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.

Since I have broken free of cigarettes, only because of ecigs, has my health greatly improved. I tried quitting countless times with no success. Since taking up using ecigs 2.5 years ago I have not smoked once. My ability to taste, smell and breathe has been regained. I do realize more testing should be done, but as a tax paying adult who can make his own decisions, please do not get involved and make laws that are not needed. I can decide for my self what is healthy enough to put in my body.

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

Thank you for your time, Louis DeLucas


[Federal Register Volume 85, Number 219 (Thursday, November 12, 2020)]
[Notices]
[Pages 71923-71924]
[FR Doc No: 2020-25023]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0998]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for
Diagnosis and Monitoring

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the collections of information in the
regulations for in vivo radiopharmaceuticals used for diagnosis and
monitoring.

DATES: Submit either electronic or written comments on the collection
of information by January 11, 2021.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 11, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 11, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-N-0998 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Regulations for In Vivo
Radiopharmaceuticals Used for Diagnosis and Monitoring.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether

the proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.

Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and
Monitoring--21 CFR Part 315

OMB Control Number 0910-0409--Extension

    This information collection supports our regulations in part 315
(21 CFR part 315) that require manufacturers of diagnostic
radiopharmaceuticals to submit information that demonstrates the safety
and effectiveness of: (1) A new diagnostic radiopharmaceutical; or (2)
a new indication for use of an approved diagnostic radiopharmaceutical.
Information about the safety or effectiveness of a diagnostic
radiopharmaceutical enables us to properly evaluate the safety and
effectiveness profiles of such radiopharmaceuticals.
    The information, which is usually submitted as part of a new drug
application (NDA) or biologics license application (BLA) or as a
supplement to an approved application typically includes, but is not
limited to, nonclinical and clinical data on the pharmacology;
toxicology; adverse events; radiation safety assessments; and
chemistry, manufacturing, and controls. The content and format of an
application for approval of a new drug are set forth in Sec.  314.50
(21 CFR 314.50) and have been approved under OMB control number 0910-
0001. This information collection supports part 315, which is currently
approved under OMB control number 0910-0409.
    In table 1, row 1, we estimate the annual reporting burden for
preparing the safety and effectiveness sections of an application. This
estimate does not include the time needed to conduct studies and
clinical trials or other research from which the reported information
is obtained.
    Based on past submissions of human drug applications, new
indication supplements for diagnostic radiopharmaceuticals, or both, we
estimate that six submissions will be received annually and that 2,000
hours would be spent preparing the portions of the application that
would be affected by this information collection. We further estimate
the total time needed to prepare complete applications for diagnostic
radiopharmaceuticals as approximately 12,000 hours. This information
collection does not impose any additional reporting burden for safety
and effectiveness information on diagnostic radiopharmaceuticals beyond
the estimated burden of 2,000 hours, because safety and effectiveness
information is already required in Sec.  314.50 and has been approved
under OMB control number 0910-0001. In fact, clarification of our
criteria for the evaluation of diagnostic radiopharmaceuticals in this
information collection is intended to streamline overall information
collection burdens, particularly for diagnostic radiopharmaceuticals
that may have well-established, low-risk safety profiles by enabling
manufacturers to tailor information submissions and avoid unnecessary
clinical studies.
    In table 1, row 2, we estimate the annual reporting burden for
preparing the safety and effectiveness sections of a supplement to an
approved application. This estimate does not include the time needed to
conduct studies and clinical trials or other research from which the
reported information is obtained.
    Based on past submissions of human drug applications, new
indication supplements for diagnostic radiopharmaceuticals, or both, we
estimate that nine submissions will be received annually. We estimate
the total time needed to prepare complete applications for supplements
to new applications for diagnostic radiopharmaceuticals as
approximately between 500 and 1,000 hours. We calculated the median of
this estimate to arrive at approximately 750 hours. We further estimate
that the total time needed to prepare the portions of the application
that would be affected by this information collection as 6,750. As
previously stated, this information collection does not impose any
additional reporting burden for safety and effectiveness information on
diagnostic radiopharmaceuticals beyond the estimated burden of 750
hours, because safety and effectiveness information is already required
in Sec.  314.50 and has been approved under OMB control number 0910-
0001.
    We estimate the burden of this collection of information as
follows:

       Table 1--Estimated Annual Reporting Burden for NDAs and Supplements to Approved NDAs for Diagnostic
                                            Radiopharmaceuticals \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
 Manufacturers' activity (21 CFR     Number of     responses per   Total annual   Average burden    Total hours
            section)                respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
NDAs (Sec.  Sec.   315.4, 315.5,               6               1               6           2,000          12,000
 and 315.6).....................
Supplements to Approved NDAs                   9               1               9             750           6,750
 (Sec.  Sec.   315.4, 315.5, and
 315.6).........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          18,750
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an
overall increase of 13 responses with a corresponding increase of
14,750 burden hours, including submissions involving NDAs. We attribute
this adjustment to an increase in the number of submissions for NDAs
for diagnostic radiopharmaceuticals we received over the past few years
and because we are now capturing supplements to approved NDAs for
diagnostic radiopharmaceuticals.

    Dated: November 5, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25023 Filed 11-10-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 106 (Friday, June 4, 2021)]
[Notices]
[Page 30036]
[FR Doc No: 2021-11747]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Number: PR21-34-001.
    Applicants: Enable Oklahoma Intrastate Transmission, LLC.
    Description: Tariff filing per 284.123(b),(e)+(g): EOIT 2021
Revised Petition for Section 311 Rate Approval (PR21-34) to be
effective 7/1/2021.
    Filed Date: 5/27/2021.
    Accession Number:<PHONE_NUMBER>23.
    Comments Due: 5 p.m. ET 6/10/2021.
    284.123(g) Protests Due: 5 p.m. ET 6/10/2021.

    Docket Numbers: RP21-844-000.
    Applicants: Kinder Morgan Louisiana Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Periodic Rate Adjustment_21 to
be effective 7/1/2021.
    Filed Date: 5/27/21.
    Accession Number: 20210527-5029.
    Comments Due: 5 p.m. ET 6/8/21.

    Docket Numbers: RP21-845-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreement
(Ameredev) to be effective 7/1/2021.
    Filed Date: 5/27/21.
    Accession Number: 20210527-5091.
    Comments Due: 5 p.m. ET 6/8/21.

    Docket Numbers: RP21-846-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreements
Filing--Elgin Energy Center LLC to be effective 6/1/2021.
    Filed Date: 5/27/21.
    Accession Number: 20210527-5144.
    Comments Due: 5 p.m. ET 6/8/21.

    Docket Numbers: RP21-847-000.
    Applicants: Colorado Interstate Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Quarterly LUF True-Up to be
effective 7/1/2021.
    Filed Date: 5/27/21.
    Accession Number: 20210527-5145.
    Comments Due: 5 p.m. ET 6/8/21.

    Docket Numbers: RP21-848-000.
    Applicants: TransColorado Gas Transmission Company LLC.
    Description: Sec.  4(d) Rate Filing: Quarterly Fuel Gas
Reimbursement Update Filing to be effective 7/1/2021.
    Filed Date: 5/27/21.
    Accession Number: 20210527-5148.
    Comments Due: 5 p.m. ET 6/8/21.

    Docket Numbers: RP21-849-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: June 21 Neg Rate Amendment to
be effective 6/1/2021.
    Filed Date: 5/27/21.
    Accession Number: 20210527-5197.
    Comments Due: 5 p.m. ET 6/8/21.

    Docket Numbers: RP21-850-000.
    Applicants: Southwest Gas Storage Company.
    Description: Sec.  4(d) Rate Filing: Implement Market Based Rates
West Area to be effective 7/1/2021.
    Filed Date: 5/27/21.
    Accession Number: 20210527-5214.
    Comments Due: 5 p.m. ET 6/8/21.

    Docket Numbers: RP21-851-000.
    Applicants: Dauphin Island Gathering Partners.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Filing 5-27-
2021 to be effective 6/1/2021.
    Filed Date: 5/27/21.
    Accession Number: 20210527-5237.
    Comments Due: 5 p.m. ET 6/8/21.

    Docket Numbers: RP21-852-000.
    Applicants: CenterPoint Energy Resources Corp., Summit Utilities
Arkansas, Inc.
    Description: Joint Petition for Limited Waiver of Capacity Release
Regulations, et al. of CenterPoint Energy Resources Corp. and Summit
Utilities Arkansas, Inc. under RP21-852.
    Filed Date: 5/27/21.
    Accession Number: 20210527-5326.
    Comments Due: 5 p.m. ET 6/8/21.

    Docket Numbers: RP21-853-000.
    Applicants: CenterPoint Energy Resources Corp., Summit Utilities
Oklahoma, Inc.
    Description: Joint Petition for Limited Waiver of Capacity Release
Regulations, et al. of CenterPoint Energy Resources Corp. and Summit
Utilities Oklahoma, Inc. under RP21-853.
    Filed Date: 5/27/21.
    Accession Number: 20210527-5327.
    Comments Due: 5 p.m. ET 6/8/21.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: May 28, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-11747 Filed 6-3-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 33 (Thursday, February 17, 2011)]
[Notices]
[Pages 9401-9402]
[FR Doc No: 2011-3643]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Waiver Petition Docket Number FRA-2010-0145]

Union Pacific Railroad Company; Notice of Public Hearing and
Extension of Public Comment Period

    On October 22, 2010, the Federal Railroad Administration (FRA)
published a notice in the Federal Register (75 FR 65399) announcing the
Union Pacific Railroad Company's (UP) request for a waiver of
compliance from certain provisions of Title 49 Code of Federal
Regulations (CFR) part 232, Brake System Safety Standards.
Specifically, UP has petitioned FRA for a determination that the
engineering principles used in its design of its Continuous Speed
Control Yard located at Roseville, California, are a sufficient primary
retarder to prevent equipment rollouts and act as an acceptable form of
alternate securement under 49 CFR 232.103(n)(1) (Securement of
unattended equipment).
    FRA has determined upon investigation that the facts of this
proceeding warrant a public hearing. Accordingly, a hearing is hereby
scheduled to begin at 9 a.m. on March 17, 2011, at the Hilton Garden
Inn Roseville, 1951 Taylor Road, Roseville, California, USA 95661.
Interested parties are invited to present oral statements at this
hearing. For information on facilities or services for persons with
disabilities or to request special assistance at the hearing, contact
FRA's Docket Clerk, Michelle Silva, by telephone, e-mail, or in
writing, at least five business days before the date of the hearing.
Ms. Silva's contact information is as follows: FRA, Office of Chief
Counsel, Mail Stop 10, 1200 New Jersey Avenue, SE., Washington, DC
20590; telephone<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>    The informal hearing will be conducted by a representative
designated by FRA in accordance with FRA's Rules of Practice (see
particularly 49 CFR 211.25). FRA's representative will make an opening
statement outlining the scope of the hearing, as well as any additional
procedures for the conduct of the hearing. The hearing will be a non-
adversarial proceeding in which all interested parties will be given
the opportunity to express their views regarding the waiver petition
without cross-examination. After all initial statements have been
completed, those individuals wishing to make brief rebuttal statements
will be given an opportunity to do so.
    In addition, FRA is hereby extending the comment period to April
17, 2011. All communications concerning these proceedings should
identify the appropriate docket number (e.g., Waiver Petition Docket
Number FRA-2010-0145) and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.

