[Federal Register: May 2, 2008 (Volume 73, Number 86)]
[Notices]
[Page 24282-24285]
[DOCID:fr02my08-79]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2008-0321; FRL-8561-5]

Protection of Stratospheric Ozone: Request for Critical Use
Exemption Applications for the Years 2010 and 2011

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Solicitation of Applications and Information on
Alternatives.

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SUMMARY: EPA is soliciting applications for the critical use exemption
from the phaseout of methyl bromide for 2011 and beyond. In addition,
applicants who missed last year's deadline to submit a critical use
application for an exemption in the year 2010 may file a supplemental
application in response to this notice. This exemption is an annual
exemption and all entities interested in obtaining a critical use
exemption must provide EPA with technical and economic information to
support a ``critical use'' claim and must do so by the deadline
specified in this notice even if they have previously applied for an
exemption. Today's notice also invites interested parties to provide
EPA with new data on the technical and economic feasibility of methyl
bromide alternatives.

DATES: Applications for the critical use exemption must be postmarked
on or before July 31, 2008. The response period reflects the
clarifications and reduction of burden in the application.

ADDRESSES: Applications for the methyl bromide critical use exemption
should be submitted in duplicate (two copies) by mail to: U.S.
Environmental Protection Agency, Office of Air and Radiation,
Stratospheric Protection Division, Attention Methyl Bromide Review
Team, Mail Code 6205J, 1200 Pennsylvania Ave., NW., Washington, DC
20460 or by courier delivery (other than U.S. Post Office overnight)
to: U.S. Environmental Protection Agency, Office of Air and Radiation,
Stratospheric Protection Division, Attention Methyl Bromide Review
Team, 1310 L St., NW., Room 1047E, Washington, DC 20005. EPA also
encourages users to submit their applications electronically to Jeremy
Arling, Stratospheric Protection Division, at<EMAIL_ADDRESS>If
the application is submitted electronically, applicants must fax a
signed copy of Worksheet 1 to Jeremy Arling at<PHONE_NUMBER> by the
application deadline.

FOR FURTHER INFORMATION CONTACT:
    General Information: U.S. EPA Stratospheric Ozone Information
Hotline, 1-800-296-1996; also http://www.epa.gov/ozone/mbr.
    Technical Information: Colwell Cook, U.S. Environmental Protection
Agency, Office of Pesticide Programs (7503P), 1200 Pennsylvania Ave.,
NW., Washington, DC 20460,<PHONE_NUMBER>, E-mail<EMAIL_ADDRESS>    Economic Information: Elisa Rim, U.S. Environmental Protection
Agency, Office of Pesticide Programs (7503P), 1200 Pennsylvania Ave.,
NW., Washington, DC 20460,<PHONE_NUMBER>, E-mail<EMAIL_ADDRESS>    Regulatory Information: Jeremy Arling, U.S. Environmental
Protection Agency, Stratospheric Protection Division (6205J), 1200
Pennsylvania Ave., NW., Washington, DC 20460,<PHONE_NUMBER>, E-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. What do I need to know to respond to this request for
applications?
    A. Who can respond to this request for information?
    B. Whom can I contact to find out if a consortium is submitting
an application form for my methyl bromide use?
    C. How do I obtain an application form for the methyl bromide
critical use exemption?
    D. What alternatives must applicants address when applying for a
critical use exemption?
    E. What portions of the applications will be considered
confidential business information?
    F. Must I submit a ``Notice of Intent to Apply?''
    G. What if I submit an incomplete application?
    H. What if I applied for a critical use exemption in a previous
year?
II. What is the legal authority for the critical use exemption?
    A. What is the Clean Air Act (CAA) authority for implementing
the critical use exemption to the methyl bromide phaseout?
    B. What is the Montreal Protocol authority for granting a
critical use exemption after the methyl bromide phaseout?
III. How is the U.S. implementing the critical use exemption?
    A. When will the exemption become available to U.S. users of
methyl bromide?
    B. What is the projected timeline for the critical use exemption
application process?

I. What do I need to know to respond to this request for applications?

A. Who Can Respond to This Request for Information?

    Entities interested in obtaining a critical use exemption must
complete the application form available at http://www.epa.gov/ozone/
mbr. The application form may be submitted either by a consortium
representing multiple users who have similar circumstances or by
individual users who anticipate needing methyl bromide in 2011 and
beyond and believe there are no technically and economically feasible
alternatives. EPA encourages groups of users with similar circumstances
of use to submit a single application (for example, any number of pre-
plant users with similar soil, pest, and climactic conditions can join
together to submit a single application). In some instances, state
agencies will assist users with the application process (see discussion
of voluntary state involvement in Part I.B. below). Given that this is
the seventh round of the critical use exemption process, EPA will take
a skeptical view regarding supporting new nominations (meaning,
specific applicants who have not previously been nominated by the USG
for an exemption) unless the applicant demonstrates that an
unforeseeable change in circumstances (e.g., withdrawal or significant
change in registration status of an alternative) justifies the need.
    In addition to requesting information from applicants for the
critical use exemption, this solicitation for information provides an
opportunity for any interested party to provide EPA with information on
methyl bromide alternatives (e.g., technical and/or economic
feasibility research). The application form for the methyl bromide
critical use exemption and other information on research relevant to
alternatives must be sent to the

addresses specified above or emailed to the address specified above.
The applicant's signature, which is required in order for EPA to
process the application, is on Worksheet 1 of the application.
Applicants submitting electronically must also fax a signed copy of
Worksheet 1 to Jeremy Arling at<PHONE_NUMBER> by the application
deadline.

B. Whom Can I Contact To Find out if a Consortium Is Submitting an
Application Form for My Methyl Bromide Use?

    Please contact your local, state, regional, or national commodity
association to find out if they plan on submitting an application on
behalf of your commodity group.
    Additionally, you should contact your state regulatory agency
(generally this will be the State Department of Agriculture or State
Environmental Protection Agency) to receive information about their
involvement in the process. If your state agency has chosen to
participate, EPA encourages all applicants to first submit their
applications to the state regulatory agency, which will then forward
them to EPA. The National Pesticide Information Center Web site is one
resource available for identifying the lead pesticide agency in each
state (http://npic.orst.edu/state1.htm).

