Overview of Amphibian Workshop International Workshop on the Use of Anuran Models for Endocrine Disruption and Reproductive Toxicology June 2003, Duluth, MN Leslie Touart International Workshop on the Use of Anuran Models for Endocrine Disruption and Reproductive Toxicology ° Experts from 11 countries participated ° Day 1  presentations   general endocrinology   reproductive biology   test methods for screening and testing ° Day 2   breakout group discussions   screening assays and testing methods for thyroid axis disruption   diagnostic indicators of amphibian endocrine disruption   reproductive endocrinology and testing ° Workshop proceedings to be submitted for publication Fall 2003 Workshop Summary ° Discussion that screening assay is intended as general vertebrate model for effects to thyroid hormone axis ° Choice of test species? X. laevis immediately practical, X. tropicalis desirable when more information available ° Many endpoints and important MOAs to consider were discussed ° Mechanistic/ diagnostic endpoints desirable, but should be balanced with integrative ( apical)

measures that are simple, unambiguous Workshop Summary ( cont.)

° Proposal to start with NF 51 to continue up to NF60, duration minimum 14 days ° Important considerations and issues were listed ( i. e., food/ feeding, water quality, mixed MOAs,

etc.)

° Flow through design preferred, but semi static ok ° Some chemicals identified for key MOAs Workshop Summary ( cont.)

° Tier 2 not focused on general vertebrate screening but for assessing ecological risk in amphibians ° Emphasis for Tier 2 on Xenopus sp., extrapolation critical ° Apical endpoints   fecundity, fertility,

hatchability, sexual development &

differentiation, and viable offspring ° Full life cycle or multi generation desirable, but partial life cycle more practical OECD Amphibian Expert Group The main objectives of the meeting were to:

° discuss and agree on the preferred approach for a frog metamorphosis assay for the detection of thyroid disruptors ° discuss and agree on the main parameters of a protocol ° agree on a timeframe and action plan for further work in the coming months. Thyroid related modes of action and possible endpoints.

+ 1 + 1 + 1 + 1 ? 1 +

? 1 ? 1 ? ?

+ 1 + 1 +

Mol. Biology:

° TR  mRNA ° TSH  mRNA ° CRF ° UDPGT ++ 2 +?

+ 2 + 2 Biochemistry :

° T3/ T4 ° Enzymes ( D2/ D3) + 1 ++ 1 + 2 +? 1 ? 1 ? 2 ++ 1 + 2 Histology:

  Thyroid   Pituitary + 1 + 1 +? 1 ? 1 ? 2 + 1 + 2 Morphology:

° Dev. Stage ° Hind limb TR  agonism  antagonism Neuroendocrine HP axis Elimination  deiodination  conjugation ( UDPGT)

Transport  TTR displacement Synthesis  I uptake  TPO inhibition MOA Possible endpoints + endpoints able to measure effects on the associated thyroid related mode of action;

1 core endpoints of the frog metamorphosis assay proposed by the Amphibian Expert Group;

2 optional endpoints of the frog metamorphosis assay proposed by the Amphibian Expert Group. Thyroid pathways and relevant chemicals.

IOP Transformation Corticosteriod ( research need)

Neuroendocrine NH3, T4, T3, brominated flame retardants ( e. g. tetrachlorobisphenol)

Thyroid Receptor Research need   not known Elimination Research need   not known Transport PTU, Methimazole, Perchlorate Synthesis Chemicals which have an action Mode of action Chemicals and countries which conducted the Amphibian metamorphosis assay.

TBBA

  trenbolone

Estradiol +

Perchlorate +

Methimazole +

+

IOP +

T3 +

+

+

T4

+

Amitrole

Zineb +

+

ETU +

+

+

PTU

United States Japan Germany Chemicals Shaded cell: country used the chemical;

+ chemical came up positive;

 chemical showed no thyroid related effect;

chemicals preferred for the optimization phase Need to establish the expression profiles of the biomarkers throughout metamorphosis Optional Core spinoff Core spinoff Semi quantve PCR Semi quantve PCR Semi quantve PCR Molecular biology:

° TR  mRNA ° TR  mRNA ° TSH  sub unit mRNA

No assay/ method available ° Deiodinase activity ( D2/ D3) ° Develop a protocol for extraction from whole body homogenates or specific tissues,