     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    All written communications concerning these proceedings are
available for examination during regular business hours (9 a.m.-5 p.m.)
at the above facility. All documents in the public docket are also
available for inspection and copying on the Internet at the docket
facility's Web site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the document (or signing the
document, if submitted on behalf of an association, business, labor
union, etc.). You may review DOT's complete Privacy Act Statement in
the Federal Register published on April 11, 2000 (Volume 65, Number 70;
Page 19477) or at http://www.dot.gov/privacy.html.

    Issued in Washington, DC on February 14, 2011.
Robert C. Lauby,
Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2011-3643 Filed 2-16-11; 8:45 am]
BILLING CODE 4910-06-P


Since none of the ten species exposed displayed $ 25% inhibition for the parameters tested, guidelines 122 1 ( a) and ( b) have been fulfilled for this TEP ( MRID No. 44283401). Requirements for future MAI TEP testing of mancozeb is being reserved and may be required if these TEP formulations are identified as being a toxicological concern to terrestrial plants. Due to the mixture of mancozeb and dimethomorph that was used in the only study evaluated for this guideline requirement, EFED still has concerns about the effects that mancozeb as a SAI TEP would have on non target terrestrial plants and is recommending the submission of Tier I seedling emergence [ guideline 122 1( a)] and vegetative vigor [ guideline 122 1( b)] studies for a mancozeb SAI TEP.

Tier II Vegetative Vigor testing is not required, at this time, for mancozeb but is being reserved pending the results of Tier I testing of a mancozeb SAI TEP. 85 Table 16: Non target Terrestrial Plant Seedling Emergence Toxicity ( Tier I)  Acrobat MZ  Mancozeb and Dimethomorph  End Use Formulation Species % ai Mancozeb/

Dimethomorp h Mancozeb/

Dimethomorp h Dose ( lbs ai/ A) % Inhibition Response/

Endpoint Affected MRID No.

Author/ Year Study Classification1 Monocot Corn 60/ 9 1.38/ 0.20 0.0/ no parameter affected 44283401/ Chetram, R. et al./ 1997 Core Monocot

Onion 60/ 9 1.38/ 0.20 12.0/ dry weight 44283401/ Chetram, R. et al./ 1997 Core Monocot

Ryegrass 60/ 9 1.38/ 0.20 4.0/ height = dry weight 44283401/ Chetram, R. et al./ 1997 Core Monocot Oat 60/ 9 1.38/ 0.20 3.0/ height 44283401/ Chetram, R. et al./ 1997 Core Dicot

Cucumber 60/ 9 1.38/ 0.20 0.0/ no parameter affected 44283401/ Chetram, R. et al./ 1997 Core Dicot Soybean 60/ 9 1.38/ 0.20 4.0/ dry weight 44283401/ Chetram, R. et al./ 1997 Core Dicot Cabbage 60/ 9 1.38/ 0.20 1.0/ height 44283401/ Chetram, R. et al./ 1997 Core Dicot Radish 60/ 9 1.38/ 0.20 2.0/ emergence 44283401/ Chetram, R. et al./ 1997 Core Dicot Lettuce 60/ 9 1.38/ 0.20 0.0/ no parameter affected 44283401/ Chetram, R. et al./ 1997 Core Dicot Tomato 60/ 9 1.38/ 0.20 4.0/ dry weight 44283401/ Chetram, R. et al./ 1997 Core 1 Core ( study satisfies guideline). Supplemental ( study is scientifically sound, but does not satisfy guideline). 86 Table 17: Non target Terrestrial Plant Vegetative Vigor Toxicity ( Tier I)  Acrobat MZ  Mancozeb and Dimethomorph  End Use Formulation Species % ai Mancozeb/

Dimethomorph Mancozeb/

Dimethomorph Dose ( lbs ai/ A) % Inhibition Response/

Endpoint Affected MRID No.

Author/ Year Study Classification1 Monocot Corn 60/ 9 1.38/ 0.20 2.0/ dry weight 44283401/ Chetram,

R. et al./ 1997 Core Monocot Onion 60/ 9 1.38/ 0.20 2.0/ dry weight 44283401/ Chetram,

R. et al./ 1997 Core Monocot Ryegrass 60/ 9 1.38/ 0.20 0.0/ no parameter affected 44283401/ Chetram,

R. et al./ 1997 Core Monocot Oat 60/ 9 1.38/ 0.20 2.0/ height 44283401/ Chetram,

R. et al./ 1997 Core Dicot Cucumber 60/ 9 1.38/ 0.20 10.0/ dry weight 44283401/ Chetram,

R. et al./ 1997 Core Dicot Soybean 60/ 9 1.38/ 0.20 0.0/ no parameter affected 44283401/ Chetram,

R. et al./ 1997 Core Dicot Cabbage 60/ 9 1.38/ 0.20 0.0/ no parameter affected 44283401/ Chetram,

R. et al./ 1997 Core Dicot Radish 60/ 9 1.38/ 0.20 5.0/ dry weight 44283401/ Chetram,

R. et al./ 1997 Core Dicot Lettuce 60/ 9 1.38/ 0.20 3.0/ dry weight 44283401/ Chetram,

R. et al./ 1997 Core Dicot Tomato 60/ 9 1.38/ 0.20 6.0/ dry weight 44283401/ Chetram,

R. et al./ 1997 Core 1 Core ( study satisfies guideline). Supplemental ( study is scientifically sound, but does not satisfy guideline).

2. Terrestrial Plant Field Studies No studies were submitted and no studies are required.

3. Aquatic Plants Aquatic plant testing is recommended for all pesticides having outdoor uses ( Keehner. July 1999). The tests are performed on species from a cross section of the non target aquatic plant population. The preferred test species are duckweed ( Lemna gibba), marine diatom ( Skeletonema costatum), blue green algae ( Anabaena flos aquae), freshwater green alga ( Selenastrum capricornutum), and a freshwater diatom. Tier I aquatic plant testing is a maximum dose test designed to quickly evaluate the toxic effects to the test species in terms of growth and reproduction and to determine the need for additional aquatic plant testing. Tier II aquatic plant testing is a multiple dose test of the plants species that showed a phytotoxic effect to the pesticide being tested at the Tier I level. Tier II testing is aimed to determine the detrimental effect levels of the chemical on the aquatic plants which showed a greater than 50% detrimental effect in Tier I testing. 21 EFED based the EC 05 on a calculated value ( that is, 17.9 ppb) since a NOAEC was not established on MRID No. 43664701. EFED used the following formula: probit k = ( log LC k  log LC 50 ) * slope + probit 50%; where: k = 5% growth inhibition and LC k = 17.9 ppb ( Urban and Cook, 1986).

87 For mancozeb, one Tier II core study has been submitted for S. capricornutum. Results of Tier II toxicity testing on the technical material are tabulated in Table 18, below. The EC 50 for S. capricornutum was 47.0 ppb a. i. based on growth inhibition; the NOAEC was < 22.0 ppb 21. The toxicity value ( EC 50 ) appearing in the shaded area of the table will be used to calculate the acute risk quotients ( RQ's) in subsequent sections. Guideline 123 2 ( Tier II) has been partially fulfilled ( MRID No. 43664701). Guideline 122 2 ( Tier I) or Guideline 123 2 ( Tier II) aquatic plant growth testing needs to be submitted for duckweed ( Lemna gibba), marine diatom ( Skeletonema costatum), bluegreen algae ( Anabaena flos aquae), and a freshwater diatom.

The results of aquatic plant Tier II toxicity for end use formulations of the active ingredients, mancozeb and dimethomorph are also tabulated in the Table 18, below. The supplemental studies did not fufill guideline requirements because the duration of the study was less than the required 120 hours and an inert ingredient control was not included in the test. Guideline 123 2 ( Tier II), for the indicated ( see Table 18), end use formulation of dimethomorph and zoxamide with mancozeb have been fulfilled for nonvascular plants ( MRID No. 44283402). A core study for this end use formulation needs to be submitted for the the vascular non target test species, duckweed ( Lemna gibba). 88 Table 18: Non target Aquatic Plant Toxicity ( Tier II)  Mancozeb Technical Species/ duration % A. I. EC50/ NOAEC ( ppb ai) MRID No.

Author/ year Classification1 Nonvascular Plants frreshwater green algae ( Selenastrum capricornutum)

/ 120 hrs. 82.4 47.0/< 22.0 slope = 4.1 Probit LD 50 = 46 95% CI = 41.3  50.1 Probit slope = 4.0 95% CI = 3.4  4.6 43664701/ Forbis, A./ 1990 Core End Use Formulation freshwater green algae ( Selenastrum capricornutum)

/ 72 hrs. 7.5 ( dimethomorph)

67.7 ( mancozeb) 19/ 4.32 43917217/ Toy, R & A.

Gray/ 1992 Supplemental freshwater green algae ( Selenastrum capricornutum)

/ 120 hrs. 9.0 ( dimethomorph)

60.0 ( mancozeb) 112/ 282 44283402/ Hughes, J. et al./ 1997 Core marine diatom ( Skeletonema costatum)/ 120 hrs. 9.0 ( dimethomorph)

60.0 ( mancozeb) 139/ 1042 44283402/ Hughes, J. et al./ 1997 Core freshwaterr diatom ( Navicula pelliculosa)/ 120 hrs. 9.0 ( dimethomorph)

60.0 ( mancozeb) 13.71/ 2.882 44283402/ Hughes, J. et al./ 1997 Core freshwater bluegreen algae ( Anabaena flosaquae 120 hrs. 9.0 ( dimethomorph)

60.0 ( mancozeb) 130/ 282 44283402/ Hughes, J. et al./ 1997 Core 1 Core ( study satisfies guideline). Supplemental ( study is scientifically sound, but does not satisfy guideline).

2 Based upon total product concentration.

4. Aquatic Plant Field Studies No studies were submitted and no studies are required. 89 APPENDIX IV: Environmental Exposure Assessment a. Overview of Risk Quotients ( RQs)

Risk characterization integrates the results of the exposure and ecotoxicity data to evaluate the likelihood of adverse ecological effects. The Agency calls this integration the quotient method. The Agency calculates risk quotients ( RQs) by dividing exposure estimates by acute and chronic ecotoxicity values.

RQ = EXPOSURE/ TOXICITY EFED compares RQs to OPP's levels of concern ( LOCs). OPP uses these LOCs to analyze potential risk to non target organisms and the need to consider regulatory action. This method signals that a pesticide used as directed has the potential to cause adverse effects on non target organisms. LOCs currently address the following risk presumption categories: ( 1) acute risks  the risks warrant regulatory action as well as restricted use classification; ( 2) acute restricted use  the potential for acute risk exists, but the restricted use classification may mitigate the risk; ( 3) acute endangered species  the risk may adversely affect endangered species; and ( 4) chronic risk  the risk may warrant regulatory action because there is a potential for chronic risk. Currently, EFED does not perform assessments for chronic risk to plants, acute or chronic risks to non target insects, or chronic risk from granular or bait formulations to birds or mammals.

The Agency gets ecotoxicity test values ( measurement endpoints) used in the acute and chronic risk quotients from required studies. Examples of ecotoxicity values gathered from short term laboratory studies that assess acute effects are: ( 1) LC 50 ( fish and birds); ( 2) LD 50 ( birds and mammals); ( 3) EC 50 ( aquatic plants and aquatic invertebrates); and ( 4) EC 25 ( terrestrial plants). Examples of toxicity test effect levels drawn from the results of long term laboratory studies that assess chronic effects are: ( 1) LOAEL or LOAEC ( birds, fish, and aquatic invertebrates) and ( 2) NOAEL or NOAEC ( birds, fish and aquatic invertebrates). For birds, mammals, fish and aquatic invertebrates, the Agency uses the NOAEL or NOAEC as the ecotoxicity test value in assessing chronic effects, although the Agency may use other values when justified. Tabulated below are risk presumptions and the matching RQs and LOCs.