C. How Do I Obtain an Application Form for the Methyl Bromide Critical
Use Exemption?

    An application form for the methyl bromide critical use exemption
can be obtained either in electronic or hard-copy form. EPA encourages
use of the electronic form. Applications can be obtained in the
following ways:
    1. PDF format and Microsoft Excel at EPA's Web site: http://
www.epa.gov/ozone/record/mbr.html;
    2. Hard copy ordered through the Stratospheric Ozone Protection
Hotline at 1-800-296-1996;
    3. Hard-copy format at DOCKET ID No. EPA-HQ-OAR-2008-0321. The
docket can be accessed at the http://www.regulations.gov site. To
obtain copies of materials in hard copy, please call the EPA Docket
Center at<PHONE_NUMBER> between the hours of 8:30 a.m.-4:30 p.m. E.S.T.,
Monday-Friday, excluding holidays, to schedule an appointment. The EPA
Docket Center's Public Reading Room address is EPA/DC, EPA West, Room
3334, 1301 Constitution Ave., NW., Washington, DC 20460.

D. What Alternatives Must Applicants Address When Applying for a
Critical Use Exemption?

    To support the assertion that a specific use of methyl bromide is
``critical,'' applicants are expected to demonstrate that there are no
technically and economically feasible alternatives available to the
user of methyl bromide. The Parties to the Montreal Protocol have
developed an ``International Index'' of methyl bromide alternatives,
which lists chemical and non-chemical alternatives, by crop. In
February 2008, the United States submitted an index of alternatives,
which includes the current registration status of available and
potential alternatives, that is available on the Ozone Secretariat Web
site (http://ozone.unep.org/Exemption--Information/Critical--use--
nominations--for--methyl--bromide/MeBr--Submissions/USA-ExI--4--1--
2008.pdf). More information about alternatives is available in the 2007
Evaluations of 2007 Critical Use Nominations for Methyl Bromide and
Related Matters (http://ozone.unep.org/teap/Reports/MBTOC/MBCUN-
Aug2007.pdf).
    Applicants must address technical, regulatory, and economic issues
that limit the adoption of ``chemical alternatives'' and combinations
of ``chemical'' and ``non-chemical alternatives'' listed for their crop
within the ``U.S. Index'' of Methyl Bromide Alternatives. Applicants
must also address technical, regulatory, and economic issues that limit
the adoption of ``non-chemical alternatives'' and combinations of
``chemical'' and ``non-chemical alternatives'' listed for their crop in
the ``International Index.''

E. What Portions of the Applications Will Be Considered Confidential
Business Information?

    The person submitting information to EPA in response to this Notice
may assert a business confidentiality claim covering part or all of the
information by placing on (or attaching to) the information, at the
time it is submitted to EPA, a cover sheet, stamped or typed legend, or
other suitable form of notice employing language such as ``trade
secret,'' ``proprietary,'' or ``company confidential.'' Allegedly
confidential portions of otherwise non-confidential documents should be
clearly identified by the applicant, and may be submitted separately to
facilitate identification and handling by EPA. If the applicant desires
confidential treatment only until a certain date or until the
occurrence of a certain event, the notice should so state. Information
covered by a claim of confidentiality will be disclosed by EPA only to
the extent, and by means of the procedures, set forth under 40 CFR part
2 subpart B; 41 FR 36752, 43 FR 40000, 50 FR 51661. If no claim of
confidentiality accompanies the information when it is received by EPA,
it may be made available to the public by EPA without further notice to
the applicant.
    If you are asserting a business confidentiality claim covering part
or all of the information in the application, please submit a non-
confidential version that EPA can place in the public docket for
reference by other interested parties. Do not include on the
``Worksheet Six: Application Summary'' page of the application any
information that you wish to claim as confidential business
information. Any information on Worksheet 6 shall not be considered
confidential and will not be treated as such by the Agency. A copy of
Worksheet 6 will be placed in the public domain by EPA. Applications
that are not confidential business information will be placed in the
Docket in their entirety. Please note, claiming business
confidentiality may delay the ability of EPA to review your
application.

F. Must I Submit a ``Notice of Intent To Apply?''

    A ``Notice of Intent to Apply'' is not required, but would
facilitate the organization of the application review during the
critical use exemption process. If EPA is aware of the consortia and
the individuals who intend to submit applications 30 days before the
application deadline, the technical experts will be better positioned
to review the application. This Notice may be submitted to Jeremy
Arling via e-mail at<EMAIL_ADDRESS>or via U.S. mail to U.S.
Environmental Protection Agency, Office of Air and Radiation,
Stratospheric Protection Division, 1200 Pennsylvania Ave., NW., 6205J,
Washington, DC 20460 or by courier to U.S. Environmental Protection
Agency, Office of Air and Radiation, Stratospheric Protection Division,
1310 L St., NW., Room 1047E, Washington, DC 20005.

G. What If I Submit an Incomplete Application?

    EPA will not accept any applications postmarked after July 1, 2008.
If the application is postmarked by the deadline but is incomplete or
missing any data elements, EPA will not accept the application and will
not include the application in the U.S. nomination submitted for
international consideration. If the application is

substantially complete with only minor errors, corrections will be
accepted. EPA reviewers may also call applicants for further
clarification of their application, even if it is complete.
    All consortia or users who have not applied to EPA in the previous
year (2007) must submit an entire completed application with all
Worksheets.

