[Federal Register Volume 81, Number 234 (Tuesday, December 6, 2016)]
[Rules and Regulations]
[Pages 87815-87817]
[FR Doc No: 2016-29106]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2015-0521; FRL-9955-90-Region 4]

Air Plan Approval; Kentucky; Revisions to Louisville Definitions
and Ambient Air Quality Standards

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve portions of the State Implementation Plan (SIP)
submission submitted by the Commonwealth of Kentucky, through the
Kentucky Division for Air Quality (KDAQ), on behalf of the Louisville
Metro Air Pollution Control District (District), on March 22, 2011, and
May 3, 2012. The revisions to the regulatory portion of the SIP that
EPA is taking final action to approve pertain to changes to the
District's air quality standards for lead (Pb), particulate matter
(both PM2.5 and PM10), ozone, nitrogen dioxide
(NO2), and sulfur dioxide (SO2) to reflect the
National Ambient Air Quality Standards (NAAQS), definitional changes,
and regulatory consolidation. EPA has determined that these portions of
the March 22, 2011, and May 3, 2012, SIP revisions are consistent with
the Clean Air Act (CAA or Act).

DATES: This rule will be effective January 5, 2017.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2015-0521. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m.,
excluding federal holidays.

FOR FURTHER INFORMATION CONTACT: Richard Wong, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. The telephone number is<PHONE_NUMBER>. Mr. Wong can be
reached via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Sections 108 and 109 of the CAA govern the establishment, review,
and revision, as appropriate, of the NAAQS to protect public health and
welfare. The CAA requires periodic review of the air quality criteria--
the science upon which the standards are based--and the standards
themselves. EPA's regulatory provisions that govern the NAAQS are found
at 40 CFR 50--National Primary and Secondary Ambient Air Quality
Standards.
    In a proposed rulemaking published on August 1, 2016, EPA proposed
to approve portions of Kentucky's revisions to the Jefferson County air
quality regulations \1\ in the Kentucky SIP, submitted by the
Commonwealth on March 22, 2011, and May 3, 2012. See 81 FR 50428. The
March 22, 2011, submission revises Jefferson County Regulation 1.02--
Definitions and consolidates Regulations 3.02--Applicability of Ambient
Air Quality Standards; 3.03--Definitions; 3.04--Ambient Air Quality
Standards; and 3.05--Methods of Measurement into Regulation 3.01--
Ambient Air Quality Standards (currently entitled Purpose of Standards
and Expression of Non-Degradation Intention in the SIP) by removing
Regulations 3.02 through 3.05 and expanding and retitling Regulation
3.01. This submission also seeks to revise Regulation 1.06--Source
Self-Monitoring and Reporting and Regulation 1.07--Emissions During
Startups, Shutdowns, Malfunctions and Emergencies. EPA is not taking
action on the proposed changes to Regulation 1.06 at this time. EPA
approved the revision to Regulation 1.07 on June 10, 2014 (79 FR
33101). The May 3, 2012, submission builds on the revisions to
Regulation 3.01 proposed in the March 22, 2011, submission by updating
the Jefferson County air quality standards for Pb, PM2.5,
PM10, O3, NO2, and SO2 to
reflect the NAAQS, reordering the sections within the regulation, and
making several textual modifications. The May 3, 2012, submission also
seeks to remove the Ford Motor Company NOX Reasonably
Available Control Technology (RACT) permit from the SIP and replace it
with a Title V permit; EPA is not taking action on the proposed permit
substitution at this time. The details of Kentucky's submission and the
rationale for EPA's action are explained in the proposed rulemaking.
See 81 FR 50428. Comments on the proposed rulemaking were due on or
before August 31, 2016. EPA received no adverse comments on the
proposed action.
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    \1\ In 2003, the City of Louisville and Jefferson County
governments merged and the ``Jefferson County Air Pollution Control
District'' was renamed the ``Louisville Metro Air Pollution Control
District.'' However, each of the regulations in the Jefferson County
portion of the Kentucky SIP still has the subheading ``Air Pollution
Control District of Jefferson County.'' Thus, to be consistent with
the terminology used in the SIP, EPA refers throughout this notice
to regulations contained in Jefferson County portion of the Kentucky
SIP as the ``Jefferson County'' regulations.
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II. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of Jefferson
County Regulation 1.02--Definitions (except for the definitions of
``Acute noncancer effect,'' ``Cancer,'' ``Carcinogen,'' and ``Chronic
noncancer effect''), effective June 21, 2005, and Regulation 3.01--
Ambient Air Quality Standards,

effective April 20, 2011. Therefore, these materials have been approved
by EPA for inclusion in the SIP, have been incorporated by reference by
EPA into that plan, are fully federally-enforceable under sections See
page 660 of the submittal PDF in G:\ARMS\RDS Files through 2015\State
Submittals\Kentucky\Finals\KY 197--Louisville SSM & misc.) 110 and 113
of the CAA as of the effective date of the final rulemaking of EPA's
approval, and will be incorporated by reference by the Director of the
Federal Register in the next update to the SIP compilation.\2\ EPA has
made, and will continue to make, these materials generally available
through www.regulations.gov and/or at the EPA Region 4 office (please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section of this preamble for more information).
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    \2\ 62 FR 27968 (May 22, 1997).
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III. Final Action

    EPA is taking final action to approve portions of Kentucky's
submissions submitted by the Commonwealth of Kentucky through KDAQ on
behalf of the District on March 22, 2011, and May 3, 2012. The
submissions revise Jefferson County Regulation 1.02--Definitions
(except for the definitions of ``Acute noncancer effect,'' ``Cancer,''
``Carcinogen,'' and ``Chronic noncancer effect''), consolidate
Regulations 3.02--Applicability of Ambient Air Quality Standards;
3.03--Definitions; 3.04--Ambient Air Quality Standards; and 3.05--
Methods of Measurement into Regulation 3.01--Ambient Air Quality
Standards (currently entitled Purpose of Standards and Expression of
Non-Degradation Intention in the SIP) by removing Regulations 3.02
through 3.05 and expanding and retitling Regulation 3.01, and revise
Regulation 3.01 by reordering the sections within the regulation,
making several textual modifications, and updating the Jefferson County
air quality standards for Pb, PM2.5, PM10,
O3, NO2, and SO2 to reflect the NAAQS.

