[Federal Register: March 12, 2009 (Volume 74, Number 47)]
[Notices]
[Page 10733-10734]
[DOCID:fr12mr09-52]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP09-194-000]

Tennessee Gas Pipeline Company; Notice of Technical Conference

March 4, 2009.
    Take notice that the Commission will convene a technical conference
in the above-referenced proceeding on

Tuesday, March 31, 2009, at 10 a.m. (EDT), in a room to be designated
at the offices of the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    The Commission determined to hold a technical conference to explore
a proposal by Tennessee Gas Pipeline Company (Tennessee) to enhance the
flexibility of shippers that using its supply area and/or market area
pooling points and issues raised by that proposal including, but not
limited to, the possible degradation of existing service, and the
possible effects on scheduling and nomination priorities, primary firm
rights, and the allocation of mainline versus receipt point capacity
among proposed and existing points.
    FERC conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an e-mail to<EMAIL_ADDRESS>or call toll free (866) 208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a fax to<PHONE_NUMBER>
with the required accommodations.
    All interested persons are permitted to attend. For further
information please contact Robert McLean at<PHONE_NUMBER> or e-mail
Robert<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
 [FR Doc. E9-5246 Filed 3-11-09; 8:45 am]

BILLING CODE 6717-01-P


                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460

	OFFICE OF CHEMICAL SAFETY
	AND POLLUTION PREVENTION

MEMORANDUM

Date:		14-April-2011

Subject:	Common Triazole Metabolites.  Updated Aggregate Human-Health Risk Assessment to Address Tolerance Petitions for Tetraconazole.

PC Code:  120603 (Tetraconazole), 600074 (1,2,4-Triazole), 600011 (Triazolylalanine), 600082 (Triazolylacetic Acid), 625618 (Triazolylpyruvic Acid)
DP Barcode:  D388544
Decision No.:  435873
Registration Nos.:  80289-7 and 80289-8
Petition Nos.:  0E7735 (13-07F and 03-07G) and 0F7737 (field corn and popcorn)
Regulatory Action:  Section 3
Risk Assessment Type:  Aggregate
Case No.:  7043 (Tetraconazole)
TXR No.:  not applicable
CAS No.:  Tetraconazole - 112281-77-3; T - 288-88-0; TA - 86362-20-1; and TAA - 28711-29-7
MRID Nos.:  none
40 CFR:  none

From:		Tom Bloem, Chemist
         Risk Assessment Branch 1, Health Effects Division (RAB1/HED); 7509P

Through:	Dana Vogel, Branch Chief
			George F. Kramer, Ph.D., Senior Chemist
         RAB1/HED (7509P)

To:			Mary Waller/Lisa Jones (RM 21)
			Barbara Madden (RM 05)
         Registration Division (7505P)

I.	Conclusions

Based on conservative, health-protective assumptions, aggregate risk estimates associated with 1,2,4-triazole (T) and the conjugated triazole metabolites are below HED's level of concern.  There are no human-heath risk issues for these metabolites that would preclude the requested uses of tetraconazole to field corn, popcorn, small fruit vine climbing (except fuzzy kiwifruit) subgroup 13-07F, and low-growing berry subgroup 13-07G (except cranberry).

II.	Detailed Considerations

T and its conjugates are residues of concern in primary crops, livestock, rotational crops, and/or water following the application of several triazole-derivative fungicides including tetraconazole.  In 2006, HED issued an aggregate human-health risk assessments for T and for the combined residue of its conjugates (D322215, M. Doherty et al., 7-Feb-06).  This assessment has been updated as needed with the most recent assessment conducted on 28-Oct-2009 (D370435, M. Negussie).  Based on the proposed tetraconazole application scenarios, new dietary and aggregate risk estimates for T and its conjugates are required (see below).  HED notes that neither the toxicological information nor the non-dietary exposure estimates detailed in the 2006 memorandum have changed; thus the only alterations to the previous aggregate exposure and risk estimates are due to changes in the dietary exposure estimates (refer to D322215 memo for information concerning the toxicological and nondietary exposure assessments).

Dietary:  HED completed an updated dietary exposure and risk analysis for T and its conjugated metabolites which included residues resulting from the proposed tetraconazole uses (D386652, T. Morton, 16-Feb-2011).  These analyses were conducted using the Dietary Exposure Evaluation Model DEEM-FCID(TM) (ver. 2.03) which incorporates food consumption data from the U.S. Department of Agriculture's (USDA) Continuing Surveys of Food Intakes by Individuals (CSFII; 1994-1996 and 1998).  Four assessments were conducted:  acute and chronic durations for T, and acute and chronic durations for combined residues of the conjugated T metabolites.  As with the previous triazole metabolite assessments, this assessment includes exposure estimates resulting from direct consumption of T or its conjugated metabolites as well as indirect exposure resulting from consumption of parent fungicides followed by in vivo conversion to these compounds.  For each food form in the acute assessment, the residue used is the maximum estimate from the various food/triazole fungicide combinations combined with the average indirect residue estimate.  For the chronic assessments, the residue estimates are the average residue from the food-specific food/triazole combinations combined with the average indirect residue estimates.  All four assessments assume 100% crop treated and include conservative estimates for residues of the metabolites in drinking water.  The resulting exposure and risk estimates are based on health-protective assumptions and should be characterized as conservative.  For all four analyses, risk estimates are below HED's level of concern for all population subgroups (see Table 2.1).

Aggregate:  The revised T short- and intermediate-term aggregate estimates are summarized below (see Tables 2.2 and 2.3, respectively).  The resulting short-and intermediate-term risk do not exceed HED's level of concern.

HED determined that the conjugated T metabolites are formed within the plant itself and not on leaf surfaces.  Therefore, these residues are not available for dermal, hand-to-mouth, or object-to-mouth exposure.  However, residues of the conjugated T metabolites may occur in soil.  For the following reasons, HED concludes that exposure to the conjugate T metabolites via soil ingestion is insignificant:  exposure to T via soil ingestion was insignificant (see Table 2.2 and 2.3); it is unlikely that exposure via soil ingestion of the conjugate T metabolites will exceed that of T; and T has lower incidental oral endpoints than those for conjugated T.