H. What If I Applied for a Critical Use Exemption in a Previous Year?

    In March 2004 and November 2004, the Parties to the Montreal
Protocol decided that critical use exemptions would be granted for one
year. As a result, users must apply to EPA for critical use exemptions
on an annual basis. However, if a user group submitted a complete
application to EPA in 2007, the user is only required to submit revised
copies of the certain Worksheets listed below, though the entire
application with all Worksheets must be on file with EPA. The following
worksheets must be completed in full regardless of whether you
submitted an application in 2007: 1, 2B, 2C, 2D, 4, 5, and 6. The
remaining worksheets must only be completed if any information has
changed since 2007. If a user has previously submitted a critical use
exemption application to EPA in 2002, 2003, 2004, 2005, or 2006 (first,
second, third, fourth, or fifth rounds) but did not submit an
application in 2007 (sixth round) then all of the worksheets in the
application must be submitted again in their entirety.

II. What is the legal authority for the critical use exemption?

A. What Is the Clean Air Act (CAA) Authority for Implementing the
Critical Use Exemption to the Methyl Bromide Phaseout?

    In October 1998, the U.S. Congress amended the Clean Air Act by
adding CAA sections 604(d)(6), 604(e)(3), and 604(h) (section 764 of
the 1999 Omnibus Consolidated and Emergency Supplemental Appropriations
Act (Pub. L. 105-277; October 21, 1998)). The amendment requires EPA to
conform the U.S. phaseout schedule for methyl bromide to the provisions
of the Montreal Protocol for industrialized countries. Specifically,
the amendment requires EPA to make regulatory changes to implement the
following phaseout schedule:
    25% reduction (from 1991 baseline) in 1999,
    50% reduction in 2001,
    70% reduction in 2003,
    100% reduction in 2005.
    EPA published regulations in the Federal Register on June 1, 1999
(64 FR 29240), and November 28, 2000 (65 FR 70795), instituting the
phaseout reductions in the production and import of methyl bromide in
accordance with the schedule listed above. Additionally, the 1998
amendment allowed EPA to exempt the production and import of methyl
bromide from the phaseout for critical uses starting January 1, 2005,
``to the extent consistent with the Montreal Protocol'' (section 764 of
the 1999 Omnibus Consolidated and Emergency Supplemental Appropriations
Act (Pub. L. 105-277, October 21, 1998), section 604(d)(6) of the Clean
Air Act).

B. What Is the Montreal Protocol Authority for Granting a Critical Use
Exemption After the Methyl Bromide Phaseout?

    The Montreal Protocol provides an exemption to the phaseout of
methyl bromide for critical uses in Article 2H, paragraph 5. The
Parties to the Protocol included provisions for such an exemption in
recognition that alternatives may not be available by 2005 for certain
uses of methyl bromide agreed by the Parties to be ``critical uses.''
    In their Ninth Meeting (1997), the Parties to the Protocol agreed
to Decision IX/6, setting forth the following criteria for a ``critical
use'' determination:
    (a) That a use of methyl bromide should qualify as ``critical''
only if the nominating Party [e.g. U.S.] determines that:
    (i) The specific use is critical because the lack of availability
of methyl bromide for that use would result in a significant market
disruption; and
    (ii) There are no technically and economically feasible
alternatives or substitutes available to the user that are acceptable
from the standpoint of environment and health and are suitable to the
crops and circumstances of the nomination.
    (b) That production and consumption, if any, of methyl bromide for
a critical use should be permitted only if:
    (i) All technically and economically feasible steps have been taken
to minimize the critical use and any associated emission of methyl
bromide;
    (ii) Methyl bromide is not available in sufficient quantity and
quality from existing stocks of banked or recycled methyl bromide, also
bearing in mind the developing countries' need for methyl bromide;
    (iii) It is demonstrated that an appropriate effort is being made
to evaluate, commercialize and secure national regulatory approval of
alternatives and substitutes, taking into consideration the
circumstances of the particular nomination.
    * * * Non-Article 5 Parties [e.g., the U.S.] must demonstrate that
research programmes are in place to develop and deploy alternatives and
substitutes. * * *
    In the context of the phaseout program, the use of the term
consumption may be misleading. Consumption does not mean the ``use'' of
a controlled substance, but rather is defined as the formula:
Consumption = Production + Imports - Exports, of controlled substances
(Article 1 of the Protocol and Section 601 of the CAA). A Class I
controlled substance that was produced or imported through the
expenditure of allowances prior to its phaseout date can continue to be
used by industry and the public after that specific chemical's phaseout
under EPA's phaseout regulations, unless otherwise precluded under
separate regulations.
    In addition to the language quoted above, the Parties further
agreed to request the Technology and Economic Assessment Panel (TEAP)
to review nominations and make recommendations for approval based on
the criteria established in paragraphs (a)(ii) and (b) of Decision IX/
6.

III. How is the U.S. implementing the critical use exemption?

A. When Will the Exemption Become Available to U.S. Users of Methyl
Bromide?

    Under the provisions of both the CAA and the Montreal Protocol, the
critical use exemption became available to approved users on January 1,
2005. Until that date, all production and import of methyl bromide
(except for those quantities that qualify for the quarantine and
preshipment exemption) was required to conform to the phaseout schedule
listed above (see SUPPLEMENTARY INFORMATION section II A). Allowances
for subsequent years are authorized through regulations. For more
information on the quarantine and preshipment exemption, please refer
to 68 FR 238 (January 2, 2003).

B. What Is the Projected Timeline for the Critical Use Exemption
Application Process?

    There is both a domestic and international component to the
critical use exemption process. The following outline projects a
timeline for the process for the next three years.
    May 2, 2008: Solicit applications for the methyl bromide critical
use exemption for 2010 and 2011.