Risk quotients are index or reference values used to show potential ecological risk. There are limits with the use of risk quotients in assessing the risk to non target animals and plants. The likelihood of an adverse effect does not increase with the size of the risk quotient. ( Urban, 2000). An LOC defined as 1 ( see table below) provides the reference point for estimating the exposure to toxicity risk ( that is, risk quotient). Values at or above this reference point trigger risk concerns. A risk quotient value of 100 compared to a value of 50 does not suggest a greater risk or a risk that is more likely to occur. Both these values are above the reference point for risk of 1. The risk quotient value of 100 reflects an exposure level that is twice has high as the risk quotient value of 50. The " exposure" in the " RQ = Exposure/ Toxicity" ratio is twice has high for RQ of 100 as for the RQ of 50. Risk quotients are nonprobabilistic and have numerical and dichotomous results. The numerical result 90 drawn from the calculation either exceeds a fixed LOC or does not exceed it. ( US EPA. June 30, 1995).

Table 1. Risk presumptions for terrestrial animals based on risk quotients ( RQ) and levels of concern ( LOC).

Risk Presumption RQ LOC Birds Acute Risk EEC1/ LC 50 or LD 50 / ft2 or LD 50 / day3 0.5 Acute Restricted Use EEC/ LC 50 or LD 50 / ft2 or LD 50 / day ( or LD 50 < 50 mg/ kg) 0.2 Acute Endangered Species EEC/ LC 50 or LD 50 / ft2 or LD 50 / day 0.1 Chronic Risk EEC/ NOAEC 1 Wild Mammals Acute Risk EEC/ LC 50 or LD 50 / ft2 or LD 50 / day 0.5 Acute Restricted Use EEC/ LC 50 or LD 50 / ft2 or LD 50 / day ( or LD 50 < 50 mg/ kg) 0.2 Acute Endangered Species EEC/ LC 50 or LD 50 / ft2 or LD 50 / day 0.1 Chronic Risk EEC/ NOAEC 1 1 abbreviation for Estimated Environmental Concentration ( ppm) on avian/ mammalian food items 2 mg/ ft2 3 mg of toxicant consumed/ day LD 50 * wt. of bird LD 50 * wt. of bird Table 2. Risk presumptions for aquatic animals based on risk quotients ( RQ) and levels of concern ( LOC).

Risk Presumption RQ LOC Acute Risk EEC1/ LC 50 or EC 50 0.5 Acute Restricted Use EEC/ LC 50 or EC 50 0.1 Acute Endangered Species EEC/ LC 50 or EC 50 0.05 Chronic Risk EEC/ NOAEC 1 1 EEC = ( ppm or ppb) in water Table 3. Risk presumptions for plants based on risk quotients ( RQ) and levels of concern ( LOC).

Risk Presumption RQ LOC Terrestrial and Semi Aquatic Plants Acute Risk EEC1/ EC 25 1 Acute Endangered Species EEC/ EC 05 or NOAEC 1 Aquatic Plants Acute Risk EEC2/ EC 50 1 Acute Endangered Species EEC/ EC 05 or NOAEC 1 1 EEC = lbs ai/ A 2 EEC = ( ppb/ ppm) in water 91 b. Exposure and Risk to Terrestrial Animals i. Birds EFED does not currently have an exposure scenario for determining the exposure risks from the use of mancozeb on caprifigs or pineapples as a dip treatment and these risks have not been evaluated in this RED.

The acute risk to avian species as a result of exposure to mancozeb from multiple applications of mancozeb nongranular products was not able to be made because an avian LC 50 has not been determined from dietary exposure. As mentioned in Appendix III, the dietary testing that would have provided this toxicity information was waived by EFED. The chronic risk quotients for multiple broadcast applications of nongranular mancozeb products are tabulated below. Analysis of the results indicate that for multiple applications of mancozeb nongranular products, avian chronic levels of concern ( LOCs) are exceeded for all uses patterns. 92 Table 4: Avian Chronic Risk Quotients for Multiple Broadcast Applications of Nongranular Mancozeb based on a Mallard Duck ( Anas platyrhynchos) NOAEC of 125 ppm.

Application Rate Chronic RQ Chronic RQ ( lbs ai/ A)/

Based on Based on Number of Mean EECs Maximum EECs Mean Maximum Applications/ Site/

( Mean EEC/ NOAEC) 2 ( Max. EEC/ NOAEC) 2 EEC ( ppm) 1 EEC ( ppm) 1 Food Items Interval Application Method 10.7 30.3 1,342 3,788 Short grass 4.8/ 4 Apples, Cranapple,

4.5 13.9 568 1,736 Tall grass 7 day interval Pear, & Quince 5.7 17.0 710 2,131 Broadleaf plants/ Insects ground & aerial 0.9 1.9 110 237 Seeds 3.3 9.4 414 1,169 Short grass 1.6/ 4 Asparagus 1.4 4.3 175 536 Tall grass 10 day interval ground & aerial 1.8 5.3 219 658 Broadleaf plants/ Insects 0.3 0.6 34 73 Seeds 6.3 17.8 790 2,230 Short grass 2.4/ 10 Bananas & Plantain 2.7 8.2 335 1,022 Tall grass 14 day interval ground & aerial 3.3 10.0 418 1,254 Broadleaf plants/ Insects 0.5 1.1 65 139 Seeds 2.9 8.1 357 1,009 Short grass 1.6/ 3 Barley, Oats, Rye,

1.2 3.7 151 463 Tall grass 7 day interval Triticale, & Wheat 1.5 4.5 189 568 Broadleaf plants/ Insects ground & aerial 0.2 0.5 29 63 Seeds 1.6 4.5 201 568 Short grass 0.9/ 3 a Citrus 0.7 2.1 85 260 Tall grass 7 day interval ground & aerial 0.9 2.6 106 319 Broadleaf plants/ Insects 0.1 0.3 17 35 Seeds 7.4 21.0 931 2,629 Short grass 1.2/ 15 Corn ( unspecified)

3.2 9.6 394 1,205 Tall grass 4 day interval ( E. of Miss. River)

3.9 11.8 493 1,479 Broadleaf plants/ Insects ground & aerial 0.6 1.3 77 164 Seeds 5.9 16.6 733 2,069 Short grass 1.2/ 10 Corn ( unspecified)

2.5 7.6 310 948 Tall grass 4 day interval ( W. of Miss. River)

3.1 9.3 388 1,164 Broadleaf plants/ Insects ground & aerial 0.5 1.0 60 129 Seeds 3.3 9.4 414 1,169 Short grass 1.6/ 4 Cotton 1.4 4.3 175 536 Tall grass 10 day interval ground & aerial 1.8 5.3 219 658 Broadleaf plants/ Insects 0.3 0.6 34 73 Seeds 8.6 24.2 1,072 3,028 Short grass 4.8/ 3 Cranberry 3.6 11.1 454 1,388 Tall grass 7 day interval ground & aerial 4.5 13.6 568 1,703 Broadleaf plants/ Insects 0.7 1.5 88 189 Seeds 93 Table 4 ( continued): Avian Chronic Risk Quotients for Multiple Broadcast Applications of Nongranular Mancozeb based on a Mallard Duck ( Anas platyrhynchos) NOAEC of 125 ppm.

Application Rate Chronic RQ Chronic RQ ( lbs ai/ A)/

Based on Based on Number of Mean EECs Maximum EECs Mean Maximum Applications/ Site/

( Mean EEC/ NOAEC) 2 ( Max. EEC/ NOAEC) 2 EEC ( ppm) 1 EEC ( ppm) 1 Food Items Interval Application Method 8.4 23.9 1,056 2,982 Short grass 2.4/ 8 Cucumber 3.6 10.9 447 1,367 Tall grass 7 day interval ground & aerial 4.5 13.4 559 1,677 Broadleaf plants/ Insects 0.7 1.5 87 186 Seeds 5.6 15.9 704 1,988 Short grass 1.6/ 8 Fennel 2.4 7.3 298 911 Tall grass 7 day interval ground & aerial 3.0 8.9 373 1,118 Broadleaf plants/ Insects 0.5 1.0 58 124 Seeds 9.5 26.8 1,187 3,350 Short grass 3.2/ 6 Grapes 4.0 12.3 503 1,536 Tall grass 7 day interval ( E. of Rocky Mtns.)

5.0 15.1 628 1,885 Broadleaf plants/ Insects ground & aerial 0.8 1.7 98 209 Seeds 3.6 10.1 447 1,262 Short grass 2.0/ 3 Grapes 1.5 4.6 189 578 Tall grass 7 day interval ( W. of Rocky Mtns.)

1.9 5.7 237 710 Broadleaf plants/ Insects ground & aerial 0.3 0.6 37 79 Seeds 8.4 23.9 1,056 2,982 Short grass 2.4/ 8 Melons & Squash 3.6 10.9 447 1,367 Tall grass 7 day interval ground & aerial 4.5 13.4 559 1,677 Broadleaf plants/ Insects 0.7 1.5 87 186 Seeds 9.5 26.7 1,182 3,337 Short grass 2.4/ 10 Onion, Garlic, & Shallot 4.0 12.2 501 1,530 Tall grass 7 day interval ground & aerial 5.0 15.0 626 1,877 Broadleaf plants/ Insects 0.8 1.7 97 209 Seeds 14.4 40.7 1,803 5,091 Short grass 4.0/ 7 Papaya 6.1 18.7 764 2,334 Tall grass 5 day interval ground & aerial 7.6 22.9 955 2,864 Broadleaf plants/ Insects 1.2 2.5 149 318 Seeds 5.6 15.9 704 1,988 Short grass 1.6/ 8 Peanuts 2.4 7.3 298 911 Tall grass 7 day interval ground & aerial 3.0 8.9 373 1,118 Broadleaf plants/ Insects 0.5 1.0 58 124 Seeds 94 Table 4 ( continued): Avian Chronic Risk Quotients for Multiple Broadcast Applications of Nongranular Mancozeb based on a Mallard Duck ( Anas platyrhynchos) NOAEC of 125 ppm.

Application Rate Chronic RQ Chronic RQ ( lbs ai/ A)/

Based on Based on Number of Mean EECs Maximum EECs Mean Maximum Applications/ Site/

( Mean EEC/ NOAEC) 2 ( Max. EEC/ NOAEC) 2 EEC ( ppm) 1 EEC ( ppm) 1 Food Items Interval Application Method 5.8 16.3 721 2,037 Short grass 1.6/ 7 Potato & Sugar Beet 2.4 7.5 305 933 Tall grass 5 day interval ground & aerial 3.1 9.2 382 1,146 Broadleaf plants/ Insects 0.5 1.0 59 127 Seeds 3.7 10.5 463 1,309 Short grass 2.0/ 3 a Tobacco 1.6 4.8 196 600 Tall grass 5 day interval ground & aerial 2.0 5.9 245 736 Broadleaf plants/ Insects 0.3 0.7 38 82 Seeds 7.8 22.1 979 2,764 Short grass 2.4/ 7 Tomato 3.3 10.1 415 1,267 Tall grass 7 day interval ground & aerial 4.1 12.4 518 1,554 Broadleaf plants/ Insects 0.6 1.4 81 173 Seeds 2.7 7.6 335 946 Short grass 1.5/ 3 a Vegetablesb 1.1 3.5 142 434 Tall grass 7 day interval ground & aerial 1.4 4.3 177 532 Broadleaf plants/ Insects 0.2 0.5 28 59 Seeds 5.1 14.3 634 1,791 Short grass 3.2/ 3 a Forestry ( Douglas Fir)

2.1 6.6 269 821 Tall grass 14 day interval ground & aerial 2.7 8.1 336 1,008 Broadleaf plants/ Insects 0.4 0.9 52 112 Seeds 5.1 14.3 634 1,791 Short grass 3.2/ 3 a Ornamental Trees c 2.1 6.6 269 821 Tall grass 14 day interval ground & aerial 2.7 8.1 336 1,008 Broadleaf plants/ Insects 0.4 0.9 52 112 Seeds 95 Table 4 ( continued): Avian Chronic Risk Quotients for Multiple Broadcast Applications of Nongranular Mancozeb based on a Mallard Duck ( Anas platyrhynchos) NOAEC of 125 ppm.