 Table 2.1.  Summary of Dietary (Food and Drinking Water) Exposure and Risk for T and its Conjugate Metabolites.
                              Population Subgroup
                                 Acute Dietary
                              (95[th] Percentile)
                                Chronic Dietary
                                     Cancer

                          Dietary Exposure (mg/kg/day)
                                    % aPAD*
                                Dietary Exposure
                                  (mg/kg/day)
                                    % cPAD*
                                Dietary Exposure
                                  (mg/kg/day)
                                      Risk
                                       T
 General U.S. Population
                                   0.006517
                                      22
                                   0.001185
                                      24
                                 not applicable
 All Infants (< 1 year old)
                                   0.011889
                                      40
                                   0.002065
                                      41

 Children 1-2 years old
                                   0.014564
                                      49
                                   0.003112
                                      62

 Children 3-5 years old
                                   0.011865
                                      40
                                   0.002542
                                      51

 Children 6-12 years old
                                   0.007790
                                      26
                                   0.001614
                                      32

 Youth 13-19 years old
                                   0.005358
                                      18
                                   0.001002
                                      20

 Adults 20-49 years old
                                   0.005085
                                      17
                                   0.000974
                                      20

 Adults 50+ years old
                                   0.004724
                                      16
                                   0.000916
                                      18

 Females 13-49 years old
                                   0.004903
                                      16
                                   0.000964
                                      19

                            Conjugated T Metabolites
 General U.S. Population
                                 not applicable
                                   0.013915
                                      16
                                 not applicable
 All Infants (< 1 year old)

                                   0.020264
                                      23

 Children 1-2 years old

                                   0.039889
                                      44

 Children 3-5 years old

                                   0.031321
                                      35

 Children 6-12 years old

                                   0.019106
                                      21

 Youth 13-19 years old

                                   0.012076
                                      13

 Adults 20-49 years old

                                   0.011326
                                      13

 Adults 50+ years old

                                   0.010308
                                      12

 Females 13-49 years old
                                   0.051668
                                      52
                                   0.011136
                                      12

 * The values for the highest exposed population for each type of risk assessment are bolded.

Table 2.2.  Short-term Aggregate Exposure and Risk Estimates for T.
                              Population Subgroup
                        Exposure Estimate, mg/kg/day[1]
                               Aggregate MOE[2]

                                    Dietary
                                    Dermal
                                    (M/L/A)
                             Dermal (Post-Applic.)
                                 Hand-to-Mouth
                                Object-to-Mouth
                                Soil Ingestion
                                   Aggregate

U.S. Population (total)
                                   0.001185
                                    0.00183
                                    0.0051
                                      N/A
                                      N/A
                                      N/A
                                   0.008088
                                     3700
All infants (< 1 year)
                                   0.002065
                                      N/A
                                    0.0086
                                    0.0041
                                    0.0010
                                   0.000019
                                   0.015744
                                     1900
Children 1-2 yrs
                                   0.003112
                                      N/A
                                    0.0086
                                    0.0041
                                    0.0010
                                   0.000019
                                   0.016769
                                     1800
Children 3-5 yrs
                                   0.002542
                                      N/A
                                    0.0086
                                    0.0041
                                    0.0010
                                   0.000019
                                   0.016205
                                     1800
Children 6-12 yrs
                                   0.001614
                                      N/A
                                    0.0086
                                      N/A
                                      N/A
                                      N/A
                                   0.010177
                                     2900
Youth 13-19 yrs
                                   0.001002
                                    0.00183
                                    0.0051
                                      N/A
                                      N/A
                                      N/A
                                   0.007904
                                     3800
Adults 20-49 yrs
                                   0.000974
                                    0.00183
                                    0.0051
                                      N/A
                                      N/A
                                      N/A
                                   0.007881
                                     3800
Adults 50+ yrs
                                   0.000916
                                    0.00183
                                    0.0051
                                      N/A
                                      N/A
                                      N/A
                                   0.007828
                                     3800
Females 13-49 yrs
                                   0.000964
                                    0.00183
                                    0.0051
                                      N/A
                                      N/A
                                      N/A
                                    0.00787
                                     3800
1 Exposure estimates for dermal, hand-to-mouth, object-to-mouth, and soil ingestion are from J. Arthur (D322240, 9-Dec-2005).
2 Aggregate MOE = NOAEL (30 mg/kg/day) / Aggregate Exposure Estimate (mg/kg/day).  Level of Concern = 1000.

Table 2.3.  Intermediate-term Aggregate Exposure and Risk Estimates for T.
                              Population Subgroup
                         Exposure Estimate, mg/kg/day
                               Aggregate MOE[2]

                                    Dietary
                               Soil Ingestion[1]
                                   Aggregate

U.S. Population (total)
                                   0.001185
                                      N/A
                                   0.001158
                                     13000
All infants (< 1 year)
                                   0.002065
                                   0.000019
                                   0.002044
                                     7200
Children 1-2 yrs
                                   0.003112
                                   0.000019
                                   0.003069
                                     4800
Children 3-5 yrs
                                   0.002542
                                   0.000019
                                   0.002505
                                     5900
Children 6-12 yrs
                                   0.001614
                                      N/A
                                   0.001577
                                     9300
Youth 13-19 yrs
                                   0.001002
                                      N/A
                                   0.000974
                                     15000
Adults 20-49 yrs
                                   0.000974
                                      N/A
                                   0.000951
                                     15000
Adults 50+ yrs
                                   0.000916
                                      N/A
                                   0.000898
                                     16000
Females 13-49 yrs
                                   0.000964
                                      N/A
                                   0.000940
                                     16000
1 Soil ingestion estimates are from J. Arthur (D322240, 9-Dec-2005).
2 Aggregate MOE = NOAEL (15 mg/kg/day) / Aggregate Exposure Estimate (mg/kg/day).  Level of Concern = 3000.


[Federal Register Volume 80, Number 66 (Tuesday, April 7, 2015)]
[Notices]
[Pages 18667-18669]
[FR Doc No: 2015-07882]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74627; File No. SR-Phlx-2015-30]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Section (a)(iv) of Rule 703, Financial Responsibility and Reporting

April 1, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 23, 2015, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I, II, and III, below,
which Items have been substantially prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ See 15 U.S.C. 78s(b)(1).
    \2\ See 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend section (a)(iv) of Rule 703,
Financial Responsibility and Reporting, as described below.\3\
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    \3\ A Registered Options Trader or ROT is a regular member or a
foreign currency options participant of the Exchange located on the
trading floor who has received permission from the Exchange to trade
in options for his own account. See Exchange Rule 1014(b)(i).
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    The text of the proposed rule change is below. Proposed new
language is in italics; proposed deletions are in brackets.