    July 31, 2008: Deadline for submitting critical use exemption
applications to EPA.
    Fall 2008: U.S. government (EPA, Department of State, U.S.
Department of Agriculture, and other interested federal agencies)
create U.S. Critical Use Nomination package.
    January 24, 2009: Deadline for U.S. government to submit U.S.
nomination package to the Protocol Parties.
    Early 2009: Review of the nomination packages for critical use
exemptions by the Technical and Economic Assessment Panel (TEAP) and
Methyl Bromide Technical Options Committee (MBTOC).
    Mid 2009: Parties consider TEAP/MBTOC recommendations.
    November 2009: Parties authorize critical use exemptions for methyl
bromide for production and consumption in 2010 (supplemental request)
and 2011.
    Early-Mid 2010: EPA publishes proposal and final rule for 2010
supplemental request, if applicable.
    Mid 2010: EPA publishes proposed rule for allocating critical use
exemptions in the U.S. for 2011.
    Late 2010: EPA publishes final rule allocating critical use
exemptions in the U.S. for the 2011 control period.
    January 1, 2011: Critical use exemption permits the limited
production and import of methyl bromide beyond the phaseout date for
specific uses for the 2011 control period.

    Authority: 42 U.S.C. 7414, 7601, 7671-7671q.

    Dated: April 24, 2008.
Brian J. McLean,
Director, Office of Atmospheric Programs.
 [FR Doc. E8-9743 Filed 5-1-08; 8:45 am]

BILLING CODE 6560-50-P


FILE NAME: company. wpt ( 7/ 1/ 2004)

ATTENTION: All commodity terms must comply with the Food and Feed Commodity Vocabulary database ( http:// www. epa. gov/ pesticides/ foodfeed/).

COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE ( 7/ 1/ 2004)

EPA Registration Division contact: [ Janet Whitehurst, ( 703) 305 6129]

INSTRUCTIONS: Please utilize this outline in preparing tolerance petition documents. In cases where the outline element does not apply please insert " NA Remove" and maintain the outline. The comment notes that appear on the left margin represent hidden typesetting codes designed to expedite the processing of the Federal Register document. Please do not remove or alter these comment notes or change the margins, font, or format in your document. Simply replace the instructions that appear in italics and brackets, i. e., "[ insert company name]," with the information specific to your action.

[ 7969 pending]

Summary of Petitions EPA has received a pesticide petition ([ 7969 pending]) from [ BASF Corporation], [ 26 Davis Drive, P. O. Box 13528, Research Triangle Park, NC 27709] proposing, 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.

Options ( pick one)

1. by establishing a tolerance for residues of [( 3 bromo 6 methoxy 2 methylphenyl)( 2,3,4 trimethoxy 6 methylphenyl) methanone] in or on the raw agricultural commodity [ table and wine grapes] at [ 0.5] parts per million ( ppm). EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition. 2 A. Residue Chemistry 1. Plant metabolism. [ In plant metabolism studies conducted in grapevines with BAS 560 F, the parent compound was the principal residue in grapes. BAS 560 F is metabolized through methyl and ring oxidative biotransformations, followed by enzymatic glucoside conjugation reactions to yield the conjugates from their corresponding aglycons. All major metabolites, which were present at very low levels, are considered non relevant as all were detected in the rat metabolism study as aglycons or conjugates, and can therefore be considered as not toxicologically significant. Thus, only parent BAS 560 F is considered relevant to define the residue in plants.

The results from a hydrolysis study designed to simulate different industrial and household processes ( pasteurization, brewing, boiling and sterilization) showed that BAS 560 F is stable. Therefore, BAS 560 F as unchanged parent is proposed as the relevant residue in grapes and industrial or household preparations of grapes.]

2. Analytical method. [ BASF Analytical Methods No. FAMS 105 01 " CL 375839: Analytical Method for the Determination of the Active Ingredient in Grapes" and No. FAMS 106 01 " CL 375839: Analytical Method for the Determination of the Active Ingredient in Must and Wine" were developed to determine residues of BAS 560 F in grapes and wine, respectively. In Method FAMS 105 01, BAS 560 F residues are extracted from the sample with n heptane / acetone 8 / 2 ( v/ v). This is followed by liquid / liquid partition with ethyl acetate / water to remove sugar coextractives and the organic phase is then dried with sodium sulfate. The extract is subjected to further clean up using high performance liquid chromatography. Quantitative determination of BAS 560 F is carried out by capillary gas chromatography with an electron capture detector ( GC/ ECD).

In Method FAMS 106 1, BAS 560 F residues are extracted from the sample by means of an Extrelut cartridge ( Extrelut NT 20, pre packed columns for extraction of lipophilic compounds from aqueous solutions). The extract is subjected to further clean up using high performance liquid chromatography. Quantitative determination of BAS 560 F is carried out by capillary gas chromatography with an electron capture detector ( GC/ ECD). An independent laboratory validation demonstrated good performance of these methods.]

3. Magnitude of residues. [ A total of 14 crop residue trials were conducted in representative vine growing areas in Northern and Southern Europe; 6 trials generated 7 results in Northern Europe and 8 trials generated 11 results in Southern Europe ( duplicate samples were taken from some of the at harvest residue trials). Trials were performed in Northern and Southern France, Germany, Italy and Spain in 1999 and 2000.

In all trials, a 500 g/ L suspension concentrate formulation of BAS 560 F ( designated BAS 560 01 F) was applied eight times at approximate weekly intervals, at a target application rate of 100 g a. i./ ha. At two sites in Germany and Italy, dose rates applied to the vines were marginally 3 higher due to differing viticulture practices in these countries. In Germany and Italy, dose rates applied to the vines are dependent upon the plant size; with time the applied dose increases, but as the surface area of the fruit is also increasing the applied concentration remains relatively constant. It is therefore considered appropriate to include results from these sites to determine the proposed tolerance.

In decline curve trials, fruit samples were taken directly before and after the last application, and at approximately 7 day intervals up to 48 days after the final ( i. e., eighth) application.

Residues in the raw agricultural commodity consisted of parent BAS 560 F only. Detectable residues were recorded immediately after the last application. For Northern Europe, initial residue levels ranged from 0.24 mg/ kg to 0.37 mg/ kg, declining to 0.10 mg/ kg to 0.19 mg/ kg by the proposed post harvest interval ( PHI) ( 28 days after the final application). For Southern Europe, initial residue levels ranged from 0.38 mg/ kg to 0.54 mg/ kg, declining to 0.07 mg/ kg to 0.30 mg/ kg by the proposed PHI ( 28 days after the final application).