° Develop a standardized RIA protocol for T3/ T4 Optional RIA using whole body/ brain Biochemistry:

° T3/ T4 Optional Pituitary histology ° Define whether quantitative evaluation is possible / needed;

° Define histological endpoints to be looked at ( eg. epithelial cell height)

Core Core/ Opti onal Qualitative Quantitative Thyroid histology Core Optional NF scale Analo/ digital calipers/ videoframe grab and image analysis software Developmental morphology:

° Staging ( includes hind limb development)

° hindlimb length Research needs Priority level Measurement technique Endpoints Additional Work   Protocol optimization underway   complete Dec 2003   Compare protocols beginning NF 51 continue for 21 days and beginning NF 54 continue for 14 days   US, Germany, Japan participating   Draft protocol for validation work Jan 2004   Interlaboratory validation exercise Summer 2004


[Federal Register Volume 80, Number 64 (Friday, April 3, 2015)]
[Proposed Rules]
[Page 18179]
[FR Doc No: 2015-07489]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2015-0159; FRL-9925-59-Region 7]

Approval and Promulgation of Implementation Plans; State of Iowa;
2015 Iowa State Implementation Plan; Permit Modifications; Muscatine,
Iowa

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the State Implementation Plan (SIP) for the State
of Iowa to include modified permits for Muscatine County, Iowa. The SIP
revision addresses modifications to construction permits that were
included in the 2006 24-hour particulate matter less than 2.5
micrometers (PM2.5) National Ambient Air Quality Standards
(NAAQS) control strategy proposed on August 11, 2014, and published as
a final rule in the Federal Register on December 1, 2014, with the
effective date of December 31, 2014. The state's submission of modified
permits includes a revised air dispersion modeling analysis that
demonstrated continued attainment of the 2006 24-hour PM2.5
NAAQS. This action will also make an administrative correction to
permit numbers.

DATES: Comments on this proposed action must be received in writing by
May 4, 2015.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2015-0159 by mail to: Heather Hamilton, Environmental Protection
Agency, Air Planning and Development Branch, 11201 Renner Road, Lenexa,
Kansas 66219. Comments may also be submitted electronically or through
hand delivery/courier by following the detailed instructions in the
ADDRESSES section of the direct final rule located in the rules section
of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Heather Hamilton<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the final rules section of the Federal
Register, EPA is approving the state's revision to the SIP as a direct
final rule without prior proposal because the Agency views this as a
noncontroversial revision amendment and anticipates no relevant adverse
comments to this action. The detailed rationale for the approval is set
forth in the technical support document that can be found in Docket ID
No. EPA-R07-OAR-2015-0159. If no relevant adverse comments are received
in response to this action, no further activity is contemplated in
relation to this action. If EPA receives relevant adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rules based on this proposed
action. EPA will not institute a second comment period on this action.
Any parties interested in commenting on this action should do so at
this time. Please note that if EPA receives adverse comments on part of
this rule and if that part can be severed from the remainder of the
rule, EPA may adopt as final those parts of the rule that are not the
subject of an adverse comment. For additional information, see the
direct final rule which is located in the rules section of this Federal
Register.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Particulate
matter, Reporting and recordkeeping requirements.

    Dated: March 20, 2015.
Mark Hague,
Acting Regional Administrator, Region 7.
[FR Doc. 2015-07489 Filed 4-2-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: February 22, 2006 (Volume 71, Number 35)]
[Notices]
[Page 9114-9115]
[DOCID:fr22fe06-85]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2005-0505; FRL-7762-9]

Tridemorph; Tolerance Reassessment Decision for Low Risk
Pesticide; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the availability of EPA's Tolerance
Reassessment Decision (TRED) for tridemorph, and opens a public comment
period on this document, related risk assessments, and other support
documents. EPA has reviewed the low risk pesticide tridemorph through a
modified, streamlined version of the public participation process that
the Agency uses to involve the public in developing pesticide tolerance
reassessment and reregistration decisions. Through the tolerance
reassessment program, EPA is ensuring that all pesticides meet current
health and food safety standards.

DATES: Comments must be received on or before March 24, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0505, by one of the following methods:
     http://www.regulations.gov/. Follow the on-line

instructions for submitting comments.
     Mail: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    Hand Delivery: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, Rm. 119, Crystal Mall 2, 1801 S. Bell St.,
Arlington, VA.
    Attention: Docket ID number EPA-HQ-OPP-2005-0505. The docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the docket facility
is<PHONE_NUMBER>. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2005-0505. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at http://www.regulations.gov/, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be captured automatically and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/docket.htm/.