* * * * *

Rule 703. Financial Responsibility and Reporting

(a) Financial Responsibility Standards.--Each member organization
effecting securities transactions shall comply with the capital
requirements set forth below:
(i) each member organization subject to SEC

rule 15c3-1 shall at all times comply with said rule and the
notification provisions of SEC rule 17a-11;
(ii) each member organization exempt from SEC rule 15c3-1 shall, at
the time of its admission to the Exchange, have a minimum of $25,000
in net liquid assets;
(iii) each member organization or foreign currency options
participant organization exempt from SEC Rule 15c3-1 and whose
principal business is as a registered options trader on the
Exchange, shall, subject to subparagraph (iv) below, at all times
maintain a minimum of $25,000 in net liquid assets;
(iv) each member organization referred to in paragraph (iii) above
shall at all times maintain positive net liquid assets and, in its
clearing account(s), positive equity, provided that said
organization has filed with the Exchange a letter of guarantee
issued on its behalf by a clearing member organization of this
Exchange which is also a clearing member of the Options Clearing
Corporation. In said letter the clearing member organization
guarantees the financial responsibilities of said organization for
all transactions and balances carried and cleared in the clearing
account(s). [Such guarantee shall remain in effect until the
Exchange receives from the clearing member organization written
notice of its intent to cancel its guarantee. Written notice of such
cancellation received by the Exchange at least one-half hour before
the normal opening of trading shall take effect on the day of
receipt; written notice received less than one-half hour before the
opening of trading shall take effect on the opening of the business
day following Exchange receipt.] Such letter of guarantee filed with
the Exchange shall remain in effect until a written notice of
revocation has been filed with the Exchange by the clearing member
organization. A revocation shall in no way relieve a clearing member
organization of responsibility for transactions guaranteed prior to
the effective date of such revocation.
(v)-(viii) No change.
(b)-(f) No change.
* * * Commentary No change.
* * * * *

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections II.A., II.B., and II.C. below, of the most significant aspects
of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to modernize the
Exchange's rules regarding the termination of letters of guarantee
provided by clearing member organizations which guarantee the financial
responsibilities of non-clearing member organizations. The proposal
would permit clearing member organizations to terminate letters of
guarantee which guarantee the financial responsibilities of non-
clearing member organizations on an intraday basis. The amendment would
conform this aspect of Rule 703 to the Letter of Guarantee termination
provisions of the NASDAQ Options Market (``NOM'') and NASDAQ OMX BX,
Inc. (``BX'') rules.\4\
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    \4\ Chapter VII, Section 8(c) of the BX Rules provides in
relevant part that ``[a] Letter of Guarantee filed with BX
Regulation shall remain in effect until a written notice of
revocation has been filed with BX Regulation by the Guarantor
Clearing Participant.'' Chapter VII, Section 8(c) of the NOM rules
is nearly identical, stating that ``[a] Letter of Guarantee filed
with Nasdaq Regulation shall remain in effect until a written notice
of revocation has been filed with Nasdaq Regulation by the Guarantor
Clearing Participant.'' The BX and NOM rules also state, like the
Phlx proposal, that a revocation shall in no way relieve the issuer
of responsibility for transactions guaranteed prior to the effective
date of such revocation.
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    Currently, Rule 703(a)(iv) provides that a clearing member
guarantee remains in effect until the Exchange receives from the
clearing member organization written notice of its intent to cancel its
guarantee. It further provides that written notice of such cancellation
received by the Exchange at least one-half hour before the normal
opening of trading shall take effect on the day of receipt, except that
written notice received less than one-half hour before the opening of
trading shall take effect only on the opening of the business day
following Exchange receipt. Consequently, a guaranteeing clearing
member organization concerned about its guaranteed member
organization's credit is unable to terminate its guarantee on an
intraday basis.
    The proposed amendment to Rule 703(a)(iv) would enable the
guaranteeing clearing member organization to terminate the guarantee
during the trading day, avoiding financial responsibility for trades
that would otherwise have occurred during the rest of the day for which
the guaranteeing member would, under the current rule, remain
financially responsible. As stated above, the change would conform the
Phlx rule to the NOM and BX rules which permit revocation of a Letter
of Guarantee to take effect upon filing of a written notice of
revocation, which permits termination to become effective without
waiting until the next trading day. The Exchange will terminate the
registered options trader's access to trading as soon as it processes
the withdrawn guarantee. Clearing member organizations will therefore
be able to react more quickly under the amended rule to any potential
rapid deterioration in the guaranteed entity's condition.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \5\ in general, and furthers the objectives of Section
6(b)(5) of the Act \6\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest,
by permitting clearing member organizations to revoke letters of
guarantee effective upon filing written notice of revocation with the
Exchange. The proposal should encourage additional clearing member
organizations to consider issuing letters of guarantee, knowing they
may revoke the guarantee more quickly upon an adverse change in the
guaranteed entity's circumstances than is currently permitted under
Rule 703(a)(iv).
---------------------------------------------------------------------------

    \5\ See 15 U.S.C. 78f(b).
    \6\ See 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act because the proposed change
would apply to all issuers of clearing member guarantees equally and
because it would also apply equally to all guaranteed entities whose
guarantees are revoked under Rule 703(a)(iv).

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect

the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \7\ and subparagraph (f)(6) of Rule 19b-4
thereunder.\8\
---------------------------------------------------------------------------

    \7\ See 15 U.S.C. 78s(b)(3)(a)(ii).
    \8\ See 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2015-30 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-Phlx-2015-30. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml).
    Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street NE., Washington,
DC 20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly.
    All submissions should refer to File Number SR-Phlx-2015-30 and
should be submitted on or before April 28, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ See 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-07882 Filed 4-6-15; 8:45 am]
BILLING CODE CODE 8011-01-P


[Federal Register Volume 84, Number 123 (Wednesday, June 26, 2019)]
[Proposed Rules]
[Pages 30068-30071]
[FR Doc No: 2019-13373]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 70

[EPA-R07-OAR-2019-0325; FRL-9995-35-Region 7]

Approval of Air Quality Improvement Plan, Operating Permits
Program, and 112(l) Plan; Missouri; Operating Permits

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing
approval of revisions to the State Implementation Plan (SIP), the
Operating Permit Program (OPP), and the 112(l) plan submitted on March
7, 2019, by the State of Missouri. The submission revises Missouri's
regulations relating to the requirement for sources of air contaminants
to obtain operating permits and to establish procedures for sources of
air contaminants to obtain and comply with operating permits. These
revisions are primarily administrative in nature and do not impact the
stringency of the SIP, the OPP, or the 112(l) plan. Specifically, the
revisions correct references, change the term ``regulated pollutant''
to ``regulated air pollutant'', removes unnecessary words, and add
definitions. Approval of these revisions will not impact air quality
and ensures Federal enforceability of the State's rules.