A comparison of data from Northern and Southern European trials demonstrate that the residue levels were comparable in the two regions. The mean residue level in Northern Europe ( 0.15 mg/ kg; 0.10   0.19 mg/ kg) was very similar to that in Southern Europe ( 0.17 mg/ kg; 0.07   0.30 mg/ kg).

The results from processing studies demonstrated the absence of detectable residues ( LOQ = 0.05 mg/ kg) in wine or in raisins following processing of treated grapes.

Since grape vines are a permanent crop, no confined or field rotation studies are needed to support this petition.]

B. Toxicological Profile 1. Acute toxicity. [ In an acute toxicity study with rats, BAS 560 F was practically non toxic ( EPA Tox. Category IV). In an acute neurotoxicity study with rats, no signs of neurotoxicity were detected up to 2,000 mg/ kg b. w., the highest dose tested.]

2. Genotoxicty. [ BAS 560 F was evaluated for its potential genotoxicity in vitro using bacterial and mammalian cell mutagenicity tests and a chromosome damage ( clastogenicity) test. The results of these studies demonstrated the absence of a genotoxic effect. In vivo, the test substance was assessed for the induction of micronuclei in mice. The result of this study showed that BAS 560 F has no chromosome damaging potential. 4 It is therefore concluded, that BAS 560 F has no mutagenic or genotoxic properties both in vitro and in vivo.]

3. Reproductive and developmental toxicity. [ The reproductive and developmental toxicity of BAS 560 F was investigated in a 2 generation reproduction study in rats as well as in prenatal toxicity studies in rats and rabbits.

In the definitive 2 generation reproduction study in rats, the NOAEL for fertility and reproduction was 10,000 ppm ( the highest concentration tested), equivalent to approximately 811 mg/ kg b. w./ day based on food consumption data during the premating periods. The parental NOAEL of BAS 560 F is 500 ppm ( approximately 39 mg/ kg b. w./ day based on food consumption data). The 1,000 ppm treatment showed statistically significant decreases in body weight and weight gain in F1 parental males and increased absolute and relative liver weights in females. The NOAEL for pup ( offspring) toxicity was 1,000 ppm ( approximately 79 mg/ kg b. w./ day based on food consumption data); the 10,000 ppm treatment showed a statistically significant decrease in pup body weight ( 31%) during lactation, an increase in relative liver weights at weaning, and a delay in vaginal opening ( F1 only).

In the prenatal toxicity study in rats, there was no treatment related maternal or developmental toxicity observed, even at the highest dose tested ( 1,000 mg/ kg b. w./ day). On the basis of these data, the maternal NOAEL of BAS 560 F is 1,000 mg/ kg b. w./ day ( highest dose tested). The 1,000 mg/ kg b. w./ day dose showed a statistically significantly increased ratio of liver weight to terminal body weights. However, no correlating microscopic changes were diagnosed, indicating that the increased relative liver weight was not considered toxicologically significant. The developmental NOAEL for BAS 560 F is 1,000 mg/ kg b. w./ day ( no effects were observed at the highest dose tested). Based on the above results, BAS 560 F is not selectively toxic to the fetus. In addition, BAS 560 F was not teratogenic in rats.

In the rabbit prenatal toxicity study, developmental toxicity was observed in the presence of maternal toxicity. Specifically, the maternal NOAEL is 50 mg/ kg b. w./ day based on the following: reduced body weight gains and reduced feed consumption ( absolute and relative) at both 350 and 700 mg/ kg b. w./ day. In addition, at these two dose levels, a doserelated statistically significant increase in absolute and relative ( to body weight) liver weights occurred, as compared to controls. Also, increased incidences and/ or severities of periportal hepatocellular hypertrophy and diffuse and/ or periportal hepatocellular vacuolation were observed at 350 and 700 mg/ kg b. w./ day. In this prenatal toxicity study in rabbits, the developmental NOAEL of BAS 560 F is 350 mg/ kg b. w./ day, as based on the slight but statistically significant reduction in fetal body weights at 700 mg/ kg b. w./ day. Therefore, because developmental toxicity was only observed at dose levels that were maternally toxic, BAS 560 F is not selectively toxic to the fetus. In addition, BAS 560 F was not teratogenic in rabbits. 5 Overall, for the reproductive and developmental toxicity studies, the lowest NOAEL for maternal/ parental toxicity was 39 mg/ kg b. w./ day ( two generation reproduction study) and for pup toxicity was 79 mg/ kg b. w./ day ( two generation reproduction study).]

4. Subchronic toxicity. [ The subchronic toxicity of BAS 560 F was investigated in a dietary 28 day study in rats, a 28 day oral toxicity study in dogs, and 3 month toxicity studies in rats, mice, and dogs. In addition, a 28 day neurotoxicity study was conducted with rats.

The signs of toxicity observed in the three species tested were overall similar and consisted of reduced body weight gain at the highest tested dose levels. The observed effects on clinical chemistry in rats and mice can be linked to the microscopic effects observed in the liver. The effects observed typically included increased cholesterol, total protein, and total bilirubin ( mice only). Organ weights and/ or pathology indicated the liver to be the only consistent target organ in all three species tested. The changes included, periportal cytoplasmic vacuolation in rats, centrilobular hepatocellular hypertrophy in mice, and increased liver weights in rats, mice, and dogs.

In the 28 day neurotoxicity study with rats, there was no evidence of neurotoxicity in all treatment groups, with an No Observed Adverse Effect Level ( NOAEL) for neurotoxicity of 15,000 in the diet ( equivalent to 1,371 mg/ kg b. w./ day for both sexes based on food consumption data). These results, coupled with lack of neurotoxic effects observed in acute, sub chronic and chronic studies with other species, indicate that BAS 560 F is not neurotoxic.]