Application Rate Chronic RQ Chronic RQ ( lbs ai/ A)/

Based on Based on Number of Mean EECs Maximum EECs Mean Maximum Applications/ Site/

( Mean EEC/ NOAEC) 2 ( Max. EEC/ NOAEC) 2 EEC ( ppm) 1 EEC ( ppm) 1 Food Items Interval Application Method 2.9 8.1 357 1,009 Short grass 1.6/ 3 a Ornamentals d 1.2 3.7 151 463 Tall grass 7 day interval ground & aerial 1.5 4.5 189 568 Broadleaf plants/ Insects 0.2 0.5 29 63 Seeds 33.1 93.4 4,133 11,670 Short grass 13.9/ 5 Ornamentals 14.0 42.8 1,751 5,349 Tall grass 10 day interval ( pachysandra groundcover)

17.5 52.5 2,188 6,564 Broadleaf plants/ Insects ground 2.7 5.8 340 729 Seeds 32.3 91.1 4,032 11,384 Short grass 17.4/ 3 a Turf ( golf course)

13.7 41.7 1,708 5,218 Tall grass 5 day interval ground 17.1 51.2 2,135 6,404 Broadleaf plants/ Insects 2.7 5.7 332 712 Seeds 35.2 99.4 4,403 12,431 Short grass 19.0/ 3 a Turf e 14.9 45.6 1,865 5,697 Tall grass 5 day interval ground & aerial 18.6 55.9 2,331 6,992 Broadleaf plants/ Insects 2.9 6.2 363 777 Seeds 1 Assumes degradation using FATE version 5.0 program with a half life of 35 days. EFED uses this value as a default value when the foliar dissipation for a particular pesticide is unknown.

2 RQ greater or equal to 1.00 exceeds chronic LOC.

a Maximum number of applications/ year or crop cycle not specified ( assumed 3 applications).

b Beets ( unspecified), Broccoli, Brussel sprouts, Cabbage, Carrots, Cauliflower, Chard ( Swiss),

Collards, Coriander, Dill, Endive, Kale, Kohlrabi, Leeks, Lettuce, Mustard, Mustard Cabbage,

Parsley, Parsnip, Radish, Rape, Roquette ( Arrugula), Rutabaga, Spinach, & Turnip c Christmas Tree Plantations d Trees, Herbaceous Plants, Non Flowering Plants, & Woody Shrubs and Vines e Commercial/ Industrial, Sod Farm, & Residential 96 The acute risk quotients for applications of mancozeb treated seed are tabulated below. Ecological risks from seed treatments are assessed by the same method used for granular and bait products. For typical in furrow planting or drill seeded, 1% of the seeds planted are assumed to be exposed. The number of lethal doses ( LD 50 s) that are available within one square foot immediately after application ( LD 50 s/ ft2) is used as the risk quotient for seeds treated with mancozeb. This calculation does not include the untreated area between rows. Birds have been reported following directly behind planting equipment to forage on worms and other invertebrates exposed by the freshly tilled soil. Therefore, it is assumed that birds will forage mostly within the planted area where the pesticide treated seed is planted. This planted area is assumed to be 1.2 inches ( 0.1 feet) wide for in furrow planting ( EEB Guidance Doc. E 02C. June, 1995). Risk quotients are calculated for three separate weight class of birds: 1000 g ( e. g., waterfowl), 180 g ( e. g., upland gamebird), and 20 g ( e. g., songbird). The amount of mancozeb on a seed was estimated to determine the number of seeds that would need to consumed to reach the LD 50 ( Keehner D. July, 1999a).

An analysis of the results indicates that for single applications of mancozeb treated seed no acute risk, acute restricted use or acute endangered species levels of concern are exceeded for the use patterns indicated. Chronic risk to birds from exposure to treated seed are not currently be performed by EFED because the appropriate exposure scenario has not been developed. Based upon the English House Sparrow, multiple dose acute oral LD 50 of approximately 1,500 mg ai/ kg for mancozeb ( MRID No. 00036094) and a food consumption of 19.0% of body wt/ day ( 5 grams), a 26 gram English House Sparrow would need to consume 591 rice seeds to reach its LD 50 ( see formula in table 5). 15,000 rice seeds per pound divided by 4.5359 x 102 grams per pound yields 33 rice seeds per gram. An English House Sparrow, assuming it is consuming only mancozeb treated rice seeds, would consume 165 rice seeds per day ( 33 rice seeds per gram * 5 grams per day). This consumption rate would be approximately 4 times less than the expected multiple dose LD 50 of 591 rice seeds and the scenario that the sparrow would consume only rice seeds in a single day is unlikely.

It should be noted that mancozeb is used for treating additional seeds and seed pieces that are not listed in Table 5, below. Table 5 represents a listing of crop seeds that are treated and no additional application methods ( i. e. broadcast, dip treatments, etc.) are used to apply mancozeb to the sites listed in Table 5. 97 Table 5: Avian Acute risk Quotients for Single Applications of Mancozeb Treated Seed Based on an English Sparrow ( Passer domesticus )

LD50 of 1500 mg ai/ kg.

Number of % ( decimal) of Site/ Application Method Seeds Seeds Pesticide Bird Body Application Pounds Planted Seed per Acre3 Consumed to Mg AI per Acute RQ 2 Exposed 1 Left on Weight Rate Seed Treatment ( lb. ai / 100 lb seed)

Reach LD50 5 Per Seed 4 Pound 3 ( LD50/ sq. ft) ( mg ai/ sq. ft) the Surface ( grams) ( lb ai/ A) Row Width ( feet) Flaxa/ In furrow Incorporated 1,356 0.022 82,000 0.00926 0.28 0.01 20 0.32 80 12,203 0.00103 180 0.40 67,792 0.00019 1000 0.1 Riceb / In furrow ( drilled) Incorporated 496 0.060 15,000 0.00312 0.09 0.01 20 0.18 90 4,464 0.00035 180 0.2 24,802 0.00006 1000 0.1 Safflowerb / In furrow Incorporated 529 0.057 8,000 0.00061 0.02 0.01 20 0.035 35 4,762 0.00007 180 0.1 26,456 0.00001 1000 0.1 Sorghumc / In furrow Incorporated 529 0.057 16,000 0.00078 0.02 0.01 20 0.018 9 4,762 0.00009 180 0.2 26,456 0.00002 1000 0.1 1 Exposed = App. Rate ( lbs. ai/ A)* 453,590 mg/ lbs * % ( decimal) on surface/[ linear ft of row/ A ( ft/ A)* row width ( ft)]

2 RQ = Exposed ( mg ai/ sq. ft.)/[ LD50( mg ai/ kg) * Weight of the Animal ( g)/ 1000 ( g/ kg)] RQ greater or equal to 0.5 exceeds acute high, acute restricted use and acute endangered species LOCs.

RQ greater or equal to 0.2 exceeds acute restricted use and acute endangered species LOCs.

RQ greater or equal to 0.1 exceeds acute endangered species LO 3 Sources: flax ( EPA file source); rice ( http:// ext. msstate. edu/ anr/ plantsoil/ rice/ riceq4. html) ;

safflower ( http:// www. montana. edu/ wwwpb/ ag/ saff_ for. html); sorghum( http:// www. aes. purdue. edu/ AgAnswrs/ 1995/ 6 13Corn_ Sorghum_ Swit 4 Mg AI per Seed = seed treatment rate ( lb ai/ 100 lb seed)/ 100 lb seed/ seeds per lb * 453,590 mg/

5 Number of Seeds Consumed to Reach LD50 = [ LD50( mg ai/ kg) * Weight of the Animal ( g)/ 1000 ( g/ kg)]/ mg ai per seed a Assumes 10 inch row spacing or 52,272 linear ft of row per acre b Assumes 6 inch row spacing or 87,120 linear ft of row per acre c Assumes 15 inch row spacing or 34,848 linear ft of row per acre 98 ii. Mammals As identified in Appendix III, mancozeb is practically nontoxic ( rat LD 50 > 5,000 mg/ kg) to mammals on an acute basis. Because of this, the acute exposure to mancozeb presents a low risk to mammals so RQs for acute exposure were not determined. The chronic mammalian risk quotients for multiple broadcast applications of nongranular products are tabulated below in table 6. The results indicate that chronic mammalian LOCs are exceeded for all mancozeb use patterns listed. 99 Table 6: Mammalian Chronic Risk Quotients for Multiple Applications of Mancozeb Nongranula NOAEL of 120 ppm Based on Parental Body Weight Decrements, Increased Relative Thyroid W Incidence of Thyroid Follicular Cell Hyperplasia in a 2 Generation Reproductive Study on labaratory rats ( Rattus n Application Rate Chronic RQ Chronic RQ ( lbs ai/ A)/

Based on Based on Number of Mean EECs Maximum EECs Mean Maximum Applications/ Site/

( Mean EEC/ NOAE 2 ( Max. EEC/ NOAE 2 EEC ( ppm) 1 EEC ( ppm1 Food Items Interval Application Method 11.2 31.6 1,342 3,788 Short grass 4.8/ 4 Apples, Cranapple,

4.7 14.5 568 1,736 Tall grass 7 day interva Pear, & Quince 5.9 17.8 710 2,131 Broadleaf plants/ Ins ground & aerial 0.9 2.0 110 237 Seeds 3.5 9.7 414 1,169 Short grass 1.6/ 4 Asparagus 1.5 4.5 175 536 Tall grass 10 day interva ground & aerial 1.8 5.5 219 658 Broadleaf plants/ Ins 0.3 0.6 34 73 Seeds 6.6 18.6 790 2,230 Short grass 2.4/ 10 Bananas & Plantain 2.8 8.5 335 1,022 Tall grass 14 day interva ground & aerial 3.5 10.5 418 1,254 Broadleaf plants/ Ins 0.5 1.2 65 139 Seeds 3.0 8.4 357 1,009 Short grass 1.6/ 3 Barley, Oats, Rye,

1.3 3.9 151 463 Tall grass 7 day interval Triticale, & Wheat 1.6 4.7 189 568 Broadleaf plants/ Ins ground & aerial 0.2 0.5 29 63 Seeds 1.7 4.7 201 568 Short grass 0.9/ 3a Citrus 0.7 2.2 85 260 Tall grass 7 day interval ground & aerial 0.9 2.7 106 319 Broadleaf plants/ Ins 0.1 0.3 17 35 Seeds 7.8 21.9 931 2,629 Short grass 1.2/ 15 Corn ( unspecified)

3.3 10.0 394 1,205 Tall grass 4 day interval ( E. of Miss. River)