IV. 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. See 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, these
actions merely proposes to approve state law as meeting federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, these actions:
     Are 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);
     do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     are 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.);
     do 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);
     do not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     are not an economically significant regulatory action
based on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     are not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     are not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     do 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, these rules
do not have tribal implications as specified by Executive Order 13175
(65 FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by February 6, 2017. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Lead, Nitrogen dioxide, Sulfur
dioxide, Particulate matter, Reporting and recordkeeping requirements.

    Dated: November 21, 2016.
Heather McTeer Toney,
Regional Administrator, Region 4.
    40 CFR part 52 is amended as follows:

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 S--Kentucky

0
2. Section 52.920(c) is amended:
0
a. Under Table 2, Reg 1--General Provisions by revising the entry for
``1.02'',
0
b. Under Table 2, Reg 3--Ambient Air Quality Standards revising the
entry for ``3.01'', and
0
c. Under Table 2, Reg 3--Ambient Air Quality Standards by removing the
entries for ``3.02'', ``3.03'', ``3.04'' and ``3.05''.
    The revisions read as follows:

Sec.  52.920  Identification of plan.

* * * * *
    (c) * * *

                                             Table 2--EPA-Approved Jefferson County Regulations for Kentucky
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                                                                  EPA approval                                District
                 Reg                         Title/subject            date        Federal Register notice  effective date           Explanation
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                                                                      * * * * * * *
1.02.................................  Definitions.............         12/6/16  [Insert citation of              6/21/05  Definitions approved except
                                                                                publication].                             for ``Acute noncancer
                                                                                effect,'' ``Cancer,''
                                                                                ``Carcinogen,'' and
                                                                                ``Chronic noncancer
                                                                                effect''.

                                                                      * * * * * * *
3.01.................................  Ambient Air Quality              12/6/16  [Insert citation of              4/20/11  .............................
                                        Standards.                                publication].

                                                                      * * * * * * *
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* * * * *
[FR Doc. 2016-29106 Filed 12-5-16; 8:45 am]
 BILLING CODE 6560-50-P


1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Date: April 30, 2002 MEMORANDUM SUBJECT: REVISED OCCUPATIONAL AND RESIDENTIAL EXPOSURE ASSESSMENT AND RECOMMENDATIONS FOR THE RE REGISTRATION ELIGIBILITY DECISION DOCUMENT FOR LINDANE FROM David Jaquith Reregistration Action Branch 4 Health Effect Division (7509C)

TO: Becky Daiss Reregistration Branch 4 Health Effect Division (7509C)

THRU Susan Hummel, Senior Scientist Reregistration Branch 4 Health Effects Division (7509C)

Please find attached the occupational and residential exposure assessment for lindane DP BARCODE D282648 Pesticide Chemical Codes: 009001 EPA Reg Nos:

EPA MRID Nos.: 452000 02, 444058 02, 422519 01 PHED: No 2 CONTENTS EXECUTIVE SUMMARY...................................................... 3 1.0 BACKGROUND ........................................................ 4 1.1 Summary of Toxicity Concerns Relating to Occupational Exposures ......... 5 1. 2 Summary of Use Pattern and Formulations.............................. 7 1.3 Method and Types of Equipment Used for Mixing/ Loading/ Applying ........ 8 1. 4 Incident Reports................................................... 8 2.0 OCCUPATIONAL EXPOSURES ........................................... 8 2.1 Handler Exposures & Assumptions .................................... 8 2.1.1 Submitted Studies ........................................... 8 2.1.2 Summary of Occupational Handler Exposures ..................... 9 2.1.3 Summary of Uncertainties ..................................... 9 2.1.4 Calculations of Exposure ..................................... 11 2.2 Risk From Handler Exposures ....................................... 12 2.2.1 Risk From Handler Exposures ................................ 12 2.2.2 Summary of MOEs ......................................... 13 2.2.3 Cancer Risks .............................................. 13 2.2.3 Insufficient Data ........................................... 13 REFERENCES .................................................. 16 Appendix A ........................................................... 17 Appendix B ........................................................... 22 Appendix C ........................................................... 29 3 Executive Summary This document presents the occupational exposure assessment for use of lindane. Lindane is the gamma isomer of 1,2,3,4,5,6 hexachlorocyclohexane, an insecticide previously used in many situations but now restricted to seed treatment only. There are no current registered uses for recreational, residential or other public (non occupational) settings. All uses other than seed treatment have been cancelled. Lice and scabies treatment is considered in the risk assessment document.

Acute Toxicity Categories Acute toxicity categories for technical grade lindane are in Toxicity Category II for oral, Toxicity Category II for dermal, and Toxicity Category II for inhalation. It is in Toxicity Category III for primary eye irritation.

The endpoints used in this document to assess lindane hazards include short term and intermediate term dermal and inhalation endpoints. The exposure duration for short term assessments is 1 to30 days or up to 1 month. Intermediate term duration is greater than 1 month to six months. Although there is little information to determine what percentage of workers apply for more than one month, it is reasonable to believe that typical uses of lindane by commercial seed treatment facilities may encompass an intermediate term duration. On farm treatments are more likely to be of short term duration. An oral developmental neurotoxicity study (MRID 45073501) in rats was selected for both dermal assessments. A 90 day inhalation toxicity study (MRID 00255003) was selected for inhalation assessment for all time periods.

