, Vol. 5, Part 300 499.

Food and Drug Administration ( 1993) Redbook II, Chapter VI: Human Studies, 176 190.

Wilson BW, Adele. ( 1997). Monitoring the pesticide exposed worker. In: Occupational Medicine: State of the Art Reviews Vol. 12, No. 2, April June, pp. 3487 363, published by Hanley and Bellus, Inc., Philadelphia, PA.


[Federal Register Volume 87, Number 6 (Monday, January 10, 2022)]
[Notices]
[Page 1140]
[FR Doc No: 2022-00196]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. NJ22-4-000]

City of Banning, California: Notice of Filing

    Take notice that on December 21, 2021, City of Banning, California
submitted its tariff filing: 2022 Transmission Revenue Balancing
Account Adjustment/Existing Transmission Contracts update, to be
effective January 1, 2022.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (https://www.ferc.gov)
using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document. At this
time, the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern Time on January 18, 2022.

    Dated: January 4, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-00196 Filed 1-7-22; 8:45 am]
BILLING CODE 6717-01-P


Summary of Georgetown University Site Visit

Site:	Georgetown University

	Washington, DC

Date: 		July 23, 2002

Purpose:	To learn about the generation and management of RCRA hazardous
waste in college and university laboratories

Attendees:

U.S. EPA, Office of Solid Waste

Kristin Fitzgerald

Lillian Bagus

Patricia Cohn

Kate Davis

Georgetown University Staff

Phil Hagan, Director, Safety & Environmental Management

To begin the site visit, staff from Georgetown University presented
general overview information about the areas of the university in which
hazardous waste is generated.  We discussed their current waste
practices within the university.  The staff from Georgetown University
indicated that Georgetown Hospital, which is on campus, was no longer
owned by Georgetown University and its hazardous wastes are managed
separately.

We visited several laboratories within the university, although since it
was summer, the teaching laboratories were not in operation.  We also
visited the university’s 90-day storage area.


[Federal Register: April 5, 2007 (Volume 72, Number 65)]
[Notices]
[Page 16779-16781]
[DOCID:fr05ap07-63]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP06-470-000; CP06-471-000; CP06-472-000; CP06-473-000;
CP06-474-000]

Southern LNG Inc.; Elba Express Company, L.L.C.; Southern Natural
Gas Company; Notice of Availability of the Draft Environmental Impact
Statement for the Elba III Project

March 30, 2007.
    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared a draft Environmental Impact Statement (EIS)
for the Elba III Project, proposed by Southern LNG Inc. (Southern LNG),
Elba Express Company, L.L.C. (EEC), and their parent company Southern
Natural Gas Company (Southern), a subsidiary of El Paso Corporation. As
described in the above-referenced dockets, this project would consist
of the following components:
     Southern LNG's expansion of the existing Elba Island
Liquefied Natural Gas (LNG) Import Terminal near Savannah in Chatham
County, Georgia;
     EEC's construction and operation of natural gas pipeline
and compression facilities (Elba Express Pipeline) extending between
existing facilities owned by Southern in Chatham County and those of
Transcontinental Gas Pipe Line Corporation (Transco) in Hart County,
Georgia and Anderson County, South Carolina; and
     Southern's abandonment by sale to EEC of an undivided
interest in its pipeline facilities that extend between the LNG import
terminal and the existing Port Wentworth Meter Station (where the Elba
Express Pipeline would begin), and purchase of an undivided interest in
the first 10 miles of the Elba Express Pipeline.
    The draft EIS was prepared to satisfy the requirements of the
National Environmental Policy Act of 1969 (NEPA), and was completed
with the cooperation of the U.S. Coast Guard (Coast Guard), the U.S.
Army Corps of Engineers (COE), and the National Oceanic and Atmospheric
Administration's National Marine Fisheries Service (NOAA Fisheries). A
cooperating agency has jurisdiction by law or special expertise with
respect to potential environmental impacts associated with the
proposal, and participates in the NEPA analysis.
    The Coast Guard is responsible for determining the suitability of a
waterway for LNG marine traffic; in this instance, the determination
would be issued as a Letter of Recommendation with conditions. The
Captain of the Port Savannah is the point of contact for this action.
The COE would need to evaluate the project and issue Section 404
Permits for wetland impacts associated with expansion of the terminal
and pipeline construction, easements where the pipeline would cross
COE-managed lands, modifications to existing COE Mitigation Lands, and
an approval for a large fuel-carrying pipeline to cross federal
property. NOAA Fisheries has responsibilities for evaluating potential
impacts on essential fish habitat and threatened or endangered aquatic
species.
    The FERC staff has concluded that if the project is constructed and
operated in accordance with applicable laws and regulations, each
project sponsor's proposed mitigation, and the staff's additional
mitigation recommendations, it would have limited adverse environmental
impact and would be an environmentally acceptable action.
    The draft EIS addresses the potential environmental effects of
construction and operation of the following LNG terminal and natural
gas pipeline facilities:

Elba Terminal Expansion

    The proposed expansion of the existing LNG import terminal would:
(a) More than double the site's LNG storage capacity by adding 405,000
cubic meters (m3) of new storage; (b) substantially increase
the facility's existing vaporization capacity; (c) upgrade the
terminal's send-out meter station to increase the natural gas send-out
capacity of the facility by an additional 900 million cubic feet per
day (MMcfd); and (d) modify the terminal's LNG tanker berthing and
unloading facilities to accommodate larger tankers and provide for
simultaneous unloading of two LNG tankers. All of the planned
facilities would be located entirely within the existing 190-acre
facility site on Elba Island.
    The LNG terminal expansion would be constructed in two phases, A
and B. Southern LNG anticipates completing Phase A as early as January
2010. Phase A would include the following facilities:
    a. One new 200,000-m3 (1.25 million barrels [bbls]) LNG
storage tank, one associated boil-off gas condenser, and three boil-off
gas compressors;
    b. three submerged combustion vaporizers, each with a peak capacity
of 180 MMcfd (providing a total peak send-out capacity of 1,755 MMcfd
for the full facility at the completion of phase A); and
    c. modifications to the unloading docks to accommodate larger LNG

tankers and to allow simultaneous unloading of two LNG tankers. The
modifications to the dual berthing slip include:

--Adding four mooring dolphins (two for each berth);
--dredging approximately 72,000 cubic yards of material from the slope
at the back of the existing slip (and disposing of dredged material
into the existing spoil disposal area adjacent to the terminal); and
--installing a sheet pile bulkhead at the back of the slip.

    These modifications would allow the slip to accommodate larger LNG
tankers with an approximate overall length of 345 meters (m) (compared
to the current 288 m), breadth of 55 m (currently 49 m), design laden
draft of 12.0 m (currently 11.7 m), and displacement of 177,000 metric
tons (currently 128,000 metric tons).
    Phase B would be completed no later than December 2012 and would
include the following facilities:
    a. one new 200,000-m3 (1.25 million bbls) LNG storage
tank; and
    b. three submerged combustion vaporizers (two for service and one
spare), each with a peak capacity of 180 MMcfd (providing a total peak
send-out capacity of 2,115 MMcfd for the full facility at the
completion of phase B).
    Each phase would include all necessary ancillary equipment
including related pumps, piping, controls and appurtenances, and
associated systems (electrical, mechanical, civil, instrumentation,
hazard detection, and fire protection) and buildings necessary to
accommodate the associated tanks and vaporizer units.

Elba Express Pipeline

    EEC proposes to construct and operate about 188 miles of new
natural gas pipeline and appurtenant facilities in Georgia and South
Carolina. The pipeline would be constructed in two phases. The first
phase is proposed to be placed in service no later than July 2011 with
a design capacity of 945 MMcfd, and would consist of:
    a. a ``Southern Segment,'' which includes about 104.8 miles of 42-
inch-diameter pipeline extending from Port Wentworth to the existing
Southern Wrens Compressor Station (Wrens) in Jefferson County, Georgia
(to be collocated with existing Southern pipelines); and
    b. a ``Northern Segment,'' which includes about 83.1 miles of 36-
inch-diameter pipeline extending from Wrens to interconnects with
Transco in Hart County, Georgia, and Anderson County, South Carolina.
    The second phase would involve construction and operation of a new
10,000-horsepower compressor station near Millen, Jenkins County,
Georgia, on a site where Southern currently operates other aboveground
facilities. The compressor station would increase the pipeline design
capacity by 230 MMcfd to a total of 1,175 MMcfd, and is proposed to be
placed in service no later than January 2013.
    The draft EIS has been placed in the public files of the FERC and
is available for distribution and public inspection at: Federal Energy
Regulatory Commission, Public Reference Room, 888 First Street, NE.,
Room 2A, Washington, DC 20426,<PHONE_NUMBER>.
    CD-ROM copies of the draft EIS have been mailed to federal, state,
and local agencies; public interest groups; individuals and affected
landowners who requested a copy of the draft EIS or provided comments
during scoping; libraries and newspapers in the project area; and
parties to this proceeding. Hard copy versions of the draft EIS were
mailed to those specifically requesting them. A limited number of hard
copies and CD-ROMs are available from the Public Reference Room
identified above.