4.1 12.3 493 1,479 Broadleaf plants/ Ins ground & aerial 0.6 1.4 77 164 Seeds 100 Table 6 ( continued): Mammalian Chronic Risk Quotients for Multiple Applications of Mancozeb Nongranular ( Br NOAEL of 120 ppm Based on Parental Body Weight Decrements, Increased Relative Thyroid W Incidence of Thyroid Follicular Cell Hyperplasia in a 2 Generation Reproductive Study on labaratory rats ( Rattus Application Rate Chronic RQ Chronic RQ ( lbs ai/ A)/

Based on Based on Number of Mean EECs Maximum EECs Mean Maximum Applications/ Site/

( Mean EEC/ NOAE 2 ( Max. EEC/ NOAEL 2 EEC ( ppm) 1 EEC ( ppm) 1 Food Items Interval Application Method 6.1 17.2 733 2,069 Short grass 1.2/ 10 Corn ( unspecified)

2.6 7.9 310 948 Tall grass 4 day interval ( W. of Miss. River)

3.2 9.7 388 1,164 Broadleaf plants/ Inse ground & aerial 0.5 1.1 60 129 Seeds 3.5 9.7 414 1,169 Short grass 1.6/ 4 Cotton 1.5 4.5 175 536 Tall grass 10 day interva ground & aerial 1.8 5.5 219 658 Broadleaf plants/ Inse 0.3 0.6 34 73 Seeds 8.9 25.2 1,072 3,028 Short grass 4.8/ 3 Cranberry 3.8 11.6 454 1,388 Tall grass 7 day interval ground & aerial 4.7 14.2 568 1,703 Broadleaf plants/ Inse 0.7 1.6 88 189 Seeds 8.8 24.8 1,056 2,982 Short grass 2.4/ 8 Cucumber 3.7 11.4 447 1,367 Tall grass 7 day interval ground & aerial 4.7 14.0 559 1,677 Broadleaf plants/ Inse 0.7 1.6 87 186 Seeds 5.9 16.6 704 1,988 Short grass 1.6/ 8 Fennel 2.5 7.6 298 911 Tall grass 7 day interval ground & aerial 3.1 9.3 373 1,118 Broadleaf plants/ Inse 0.5 1.0 58 124 Seeds 9.9 27.9 1,187 3,350 Short grass 3.2/ 6 Grapes 4.2 12.8 503 1,536 Tall grass 7 day interval ( E. of Rocky Mtns.)

5.2 15.7 628 1,885 Broadleaf plants/ Inse ground & aerial 0.8 1.7 98 209 Seeds 101 Table 6 ( continued): Mammalian Chronic Risk Quotients for Multiple Applications of Mancozeb Nongranular ( Broadca NOAEL of 120 ppm Based on Parental Body Weight Decrements, Increased Relative Thyroid Weigh Incidence of Thyroid Follicular Cell Hyperplasia in a 2 Generation Reproductive Study on labaratory rats ( Rattus norve Application Rate Chronic RQ Chronic RQ ( lbs ai/ A)/

Based on Based on Number of Mean EECs Maximum EECs Mean Maximum Applications/ Site/

( Mean EEC/ NOAEL 2 ( Max. EEC/ NOAEL 2 EEC ( ppm) 1 EEC ( ppm) 1 Food Items Interval Application Method 3.7 10.5 447 1,262 Short grass 2.0/ 3 Grapes 1.6 4.8 189 578 Tall grass 7 day interval ( W. of Rocky Mtns.)

2.0 5.9 237 710 Broadleaf plants/ Inse ground & aerial 0.3 0.7 37 79 Seeds 8.8 24.8 1,056 2,982 Short grass 2.4/ 8 Melons & Squash 3.7 11.4 447 1,367 Tall grass 7 day interval ground & aerial 4.7 14.0 559 1,677 Broadleaf plants/ Inse 0.7 1.6 87 186 Seeds 9.8 27.8 1,182 3,337 Short grass 2.4/ 10 Onion, Garlic, & Shallot 4.2 12.7 501 1,530 Tall grass 7 day interval ground & aerial 5.2 15.6 626 1,877 Broadleaf plants/ Inse 0.8 1.7 97 209 Seeds 15.0 42.4 1,803 5,091 Short grass 4.0/ 7 Papaya 6.4 19.4 764 2,334 Tall grass 5 day interval ground & aerial 8.0 23.9 955 2,864 Broadleaf plants/ Inse 1.2 2.7 149 318 Seeds 5.9 16.6 704 1,988 Short grass 1.6/ 8 Peanuts 2.5 7.6 298 911 Tall grass 7 day interval ground & aerial 3.1 9.3 373 1,118 Broadleaf plants/ Inse 0.5 1.0 58 124 Seeds 6.0 17.0 721 2,037 Short grass 1.6/ 7 Potato & Sugar Beet 2.5 7.8 305 933 Tall grass 5 day interval ground & aerial 3.2 9.5 382 1,146 Broadleaf plants/ Inse 0.5 1.1 59 127 Seeds 3.9 10.9 463 1,309 Short grass 2.0/ 3a Tobacco 1.6 5.0 196 600 Tall grass 5 day interval ground & aerial 2.0 6.1 245 736 Broadleaf plants/ Inse 0.3 0.7 38 82 Seeds 102 Table 6 ( continued): Mammalian Chronic Risk Quotients for Multiple Applications of Mancozeb Nongranular ( Bro NOAEL of 120 ppm Based on Parental Body Weight Decrements, Increased Relative Thyroid W Incidence of Thyroid Follicular Cell Hyperplasia in a 2 Generation Reproductive Study on labaratory rats ( Rattus n Application Rate Chronic RQ Chronic RQ ( lbs ai/ A)/

Based on Based on Number of Mean EECs Maximum EECs Mean Maximum Applications/ Site/

( Mean EEC/ NOAE 2 ( Max. EEC/ NOAEL 2 EEC ( ppm) 1 EEC ( ppm) 1 Food Items Interval Application Method 8.2 23.0 979 2,764 Short grass 2.4/ 7 Tomato 3.5 10.6 415 1,267 Tall grass 7 day interval ground & aerial 4.3 13.0 518 1,554 Broadleaf plants/ Inse 0.7 1.4 81 173 Seeds 2.8 7.9 335 946 Short grass 1.5/ 3a Vegetables b 1.2 3.6 142 434 Tall grass 7 day interval ground & aerial 1.5 4.4 177 532 Broadleaf plants/ Inse 0.2 0.5 28 59 Seeds 5.3 14.9 634 1,791 Short grass 3.2/ 3a Forestry ( Douglas Fir)

2.2 6.8 269 821 Tall grass 14 day interva ground & aerial 2.8 8.4 336 1,008 Broadleaf plants/ Inse 0.4 0.9 52 112 Seeds 5.3 14.9 634 1,791 Short grass 3.2/ 3a Ornamental Trees c 2.2 6.8 269 821 Tall grass 14 day interva ground & aerial 2.8 8.4 336 1,008 Broadleaf plants/ Inse 0.4 0.9 52 112 Seeds 3.0 8.4 357 1,009 Short grass 1.6/ 3a Ornamentals d 1.3 3.9 151 463 Tall grass 7 day interval ground & aerial 1.6 4.7 189 568 Broadleaf plants/ Inse 0.2 0.5 29 63 Seeds 34.4 97.2 4,133 11,670 Short grass 13.9/ 5 Ornamentals 14.6 44.6 1,751 5,349 Tall grass 10 day interva ( pachysandra groundco 18.2 54.7 2,188 6,564 Broadleaf plants/ Inse ground 2.8 6.1 340 729 Seeds 103 104 Table 6 ( continued): Mammalian Chronic Risk Quotients for Multiple Applications of Mancozeb Nongranular ( B NOAEL of 120 ppm Based on Parental Body Weight Decrements, Increased Relative Thyroid Incidence of Thyroid Follicular Cell Hyperplasia in a 2 Generation Reproductive Study on labaratory rats ( Rattu Application Rate Chronic RQ Chronic RQ ( lbs ai/ A)/

Based on Based on Number of Mean EECs Maximum EECs Mean Maximum Applications/ Site/

( Mean EEC/ NOAE 2 ( Max. EEC/ NOAE 2 EEC ( ppm) 1 EEC ( ppm1 Food Items Interval Application Method 33.6 94.9 4,032 11,384 Short grass 17.4/ 3a Turf ( golf course)

14.2 43.5 1,708 5,218 Tall grass 5 day interval ground 17.8 53.4 2,135 6,404 Broadleaf plants/ Inse 2.8 5.9 332 712 Seeds 36.7 103.6 4,403 12,431 Short grass 19/ 0/ 3a Turf e 15.5 47.5 1,865 5,697 Tall grass 5 day interval ground & aerial 19.4 58.3 2,331 6,992 Broadleaf plants/ Inse 3.0 6.5 363 777 Seeds 1 Assumes degradation using FATE version 5.0 program with a half life of 35 days. EFED uses this a default value when the foliar dissipation for a particular pesticide i 2 RQ greater or equal to 1.0 exceeds chronic risk LOCs.

a Maximum number of applications/ year or crop cycle not ( assumed 3 applicatio b Beets ( unspecified), Broccoli, Brussel sprouts, Cabbage, Carrots, Cauliflower, C Collards, Coriander, Dill, Endive, Kale, Kohlrabi, Leeks, Lettuce, Mustard, Mus Parsley, Parsnip, Radish, Rape, Roquette ( Arrugula), Rutabaga, Spin c Christmas Tree Plantations d Trees, Herbaceous Plants, Non Flowering Plants, & Woody Shrubs e Commercial/ Industrial, Sod Farm & Residential 105 iii. Insects and Mites Currently, EFED does not assess risk to non target insects or mites using risk quotient methodology. Results of acceptable studies are used for recommending appropriate label precautions. Since mancozeb was determined to be practically nontoxic to honey bees ( LD 50 > 179 µ g/ bee) no bee precautionary labeling is required on mancozeb product labeling. A beneficial mite study ( MRID No. 45577201) determined that mancozeb's LR 50 ( residue concentration on foliage causing 50% lethality) for Typhlodromus pyri is 0.1 lb active ingredient/ A and the LOAEC which can be expected to cause adverse reproductive effects is 0.02 lb active ingredient/ A ( lowest concentration tested). The current maximum single application rate for mancozeb to apple orchards ( where Typhlodromus pyri is commonly found) is 4.8 lb active ingredient/ A with a maximum of 4 applications made per crop cycle at a minimum of every 7 days. Based on current registered mancozeb application rates and the toxicity indicated from this study it would appear that adverse effects to Typhlodromus pyri from mancozeb uses can be expected.

c. Aquatic Organisms i. Overview Because monitoring data from field locations are not available for mancozeb, EFED based the surface water exposure EECs of mancozeb on screening models. EFED used Tier II modeling, the Pesticide Root Zone Model version 3.1.2 beta ( Carsel and others., 1997) and Exposure Analysis Modeling System version 2.98.04 ( Burns, 1997) ( PRZM/ EXAMS), to estimate aquatic EECs.