In the developmental neurotoxicity study the maternal toxicity NOAEL is 50 ppm (5.6 mg/ kg/ day) based on reduced pup survival, decreased body weights and body weight gains during lactation, increased motor activity, and decreased motor activity habituation. The offspring toxicity NOAEL was 10 ppm (1.2 mg/ kg/ day).

In the subchronic inhalation toxicity study (Accession No. 255003) Tte systemic toxicity NOAELs for short term exposure was 0.5 mg/ m 3 (0.13 mg/ kg/ day), based on lesions in the kidney and increased kidney weights.( 1).

Exposure data on lindane are available but limited. An exposure study addressing on farm seed treatment has been conducted (MRID 444058 02). A detailed description along with the exposure calculations are presented in Appendix A. Another study addressing commercial seed treatment with another chemical has been reviewed by the Agency. The an excerpt of the review of that study (MRID 452000 02), along with the calculations for lindane exposure are presented in Appendix B.

The results of the handler assessments indicate that the on farm seed treatment provide dermal MOEs less than 100 with the attire worn during the study (long pants, long sleeved shirts, gloves). The assessments, both dermal and inhalation, yielded MOEs of less than 100 for 4 mixing/ loading/ application and bagging/ sewing/ stacking during commercial seed treatment of canola. All other exposure scenarios provide MOEs greater than or equal to 100 when wearing the clothing used in the study (coveralls over single layer of clothing, gloves for commercial other seed treatment workers) or at baseline attire (single layer of clothing, gloves for mixer/ loaders) for loading seed for planting or for planting treated seed.

Due to the method of seed treatment, HED has determined that soil incorporated, postapplication agricultural exposure is considered to be negligible as long as the soil is not directly contacted. The exception is farmers handling treated seed. An estimate of the inherent risk from handling treated seed was conducted using relatively conservative assumptions. There are no study data available on exposure to lindane from handling treated seed and therefore the exposure was estimated using surrogate data. An excerpt of that review of that study (MRID 422519 01) and exposure calculations are presented in Appendix C.

1.0 BACKGROUND Purpose This document is for use in development of the Reregistration Eligibility Decision Document (RED) for the insecticide lindane and presents a review of the potential human health effects of occupational exposure to lindane.

Criteria for Conducting Exposure Assessments An occupational and/ or residential exposure assessment is required for an active ingredient if (1) certain toxicological criteria are triggered and (2) there is potential exposure to handlers (mixers, loaders, applicators, etc.) during use or to persons entering treated sites after application is complete. For lindane, both of these criteria are met. 5 1.1 Summary of Toxicity Concerns Relating To Occupational Exposures Acute Toxicology Categories Table 1 presents the acute toxicity categories as outlined in the Report of the Hazard Identification Assessment Review Committee (1).

Table 1: Acute Toxicity Categories for Lindane (Technical)

STUDY TYPE MRID CATEGORY RESULT 81 1 Acute oral 00049330 II LD50 88 mg/ kg  males 91 mg/ kg  females 81 2 Acute dermal 00109141 II LD50 1000 mg/ kg  males 900 mg/ kg  females 81 3 Acute inhalation Acc. 263946 III LC50 1.56 mg/ L both sexes 81 4 Eye irritation Acc. 263946 III PIS = 0.6 no corneal involvement irritation cleared after 24 hours 81 5 Dermal irritation Acc. 263946 IV PIS = 0 not an irritant 81 6 Dermal sensitization Acc. 263946 NA not a sensitizer Other Endpoints of Concern The Report of the Hazard Identification Assessment Review Committee (HIARC) for lindane, (1) indicates that there are toxicological endpoints of concern for lindane. The endpoints used in assessing the risks for lindane are presented in Table 2. 6 Table 2. Doses and Toxicological Endpoints Selected for Risk Assessment of Lindane EXPOSURE SCENARIO DOSE (mg/ kg/ day) ENDPOINT STUDY TYPE/ MRID Acute Dietary general population NOAEL= 6 mg/ kg UF = 100 LOAEL is 20 mg/ kg based on increased grip strength, increased motor activity Acute Neurotoxicity in Rats/ 44769201 Acute RfD = 0.06 mg/ kg/ day aPAD = 0.02 mg/ kg/ day Chronic Dietary NOAEL= 0.47 mg/ kg/ day UF = 300 LOAEL is 100 ppm (4.81 mg/ kg/ day) periacinar hepatocyte hypertrophy, increased liver/ spleen weight, decreased platelets Chronic Feeding and Carcinogenicity in Rats 41094101, 41853701 42891201 Chronic RfD = 0.0047 mg/ kg/ day cPAD = 0.0016 mg/ kg/ day Short Term 1 (Dermal) NOAEL= 1.2 mg/ kg/ day LOAEL is 50 ppm based on reduced pup survival, decreased body weights and body weight gains during lactation, increased motor activity, and decreased motor activity habituation. Developmental Neurotoxicity Study in Rats (oral) 45073501 Intermediate Term 1 (Dermal) NOAEL= 1.2 mg/ kg/ day LOAEL is 50 ppm based on reduced pup survival, decreased body weights and body weight gains during lactation, increased motor activity, and decreased motor activity habituation. Developmental Neurotoxicity Study in Rats (oral) 45073501 Long Term 1 (Dermal) NOAEL= 0.47 mg/ kg/ day LOAEL is 100 ppm (4.81 mg/ kg/ day) periacinar hepatocyte hypertrophy, increased liver/ spleen weight, decreased platelets Chronic Feeding and Carcinogenicity in Rats 41094101, 41853701 42891201 Dermal Absorption Factor = 10%