Comment Procedures and Public Meetings

    Any person wishing to comment on the draft EIS may do so. To ensure
consideration prior to a Commission decision on the proposal, it is
important that the Commission receive your comments before the date
specified below. Please carefully follow these instructions to ensure
that your comments are received and properly recorded:
     Send an original and two copies of your comments to:
Philis J. Posey, Acting Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Room 1A, Washington, DC 20426.
     Reference Docket Nos. CP06-470-000, et al.
     Label one copy of the comments for the attention of Gas
Branch 1, DG2E.
     Mail your comments so that they will be received in
Washington, DC on or before May 21, 2007.
    Please note that the Commission strongly encourages electronic
filing of any comments or interventions or protests to this proceeding.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site at http://www.ferc.gov under the ``e-Filing'' link and the

link to the User's Guide. Before you can file comments you will need to
create a free account, which can be created by clicking on ``Login to
File'' and then ``New User Account.'' You will be asked to select the
type of filing you are making. This filing is considered a ``Comment on
Filing.''
    In lieu of sending written comments, you are invited to attend
public comment meetings the FERC staff will conduct in the project area
to receive comments on the draft EIS. Date, time, and location of these
meetings will be sent under separate cover. Interested groups and
individuals are encouraged to attend and present oral comments on the
draft EIS. Transcripts of the meetings will be prepared.
    After these comments are reviewed, any significant new issues are
investigated, and modifications are made to the draft EIS, a final EIS
will be published and distributed. The final EIS will contain the FERC
staff's responses to timely comments received on the draft EIS.
    Comments will be considered by the Commission but will not serve to
make the commenter a party to the proceeding. Any person seeking to
become a party to the proceeding must file a motion to intervene
pursuant to Rule 214 of the Commission's Rules of Practice and
Procedures (18 CFR 385.214). Anyone may intervene in this proceeding
based on this draft EIS. You must file your request to intervene as
specified above.\1\ You do not need intervener status to have your
comments considered.
---------------------------------------------------------------------------

    \1\ Interventions may also be filed electronically via the
Internet in lieu of paper. See the previous discussion on filing
comments electronically.
---------------------------------------------------------------------------

    Additional information about the project is available from the
Commission's Office of External Affairs, at 1-866-208-FERC or on the
FERC Internet Web site (http://www.ferc.gov) using the eLibrary link. Click on

the eLibrary link, click on ``General Search'' and enter the docket
number excluding the last three digits in the Docket Number field. Be
sure you have selected an appropriate date range. For assistance,
please contact FERC Online Support at<EMAIL_ADDRESS>or
toll free at 1-866-208-3676, or for TTY, contact<PHONE_NUMBER>. The
eLibrary link on the FERC Internet Web site also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission now offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings,

document summaries and direct links to the documents. Go to the
eSubscription link on the FERC Internet Web site.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-6315 Filed 4-4-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Pages 43356-43357]
[FR Doc No: 2017-19691]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0008; FRL-9965-38]

Pesticide Product Registration; Receipt of Applications for New
Uses

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA has received applications to register new uses for
pesticide products containing currently registered active ingredients.
Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), EPA is hereby providing notice of receipt and opportunity to
comment on these applications.

DATES: Comments must be received on or before October 16, 2017.

ADDRESSES: Submit your comments, identified by the Docket
Identification (ID) Number and the File Symbol of interest as shown in
the body of this document, 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 Confidential Business
Information (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://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (7511P), main telephone number: (703)
305-7090; email address<EMAIL_ADDRESS>Michael Goodis,
Registration Division (7505P), main telephone number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>Steve Knizner, Antimicrobials
Division (7510P), main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>The mailing address for each contact person is:
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Registration Applications

    EPA has received applications to register new uses for pesticide
products containing currently registered active ingredients. Pursuant
to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA
is hereby providing notice of receipt and opportunity to comment on
these applications. Notice of receipt of these applications does not
imply a decision by the Agency on these applications:

    1. EPA Registration Numbers: 100-815, 100-1406, 100-1407, and
100-1442. Docket ID number: EPA-HQ-OPP-2017-0211. Applicant:
Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419.
Active ingredient: S-metolachlor. Product type: Herbicide. Proposed
use: Sugarcane. Contact: RD.
    2. EPA Registration Numbers: 264-1137 and 264-1169. Docket ID
number: EPA-HQ-OPP-2016-0508. Applicant: Bayer CropScience, 2 T.W.
Alexander Drive, Research Triangle Park, NC 27709. Active
ingredient: Fluoxastrobin. Product type: Fungicide. Proposed uses:
Sorghum (seed treatment) and Wheat (seed treatment). Contact: RD.
    3. EPA Registration Numbers: 279-3460, 279-3052, and 279-3158.
Docket ID Number: EPA-HQ-OPP-2017-0372. Applicant: FMC Corporation,
2929 Walnut Street, Philadelphia, PA 19104. Active ingredient:
Clomazone. Product type: Herbicide. Proposed uses: Cilantro; dill;
vegetable, cucurbit, group 9; rapeseed subgroup 20A; vegetable,
brassica, head and stem, group 5-16; cottonseed subgroup 20C;
Chinese broccoli; kohlrabi; bean, dry; bean, succulent; and the
stalk and stem vegetable subgroup 22A, except kohlrabi. Contact: RD.
    4. EPA Registration Number: 6836-378. Docket ID number: EPA-HQ-
OPP 2017-0348. Applicant: Lonza Inc., 90 Boroline Road, Allendale,
NJ 07401. Active ingredient: Sodium Pyrithione. Product type:
Materials Preservative. Proposed use: Dishwasher rinse aid. Contact:
AD.
    5. EPA File Symbol: 46197-E. Docket ID number: EPA-HQ-OPP-2017-
0232. Applicant: Technology Sciences Group, Inc. on behalf of Kansai
Paint Co., Ltd., 1150 18th St. NW., Suite 1000, Washington, DC
20036. Active ingredient: Permethrin. Product type: Insecticide.
Proposed use: Permethrin-treated paint to be applied to walls as a
means to kill mosquitoes. Contact: RD.
    6. EPA Registration Numbers: 62719-144 and 62719-659. Docket ID
number: EPA-HQ-OPP-2016-0650. Applicant: Interregional Research
Project No. 4 (IR-4) Project Headquarters, Rutgers, The State
University of NJ, 500 College Road East, Suite 201, W. Princeton, NJ
08540. Active ingredient: Isoxaben: N-[3-(1-ethyl-1-methylpropyl)-5-
isoxazolyl]-2, 6-dimethoxybenzamide and isomers. Product type:
Herbicide. Proposed use: Apples, bushberry subgroup 13-07B, the
fruit, small, vine climbing, except fuzzy kiwi fruit, subgroup 13-
07F; the nut, tree, group 14-12. Contact: RD.
    7. EPA Registration Number: 73049-407. Docket ID number: EPA-HQ-
OPP-2017-0289. Applicant: Valent BioSciences, LLC, 870 Technology
Way, Libertyville, IL 60048. Active ingredient: 6-benzyladenine.
Product

type: Plant regulator. Proposed use: End-use product plant regulator
for use on avocados to increase fruit size and yield and to reduce
alternate bearing.Contact: BPPD.
    8. EPA Registration Number: 73049-407. Docket ID number: EPA-HQ-
OPP-2017-0287. Applicant: Valent BioSciences, LLC, 870 Technology
Way, Libertyville, IL 60048. Active ingredient: 6-benzyladenine.
Product type: Plant regulator. Proposed use: End-use product plant
regulator for use on fruiting vegetables (peppers and tomatoes) and
cucurbits (cucumbers, melons, and squash) for enhancement of fruit
size. Contact: BPPD.
    9. EPA Registration Number: 11678-73 and 66222-243. Docket ID
number: EPA-HQ-OPP-2017-0169. Applicant: Makhteshim Agan of North
America d/b/a ADAMA, 3120 Highlands Blvd., Suite 100, Raleigh, NC
27604. Active ingredient: Fluensulfone. Product type: Nematicide.
Proposed use: Pome Fruit Group 11-10, Stone Fruit Group 12-12, Small
Fruit Vine Climbing Subgroup 13-07D, Tree Nuts Group 14-12,
Sugarcane, and inadvertent tolerances for Cereal Grain, Group 15;
Forage, Fodder and Straw of Cereal Grains Group 16. Contact: RD

    Authority: 7 U.S.C. 136 et seq.

    Dated: July 26, 2017.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Pesticide Programs.
[FR Doc. 2017-19691 Filed 9-14-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 47 (Monday, March 13, 2017)]
[Notices]
[Pages 13454-13455]
[FR Doc No: 2017-04881]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2225-021]