5. Chronic toxicity. [ The chronic toxicity of BAS 560 F was evaluated in a 1 year oral administration study in dogs, a 24 month feeding study with rats and an 18 month feeding study with mice.

Administration of BAS 560 F to dogs for one year resulted in mild increases in mean alkaline phosphatase in males after 9 and 12 months of dosing at 500 mg/ kg b. w./ day ( highest dose tested). Mean absolute and relative liver weights were both statistically significantly increased in females at 500 mg/ kg b. w./ day and relative liver weights were statistically significantly increased in males at 500 mg/ kg b. w./ day. However, there were no associated macroscopic or microscopic findings in the livers of these animals. Therefore, the slight but statistically significant differences in liver weights and alkaline phosphatase ( in males) were not considered to be of toxicological significance. All other parameters evaluated including mortality, clinical observations, body weights and food consumption data, ophthalmology, hematology, coagulation and urinalysis data, and macroscopic and microscopic examinations revealed no adverse effects due to administration of BAS 560 F. Therefore, the NOAEL for oral administration of BAS 560 F to pure bred Beagle Dogs was 500 mg/ kg b. w./ day, the highest dose tested. 6 Treatment of Sprague Dawley rats with BAS 560 F for 24 months resulted in markedly reduced body weight gains in females at 5,000 ( 26%) and 20,000/ 10,000 ppm ( 42%) and a lesser reduction in body weight gain for males at 20,000 ppm ( 14%). Microscopic effects in the liver and kidney were associated with clinical chemistry changes in males and females at doses of 5,000 ppm and greater. Slight anemia was observed in females at 5,000 ppm and higher, which was reversed at 24 months. An increase in the incidence of hepatocellular necrosis after 12 months and benign hepatocellular adenomas was observed in females at 5,000 ppm and greater which are dietary concentrations that exceeded the MTD. Therefore, the NOAEL for systemic toxicity and for oncogenic effects following dietary administration of BAS 560 F to Sprague Dawley rats for 24 months, was 500 ppm ( 25 mg/ kg b. w./ day as based on food consumption data).

Treatment of albino mice with BAS 560 F for 18 months resulted in statistically significant increases in the following: liver weights ( absolute and relative, in females), hepatocellular hypertrophy in males, renal chronic nephropathy in males and extramedullary hematopoiesis in the spleen of females at 1,000 ppm, the next highest concentration tested. Therefore, the NOAEL for systemic toxicity following dietary administration of BAS 560 F to albino mice for 18 months, was 250 ppm ( 46 mg/ kg b. w./ day as based on food consumption data).

A statistically significant ( P< 0.01) increase in the incidence of hepatocellular neoplasms ( adenomas and carcinomas) was observed in the livers of male mice receiving 7,000 ppm ( 19/ 66, 28.8%), as compared to controls ( 6/ 65, 9.2%). There was also a marginal increase in the incidence of hepatocellular neoplasms in females receiving 7,000 ppm ( 4/ 65), as compared to the control mice ( 2/ 65). The incidence of 14/ 66 ( 21.2%) hepatocellular adenoma for males at 7,000 ppm is slightly above the maximum range of historical control data at the testing laboratory ( 14.8%) and at Charles River Laboratories ( 19.2%). The incidence of 5/ 66 ( 7.6%) hepatocellular carcinoma in males at 7,000 ppm is within the maximum range of historical control data at both the testing facility ( 9.2%) and Charles River Laboratories ( 11.5%). Although the number of hepatocellular neoplasms in males receiving 1,000 ppm was also slightly increased ( 9/ 65, 13.8%) compared to the untreated controls ( 6/ 65, 9.2%), this slight increase was not statistically significant ( p< 0.05) and was within the range of the historical controls ( 9.2 18.5%) at the testing laboratory. The slight increase in hepatocellular neoplasms in male mice at 1,000 ppm may have resulted from increased survival observed at termination in male mice at 1,000 ppm as compared to controls ( 55 versus 45 in the surviving male controls). The incidences of hepatocellular neoplasms in terminally sacrificed male mice were 5/ 45 or 11%, 3/ 53 or 6%, 8/ 55 or 15% and 18/ 54 or 33%, at respective treatment levels of 0, 250, 1,000 and 7,000 ppm.

For females, whereas the incidence of hepatocellular adenoma was the same ( 2/ 65 or 3.1%) at 7,000 ppm and for controls, the incidence of hepatocellular carcinoma was slightly increased at 7,000 ppm ( 2/ 65 or 3.1%) versus control ( 0/ 65 or 0%). Since this incidence of hepatocellular carcinoma ( 3.1%) for females at 7,000 ppm is slightly above the maximum range of historical control data at both the testing facility ( 1.5%) and Charles River Laboratories ( 2.0%), the incidence represents an equivocal finding. However, because this increase was very small, was 7 not statistically significant, and did not demonstrate decreased latency compared to the controls, this finding was considered to represent only equivocal toxicologic significance.

Therefore, based on the weight of the evidence analysis, the NOAEL for oncogenicity is 1,000 ppm ( approximately 190 mg/ kg of b. w./ day, calculated from food consumption data and nominal concentrations) based on the increased incidence of hepatocellular neoplasms observed in male mice at 7,000 ppm, as compared to controls.

In summary, long term exposure studies with BAS 560 F in dogs, rats and mice resulted in increased liver weights with corresponding changes in clinico chemical parameters. Microscopic pathological changes were identified in the liver, kidney, and spleen for rats and/ or mice. The main target organ was identified as the liver in all species. Additionally, increased incidences of primary hepatocellular neoplasms were observed at the highest doses in rats and mice.]