Short Term 1 (Inhalation) 0.13 mg/ kg/ day (0.5 mg/ m 3 ) based on clinical signs (diarrhea, piloerection) seen at day 14 and continuing for 20 days 90 Day Inhalation Toxicity / 00255003 Intermediate Term 1 (Inhalation) 0.13 mg/ kg/ day (0.5 mg/ m 3 ) LOAEL is 5.0 mg/ m 3 based on increased kidney weights of female rats and bone marrow effects. 90 Day Inhalation Toxicity / 00255003 Long Term 2 (Inhalation) N/ A N/ A N/ A 1 Since an oral NOAEL was selected, the dermal absorption factor (10%) should be used in route to route extrapolation. 2 Exposure thru this route for this duration is not expected 7 1.2 Summary of Use Patterns and Formulations The only use remaining for lindane is for seed treatment. The use closure memorandum (4) allows the seed treatment of the following crops: barley, broccoli, Brussels sprouts, cabbage, cauliflower, corn, lettuce, oats, radishes, rye, sorghum, spinach, and wheat. The crops and application rates are presented in Table 3. Wheat and canola were used as a representative crops for all other seeds treated with lindane because of the relatively large farm size, application rate, and nature of the product treated.

Table 3. Summary of Application Rates for Seed Treatment Using Lindane on Various Crops.

Commodity Formulation/ Reg. No. Use Rate barley 0.0375 lb ai/ 100 pound seed corn dust (19713 262) EC (71096 2) 0.125 lb ai/ bushel seed 0.125 lb ai/ 100 pound seed oats 7501 38, 10107 121 0.03125 lb ai/ 100 pound seed rye 19713 401 554 144 19713 387 0.032813 lb ai/ 100 pound seed sorghum 42056 15 0.0628 lb ai/ 100 pound seed spinach dust (7501 38, 34704 653, 34704 658, 19713 262, 34704 658, 42056 14, 10107 121, 66330 19) 0.0625 lb ai/ 100 pound seed wheat dust, 2935 492 0.042578 lb ai/ 100 pound seed canola Not currently registered 1.5 lb ai/ 100 pounds seed (a rate of 0.75 lb/ 100 lbs seed has been proposed)

1.3 Method and Type of Equipment Used for Mixing/ Loading/ Applying The flowable concentrate, and emulsifiable concentrate formulations for commercial application all require mixing with water to the label specified dilution. This is usually performed by scooping or pouring the formulation into a mixing tank, often of 100 gallons or more in capacity, with mechanical agitation to keep the resulting emulsion homogenized and prevent variations in application strength. Smaller amounts may be handled using a tiller planter (or seed drill) mounted system. Large commercial operations, may have mechanical, automated, 8 metered pumps which require only connecting the formulation to the pump. Again, small seed treatment operations, such as seed box (or "hopper box") mixing, may be done by pouring small amounts in to a mixing device before planting the seeds in to the soil. Dry formulations may also be used, particularly for on farm treatment.

Timing and Frequency of Application Generally, seed will be treated on an as needed basis. However, it is industry practice only to treat enough seeds as are needed to be used that season.

1.4 Incident Data No information regarding seed treatment incidents is available at this time.

2.0 OCCUPATIONAL EXPOSURES 2.1 Handler Exposures & Assumptions HED has determined that there are potential exposures to mixers, loaders, applicators, or other handlers during usual use patterns associated with lindane. Based on the use patterns and potential exposures described above, 5 major exposure scenarios were identified to represent the extent of lindane uses: (1) mixing/ loading/ application of formulations for on farm seed treatment, (2) mixing/ loading and applying liquid with commercial seed treatment equipment, (3) bagging and otherwise handling treated seeds, (5) forklift operation, (6) cleaning seed treatment equipment, (7) mixing/ loading/ planting of treated seed for planting.

2.1.1 Submitted Studies Mixer/ loader/ applicator exposure data for lindane were required since one or more toxicological criteria had been triggered. Requirements for applicator exposure studies are addressed by Series 875 Group A (formerly Subdivision U of the Pesticide Assessment Guidelines). Three exposure studies, one addressing on farm treatment have been provided (Appendix A), another addressing commercial seed treatment (Appendix B), a third addressing planting of treated seed (Appendix C)

2.1.2 Summary of Occupational Handler Exposures Table 5 presents the exposure scenarios, application rates, and amount potentially handled that have been used for the exposure calculations. These are restricted to canola and wheat for commercial seed treatment and wheat for on farm treatments as representative of typical applications. Exposures for handling treated seed before planting and planting treated seed use parameters for wheat and canola as representative crops. Therefore, the rates/ seed types presented in Table 5 are not all conclusive and no attempt has been made to assess a range of application rates to ensure that all use rates and exposure scenarios are represented. 9 2.1.3 Summary of Uncertainties The assumptions and uncertainties are identified below to be used in risk management decisions:

C Application Rates: Based on wheat for on farm treatment and canola for commercial seed treatment. Other types of seed may have slightly different rates but these differences are unlikely to appreciably alter the exposure/ risk assessment.

C Amount Handled: For commercial seed treatment the amounts handled are assumed to be equal to the amounts handled at the facilities used in the study described in the Appendices. On farm treatment exposures were estimated assuming that enough wheat seed could be treated and planted for 100 acres per day at a rate of 120 pounds of seed per acre.