The PRZM/ EXAMS modeling tools used by EFED are designed to be conservative tools; with 90% of simulated sites expected to have environmental concentrations lower than the Tier II estimates. EFED uses environmental fate and transport computer models to calculate refined EECs. PRZM simulates pesticide surface water runoff on daily time steps, incorporating runoff, infiltration, erosion, and evaporation. The model calculates foliar dissipation and runoff, pesticide uptake by plants, soil microbial transformation, volatilization, and soil dispersion and retardation. EXAMS simulates pesticide fate and transport in an aquatic environment ( one hectare body of water, two meters deep with no outlet). The EECs used in the assessment has both an average magnitude and a duration over which that average magnitude is calculated. Concentration values chosen for use in the assessment are those that would be expected to be equaled or exceeded only once every ten years based on the 30 year weather history at the site. The Tier II model uses a single site which represents a high exposure scenario for the use of the pesticide on a particular crop use site. The model simulates weather and agricultural practice at the site over multiple years so the probability of an EEC occurring at that site can be estimated. The PRZM/ EXAMS modeling approach is an uncertain predictor of water concentrations in estuarine/ marine systems. EFED suspects, though it hasn't been empirically proved, that flushing and exchange rates within these systems may differ from those assumed in the existing surface water modeling. Sometimes, flushing and exchange may be greater than accounted for in the EXAMS model and true estuarine/ marine water concentrations may be lower. In other cases tidal entrapment of pollutants may contribute to higher effective pesticide concentrations than predicted by the model. 106 Table 9: Mancozeb Acute and Chronic Risk Quotients for Freshwater Fish Based On a Rainbow Trout ( Salmo gairdneri ) LC50 of 460 ppb and a Fathead Minnow ( Pimephales promelas ) NOAEC of 2.19 ppb. Application Rate ( lbs ai/ A)/

Number of Chronic RQ Acute RQ EEC 60 Day Applications/ Site/

( 60 Day EEC/ NOAEC) 3 ( Peak EEC/ LC50) 2 Average ( ppb) 1 EEC Peak ( ppb) 1 Interval Application Method/

1.46 0.16 3.2 73.4 4.8/ 4 Apples 7 day interval ground & aerial 2.05 0.15 4.5 68.2 1.2/ 15 Corn ( Sweet)

4 day interval ground & aerial 1.00 0.10 2.2 46.8 1.6/ 7 Potato 5 day interval ground & aerial 3.33 0.46 7.3 210.8 2.4/ 7 Tomato 7 day interval ground & aerial 1.46 0.22 3.2 103.4 1.6/ 3 Wheat 7 day interval ground & aerial 1 Based on PRZM version 3.12/ EXAMS version 2.97.5 modeling. 2 RQ greater or equal to 0.5 exceeds acute risk, acute restricted use and acute endangered species LOCs.

RQ greater or equal to 0.1 exceeds acute restricted use and acute endangered species LOCs.

RQ greater or equal to 0.05 exceeds acute endangered species LOCs.

3 RQ greater or equal to 1.00 exceeds chronic LOC. EFED uses the EECs for assessing acute and chronic risks to aquatic organisms. EFED uses peak EEC values to calculate acute RQs for single and multiple applications for all aquatic organisms. EFED uses 21 day EECs for invertebrates and 60 day EECs for fish to calculate chronic RQs.

EFED selected boundaries used Tier II ( PRZM/ EXAMS) modeling using Agency guidance ( WQTT/ EFED/ OPP. August, 2000) and EFED calculated degradation rate constants from review of registrant filed environmental fate studies. EFED provides summary, of the environmental fate limits used in the model for mancozeb and the EECs, in section V Water Resource Assessment.

ii. Freshwater Fish Tabulated below in Table 9 are mancozeb's acute and chronic risk quotients for freshwater fish. The results show that acute RQs exceed endangered species LOCs for all mancozeb uses ( acute RQ ranges from 0.1 to 0.46). The chronic RQs exceed LOCs for freshwater fish for all mancozeb's modeled uses ( chronic RQ ranges from 1.00 to 3.33). EFED modeled on representative mancozeb uses. EFED has not developed PRZM/ EXAMS schemes for modeling all mancozeb uses. 107 Table 10: Mancozeb Acute and Chronic Risk Quotients for Freshwater Invertebrates Based On a water flea ( Daphnia magna)

EC50 of 580 ppb and a NOAEC of 7.3 ppb Application Rate ( lbs ai/ A)/

Number of Chronic RQ Acute RQ EEC 21 Day Applications/ Site/

( 21 Day EEC/ NOAEC) 3 ( Peak EEC/ EC50) 2 Average ( ppb) 1 EEC Peak ( ppb) 1 Interval Application Method/

0.96 0.13 7.00 73.4 4.8/ 4 Apples 7 day interval ground & aerial 1.32 0.12 9.60 68.2 1.2/ 15 Corn ( Sweet)

4 day interval ground & aerial 0.59 0.08 4.30 46.8 1.6/ 7 Potato 5 day interval ground & aerial 2.29 0.36 16.70 210.8 2.4/ 7 Tomato 7 day interval ground & aerial 1.05 0.18 7.7 103.4 1.6/ 3 Wheat 7 day interval ground & aerial 1 Based on PRZM version 3.12/ EXAMS version 2.97.5 modeling. 2 RQ greater or equal to 0.5 exceeds acute risk, acute restricted use and acute endangered species LOCs.

RQ greater or equal to 0.1 exceeds acute restricted use and acute endangered species LOCs.

RQ greater or equal to 0.05 exceeds acute endangered species LOCs.

3 RQ greater or equal to 1.00 exceeds chronic LOC. iii. Freshwater Invertebrates Tabulated below in Table 10 are mancozeb's acute and chronic risk quotients for freshwater invertebrates. The results show that acute RQs exceed endangered species LOCs for all mancozeb uses ( acute RQ ranges from 0.08 to 0.36). The chronic RQs exceed LOCs for freshwater invertebrates for mancozeb's use on sweet corn, tomatoes, and wheat ( chronic RQ ranges from 1.05 to 2.29). 108 Table 11: Mancozeb Acute Risk Quotients for Estuarine/ Marine Fish Based on a Sheepshead Minnow ( Cyprinodon variegatus) LC50 of 1,600 ppb. Application Rate ( lbs ai/ A)/

Number of Acute RQ Applications/ Site/

( Peak EEC/ LC50) 2 EEC Peak ( ppb) 1 Interval Application Method/

0.05 73.4 4.8/ 4 Apples 7 day interval ground & aerial 0.04 68.2 1.2/ 15 Corn ( Sweet)

4 day interval ground & aerial 0.03 46.8 1.6/ 7 Potato 5 day interval ground & aerial 0.13 210.8 2.4/ 7 Tomato 7 day interval ground & aerial 0.06 103.4 1.6/ 3 Wheat 7 day interval ground & aerial 1 Based on PRZM version 3.12/ EXAMS version 2.97.5 modeling. 2 RQ greater or equal to 0.5 exceeds acute risk, acute restricted use and acute endangered species LOCs.

RQ greater or equal to 0.1 exceeds acute restricted use and acute endangered species LOCs.

RQ greater or equal to 0.05 exceeds acute endangered species LOCs. iv. Estuarine/ Marine Fish Tabulated below in Table 11 are mancozeb's acute risk quotients for esturarine/ marine fish. The results show that acute RQs exceed endangered species LOCs for mancozeb uses on apples, tomatoes, and wheat ( acute RQ ranges from 0.05 to 0.13). 109 Table 12: Mancozeb Acute Risk Quotients for Estuarine/ Marine Invertebrates Based on a Mysid shrimp ( Americamysis bahia ) EC50 of 10.5 ppb Application Rate ( lbs ai/ A)/

Number of Acute RQ Applications/ Site/

( Peak EEC/ EC50) 2 EEC Peak ( ppb) 1 Interval Application Method/

6.99 73.4 4.8/ 4 Apples 7 day interval ground & aerial 6.50 68.2 1.2/ 15 Corn ( Sweet)

4 day interval ground & aerial 4.46 46.8 1.6/ 7 Potato 5 day interval ground & aerial 20.08 210.8 2.4/ 7 Tomato 7 day interval ground & aerial 9.85 103.4 1.6/ 3 Wheat 7 day interval ground & aerial 1 Based on PRZM version 3.12/ EXAMS version 2.97.5 modeling. 2 RQ greater or equal to 0.5 exceeds acute risk, acute restricted use and acute endangered species LOCs.

RQ greater or equal to 0.1 exceeds acute restricted use and acute endangered species LOCs.

RQ greater or equal to 0.05 exceeds acute endangered species LOCs. v. Estuarine/ Marine Invertebrates Tabulated below in Table 12 are mancozeb's acute risk quotients for esturarine/ marine invertebrates. The results show that acute RQs exceed LOCs for all mancozeb uses ( acute RQ ranges from 4.46 to 20.08). There are currently no estuarine/ marine invertebrates listed as endangered species. 110 Table 13: Acute Risk Quotients for Aquatic Non Vascular Plants Based Upon a Green Algae( Selenastrum capricornutum) EC50 of 47.0 ppb Application Rate ( lbs ai/ A)/

Number of Non Target Plant Applications/ Site/ RQ ( EEC/ EC50) 3 EEC Peak ( ppb) 1 Interval Application Method/

1.56 73.4 4.8/ 4 Apples 7 day interval ground & aerial 1.45 68.2 1.2/ 15 Corn ( Sweet)

4 day interval ground & aerial 1.00 46.8 1.6/ 7 Potato 5 day interval ground & aerial 4.49 210.8 2.4/ 7 Tomato 7 day interval ground & aerial 2.20 103.4 1.6/ 3 Wheat 7 day interval ground & aerial 1 Based on PRZM version 3.12/ EXAMS version 2.97.5 modeling.

2 RQ greater or equal to 1.0 exceeds acute risk LOCs. d. Exposure and Risk to Non target Plants: Aquatic Plants Exposure to non target aquatic plants may occur through runoff or spray drift from adjacent treated sites or directly from such uses as aquatic weed or mosquito larvae control. EFED assesses an aquatic vascular plant risk for acute risk from the surrogate duckweed Lemna gibba. EFED makes nonvascular aquatic plant acute risk assessments using either algae or a diatom, whichever is the most sensitive species. So far, there are no known nonvascular plant species on the endangered species list. Runoff and drift exposure is computed from PRZM/ EXAMS. EFED calculates the risk quotient by dividing the pesticide's initial or peak concentration in water by the plant EC 50 value.