    Docket: All documents in the docket are listed in the
regulation.gov index. Although listed in the index, some information is
not publicly available, i.e., CBI or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available either electronically at
http://www.regulations.gov/ or in hard copy at the Public Information

and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1801 S. Bell St., Arlington, VA. The docket facility is
open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the docket facility is (703) 305-
5805.

FOR FURTHER INFORMATION CONTACT: Molly Clayton, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of the

information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.

    2. Tips for Preparing your Comments. When submitting comments,
remember to:
    i. Identify the document by docket number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What Action is the Agency Taking?

    EPA has reassessed the uses of tridemorph, reassessed one existing
tolerance or legal residue limit, and on January 11, 2006, reached a
tolerance reassessment decision for this low risk pesticide. Tridemorph
is a systemic fungicide used to control yellow and black sigatoka on
imported bananas and plantain. There are no U.S. registrations for
tridemorph. The Agency is now issuing for comment the resulting Report
on Food Quality Protection Act (FQPA) Tolerance Reassessment Progress
and Risk Management Decision for tridemorph, known as a TRED, as well
as related risk assessments and technical support documents.
    EPA developed the tridemorph TRED through a modified, streamlined
version of its public process for making tolerance reassessment and
reregistration eligibility decisions. Through these programs, the
Agency is ensuring that pesticides meet current standards under the
Federal Food, Drug, and Cosmetic Act (FFDCA) and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended by
FQPA. EPA must review tolerances and tolerance exemptions that were in
effect when the FQPA was enacted, to ensure that these existing
pesticide residue limits for food and feed commodities meet the safety
standard established by the new law. Tolerances are considered
reassessed once the safety finding has been made or a revocation
occurs. EPA has reviewed and made the requisite safety finding for the
tridemorph tolerances included in this notice.
    EPA is applying the principles of public participation to all
pesticides undergoing reregistration and tolerance reassessment. The
Agency's Pesticide Tolerance Reassessment and Reregistration; Public
Participation Process, published in the Federal Register of May 14,
2004 (69 FR 26819) (FRL-7357-9) explains that in conducting these
programs, the Agency is tailoring its public participation process to
be commensurate with the level of risk, extent of use, complexity of
issues, and degree of public concern associated with each pesticide.
EPA can expeditiously reach decisions for pesticides like tridemorph,
which pose no risk concerns and require no risk mitigation. Once EPA
assesses uses and risks for such low risk pesticides, the Agency may go
directly to a decision and prepare a document summarizing its findings,
such as the tridemorph TRED.
    The tolerance reassessment program is being conducted under
Congressionally mandated time frames, and EPA recognizes the need both
to make timely decisions and to involve the public in finding ways to
effectively mitigate pesticide risks. Tridemorph, however, poses no
risks that require mitigation. The Agency therefore is issuing the
tridemorph TRED, its risk assessments, and related support documents
simultaneously for public comment. The comment period is intended to
provide an opportunity for public input and a mechanism for initiating
any necessary amendments to the TRED. All comments should be submitted
using the methods in Unit I of the SUPPLEMENTARY INFORMATION, and must
be received by EPA on or before the closing date. These comments will
become part of the Agency Docket for tridemorph. Comments received
after the close of the comment period will be marked ``late.'' EPA is
not required to consider these late comments.
    EPA will carefully consider all comments received by the closing
date and will provide a Response to Comments Memorandum in the Docket
and electronic EDOCKET. If any comment significantly affects the
document, EPA also will publish an amendment to the TRED in the Federal
Register. In the absence of substantive comments requiring changes, the
decisions reflected in the TRED will be implemented as presented.

B. What is the Agency's Authority for Taking this Action?

    Section 408(q) of the FFDCA, 21 U.S.C. 346a(q), requires EPA to
review tolerances and exemptions for pesticide residues in effect as of
August 2, 1996, to determine whether the tolerance or exemption meets
the requirements of section 408(b)(2) or (c)(2) of FFDCA. This review
is to be completed by August 3, 2006.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: February 13, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-2509 Filed 2-21-06; 8:45 am]

BILLING CODE 6560-50-S