C Unit Exposures: The unit exposure values for commercial seed treatment and planting of treated seed were derived from surrogate studies. The median exposure value was used for commercial seed treatment (Appendix B) and the arithmetic mean was used for the loading/ planting task (Appendix C). 10 Table 4: Exposure Variables for Uses of Lindane Exposure Scenario (Scenario #) Are Chemical Specific Monitoring Data Available Are PHED Data Available? Application Rates (lb ai/ amt of seed) Daily lb Seed Treated/ Handled Lb ai Handled/ day Applicator/ Handler Exposure (1) mixing/ loading/ planting of dry formulations for on farm treatment Yes MRID #44440585 02 No 0.023 lb ai/ bushel (60 lbs seed) for wheat 12000 lbs seed, see Appendix A) 4.7 a (2) mixing/ loading and applying liquid with a commercial seedtreatment equipment No MRID #45200002 No Wheat: 0.043lb ai/ 100 lb seed treated 176000 76 Canola (low end): 0.75 lb ai/ 100 lb seed treated 176000 1320 Canola (high end): 1.5 lb ai/ 100 lb seed treated 176000 2640 (3) handler for commercial seedtreatment equipment (i. e. bagging, sewing, stacking) with chemical resistant coveralls over long sleeve shirt long pants, chemical resistant gloves No MRID #45200002 No Wheat: 0.043lb ai/ 100 lb seed treated 176000 76 Canola (low end): 0.75 lb ai/ 100 lb seed treated 176000 1320 Canola (high end): 1.5 lb ai/ 100 lb seed treated 176000 2640 (4) handler for commercial seedtreatment equipment (i. e. bagging, sewing, stacking) with cotton/ polyester coveralls over long sleeve shirt long pants, chemical resistant gloves No MRID #45200002 No Wheat: 0.043lb ai/ 100 lb seed treated 176000 76 Canola (low end): 0.75 lb ai/ 100 lb seed treated 176000 1320 Canola (high end): 1.5 lb ai/ 100 lb seed treated 176000 2640 (5) Forklift operator  chemical resistant coveralls over long sleeve shirt long pants, chemical resistant gloves No MRID #45200002 No Wheat: 0.043lb ai/ 100 lb seed treated 176000 76 Canola (low end): 0.75 lb ai/ 100 lb seed treated 176000 1320 Canola (high end): 1.5 lb ai/ 100 lb seed treated 176000 2640 (6) Worker Cleaning seed treatment equipment  chemical resistant coveralls over long sleeve shirt long pants, chemical resistant gloves No MRID #45200002 No Wheat: 0.043lb ai/ 100 lb seed treated NA NA Canola (low end): 0.75 lb ai/ 100 lb seed treated NA NA Table 4: Exposure Variables for Uses of Lindane Exposure Scenario (Scenario #) Are Chemical Specific Monitoring Data Available Are PHED Data Available? Application Rates (lb ai/ amt of seed) Daily lb Seed Treated/ Handled Lb ai Handled/ day 11 Canola (high end): 1.5 lb ai/ 100 lb seed treated NA NA (7) Planting treated seed Enclosed cab No MRID #42251901 No Wheat: 0.043lb ai/ 100 lb seed treated 3000 12.9 Canola (low end): 0.75 lb ai/ 100 lb seed treated 1000 7.5 Canola (high end): 1.5 lb ai/ 100 lb seed treated 1000 15 a Data are available from on farm treatment study (Appendix A) c Daily amount treated based on HEDs estimates of acreage that would be reasonably expected to be planted in a day for commercially treated seed. The acres per day assumed 120 lbs. of wheat per acre, planting an average of 250 acres per day (2).

2.2 Risk From Handler Exposures EPA calculated the potential risk to persons from handler exposures and planting of treated seed using the daily dermal exposure scenarios identified in the exposure section.

Potential dermal and inhalation daily exposures for occupational handlers were calculated using the following formulas (10 percent dermal absorption was assumed):

The inhalation and dermal daily doses were calculated using the following formulas: 12 2.2.1 Risk From Handler Exposures Margins of Exposure (MOEs) were calculated for handlers for short term (one to seven days) and intermediate term (one week to several months) durations for both dermal and inhalation exposures.

The MOEs were calculated using the following formulas: 13 2.2.2 Summary of MOEs The daily exposures, resulting short and intermediate term MOEs are presented in Table 7. The exposure scenario descriptions are presented in Table 8. The results of the short term dermal exposure duration indicate that the MOEs range from 5.2 for on farm seed treatment to 34000 for the planting of treated seed . A total of 9 dermal and inhalation MOEs were calculated for the various scenarios. Based on the level of protection used in the studies, all of the MOEs for the application portion of seed treatment were less than 100. All other dermal MOEs were above 100. Inhalation MOEs for workers other than applicators for commercial treatment and seed handlers at large facilities are greater than 100.

2.2.3 Cancer Risks The OPP/ Cancer Assessment Review Committee (CARC) has completed the review of newly submitted carcinogenicity study in CD 1 mice along with other data. In accordance with the EPA Draft Guidelines for Carcinogen Risk Assessment (July, 1999), the CARC has classified lindane into the category "Suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential" based on an increased incidence of benign lung tumors in female mice only. The Committee, therefore, recommended that the quantification of human cancer risk is not required.

2.2.4 Insufficient Data Other studies are undergoing review by HED personnel at this time and may alter our estimate of exposure. 14 Table 5 Daily Exposures and MOEs for Commercial Seed Treatment Plant Worker Exposure Exposure Scenario (Scenario #) Application Rates ( lb ai/ 100 lbs seed or Lb/ A) Amount Handled per Day (lbs a. i.) Unit Exposure (mg/ lb ai) a Daily Exposure (mg/ kg/ day) Short Term MOEs &