DATES: Comments must be received on or before July 26, 2019.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-R07-
OAR-2019-0325 to https://www.regulations.gov. Follow the online
instructions for submitting comments.
    Instructions: All submissions received must include the Docket ID
No. for this rulemaking. Comments received will be posted without
change to https://www.regulations.gov/, including any personal
information provided. For detailed instructions on sending

comments and additional information on the rulemaking process, see the
``Written Comments'' heading of the SUPPLEMENTARY INFORMATION section
of this document.

FOR FURTHER INFORMATION CONTACT: Deborah Bredehoft, Environmental
Protection Agency, Region 7 Office, Air Quality Planning Branch, 11201
Renner Boulevard, Lenexa, Kansas 66219; telephone number (913) 551-
7164; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refer to the EPA.

Table of Contents

I. Written Comments
II. What is being addressed in this document?
III. What part 52 revision is the EPA approving?
IV. What part 70 revision is the EPA approving?
V. What 112(l) revision is the EPA approving?
VI. Have the requirements for approval of a SIP revision been met?
VII. What action is the EPA taking?
VIII. Incorporation by Reference
IX. Statutory and Executive Order Reviews

I. Written Comments

    Submit your comments, identified by Docket ID No. EPA-R07-OAR-2019-
0325, at https://www.regulations.gov. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e. on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

II. What is being addressed in this document?

    The EPA is proposing to approve revisions to the Missouri State
Implementation Plan (SIP) that were submitted to EPA on March 7, 2019.
The SIP revises Missouri's regulation, Title 10 Code of State
Regulations (10 CSR) 10-6.065, ``Operating Permits'', which requires
sources of air contaminants to obtain operating permits and establishes
procedures for obtaining and complying with operating permits. The
revisions correct references, change the term ``regulated pollutant''
to ``regulated air pollutant'' to match the Federal use of the term,
exempt minor permit modification applications from the public noticing
requirement, add definitions specific to the regulatory text of 10 CSR
10-6.065, and make administrative updates. Additionally, Missouri's
submission included removal of two sections that were not approved into
the SIP or under part 70. These two sections are the basic state
operating permit program and the requirement for certain greenhouse gas
sources to have permits. The removal of these sections primarily
impacts organization and section specific references. The EPA's
analysis of the SIP, part 70 and 112(l) revision can be found in the
Technical Support Document (TSD) included in this docket.

III. What part 52 revision is the EPA approving?

    The EPA is proposing approval of requested revisions to the
Missouri SIP relating to 10 CSR 10-6.065--Operating Permits.
Specifically, the EPA is proposing to approve sections (1), (2), (3),
(4), and (6) as they pertain to the intermediate state operating permit
program in Missouri's SIP. The revisions include correcting references;
adding definitions specific to this specific section of the regulatory
text; and making administrative updates. The EPA has conducted analysis
on the state's revisions and has found that the revisions would not
impact air quality, ensures consistency between the state and
federally-approved rules, and ensures Federal enforceability of the
State's rules. Additional information on the EPA's analysis can be
found in the Technical Support Document (TSD) included in this docket.

IV. What part 70 revision is the EPA approving?

    The EPA is proposing approval of requested revisions to the
Missouri Operating Permit Program relating to 10 CSR 10-6.065--
Operating Permits. Specifically, the EPA is proposing approval of
sections (1), (2), (3), (5) and (6) as they pertain to the Missouri
Title V operating permit program. The revisions include correcting
references; changing the term ``regulated pollutant'' to ``regulated
air pollutant'' to match the Federal use of the term; adding
definitions specific to this specific section of the regulatory text;
and making administrative updates. The EPA has conducted analysis on
the state's revisions and has found that the revisions would not impact
air quality, ensures consistency between the state and federally-
approved rules, and ensures Federal enforceability of the State's
rules. Additional information on the EPA's analysis can be found in the
TSD included in this docket.

V. What 112(l) revision is the EPA approving?

    Missouri's submission indicated that the revisions made to 10 CSR
10-6.065 ``include any revisions necessary to retain 112(l) approval
under the Clean Air Act.'' The John S. Seitz Memo of April 13, 1993,
titled ``Title V Program Approval Criteria for Section 112
Activities,'' provides guidance on revisions to state Title V programs
and how they intersect with section 112 requirements. It states, ``As
for part 70 program revisions, no formal amendment to the initial title
V program should typically be needed with respect to section 112
requirements taking effect after the effective date of the program. The
State's up-front commitment and demonstrations (i.e., legal authorities
and mechanisms to adopt additional section 112 requirements) coupled
with the EPA's ability to review individual permits and to audit part
70 programs periodically should provide reasonable assurance of
adequate State implementation.'' The guidance further explains that,
``The State, however, remains responsible for maintaining and enhancing
as necessary its authority to implement section 112, including any new
regulations. In light of the demonstrations and/or commitments required
for part 70 approval, the EPA will presume that a State's request for
approval of its operating permits program will be an implicit request
under section 112(l) for delegation of authority to implement
federally-promulgated section 112 requirements in the same form in
which EPA issues them.'' Our September 25, 1995, 112(l) delegation to
Missouri remains in effect. Per MoDNR's request, we are approving these
revisions under the authority of Clean Air Act (CAA) 112(l).

VI. Have the requirements for approval of a SIP revision been met?

    The state submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. The
state provided public notice on this SIP revision from

August 1, 2018, to October 4, 2018, and received seven (7) comments.
The EPA provided three of the seven comments. The state reviewed and
responded to the comments on February 1, 2019. The state did not revise
any of the regulatory text; however, the state did revise the
Regulatory Impact Report. In addition, as explained above and in more
detail in the technical support document which is part of this
document, the revision meets the substantive SIP requirements of the
CAA, including section 110 and implementing regulations. The submittal
also meets the substantive requirements of title V of the 1990 CAA
Amendments and 40 CFR part 70.

VII. What action is the EPA taking?

    The EPA is proposing to amend the Missouri SIP by approving the
State's request to amend 10 CSR 10-6.065, ``Operating Permits.''
Approval of these revisions will ensure consistency between state and
Federally-approved rules. The EPA has determined that these changes
will not adversely impact air quality.
    We are processing this as a proposed action because we are
soliciting comments on this proposed action. Final rulemaking will
occur after consideration of any comments.

VIII. Incorporation by Reference

    In this document, the EPA is proposing to include regulatory text
in an EPA final rule that includes incorporation by reference. In
accordance with requirements of 1 CFR 51.5, EPA is proposing to
incorporate by reference the Missouri Regulations described in the
proposed amendments to 40 CFR part 52 set forth below. The EPA has
made, and will continue to make, these materials generally available
through www.regulations.gov and at the EPA Region 7 Office (please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section of this preamble for more information).