Public Utility District No. 1 of Pend Oreille County, Washington;
Notice of Application Accepted for Filing, Soliciting Comments, Motions
To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:

    a. Type of Proceeding: Amendment of License.
    b. Project No.: 2225-021.
    c. Date Filed: January 30, 2017.
    d. Licensee: Public Utility District No. 1 of Pend Oreille County,
Washington.
    e. Name of Project: Sullivan Lake Storage Project.
    f. Location: The project is located on Sullivan Creek near the town
of Metaline Falls, Pend Oreille County, Washington. The project
occupies federal lands administered by the U.S. Forest Service within
the Colville National Forest.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Licensee Contact: Mr. Mark Cauchy, Director Regulatory and
Environmental Affairs, Pend Oreille County Public Utility District,
P.O. Box 190, Newport, WA 99156,<PHONE_NUMBER>.
    i. FERC Contact: Ms. Rebecca Martin,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, interventions, and protests is 30
days from the issuance date of this notice by the Commission. The
Commission strongly encourages electronic filing. Please file motions
to intervene, protests and comments using the Commission's eFiling
system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. The first page of any filing should
include docket number P-2225-021.
    k. Description of Request: The licensee proposes to change its
method for removing Mill Pond Dam that was approved by the Commission
in its Order Accepting Surrender of License and Authorizing Disposition
of Project Facilities issued March 20, 2013 (142 FERC ] 62,232).
Instead of removing the dam by siphoning water out of Mill Pond and
building a cofferdam licensee is proposing to demolish the dam without
building a cofferdam to promote sediment outflow and facilitate
sediment transport to the downstream reaches of Sullivan Creek.
    l. This filing may be viewed on the Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number
excluding the last three digits in the docket number field to access
the document. If the document is unavailable using the general or
advanced searches select the docket search option. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction in the Commission's
Public Reference Room located at 888 First Street NE., Room 2A,
Washington, DC 20426, or by calling<PHONE_NUMBER>.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.212 and .214. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading

the name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis and otherwise comply with the requirements of 18 CFR
4.34(b). All comments, motions to intervene, or protests should relate
to project works which are the subject of the license amendment.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application. If an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.

    Dated: March 7, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-04881 Filed 3-10-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 88 (Wednesday, May 7, 2014)]
[Proposed Rules]
[Page 26195]
[FR Doc No: 2014-10381]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2014-0108]
RIN 1625-AA08

Special Local Regulations for Marine Events, Choptank River;
Between Cambridge, MD and Trappe, MD

AGENCY: Coast Guard, DHS.

ACTION: Proposed rule; withdrawal.

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SUMMARY: The Coast Guard is withdrawing its proposed rule concerning
amendments to the regattas and marine parades regulations. The
rulemaking was intended to establish special local regulations during
the swim segment of the ``Choptank Bridge Swim,'' a marine event to be
held on the waters of Choptank River between Cambridge, MD and Trappe,
MD on May 10, 2014. The Coast Guard was notified on April 9, 2014 that
the event had been cancelled.

DATES: The proposed rule is withdrawn on May 7, 2014.

ADDRESSES: The docket for this withdrawn rulemaking is available for
inspection at the Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., between 9 a.m. and 5 p.m., Monday through Friday,
except federal holidays. You may also find this docket on the Internet
by going to http://www.regulations.gov, inserting USCG 2014-0108 in the
``Keyword'' box, and then clicking ``Search.''

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice, call or email Mr. Ronald Houck, Waterways Management Division,
Sector Baltimore, MD, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing material in
the docket, call Cheryl Collins, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    On March 18, 2014, we published a notice of proposed rulemaking
entitled ``Special Local Regulations for Marine Events, Choptank River;
Between Cambridge, MD and Trappe, MD'' in the Federal Register (79 FR
15068). The rulemaking concerned the Coast Guard's proposal to
establish temporary special local regulations on specified waters of
Choptank River between Cambridge, MD and Trappe, MD, effective from 9
a.m. to 3 p.m. on May 20, 2014. The regulated area included all waters
of the Choptank River, from shoreline to shoreline, within and area
bounded on the east by a line drawn from latitude 38[deg]35'13'' N,
longitude 076[deg]02'33'' W, thence south to latitude 38[deg]33'50'' N,
longitude 076[deg]02'07'' W, and bounded on the west by a line drawn
from latitude 38[deg]35'37'' N, longitude 076[deg]03'09'' W, thence
south to latitude 38[deg]34'25'' N, longitude 076[deg]04'05'' W,
located at Cambridge, MD. The regulations were needed to temporarily
restrict vessel traffic during the event to provide for the safety of
participants, spectators and other transiting vessels.

Withdrawal

    The Coast Guard is withdrawing this rulemaking because the event
has been cancelled.

Authority

    We issue this notice of withdrawal under the authority of 33 U.S.C.
1233.

    Dated: April 16, 2014.
M.M. Dean,
Commander, U.S. Coast Guard, Acting Captain of the Port Baltimore.
[FR Doc. 2014-10381 Filed 5-6-14; 8:45 am]
BILLING CODE 9110-04-P