Intermediate Term MOES Dermal Inhalation Dermal b Inhalation s Dermal c Inhalation e Mixing/ loading /planting dry formulation for on farm seed treatment (1) 0.043 4.7 9.4 0. 0016 0.074 0.00011 16 1200 Treater  Closed Transfer

chemical resistant coveralls over long sleeved shirt, long pants, chemical resistant gloves (2) 1.5 (canola high end) 76 0.00083 0.00012 0.036 0.0053 329 25 0.75 (canola low end) 1320 0.00083 0.00012 0.018 0.0026 657 49 0.043 (wheat) 2640 0.00083 0.00012 0.0010 0.00015 11462 859 Bagger/ Sewer /Stacker

chemical resistant coveralls over long sleeved shirt,

longpants, chemical resistant gloves  (3) 1.5 (canola high end) 76 0.00026 0.00006 0.011 0.0026 1049 49 0.75 (canola low end) 1320 0.00026 0.00006 0.0057 0.0013 2098 98 0.043 (wheat) 2640 0.00026 0.00006 0.00033 0.000076 36591 1718 Bagger/ Sewer /Stacker cotten/ polyester coveralls over long sleeved shirt,

longpants, chemical resistant gloves (4) 1.5 (canola high end) 76 0.0003 0.00006 0.013 0.00264 909 49 0.75 (canola low end) 1320 0.0003 0.00006 0.0066 0.0013 1818 98 0.043 (wheat) 2640 0.0003 0.00006 0.00038 0.000076 31712 1718 Forklift Operator  chemical resistant coveralls over long

sleeved shirt, longpants,

chemical resistant gloves (5) 1.5 (canola high end) 76 0.00008 7.7E 06 0. 0035 0.00034 34091 384 0.75 (canola low end) 1320 0.00008 7.7E 06 0. 0018 0.00017 6818 767 0.043 (wheat) 2640 0.00008 7.7E 06 0. 00010 9.7E 06 118922 13385 Cleaner  chemical resistant coveralls over long sleeved shirt, longpants, chemical resistant gloves (6) 1.5 (canola high end) 76 0.00669 0.00119 0.00011 1.98E 05 107623 6555 0.75 (canola low end) 1320 0.00669 0.00119 0.00011 1.98E 05 107623 6555 0.043 (wheat) 2640 0.00669 0.00119 0.00011 1.98E 05 107623.3 6555 a Median unit dermal and arithmetic mean inhaltion unit exposures b Dermal Exposure (mg/ kg/ day) = unit exposure (mg/ lb ai) x amount handled per day (lbs a. i.) / bw (60 kg).

c Dermal MOE = Dermal NOAEL (1. 2 mg/ kg) / [daily exposure (mg/ kg/ day) x dermal absorption factor (10%)].

d Inhalation Exposure (mg/ kg/ day) = inhalation unit exposure (mg/ lb ai) x amount handled per day (lbs a. i.) / body weight (70 kg).

e Inhalation MOE = NOAEL (0. 13 mg/ kg/ day) / daily exposure (mg/ kg/ day). 15 Table 6. Exposure Scenario Descriptions for the Use of Lindane.

Exposure Scenario (Scenario #) Data Source Standard Assumptions a Comments b Mixing/ loading /planting dry formulation for on farm seed treatment (1) Rhone Poulenc Data MRID # 444058 02 Assumes enough seed treated and planted for 100 Acres per day All data were for gloved hands; (see study,

Appendix A. )

Mixing/ loading/ application of liquid formulation for commercial seed treatment (2) Uniroyal Data MRID # 447305 01 176000 lbs of seed per day See study review; based on geometric mean of data and amounts of seed from study data Seed Handler for commercial seed treatment (3,

4,5,6) Uniroyal Data MRID # 447305 01 176000 lbs of seed per day See study review; based on geometric mean of data and amounts of seed from study data Loading and planting treated seed for planting (7) MRID 422519 01 Assumes 250 acres are planted per day at 120 lbs of seed per acre for wheat; 4 lbs per acre for canola, commercially treated seed Appendix C a All Standard Assumptions are based on an 8 hour work day as estimated by HED. 16 REFERENCES 1) Lindane  Report of the Hazard Identification Assessment Review Committee, July 27, 2000.

2) Memorandum from S. Tadayon (CEB1) to A. Khasawinah (RRB4) titled "Occupational and Residential Exposure Assessment and Recommendations for the Registration Eligibility Decision Document for Imazalil", dated April 15, 2,000.

3) EPA (1998) Surrogate Exposure Guide, Estimates of Worker Exposure from the Pesticide Handler Exposure Database Version 1.1 4) Memorandum from M. Howard (SRRD) to Lindane RED Team Members titled "Final Lindane Use Closure Memo" dated May 17, 2000 (EMAIL).

cc: Lindane file (009001) Correspondence file R. Kent (RRB4/ 7509C) D. Jaquith (RRB4/ 7509C) 17 APPENDIX A. MANUAL SEED TREATMENT (at farm):

CITATION: Fenske, R. A., A. M. Blacker, S. J. Hamburger, and G. S. Simon (1990) Worker Exposure and Protective Clothing Performance During Manual Seed Treatment with Lindane. Arch. Environ. Contam. Toxicol. 19, 190 196.

Fenske, R. A. Reregistration of Lindane Technical Case No. 0315, Chemical No. 9001. Worker Exposure to Lindane During Manual Seed Treatment. MRID No. 444058 02 Dermal and respiratory exposures of 4 male workers with prior experience were monitored during the manual treatment of winter wheat at a commercial wheat farm in South Dakota. The operations are considered to be representative of manual seed treatments in the midwest. A dust formulation containing 18.75 percent lindane, packaged in 10 lb bags was applied at the label rate of 2 ounces per bushel of seed. A total of 720 bushels of seed were treated. The treatment procedure involved the addition of grain to a 4 compartment, 12 bushel grain drill. The label instructions indicate the user is to fill the drill box half full of seed and add half of the formulation. The seed and formulation are then mixed with a stick. The rest of the grain is then added and the procedure repeated. After thorough mixing the seed was removed by a vacuum. Workers monitored in this study did not participate in the vacuuming procedure.