6. Animal metabolism. [ BAS 560 F was rapidly absorbed and efficiently excreted following oral administration in the rat. The amount of absorption ranged from approximately 89 to 92% of the administered dose of 10 mg/ kg b. w. Most of the administered dose was eliminated via bile within 72 hours ( 85.2 to 90.1%) and feces within 7 days ( 84.1 to 98.8%), with a small amount ( 0.69 to 6.6%) in urine. BAS 560 F related residues showed no potential for accumulation as < 1.2% of the applied dose was retained over seven days, with highest levels of residues found in the liver, GI tract, plasma, blood, kidney, and fat. The tissue retention of the orally administered dose was less than 2% at 48 72 hours and less than 1.2% at 168 hours. BAS 560 F was extensively metabolized in the rat to multiple metabolites formed via demethylation of the aromatic methoxy group( s) followed by mono O glycosidation, hydroxylation of the bromophenyl ring, and hydroxylation of the methyl substituent to hydroxymethyl followed by O glycosidation or further oxidation to aldehyde or lactone.]

7. Metabolite toxicology. [ In plant metabolism studies conducted in grapevines with BAS 560 F, the parent compound was the principal residue in grapes. BAS 560 F is metabolized through methyl and ring oxidative biotransformations, followed by enzymatic glucoside conjugation reactions to yield the conjugates from their corresponding aglycons. All major metabolites, which were present at very low levels, are considered non relevant as all were detected in the rat metabolism study as aglycons or conjugates, and can therefore be considered as not toxicologically significant. Thus, only parent BAS 560 F is considered relevant to define the residue in plants.

The results from a hydrolysis study designed to simulate different industrial and household processes ( pasteurization, brewing, boiling and sterilization) showed that BAS 560 F is stable. Therefore, BAS 560 F as unchanged parent is proposed as the relevant residue in grapes and industrial or household preparations of grapes. 8 Since BAS 560 F is not registered for use in the United States, the toxicity of metabolites formed in matrices other than the raw or processed treated commodity ( e. g., water, soil) is not relevant.]

8. Endocrine disruption. [ Data from the reproduction / developmental toxicity and short and long term repeated dose toxicity studies with BAS 560 F in the rat, rabbit, mouse, or dog, do not suggest any endocrine disruption activity. This information is based on the absence of any treatment related effects from the histopathological examination of endocrine organs as well as the low level of concern for possible effects on fertility, reproductive performance, or any other aspect of reproductive function, or on growth and development of the offspring.]

C. Aggregate Exposure 1. Dietary exposure. [ Assessments were conducted to evaluate the potential risk due to chronic and acute dietary exposure of the U. S. population to residues of BAS 560 F. This fungicide is not registered for use in the United States and therefore exposure to BAS 560 F residues is limited to consumption of imported food commodities. This analysis was conducted to support the BAS 560 F U. S. import tolerance for grapes and wine.]

i. Food. [ The dietary assessment analysis followed an initial tier approach. Default processing factors, 100% crop treated, and proposed tolerance values were assumed in the assessment. Dietary exposure assessments were conducted using both Exponent's Dietary Exposure Evaluation Module ( DEEM FCID) and Infoscientific's Cumulative and Aggregate Risk Evaluation System ( CARES, version 1.1) software. Results of the chronic exposure estimates were compared against the chronic Population Adjusted Dose ( cPAD) of 0.25 mg/ kg b. w./ day that was based on the NOAEL from the rat chronic toxicity study, a safety factor of 100, and no additional FQPA safety factor. The acute dietary exposure estimates are reported but were not compared to aPAD values since BAS 560 F is not acutely toxic and therefore aRfD and aPAD values were not warranted ( see toxicology results).

Results of the chronic dietary exposure assessments are listed in Table 1. The estimated chronic dietary exposure from imported grapes was less than 1% of the cPAD for all subpopulations. 9 Table 1. Chronic Dietary Exposure Assessment for BAS 560 F Population Exposure Estimate % cRfD % cPAD Subgroups ( mg/ kg b. w./ day)

U. S. population 0.000268 0.11 0.11 Birth to 1 year 0.000523 0.21 0.21 1 2 years 0.001881 0.75 0.75 3 5 years 0.001138 0.46 0.46 1 6 years 0.001289 0.52 0.52 6 12 years 0.000427 0.17 0.17 13 19 years 0.00015 0.06 0.06 Females 13 49 years 0.000132 0.05 0.05 Males 20 49 years 0.000121 0.05 0.05 Adults 50+ years 0.000138 0.06 0.06 Calculated using DEEM FCID software Assessment conducted with import tolerance values, 100% CT, and default process values % cPAD = percent of chronic population adjusted dose Exposure estimates for BAS 560 F acute dietary assessment ranged from 0.00182 to 0.06725 mg/ kg b. w./ day for all subpopulations at the 99.9th percentile ( Tables A 2 and A 3). The acute reference dose and PAD were not calculated for the acute dietary assessment since toxicology studies have shown that BAS 560 F poses no acute dietary risk. Therefore no % aPAD has been established.

Table A 2. Acute Dietary Exposure Assessment for BAS 560 F Conducted using DEEM FCID Software Population 95th percentile 99.9th percentile % aRf D % aPAD Exposure Estimate Exposure Estimate Subgroups ( mg/ kg b. w./ day) ( mg/ kg b. w./ day)

U. S. population 0.00118 0.01646 NA NA Birth to 1 year 0.00307 0.03087 NA NA 1 2 years 0.00995 0.06725 NA NA 3 5 years 0.00625 0.03076 NA NA 1 6 years 0.00721 0.03873 NA NA 6 12 years 0.00223 0.01643 NA NA 13 19 years 0.00076 0.00831 NA NA Females 13 49 years 0.00067 0.00565 NA NA Males 20 49 years 0.00056 0.00492 NA NA Adults 50+ years 0.00069 0.00438 NA NA Assessment conducted with import tolerance values, 100% CT, and default process values % aPAD = percent of chronic population adjusted dose 10 NA = not applicable Table A 3. Acute Dietary Exposure Assessment for BAS 560 F Conducted using CARES Software Population Exposure Estimate % aPAD Subgroups ( mg/ kg b. w./ day) Birth to 1 year 0.02475 NA 1 2 years 0.02238 NA 3 5 years 0.01328 NA 1 6 years 0.01678 NA 6 12 years 0.00695 NA 13 19 years 0.00235 NA Females 13 49 years 0.00278 NA Males 20 49 years 0.00182 NA Adults 50+ years 0.00239 NA Exposure estimates represent the 99.9th percentile Assessment conducted with import tolerance values, 100% CT, and default process values % aPAD = percent of chronic population adjusted dose NA = not applicable ii. Drinking water. [ The only potential exposure of BAS 560 F to the U. S. population is through the consumption of imported wine or grapes from the European Union. BAS 560 F products are not labeled for any uses in the U. S. Therefore, this eliminates the potential for contamination of U. S. drinking water supplies. The potential for drinking water exposure to the U. S. general population is considered to be insignificant.]