IX. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of the National Technology
Transfer and Advancement Act (NTTA) because this rulemaking does not
involve technical standards; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications and will not impose substantial direct
costs on tribal governments or preempt tribal law as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

40 CFR Part 70

    Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Operating permits,
Reporting and recordkeeping requirements.

    Dated: June 18, 2019.
James Gulliford,
Regional Administrator, Region 7.
    For the reasons stated in the preamble, the EPA proposes to amend
40 CFR parts 52 and 70 as set forth below:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart--AA Missouri

0
2. In Sec.  52.1320, the table in paragraph (c) is amended by revising
the entry ``10-6.065'' to read as follows:

Sec.  52.1320   Identification of plan.

* * * * *
    (c)* * *

                                                            EPA-Approved Missouri Regulations
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                State
         Missouri citation                  Title          effective date             EPA Approval date                         Explanation
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        Missouri Department of Natural Resources
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
     Chapter 6--Air Quality Standards, Definitions, Sampling and Reference Methods, and Air Pollution Control Regulations for the State of Missouri
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
10-6.065..........................  Operating Permits....       3/30/2019  [Date of publication of the final rule  Section (5) contains provisions
                                                                            in the Federal Register], [Federal      pertaining only to Missouri's Part
                                                                            Register citation of the final rule].   70 program and is not approved as a
                                                                                revision to the SIP.

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

PART 70--STATE OPERATING PERMIT PROGRAMS

0
3. The authority citation for part 70 continues to read as follows:

    Authority:  42 U.S.C. 7401, et seq.

0
4. Appendix A to part 70, as proposed to be amended June 11, 2019, at
84 FR 27057, is further amended by adding paragraph (ii) under
``Missouri'' to read as follows:

Appendix A to Part 70--Approval Status of State and Local Operating
Permits Programs

* * * * *

Missouri

* * * * *
    (ii) The Missouri Department of Natural Resources submitted
revisions to Missouri rule 10 CSR 10-6.065, ``Operating Permits'' on
March 7, 2019. The state effective date is March 30, 2019. The
proposed revision effective date is [DATE 30 DAYS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE Federal Register].
* * * * *
[FR Doc. 2019-13373 Filed 6-25-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 132 (Wednesday, July 14, 2021)]
[Notices]
[Page 37150]
[FR Doc No: 2021-14943]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP20-48-000]

Iroquois Gas Transmission System, L.P.; Notice of Revised Comment
Period Deadline

    On June 11, 2021, the Commission issued a notice setting August 2,
2021, as the date to file comments on the draft Environmental Impact
Statement (EIS) for the Enhancement by Compression Project. The comment
due date was based on the Environmental Protection Agency (EPA) issuing
its Federal Register Notice of Availability of the EIS on the following
Friday, June 18, 2021, consistent with EPA's filing guidance and
procedures. However, in observance of Juneteenth (as announced on June
17, 2021), the EPA did not issue its Federal Register notice for the
EIS until June 25, 2021. Per Title 40 Code of Federal Regulations
Section 1506.11, it is the EPA's notice that establishes the beginning
dates for comment periods on EISs. Therefore, the Commission is
notifying all interested parties that the comment period now expires on
August 9, 2021.

    Dated: July 8, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-14943 Filed 7-13-21; 8:45 am]
BILLING CODE 6717-01-P


INCIDENT REPORTS ASSOCIATED WITH

Iodine and iodophors

PC CODE:

046923, 046903, 046904, 046905, 075701, 046901, 046914

May 10, 2005

U.S. Environmental Protection Agency

Office of Pesticide Programs

Antimicrobials Division

TABLE OF CONTENTS

 TOC \f

0.0	INTRODUCTION	1

1.0 	INCIDENT REPORT DATA ASSOCIATED WITH HEALTH EFFECTS OF IODINE and IODOPHORS  EXPOSURE	1

1.1 	OPP(s Incident Data System (IDS)	2

1.2 	 Poison Control Center	2

1.3 	California Data - 1982 through 2003	2

1.4 	National Pesticide Telecommunications Network (NPTN)	3

1.5 	Incident Reports Associated with Toxic Effects of phenols Published in Scientific Literature.	4

2.0	SUMMARY AND CONCLUSION	10

3.0	REFERENCE	11

0.0	INTRODUCTION tc \l1 "0.0	INTRODUCTION

Iodine, a halogen,  is a bluish-black, lustrous solid, volatizing at ordinary temperatures into a blue-violet gas with an irritating odor; it forms compounds with many elements, but is less active than the other halogens, which displace it from iodides. Iodine exhibits some metallic-like properties. It dissolves readily in chloroform, carbon tetrachloride, or carbon disulfide to form beautiful purple solutions. It is only slightly soluble in water. Iodine compounds are important in organic chemistry and very useful in medicine.  This reports summarized the potential health effects of iodine and iodophores in humans, reported as incident reports from different sources. Seven active ingredient are covered in this report:  PC code 046923 ,046903,  046904, 046905, 075701, 046901, and 046914.

Two approaches are used in this section:

The potential health effects of phenol in humans, reported as incident reports from different sources, are summarized.

A literature search of chronic health effects associated with phenol exposure, including results of epidemiological studies, are summarized.

1.0 	INCIDENT REPORT DATA ASSOCIATED WITH HEALTH EFFECTS OF PHENOL EXPOSURE tc \l1 "1.0 	INCIDENT REPORT DATA ASSOCIATED WITH HEALTH EFFECTS OF PHENOL EXPOSURE

The following databases have been consulted for the poisoning incident data

OPP Incident Data System (IDS) - The Incident Data System of The Office of Pesticide Programs (OPP) of the Environmental Protection Agency (EPA) contains  reports of incidents from various sources, including registrants, other federal and state health and environmental agencies and individual consumers, submitted to OPP since 1992.  Reports submitted to the Incident Data System represent anecdotal reports or allegations only, unless otherwise stated.  Typically no conclusions can be drawn implicating the pesticide as a cause of any of the reported health effects.  Nevertheless, sometimes with enough cases and/or enough documentation risk mitigation measures may be suggested.

Poison Control Centers - as the result of a data purchase by EPA, OPP received Poison Control Center data covering the years 1993 through 1998 for all pesticides.  Most of the national Poison Control Centers (PCCs) participate in a national data collection system, the Toxic Exposure Surveillance System, which obtains data from about 65-70 centers at hospitals and universities.  PCCs provide telephone consultation for individuals and health care providers on suspected poisonings, involving drugs, household products, pesticides, etc.