Each mixing consisted of the application of 24 oz (680 g) of the formulation to 12 bushels of grain. A plastic scoop, cut from a plastic bottle and determined to hold 12 oz of formulation, was used to remove the powder from the bag. The scoop was used to spread the formulation evenly over the seed.

Each replicate consisted of five mixings conducted by each of the four workers, the mixing activity lasting 4 6 minutes. The mixing periods averaged 24 minutes and were separated by 10 20 minute breaks. This was considered to be equal to one "work period". During this time a worker handled 120 oz of formulation or 1.4 lb of active ingredient. Each volunteer performed the tasks three times (total of 60 mixings), yielding a total of 12 work periods. During treatments the workers wore the label required long sleeve shirt, long pants, Nitrile gloves, a baseball cap, and a pesticide respirator. All clothing was new and/ or prewashed to avoid confounding analytical problems. The workers did not remove their gloves during the procedure but did during breaks.

Dermal exposures were monitored using gauze dosimeters encased in an envelope with a 5.6 cm diameter circle exposed to the environment (25 cm² total area). Dosimeters were either attached to the clothing or taped to the skin on the chest, back, shoulders, forearms, upper legs, or lower legs. Two sets of dosimeters were used, one outside the clothing and the other inside the work garments. Care was taken to avoid overlap of the dosimeters, which could confound the results of the inner monitors. Surface areas were assumed to be those outlined in the Agency's Guidance (OPPTS 875 Group A test guidelines, formerly Subdivision U).

Dermal exposure of the hands was monitored by hand wash with 250 mL of 10 percent isopropanol in distilled water. A plastic bag was wrapped around the wrist and the bag shaken for about 30 seconds. This procedure was repeated 3 times, resulting in a pooled volume of 750 mL for each hand. Hand rinses were conducted for each hand immediately prior to the exposure period and again 18 immediately after. Approximately 75 mL was transferred to a glass jar for storage.

Respiratory exposure was monitored using calibrated battery powered pumps attached to the belt with a 37 mm fiberglass filter attached to the collar in the breathing zone. The flow rate was approximately 2 liters per minute.

Dermal dosimeters and air filter cassettes were removed immediately after the exposure period. Gauze pads were removed from their holders with solvent rinsed tweezers and placed in individual 4 ounce glass jars. Filter were sealed and replaced in their original packing containers. All samples were maintained at 4° C during shipment and storage. Samples arrived at the analytical laboratory within 6 days of collection and analyzed within the next 2 months.

Fifty mL of hexane/ acetone (1/ 1, v/ v) was added to the dermal dosimeters jars and the jars shaken for 1 hour. A 100 : L aliquot of the extract was added to a 10 mL volumetric flask and 2 : L of internal standard/ surrogate chemical (aldrin and heptachlor, respectively). The resulting solution was brought to volume with hexane The results of exposure monitoring are presented in Table A1. 19 Table A1. Exposures of Workers Applying Lindane as a Seed Treatment at a Rate of 1.4 lb ai) Pounds of Active Ingredient per 60 Bushels of Grain (3600 lbs of seed, total. Values used for exposure estimation are in boldface.

Body Region Monitor Location Exposure (mg) Exposure (mg/ lb ai)

Mean Median Range Mean Median Chest Outer 3.21 2.43 0.92 7.84 2.3 1.7 Back Outer 2.48 2.48 0.85 4.58 1.8 1.8 Forearms Outer 17.75 15.25 5.57 51.79 13.0 11.0 Upper arms Outer 4.43 3.88 0.99 10.10 3.2 2.7 Upper legs Outer 33.96 20.46 2.90 132.55 24.0 15 Lower legs Outer 1.34 9.64 0.43 5.95 0.96 6.9 Chest Inner 0.45 0.44 0.07 0.71 0.32 0.31 Back Inner 0.71 0.52 0.11 2.59 0.51 0.37 Forearms Inner 5.43 3.46 1.31 16.70 3.9 2.5 Upper arms Inner 1.12 0.79 0.12 2.91 0.80 0.56 Upper legs Inner 2.88 2.18 0.08 9.32 2.1 1.6 Lower legs Inner 0.16 0.12 0 0.33 0.11 0.086 Hands 0.74 0.71 0.4 1.27 0.53 0.51 Head/ Neck 1.72 1.47 0.7 3.58 1.2 1.1 Total Dermal 13.21 9.69 9.4 7.1 Respiratory 0.0022 0 0 0.016 0.0016 0 mg/ lb ai = Exposure (mg) ÷ 1.4 lb ai 20 Calculation of Daily Exposures:

Assumptions:

1) An average worker weighs 60 kg for dermal risk assessment and 70 kg for inhalation exposure and has standard body surface areas and respiration rates as presented in the Pesticide Assessment Guidelines (OPPTS 875 Group A test guidelines).

2) Examination of the Census of Agriculture data for Kansas yielded a median farm sizes of in the 100 to 249 acre range. Three other wheat producing states (North Dakota, Washington, and Montana) had median farm sizes in the 250 to 499 acre range. A farm size of 500 acres was assumed. Workers were assumed to treat and plant enough seed for 250 Acres per day, yielding a short term exposure scenario.

3) Workers are assumed to wear the same clothing as those participating in the study. Typical clothing consists of a long sleeved shirt, long pants, and chemical resistant gloves.

4) Wheat is planted at a rate of 120 pounds of seed per acre and each bushel of seed weighs 60 pounds (Hanson, A. A. (Ed) (1989) Practical Handbook of Agricultural Science. CRC Press, Inc., Boca Raton, FLA.) and BEAD report.

5) While the application rate varies somewhat for various types of seeds, the application rate/ farm size is considered typical for lindane seed treatment products.