2. Non dietary exposure. [ The only potential exposure of BAS 560 F to the U. S. population is through the consumption of imported wine or grapes from the European Union. BAS 560 F products are not labeled for any uses in the U. S. Therefore, this eliminates the potential for occupational or residential exposure. The potential for nondietary exposure to the U. S. general population is considered to be insignificant.]

D. Cumulative Effects [ At this time, there is no available information to indicate that BAS 560 F or its metabolites have a common mechanism of toxicity with other substances. Therefore, there is no reason to include this pesticide or its metabolites in a cumulative risk assessment. For the purposes of this tolerance action EPA has not assumed that BAS 560 F and its metabolites have a common mechanism of toxicity with other substances.]

E. Safety Determination 11 1. U. S. population. [ Results of the dietary exposure analysis demonstrate with reasonable certainty that no harm to the general U. S. population or any subpopulation would results from the acceptance of the proposed BAS 560 F U. S. import tolerances for table and wine grapes. Exposure estimates remained well below the U. S. EPA's level of concern ( 100% of PAD) with % cPAD values not exceeding 1% for all subpopulations.]

2. Infants and children. [ Results of the dietary exposure analysis demonstrate with with reasonable certainty that no harm to the general U. S. population or any subpopulation, including infants and children, would results from the acceptance of the proposed BAS 560 F U. S. import tolerances for table and wine grapes. Exposure estimates remained well below the U. S. EPA's level of concern ( 100% of PAD) with % cPAD values not exceeding 1% for all subpopulations, including infants and children.]

F. International Tolerances [ No maximum residue levels ( MRLs) have been established for BAS 560 F by the Codex Alimentarius Commission ( CODEX) or in Canada or Mexico.]


[Federal Register Volume 86, Number 155 (Monday, August 16, 2021)]
[Notices]
[Page 45795]
[FR Doc No: 2021-17624]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: 2:00 p.m. on Thursday, August 19, 2021.

PLACE:  The meeting will be held via remote means and/or at the
Commission's headquarters, 100 F Street NE, Washington, DC 20549.

STATUS: This meeting will be closed to the public.

MATTERS TO BE CONSIDERED: Commissioners, Counsel to the Commissioners,
the Secretary to the Commission, and recording secretaries will attend
the closed meeting. Certain staff members who have an interest in the
matters also may be present.
    In the event that the time, date, or location of this meeting
changes, an announcement of the change, along with the new time, date,
and/or place of the meeting will be posted on the Commission's website
at https://www.sec.gov.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10),
permit consideration of the scheduled matters at the closed meeting.
    The subject matter of the closed meeting will consist of the
following topics:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Resolution of litigation claims; and
    Other matters relating to examinations and enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting agenda items that may consist of
adjudicatory, examination, litigation, or regulatory matters.

CONTACT PERSON FOR MORE INFORMATION: For further information; please
contact Vanessa A. Countryman from the Office of the Secretary at (202)
551-5400.

    Dated: August 12, 2021.
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2021-17624 Filed 8-12-21; 4:15 pm]
BILLING CODE 8011-01-P


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

General Comment:Dear Mr. Zeller:

My name is Bethany Fayard and I'm from Biloxi, MS. I am writing as as a 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. 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 prompts many questions and further research on my part that will be very time consuming. 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.

Electronic cigarettes saved my life and 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.


[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)]
[Notices]
[Page 34566]
[FR Doc No: 2018-15485]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13318-003]

Swan Lake North Hydro LLC; Notice of Modification of Procedural
Schedule

    Take notice that the schedule for processing the following
hydroelectric application has been modified.
    a. Type of Application: Original License (Major Project).
    b. Project No.: 13318-003.
    c. Date Filed: October 28, 2015.
    d. Applicant: Swan Lake North Hydro LLC.
    e. Name of Project: Swan Lake North Pumped Storage Hydroelectric
Project.
    f. Location: The project would be located about 11 miles northeast
of Klamath Falls, in Klamath County, Oregon. The project would occupy
about 730 acres of federal lands administered by the Bureau of Land
Management and the Bureau of Reclamation, state lands, and private
lands.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Erik Steimle, Rye Development LLC, 745
Atlantic Avenue, 8th Floor, Boston, MA 02111. Telephone: (503) 998-
0230; Email: [email protected].
    i. FERC Contact: Dianne Rodman at<PHONE_NUMBER> or
[email protected].
    j. Procedural Schedule: The Commission's December 20, 2017 Notice
of Application Ready for Environmental Analysis established August 2018
as the estimated date for issuing the Draft Environmental Impact
Statement (EIS). The revised estimate for issuing the Draft EIS is now
September 2018. As such, the application will be processed according to
the following revised schedule. Revisions to the schedule may be made
as appropriate. If a date falls on a weekend or holiday, the due date
will be the following business day.

------------------------------------------------------------------------
                 Milestone                           Target date
------------------------------------------------------------------------
Commission Issues Draft EIS...............  September 2018.
Comments on Draft EIS.....................  November 2018.
Commission Issues Final EIS...............  January 2019.
------------------------------------------------------------------------

    Dated: July 13, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-15485 Filed 7-19-18; 8:45 am]
 BILLING CODE 6717-01-P


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