California Department of Pesticide Regulation - California has collected uniform data on suspected pesticide poisonings since 1982.  Physicians are required, by statute, to report to their local health officer all occurrences of illness suspected of being related to exposure to pesticides.  The majority of the incidents involve workers.  Information on exposure (worker activity), type of illness (systemic, eye, skin, eye/skin and respiratory), likelihood of a causal relationship, and number of days off work and in the hospital are provided.

National Pesticide Telecommunications Network (NPTN) - NPTN is a toll-free information service supported by OPP.  A ranking of the top 200 active ingredients for which telephone calls were received during calendar years 1984-1991, inclusive, has been prepared.  The total number of calls was tabulated for the categories human incidents, animal incidents, calls for information, and others.

Published Incident Reports - Some incident reports associated with hydantoins related human health hazard are published in the scientific literature.

1.1 	OPP(s Incident Data System (IDS) tc \l2 "1.1 	OPPs Incident Data System (IDS)

A total of 8 individual human incident cases submitted to the EPA Office of Pesticide Programs are associated with exposed to Iodine containing compounds.  Inhalation and dermal are the two important routes of exposure.  The most common symptoms reported for cases of inhalation exposure were coughing, wheezing, tightness of chest and shortness of breath. Dermal irritation caused skin burning, blisters and rash have been reported when expose to the chemical through dermal exposure. None of these effects were considered severe effects.

1.2 	 Poison Control Center tc \l2 "1.2 	 Poison Control Center

There is no iodine incident been reported in the American Association of Poison Control Centers (PCC)  Toxic Exposure Surveillance System (TESS) in the years between 1993 - 1998.

1.3 	California Data - 1982 through 2003 tc \l2 "1.3 	California Data - 1982 through 2003

Detailed descriptions of 61 cases with a definite, probable or possible relationship cases associated with phenolic disinfectants submitted to the California Pesticide Illness Surveillance Program (1982-2003) were reviewed.  Table 1 presents the types of illnesses reported by year.  Table 2 gives the total number of workers that took time off work as a result of their illness and how many were hospitalized and for how long..

Table 1: Cases Due to Iodine, Iodine-Complex or Potassium Iodide Exposure in California Reported by Type of Illness and Year, 1986-2002.

Year

Illness Type

Systemic

Gastrointestinal

Eye

Skin

Respiratory

Combinationa

Total

1986

10

-

-

1

-

-

11

1987

-

-

1

2

1

-

4

1988

-

-

-

1

-

-

1

1989

5

-

-

3

-

2

10

1990

1

-

-

1

1

2

5

1991

1

-

3

3

3

-

10

1992

2

-

2

-

1

-

5

1993

1

-

1

-

1

-

3

1994

1

-

-

1

1

-

3

1995

-

-

1

-

-

-

1

1996

1

-

1

1

-

-

3

1997

-

-

-

1

-

-

1

1998

-

-

-

1

-

1

2

1999

-

-

-

-

-

-

-

2000

-

-

-

-

-

-

-

2001

-

-

1

-

-

-

1

2002

-

-

-

1

-

-

1

Total

22

-

10

16

8

5

61

a Category includes combined irritative effects to eye, skin, gastrointestinal and respiratory systems.

Table 2: Number of Persons Disabled (taking time off work) or Hospitalized for Indicated Number of Days After Iodine, Iodine-Complex or Potassium Iodide Exposure in California, 1986-2002.

Number of Persons Disabled

Number of Persons Hospitalized

One day

13

-

Two days

-

-

3-5 days

3

-

6-10 days

1

-

More than 10 days

-

-

Unknown

1

-

1.4 	National Pesticide Telecommunications Network (NPTN) tc \l2 "1.4  National Pesticide Telecommunications Network (NPTN)

There is no incident reported in the  NPTN database related to 4-tert-amylphenol.

1.5 	Incident Reports Associated with Toxic Effects of Iodine and iodine compounds Published in Scientific Literature. tc \l2 "1.5 	Incident Reports Associated with Toxic Effects of Iodine and iodine compounds Published in Scientific Literature.

There are a large number of human incident reports and epidemiological studies on the effects of excess iodine on human health have been reported.  Based on the effects noticed in the incidents reported, it appears that pure iodine would exert more severe acute toxic effects than iodine related salts.  It was reported that death can be caused from ingestion of iodine at dosage of  tinctures ranged from 1,200 to 9,500 mg (17(120 mg/kg), and deaths usually occurred within 48 hours of the dose.  Acute irritation effects was noticed through both oral or dermal routes of exposure osure to both iodine and iodides at high dose of exposure.  Goetrogenic effects were  noticed in several incidences.

Table 3: Incident Reports Associated with Oral or Dermal exposure to Iodine Containing Mixtures

Reference

Description of Incident

Dose

Effects

Finkelstein and Jacobi, 1937

18 deaths over a period of 6 years from suicides in which adults ingested iodine tinctures (mixtures of molecular iodine and sodium triiodide)

1,200-9,500 mg (17-120 mg/kg)

death within 48 hours of the dose

Finkelstein and Jacobi, 1937

a 29-year-old man was admitted to the hospital four days after attempting suicide by taking tincture of iodine

unknown amount of tincture of iodine

ulcerations in the mouth, increased respiratory rate, vomiting, abdominal soreness/cramps, urinary retention, twitching, irrationality, fever, coma, death

Clark, 1981

a man was found dead in his residence with a skull fracture and severe pneumonia, he was known to be epileptic and a heavy consumer of alcohol; a 13 oz. rye whiskey bottle was found with him that was 3/4 full of a brownish liquid that turned out to be iodine

unclear

death

Dyck et al., 1979

a woman was admitted to the hospital after attempting suicide by ingesting an unknown quantity of Lugol(s iodine (5% diatomic iodine and 10% potassium iodide)

not reported

throat burning, esophagitis, gastritis, dyspnea, tachycardia, hyperthyroidism, acute renal failure, metabolic acidosis

Vicens-Colvet et al., 1998

woman ingested iodine during pregnancy

260-390 mg I/day (4.6 mg/kg/day)

infant developed goiter in utero

Shetty and Duthie, 1990

an adult male received providone-iodine skin washes for 6 months to treat dermal ulcers; he had no other history of excess iodine intake.

not reported

hyperthyroidism and thyrotoxicosis

Prager and Gardner, 1979

an adult female had an open fistula which was swabbed 3 days/week for 22 months with providone-iodine and packed with iodoform impregnated gauze

22 mg I, 3 days/week for 22 months

clinical hypothyroidism with thyroid enlargement; became euthyroid within 6 weeks after the treatment was discontinued