Shown in Table 13 are the acute risk quotients for freshwater, nonvascular green alga ( Selenastrum capricornutum). Mancozeb's use patterns on all modeled uses exceed acute risk LOCs for nonvascular aquatic plants ( acute RQ ranges from 1.00 to 4.49). 111 e. Endangered Species Based on available screening level information, there is a potential concern for mancozeb's acute and chronic effects on listed Endangered and Threatened species of freshwater animals, acute effects on listed estuarine/ marine fish, and chronic effects on listed birds and mammals should exposure actually occur. EFED is uncertain about mancozeb's risk to endangered/ threatened non target terrestrial plants and needs testing performed at mancozeb's maximum rate of application in the environment. There are no nonvascular aquatic plant or estuarine/ marine invertebrate species on the endangered species list.

f. Ecological Incidents The Ecological Incident Information System ( EIIS) ( see Appendix V for background information) showed that mancozeb was reported in three fish kill incidents. One incident occurred in 1970, another in 1992 and the latest occurred in 1995. In the 1970 and 1992 incidents, mancozeb had been applied with an insecticide highly toxic to fish and, because of sample analysis, EFED classified mancozeb as unlikely to have been responsible for the these fish kills. The third incident in 1995 involved a mancozeb accidental spill into a stream that was the source water for a salmon hatchery which resulted in a fish kill at the salmon hatchery. Although no samples were analyzed ( fish or water), EFED classed mancozeb to be a probable contributory cause to the kill. A fourth incident involved mancozeb in a 1992 bird kill on an island near France. In this case, mancozeb had been applied with an insecticide ( methomyl) highly toxic to birds. The insecticide was confirmed through sampling and mancozeb was classified as a possible contributory reason for the bird kill. The acute toxicity data provided in this document for birds shows mancozeb is slightly to practically nontoxic to birds ( oral LD 50 ~ 1500 mg/ kg for the sparrow and > 6400 mg/ kg for the duck and quail). Methomyl is highly toxic to birds [ acute oral LD 50 = 15.9 mg/ kg ( US EPA. 1998)]. It is unlikely mancozeb contributed to this bird kill and more likely methomyl caused the kill. A fifth, and final incident, reported that mancozeb tanked mixed with benomyl and applied to apple trees may have caused leaves and blossoms to drop from the trees. According to the registrant, identical applications made by other growers in the area to apple orchards did not result in this damage and EFED classed mancozeb as a possible contributory cause of the damage. 112 Mancozeb Incidents from EIIS Incident Number Pesticide( s) Involved Date ( month/ year) Adverse Effect Magnitude of Damage B0000 501 42 mancozeb & benomyl unknown Plant damage not reported B0000 233 mancozeb, sulfur, & thiodan 7/ 1970 Fish kill thousands I006382 002 mancozeb & methomyl 9/ 1972 Bird kill  35 birds killed  31 intoxicated  involved green finches, gold finches, and linnets I000799 008 mancozeb, maneb, fenarimol, & endosulfan 4/ 1992 Fish kill > 600 fish I008745 004 mancozeb 7/ 1995 Fish kill 30,000 to 35,000 fish 113 APPENDIX V: US EPA Ecological Incident Information System The Office of Pesticide Programs ( OPP) has tracked incidents reports, given to EPA since about 1994, by assigning identification number in an Incident Data System ( IDS) and microfiching the reports. The Environmental Fate and Effects Division ( EFED) then enters the ecological related incident reports into a second database, the Ecological Incident Information System ( EIIS). This second database has some 85 fields for potential data entry. EFED has also made an effort to enter information into EIIS on incident reports received before establishment of current databases. Although EFED has added many of these reports, EIIS does not yet provide a listing of all incident reports received by EPA. OPP does not receive incident reports in a consistent format. For example, states and various labs usually have their own report formats. The incidents reports may involve multiple incidents involving multiple chemicals in one report, and may report on only part of an incident investigation ( for example, residues). EFED has made some progress in recent years, both in getting incident reports sent and entered. However, there has never been enough staff time and effort assigned to recording incidents. For example, the staff time and effort assigned to tracking and reviewing laboratory toxicity studies are greater than those assigned to tracking incidents.

EFED classifies EIIS entered incidents into one of several certainty levels: highly probable, probable, possible, unlikely, or unrelated. In brief, " highly probable" incidents usually need carcass residues, show large cholinesterase inhibition ( for chemicals such as organophosphates that depress brain and blood cholinesterase), or clear circumstances about the exposure. " Probable" incidents include those where residues were not available or circumstances were less clear than for " highly probable." " Possible" incidents include those where multiple chemicals may have been involved and it is not clear what the contribution was of a given chemical. OPP uses the " unlikely" category, for example, where a given chemical is almost nontoxic to the category of organism killed or the chemical was tested for but not detected in samples. " Unrelated" incidents are those that OPP confirms was not pesticiderelated

EFED also classes EIIS entered incidents as use or misuse. Unless specifically confirmed by a state or federal agency to be misuse, or there was clear misuse such as intentional baiting to kill wildlife, EFED would not typically consider incidents to be misuse. For example, data entry personnel often do not have a copy of the specific label used in a given application, and would not usually be able to detect various label specific violations.

EFED believes the number pesticide related incidents reported in EIIS, while large, are a small fraction of pesticide incidents. EIIS entered incidents requires that mortality incidents be seen, reported, examined, and have investigation reports sent to EPA. Incidents often are not seen, because of scavenger removal of carcasses, decay in a field, or simply because carcasses may be hard to see on many sites. Poisoned wildlife may also move off site to less visible areas before dying. Incidents often are not seen because few people are systematically looking. Finders, seeing incidents, may not report incidents to suitable authorities to examine the incident. The finder may not know that it is important to report incidents or may not know who to contact. He or she may not feel they have the time or wish to make a telephone call, may hesitate to call because of their own involvement in the kill, or the call may be long distance which may discourage the caller. Incidents reported may not get examined if time or people are limited or may not get examined thoroughly, with residue and cholinesterase analyzes, for example. Also, if kills are not reported and examined at once, there will be little chance of documenting the cause, since tissues and residues may decay quickly. States often do not send reports of examined incidents to EPA, since reporting by states is voluntary and some investigators may believe that they don't have the time or people to send incident reports to EPA. ( Felkel. 2000) 114 APPENDIX VI: EBDC Aquatic Studies EBDC Aquatic Studies Used for Calculating Risk Quotients With Associated Study Parameters  3/ 13/ 2003 MRID No. Chemical Species Tested Water type Water Analysis ( cations, anions,

EC) Test Type1 Nominal Test Concentrations Range ( ppm) Measured ( unfiltered)

Test Concentrations Range ( ppm) Measured ( filtered)

Test Concentrations Range ( ppm) and Filter Size ( µ m) Test Aquaria Size ( L) Chemical Analyses ( Parent or Other?) Toxicity Endpoint ( ppm) Exposure Time ( hours) Study Categorization 43525001 metiram Rainbow trout freshwater mixture of tap water, unchlorinated water, deionized water ( chemical analysis  not reported) F 0.01  1.0 ND2  0.527 ND2  0.233 filter size =

0.05 60 GC3 for CS 2 LC 50 =

0.2294 96 core 44301101 metiram water flea freshwater deionized water,

EDTA free, and HCL fortified samples for analysis S 0.1  1.0 0.051  0.511 Not applicable 0.25 GC3 for CS 2 EC 50 >

0.3586 ( highest concentr a tion tested) 48 supplemental 43199601 metiram green algae freshwater Na 2 EDTA S 0.001

1.0 Not applicable Not applicable 0.1 Not applicable EC 50 =

0.0775 72 supplemental 40706001 maneb Rainbow trout freshwater softwater and well water ( chemical analysis  not reported) S 0.08  1.0 0.009  0.225 Not applicable 30 GC3 for CS 2 LC 50 = 0.04166 96 supplemental 41346301 maneb fathead minnow freshwater EDTA F 0.0013

0.020 0.00096

0.012 Not applicable 11.5 GC3 for CS 2 NOAEC = 0.00616 35 days core EBDC Aquatic Studies Used for Calculating Risk Quotients With Associated Study Parameters  3/ 13/ 2003 MRID No. Chemical Species Tested Water type Water Analysis ( cations, anions,

EC) Test Type1 Nominal Test Concentrations Range ( ppm) Measured ( unfiltered)

Test Concentrations Range ( ppm) Measured ( filtered)

Test Concentrations Range ( ppm) and Filter Size ( µ m) Test Aquaria Size ( L) Chemical Analyses ( Parent or Other?) Toxicity Endpoint ( ppm) Exposure Time ( hours) Study Categorization 115 40749402 maneb water flea freshwater softwater and well water S 0.08  1.0 ND2  0.39 Not applicable 0.1 GC3 for CS 2 LC 50 =

0.126 48 core 40943101 maneb Atlantic silverside Estuari ne/ mar ine filtered ( 0.5 µ m)

seawater ( salinity ~ 20%)

& EDTA F 0.12  1.5 ND2  1.10 Not applicable 9 GC3 for CS 2 LC 50 =

0.186 96 core 41000002 maneb mysid shrimp Estuari ne/ mar ine filtered ( 0.5 µ m)

seawater ( salinity ~ 20%)

& EDTA F 0.005

0.060 ND2  0.0064 Not applicable 6.4 GC3 for CS 2 LC 50 =

0.0036 96 supplemental 40943501 maneb green algae freshwater Na 2 EDTA S 0.0026

0.040 0.0004

0.0067 Not applicable 0.25 GC3 for CS 2 EC 50 = 0.01348 120 core 40118502 mancozeb Rainbow trout freshwater Not reported S 0.22  4.5 Not applicable Not applicable Not reported Not applicable LC 50 =

0.465 96 core9 43230701 mancozeb fathead minnow freshwater EDTA added F 0.0003

0.02 0.000236

0.01910 ND2  0.007973 Not applicable ~ 12.2 GC3 for CS 2 &

LSC10 for 14C NOAEC = 0.002196 for GC &

0.00237 for LSC 28 days core 40118503 mancozeb water flea freshwater Not reported S 0.026

2.0 Not applicable Not applicable Not reported Not applicable EC 50 =

0.585 48 core9 EBDC Aquatic Studies Used for Calculating Risk Quotients With Associated Study Parameters  3/ 13/ 2003 MRID No. Chemical Species Tested Water type Water Analysis ( cations, anions,

EC) Test Type1 Nominal Test Concentrations Range ( ppm) Measured ( unfiltered)

Test Concentrations Range ( ppm) Measured ( filtered)

Test Concentrations Range ( ppm) and Filter Size ( µ m) Test Aquaria Size ( L) Chemical Analyses ( Parent or Other?) Toxicity Endpoint ( ppm) Exposure Time ( hours) Study Categorization 116 mancozeb water flea freshwater EDTA added F 0.003

0.05 0.0029

0.053 Not applicable 1.0 GC3 for CS 2 &

LSC10 for 14C NOAEC = 0.00736 for LSC 21 days core 41844901 mancozeb sheepshead minnow Estuari ne/ mar ine filtered seawater with well water ( salinity ~ 20%)

Na 3 EDTA added F 0.6  7.7 0.28  3.7 Not applicable 9 GC3 for CS 2 LC 50 =

1.66 96 supplemental 41822901 mancozeb mysid shrimp Estuari ne/ mar ine filtered seawater with well water ( salinity ~ 20%)

Na 3 EDTA added F 0.003

0.04 0.0034

0.017 Not applicable 6 GC3 for CS 2 LC 50 = 0.01056 96 supplemental 43664701 mancozeb green algae freshwater Na 2 EDTA S 0.033

0.50 0.022  0.376 Not applicable 0.1 GC3 for CS 2 EC 50 =

0.047 120 core 1. For aquatic organisms ( fish, zooplankton, and phytoplankton), tests are carried out using either static ( S) or flow through ( F) methods. In the static method, the pesticide and test organisms are added to the test solution and kept there for the remainder of the study time. In the flow through method, a freshly prepared, pesticide spiked test solution flows through the test chamber continuously for the duration of the test. The flow through method provides a higher continuous dose of the pesticide; however, the static method does not remove waste products and may accumulate toxic pesticide breakdown products and metabolites. Neither method exactly mimics a natural system. ( http:// docs. pesticideinfo. org/ documentation4/ ref_ ecotoxicity4. html ) Flow through system allows the testing of volatile and instable chemicals, problematic in static test systems.

2. None detected 3. Gas chromatography EBDC Aquatic Studies Used for Calculating Risk Quotients With Associated Study Parameters  3/ 13/ 2003 MRID No. Chemical Species Tested Water type Water Analysis ( cations, anions,

EC) Test Type1 Nominal Test Concentrations Range ( ppm) Measured ( unfiltered)

Test Concentrations Range ( ppm) Measured ( filtered)

Test Concentrations Range ( ppm) and Filter Size ( µ m) Test Aquaria Size ( L) Chemical Analyses ( Parent or Other?) Toxicity Endpoint ( ppm) Exposure Time ( hours) Study Categorization 117 4. Based on filtered and measured concentration.