Okano, 1989

a 2-year-old girl suffered extensive, patchy erythema on her back, buttocks and thighs after these areas were in contact with a 10% providone-iodine solution for 8 hours

10% providone-iodine solution (exact dose unknown)

acute irritant contact dermititis

Table 4: Incident Reports Associated with Oral or Dermal exposure to Iodides

Reference

Description of Incident

Dose

Effects

Galina et al., 1962

two cases of infant deaths: death was from complications related to compression of the trachea by a goiterous thyroid gland; mothers had ingested potassium iodide during their pregnancies

approx. 850-1,180 mg I/day (12-17 mg/kg/day)

Infant death from goiter in infant

Iancu et al., 1974

woman consumed sodium iodide for two years including during pregnancy

200 mg I/day (2.9 mg/kg/day)

hypothyroidism and goiter in infant

Coakley et al., 1989

two cases in which women ingested iodide during pregnancy

96 mg I/day during the first 8 months of pregnancy and 510 mg I/day during the last month

infants had a transient goiter at birth

Penfold et al., 1978

two cases in which mothers ingested potassium iodide during the last trimester of pregnancy in one case and during the last four months of pregnancy in the other case

approx. 380 mg I/day (5.4 mg/kg/day) and approx. 460 mg I/day (6.6 mg/kg/day)

one infant born with a goiter and second infant born with a goiter and hypothyriodism

Hassan et al., 1968

three cases of mothers ingesting a daily dose of potassium iodide during pregnancy

approx. 450-765 mg I/day (6-11 mg/kg/day)

infants born with goiter and hypothyroidism

Bostanci et al., 2001

mother ingested potassium iodide during the last four months of pregnancy

130 mg I/day

infant born with goiter and hypothyroidism

Martin and Rento, 1962

two cases where mothers ingested potassium iodide during pregnancy

920 and 1,530 mg I/day (13-22 mg/kg/day)

infants born with goiter and severe but reversible hypothyroidism

Shilo and Hirsch, 1986

72-year-old woman without apparent preexisting thyroid problems ingested sea-kelp tablets; her thyroid status reverted to normal within 6 months after she stopped taking the tablets

2.8-4.2 mg I/day (0.05 mg/kg/day)

hyperthyroidism

Reference

Description of Incident

Dose

Effects

Rajatanavin et al., 1984

a 56-year-old man had been treated for asthma for two years with potassium iodide

270 mg potassium iodide and 50 mg niacinamide hydroiodide

hyperthyroidism, thyrotoxicosis, chest pain, heat intolerance, tremor, fatigue

Rajatanavin et al., 1984

a 64-year-old man was given amiodarone (75 mg of iodine per 200 mg tablet) for intermittent atrial flutter

75 mg I/day

angina, fatigue, weight loss, hyperthyroidism, tremor, muscle weakness

Vaginalis et al., 1972

four healthy adult females, who had nontoxic goiter, received oral doses of a saturated potassium iodide solution for 10-18 weeks

180 mg I/day (2.6 mg/kg/day)

clinical hyperthyroidism and thyrotoxicosis

Ahmed et al., 1974

a 15-year-old male received a saturated solution of potassium iodide for 4 months; his thyroid status reverted to normal within 6 months after the potassium iodide was discontinued

1,440 mg I/day (23 mg/kg/day)

hyperthyroidism and thyrotoxicosis

Vagenakis et al., 1972

in a clinical study, eight healthy adult females with nontoxic goiter received oral doses of a saturated potassium iodide solution for 10-18 weeks

180 mg I/day (2.6 mg/kg/day)

four of the eight patients developed hyperthyroidism and thyrotoxicosis

Shelly, 1967

two cases where transient dermal lesions resulted from a single oral dose of potassium iodide

360 and 500 mg iodide (5.1 and 7.1 mg/kg/day)

transient dermal lesions typical of ioderma

Soria et al., 1990

an adult male received potassium iodide along with penicillin for an acute respiratory tract infection

300 mg I/day (5.1 mg/kg/day)

five days after dose, developed proliferating dermal lesions of the face, scalp and trunk

Reference

Description of Incident

Dose

Effects

Soria et al., 1990

an adult male received potassium iodide along with theophylline for obstructive pulmonary disease for 8 months

600 mg I/day (10 mg/kg/day)

vegetative dermal lesions of the neck and trunk

Kincaid et al., 1981

an adult female received oral doses of potassium iodide for 6 months as part of a treatment for obstructive lung disease.  Other drugs used in the patient(s treatment were ephedrine, theophylline and phenobarbitol

740 mg I/day (11 mg/kg/day)

lesions on the face and conjunctiva of the eye; healed several weeks after the potassium iodide was discontinued

Rosenburg et al., 1972

an adult female received oral doses of potassium iodide for 1 year as part of a treatment for asthma.  Other drugs used in the patient(s treatment were ephedrine, theophylline and phenobarbitol

990 mg I/day (14 mg/kg/day)

vegetative lesions on the face and arms; healed within 3 weeks after the potassium iodide was discontinued

Baumgartner, 1976

a 75-year-old male suffering from pneumonia was giving a saturated solution of potassium iodide among other medication

1,200 mg potassium iodide per day

skin lesions

Soria et al., 1990

a woman received potassium iodide for pneumonia

400 mg I/day (6 mg/kg/day)

lesions of the skin and oral mucosa which healed within 3 weeks after the treatment was discontinued

Reference

Description of Incident

Dose

Effects

Khan et al., 1973

a 65-year-old woman with pneumonia, left ventricular failure and chronic bronchitis was given potassium iodide daily by mouth

approx. 200 mg potassium iodide per day

skin lesions on the face and hands, which healed completely within 3 weeks after the potassium iodide was discontinued

Pena-Penabad et al., 1993

a 75-year-old man had suffered from numerous colds that were treated with  potassium iodide and theophylline taken orally

not reported

outbreaks of papulo-pustulous lesions that formed vegetating masses on the head and arms and conjunctival hemorrhage; lesions disappeared within one week after treatment with iodine was discontinued

Kint and Van Herpe, 1977

two women were taking Calcidrine, an expectorant that contains 150 mg calcium iodide per 5 ml syrup, for respiratory infections

not specified

vegetative skin lesions

Kurtz and Abner, 1982

an adult male received oral doses of a potassium iodide solution for 15 years

1,080 mg I/day (15 mg/kg/day)

recurrent fevers; fevers stopped within 2 weeks after the potassium iodide was discontinued

Horn and Kabins, 1972

an adult male was given a daily regimen of a saturated solution of potassium iodide for treatment of a respiratory illness

1,440 mg I/day

fever; fever stopped within 3 days after the potassium iodide was discontinued

Horn and Kabins, 1972

an adult female received a saturated potassium iodide solution along with ampicillin to treat pneumonia

1,620 mg I/day (23 mg/kg/day)

fever; fever stopped within 36 hours after the potassium iodide was discontinued

Horn and Kabins, 1972

an adult female diabetic patient received a saturated potassium iodide solution along with antibiotics, cortisone, and aminophylline for pneumonia

1,080 mg I/day (15 mg/kg/day)

fever, which stopped when the potassium iodide was discontinued

Tresch et al., 1974

an adult male inadvertently drank a potassium iodide solution

15 grams of iodide

cardiac irritability; ventricular tachycardia; swelling of the face, neck and mouth; edema; conjunctivitis; enlarged salivary glands

2.0 Conclusion and Summary

Iodine is a naturally occurring element that is essential for the good health of people and animals. Iodine is found in small amounts in sea water and in certain rocks and sediments. Iodine occurs in many different forms. Most forms of iodine easily dissolve in water or alcohol. Iodine has many uses. Its most important use is as a disinfectant. Death incidences have been reported but only happened at high dose of exposure to iodine.  Irritation effects were reported when exposure to iodine compounds through either any routs of exposure (oral, dermal, or inhalation).

 PAGE  10

Table 4: Incident Reports Associated with Oral or Dermal exposure to Iodides (Continue)


[Federal Register Volume 76, Number 218 (Thursday, November 10, 2011)]
[Notices]
[Pages 70127-70128]
[FR Doc No: 2011-29186]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2011-0210; FRL-9490-4]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NSPS for Municipal Waste
Combustors (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before December 12,
2011.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2011-0210, to (1) EPA online using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
2822IT, 1200 Pennsylvania Avenue NW., Washington, DC 20460; and (2) OMB
at: Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2223A, Environmental Protection Agency, 1200 Pennsylvania Avenue
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On May 9, 2011 (76 FR 26900), EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional
comments on this ICR should be submitted to both EPA and OMB within 30
days of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2011-0210, which is available for public viewing
online at http://www.regulations.gov, or in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC),
EPA West, Room 3334, 1301 Constitution Avenue NW., Washington, DC The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Reading Room is<PHONE_NUMBER>, and the telephone number
for the Enforcement and Compliance Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://www.regulations.gov to submit or view public comments, access the index
listing of the contents of the docket and to either access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to
www.regulations.gov.
    Title: NSPS for Municipal Waste Combustors (Renewal).
    ICR Numbers: EPA ICR Number 1506.12, OMB Control Number 2060-0210.
    ICR Status: This ICR is scheduled to expire on December 31, 2011.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
    Abstract: The New Source Performance Standards (NSPS) for Municipal
Waste Combustors apply to municipal waste combustors with unit
capacities greater than 225 megagrams per day. Owners or operators of
the affected facilities must make one-time-only notifications and
reports and must keep records of all facilities subject to NSPS
requirements. Owners or operators are also required to maintain records
of the occurrence and duration of any startup, shutdown, or malfunction
in the operation of an affected facility, or any period during which
the monitoring system is inoperative. The pollutants of concern for
subpart Ea are metals, municipal waste combustor (MWC) organics, MWC
acid gases, and nitrogen oxides. In subpart Eb, the additional
pollutants of concern are cadmium (Cd), lead (Pb), and mercury (Hg).
Subparts Ea and Eb require owners and operators with unit capacity
above 225 megagrams per day to notify the Agency of intent to construct
and initiate operation of a new, modified, or reconstructed MWC. The
notification must contain supporting information regarding unit design
capacity, the calculations used to determine capacity, and estimated
startup dates.
    Owners and operators must submit semiannual and annual compliance
reports. In addition, facilities subject to subpart Eb are required to
keep records of the weekly amount of carbon used for activated carbon
injection and to calculate the estimated hourly carbon injection rate
for hours of operation as a means of determining continuous compliance
for Hg. Annual reports of excess emissions are required under subpart
Ea, while semiannual reports of excess emissions are required under
subpart Eb. These notifications, reports, and records are essential in
determining compliance and are required, in general, of all sources
subject to the standard.
    Any owner or operator subject to subpart Ea will maintain a file of
these measurements, and retain the file for at least two years. For
those facilities subject to subpart Eb, all records are required to be
maintained at the source for a period of five years.
    Notifications are used to inform the Agency or delegated authority
when a source becomes subject to the standard. The reviewing authority
may then inspect the source to check if the pollution control devices
are properly installed and operated and that the standard is being met.
Performance test reports are needed as these are the Agency's records
of a source's initial capability to comply with the emission standards,
and serve as a record of the operating conditions under which
compliance was achieved. The information generated by monitoring,
recordkeeping, and reporting requirements described in this ICR is used
by the Agency to ensure that facilities affected by the standard
continue to operate the control equipment and achieve continuous
compliance with the regulation.
    All reports are sent to the delegated state or local authority. In
the event that

there is no such delegated authority, the reports are sent directly to
the EPA regional office. This information is being collected to assure
compliance with 40 CFR part 60, subparts Ea and Eb, as authorized in
section 112 and 114(a) of the Clean Air Act. The required information
consists of emissions data and other information that have been
determined to be private.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB Control Number. The OMB Control Numbers for the EPA
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are
identified on the form and/or instrument, if applicable.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 198
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Municipal waste combustors.
    Estimated Number of Respondents: 12.
    Frequency of Response: Initially, quarterly, annually, and
semiannually.
    Estimated Total Annual Hour Burden: 20,421.
    Estimated Total Annual Cost: $1,916,503, which includes $1,757,811
in labor costs, $60,000 in capital/startup costs, and $98,692 in
operation and maintenance (O&M) costs.
    Changes in the Estimates: There is no change in the labor hours or
cost in this ICR compared to the previous ICR. This is due to two
considerations: (1) The regulations have not changed over the past
three years and are not anticipated to change over the next three
years; and (2) the growth rate for the industry is very low, negative,
or non-existent, so there is no significant change in the overall
burden. There is, however, an increase in the estimated burden cost as
currently identified in the OMB Inventory of approved Burdens. The
increase is not due to any program changes. The change in burden cost
is due to the use of the most updated labor rates.
    Since there are no changes in the regulatory requirements and there
is no significant industry growth, the labor hours from the previous
ICR are used in this ICR.

    Dated: November 4, 2011.
John Moses,
Director, Collection Strategies Division.
[FR Doc. 2011-29186 Filed 11-9-11; 8:45 am]
BILLING CODE 6560-50-P