5. Based on nominal concentration.

6. Based on measured ( unfiltered) concentration.

7. Measured estimate is based on 15% of nominal test concentrations remaining at end of test. No actual values were provided in DER and the limits of detection at lower values is questionable. Measured EC 50 was based on actual mean green algae cell counts at end of study. Aquatic plant studies base the test concentrations on the 0 hour concentrations because the plants will take up test material during the study period and loss of test material is not necessarily due to instability of test material.

8. Based on actual cell counts, not on measured concentration levels.

9. Categorization based on acceptance in 1987 Mancozeb Standard 10. LSC detection. The process by which radioactive decay energy is converted to visible light and measured in an organic liquid environment is called LIQUID SCINTILLATION COUNTING ( LSC). In Liquid Scintillation Counting, the amount of light produced is proportional to the amount of radiation present in the sample and the energy of the light produced is proportional to the energy of the radiation that is present in he sample. This makes LSC a very convenient tool to measure radioactivity. http:// www. sfu. ca/~ rsafety/ APPEND9. pdf 118 REFERENCES Atkins, E. L. et al. Reducing Pesticide Hazards to Honey Bees. ( 1981). Univ. of California. Division of Agricultural Science . Leaflet 2883. ° URL: http:// bees. ucr. edu/ tox. html Beyer, W. N.. and E. E. Connor, " Estimates of Soil Ingestion by Wildlife," U. S. Fish and Wildlife Service, Patuxent Wildlife Research Center at Laurel, MD and S. Gerould, U. S. Geological Survey, Reston, VA.

Biswas, S. K. and K. Banerjee, S. K. Handa. 2003. Metabolic fate of mancozeb in tomato ( Lycopersicon esculentum). Toxicol. And Environ. Chem. 85( 1 3): 33 38.

Brooks, H. L. et al. 1973. Insecticides. Cooperative Extension Service. Kansas State Univ. Manhattan, Kansas.

Burns, L. A. 1997. EXAMS 2.97.5 Users Manual. National Exposure Research Lab, Office of Research and Development, U. S. Environmental Protection Agency. Athens, Georgia. ° URL: http:// www. epa. gov/ oppefed1/ models/ water/ index. htm Carsel, R. F., Imhoff, J. C., Hummel, P. R., Cheplick, J. M. and Donigan, A. S. 1997. PRZM 3.1 Users Manual. National Exposure Research Lab, Office of Research and Development, U. S. Environmental Protection Agency. Athens, Georgia. ° URL: http:// www. epa. gov/ oppefed1/ models/ water/ index. htm Dole, Tim and Jeff Dawson. Issued: 5/ 15/ 2003. Mancozeb: Occupational and Residential Exposure Assessment and Recommendations for the Reregistration Eligibility Decision Document. PC Code 014504; DP Barcode: D286871.

Dole, Tim and Jeff Dawson. Issued: 12/ 05/ 2003a. Metiram: Occupational and Residential Exposure Assessment and Recommendations for the Reregistration Eligibility Decision Document. PC Code 014601; DP Barcode: D287664.

Ecological Planning and Toxicology, Inc. 1996. Toxicity Extrapolations in Terrestrial Systems submitted to the Office of Environmental Health, Hazard Assessment, Reproductive and Cancer Hazard Assessment Section, of the California EPA. Ecological Planning and Toxicology, Inc. Corvallis, Oregon. p. 4 EEB Guidance Document E 02C. June, 1995. How to Estimate Acute Exposure to Birds and Small Mammals from Granular Pesticides and Toxic Food Baits.

Felkel, J. 2000. Reregistration Eligibility Document ( RED) for Diazinon. US EPA, OPP, EFED Fite, E. Feb. 1995. Mammalian Risk Assessments. US EPA, OPP, EFED.

Fletcher, J. S., J. E. Nellessen, and T. G. Pfleeger. 1994. Literature review and evaluation of the EPA food chain ( Kenaga) nomogram, an instrument for estimating pesticide residues on plants. Environ. Toxicol. Chem. 13: 1383 1391.

Gusey, W. F. and Z. D. Maturgo. April, 1973. Wildlife Utilization of Croplands. Environmental Affairs. Shell Oil Co. Houston, TX.

Hoerger, F. and E. E. Kenaga. 1972. Pesticide residues on plants: Correlation of representative data as a basis for estimation of their magnitude in the environment. In F. Coulston and F. Korte ( eds), 119 Environmental Quality and Safety: Chemistry, Toxicology and Technology. Georg Thieme Publishers, Stuttgart, pp. 9 28.

Keehner, D. Jul. 1999. Memorandum dated 7 1 99 to Environmental Fate and Effects Division/ OPP/ EPA concerning the interim policy on data requirements for non target plant testing.

Keehner, D. Jul. 1999a. Memorandum dated 7 30 99 to Environmental Fate and Effects Division/ OPP/ EPA concerning the policy for ecological risk and drinking water assessments of seed treatment pesticides.

Libelo, L. Feb. 1999. ELL Fate: A spreadsheet based model that calculates the decay of a chemical applied to foliar surfaces for single or multiple applications. Environmental Fate and Effects Division, Office of Pesticides Programs, U. S. Environmental Protection Agency.

Libelo, L. Jul. 2001. ELL Fate Version 1.2: A spreadsheet based model that calculates the decay of a chemical applied to foliar surfaces for single or multiple applications. Environmental Fate and Effects Division, Office of Pesticides Programs, U. S. Environmental Protection Agency.

NatureServe: An online encyclopedia of life [ web application]. 2000. Version 1.2 . Arlington, Virginia, USA: Association for Biodiversity Information. Available: http:// www. natureserve. org/. ( Accessed: March 28, 3901 ). ° URL: http:// www. natureserve. org/ summary Ollinger, J. Mar. 7, 2005. Literature supporting revised mancozeb and ETU half lives. Mancozeb Task Force  Cerexagri, Inc; Dow AgroSciences, LLC; and Griffin LLC ( a DuPont Company). Washington, DC Parker, R. D. 2001. GENEEC Users Manual: Tier One Screening Model for Pesticide Aquatic Ecological Exposure Assessment Version 2.0. Environmental Fate and Effects Division, Office of Pesticides Programs, U. S. Environmental Protection Agency. ° URL: http:// www. epa. gov/ oppefed1/ models/ water/ index. htm SETAC. Jul. 1991. Guidance Document on Testing Procedures for Pesticides in Freshwater Mesocosms. Society of Environmental Toxicology and Chemistry  Europe. Monks Wood Experimental Station. Abbots Ripton, Huntington, UK.

Touart, L. W. Mar. 1988. Aquatic Mesocosm Tests to Support Pesticide Registrations EPA 540/ 09 88 035. Hazard Evaluation Division Technical Guidance Document. US EPA. Washington, DC.

Urban D. J. and N. J. Cook. 1986. Hazard Evaluation Division Standard Evaluation Procedure Ecological Risk Assessment. EPA 540/ 9 85 001. U. S. Environmental Protection Agency, Office of Pesticide Programs, Washington, DC.

Urban, Douglas J. Apr. 28, 2000. Guidance for Conducting Avian Risk Assessments for Spray Applications of Pesticides. Environmental Fate & Effects Division. Office of Pesticide Programs. U. S. Environmental Protection Agency. Washington, D. C.

U. S. EPA 40 Code of Federal Regulations ( CFR). Part 156, Subpart A, Section 156.10.( h)( 1) Labeling Requirements. ° URL: http:// www. epa. gov/ oppfead1/ labeling/ lrm/ chap 08. htm US EPA. June 30, 1995. EEB Guidance Document Number A 02. What Are Our Levels of Concern and How Are They Used. Office of Pesticide Programs. Environmental Fate & Effects Division. Washington, D. C. 120 US EPA. Oct. 6, 1997. Announcement of the Draft Drinking Water Contaminant List. FR Vol. 62, No. 193. pp 52193 52219 ° URL: http:// www. epa. gov/ ogwdw000/ ccl/ dwccl. html US EPA. April, 1998. Guidelines for Ecological Risk Assessment. Risk Assessment Forum. Washington, DC. EPA/ 630/ R 95/ 002F US EPA. 1998. Reregistration Eligibility Decision ( RED) on Methomyl. Environmental Fate and Effects ( EFED) Risk Assessment. p. 65. ° URL: http:// www. epa. gov/ pesticides/ reregistration/ status2. htm# M US EPA. 2001. Reregistration Eligibility Decision ( RED) on Benomyl. Benomyl RED Facts. ° URL: http:// www. epa. gov/ oppsrrd1/ REDs/ factsheets/ benomyl_ fs. htm US EPA December, 2002. TXR# 0050408. Ethylene bisdithiocarbamates ( EBDCs): Mancozeb, Maneb, and Metiram. Outcome of the HED Metabolism Assessment Review Committee ( MARC) Meeting. Office of Pesticide Programs. Health Effects Division. Washington, D. C.

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[Federal Register Volume 78, Number 152 (Wednesday, August 7, 2013)]
[Notices]
[Pages 48172-48173]
[FR Doc No: 2013-19018]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1092]

Minimizing Risk for Children's Toy Laser Products; Draft Guidance
for Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Minimizing Risk for
Children's Toy Laser Products.'' This draft guidance is to inform
manufacturers of laser products, FDA headquarters and field personnel,
and the public of the Center for Devices and Radiological Health's
(CDRH) proposed approach on the safety of toy laser products. This
draft guidance is not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 5, 2013.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Minimizing Risk for Children's Toy Laser
Products'' to the Division of Small Manufacturers, International and
Consumer Assistance, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request, or fax your request to
301-847-8149. See the SUPPLEMENTARY INFORMATION section for information
on electronic access to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Robert J. Doyle, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4672, Silver Spring, MD 20993-0002, 301-
796-5863.

I. Background

    This draft guidance is to inform manufacturers of laser products,
FDA headquarters and field personnel, and the public of CDRH's proposed
approach on the safety of children's toy laser products. Lasers with
outputs above certain levels that are operated in

an unsafe and uncontrolled manner may cause injury to the user and/or
others within range of the laser beam. This is a particular concern for
lasers intended for entertainment purposes, especially when intended to
be used as toys by children. Although Federal law requires all laser
products sold in the United States to be in compliance with the Federal
Performance Standards for Laser Products (21 CFR 1040.10 and 1040.11),
at present FDA regulations do not specifically address children's toy
laser products. FDA recently issued a proposed rule (78 FR 37723) that
proposes to define children's toy laser products and require them to be
within International Electrotechnical Commission (IEC) Class 1 emission
limits. While this rulemaking process is ongoing, CDRH encourages
manufacturers to keep children's toy laser products within IEC Class 1
emission limits in order to minimize the risk they pose to this
vulnerable population.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance
represents the Agency's proposed approach on children's toys that are
or that contain laser products. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. To receive ``Minimizing Risk for Children's
Toy Laser Products,'' you may either send an email request to
<EMAIL_ADDRESS>to receive an electronic copy of the document or
send a fax request to<PHONE_NUMBER> to receive a hard copy. Please use
the document number 1810 to identify the guidance you are requesting. A
search capability for all CDRH guidance documents is available at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at
http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to a currently approved collection of
information found in FDA regulations. This collection of information is
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information in 21 CFR part 1040 is approved under OMB
control number 0910-0025.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments
regarding this document to the Division of Dockets Management (see
ADDRESSES). It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday, and will
be posted to the docket at http://www.regulations.gov.

    Dated: August 1, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19018 Filed 8-6-13; 8:45 am]
BILLING CODE 4160-01-P