Amount of seed treated per 8 hour day:

Seed treated (lbs) = 100 A/ day x 120 lbs seed/ A l = 12000 lb seed/ day Amount of lindane handled per day:

Lbs ai handled per day = 2 oz/ bushel x 0.1875 x 200 bushels seed/ day x 1 lb/ 16 oz = 4.7 lbs ai/ day 21 Estimation of Exposure (manual seed treatment):

Dermal:

Dermal Exposure (mg/ kg/ day) = 9.4 mg/ lb ai x 4.7 lbs ai/ day ÷ 60 kg x 0.1 = 0.074 mg/ kg/ day Respiratory:

Respiratory Exposure (mg/ kg/ day) = 0.0016 mg/ lb ai x 12 lbs ai/ day ÷ 70 kg = 0.00011 mg/ kg/ day The resulting Dermal MOE is:

MOED = 1.2 mg/ kg/ day ÷ 0.074 mg/ kg/ day = 16 The resulting Inhalation MOE is:

MOEI = 0.13 mg/ kg/ day ÷ 0.00011 mg/ kg/ day = 1200 22 APPENDIX B UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 Date: April 23, 2002 MEMORANDUM SUBJECT: LINDANE: REVISION OF EXPOSURE ASSESSMENT FOR COMMERCIAL SEED TREATMENT PLANT WORKER (MRID 45200002, DP Barcode D282419) (Excerpt)

FROM David Jaquith Reregistration Action Branch 4 Health Effect Division (7509C)

TO: Rebecca Daiss Reregistration Branch 4 Health Effect Division (7509C)

2.2 Revised Exposure and Risk Estimates HED has reevaluated the estimates of exposure and risk from treatment of wheat and canola seed with lindane using median unit dermal and inhalation exposures provided in the HELIX 289FS Study. Unit exposures used for this assessment are summarized in Table 2. Unit exposure data from the HELIX study are presented in detail in Appendix A.

Table 2. Unit Dermal and Inhalation Exposures of Workers During Seed Treatment and Handling of Treated Seed 1 Median Unit Dermal and Inhalation Exposures Treater  Closed Transfer  Chemical Resistant coveralls over long sleeve shirt, long pants; chemical resistant gloves Dermal (n= 17) 0.83 : g/ lb/ ai Inhalation (n= 17) 0.12 : g/ lb/ ai Cleaner  Chemical Resistant coveralls over long sleeve shirt, long pants; chemical resistant gloves Dermal (n= 7) 6.70 : g/ kg bw Inhalation (n= 7) 1.20 : g/ kg bw Bagger/ Sewer/ Stacker  Chemical Resistant coveralls over long sleeve shirt, long pants; chemical resistant gloves Dermal  chemical resistant coveralls (n= 34) 0.26 : g/ lb/ ai Dermal  Cotton/ polyester coveralls (n= 19) 0.30 : g/ lb/ ai Table 2. Unit Dermal and Inhalation Exposures of Workers During Seed Treatment and Handling of Treated Seed 1 Median Unit Dermal and Inhalation Exposures 23 Inhalation (n= 53) 0.06 : g/ lb/ ai Forklift Operator  cotton/ polyester coveralls over long sleeve shirt, long pants; chemical resistant gloves Dermal (n= 12) 0.08 : g/ lb/ ai Inhalation (n= 12) 0.008 : g/ lb/ ai 1 Commercial Seed Treatment Plant Worker Exposure Study with Helix 289FS Seed Treatment on Canola (MRID 452000 02)

The application rate in the HELIX study was 400 gm thiamethoxam/ 100 kg seed (0.88 lb/ 220000 lb seed). The throughput of seed of 7000 kg/ hr (15400 lb/ hr), 6800 kg /hr( 14960 lb/ hr), 5000 kg/ hr (11000 lb/ hr), 5000 kg/ hr (11000 lb/ hr), 10000 kg/ hr (22000 lb/ hr) for sites 1 to 5, respectively. The following assumptions were used to estimate exposure:

6) The throughput of seed for both wheat and canola is 22000 lb/ per hour or 176000 lbs per 8 hour day.

7) The application rate for wheat is 0.043 lb ai per hundred weight of seed. The application rate for canola is 1.5 lb (high end) and 0.75 lb (low end) ai per hundredweight of seed.

3) Pounds handled per day for wheat:

lbs handled per day wheat = 176000 lbs/ day x 0.043 ÷ 100 lbs = 76 lbs/ day lbs handled per day canola (high end) = 176000 lbs/ day x 1.5 ÷ 100 lbs = 2640 lbs/ day lbs handled per day canola (low end) = 176000 lbs/ day x 0.75 ÷ 100 lbs = 1320 lbs/ day 4) Median unit dermal and inhalation exposures were used based on data distribution.

5) Worker body weight for dermal exposure = 60 kg (female body weight used for developmental endpoint) Worker body weight for inhalation exposure = 70 kg 24 APPENDIX C Date: April 24, 2002 MEMORANDUM SUBJECT: REVISION OF EXPOSURE ASSESSMENT FOR PLANTING OF SEED TREATED WITH LINDANE DP BARCODE D282418, MRID 42251901 (Excerpt)

FROM David Jaquith Reregistration Action Branch 4 Health Effect Division (7509C)

TO: Becky Daiss Reregistration Branch 4 Health Effect Division (7509C)

THRU Susan Hummel, Senior Scientist Reregistration Branch 4 Health Effects Division (7509C)

2.0 CONCLUSIONS HED has reevaluated the estimates of exposure and risk from planting of wheat and canola seed with lindane using a study specifically addressing this scenario rather than using PHED as a model for planting seeds. Using an oral NOAEL of 1.2 mg/ kg/ day to assess dermal risk and an inhalation NOAEL of 0.13 mg/ kg/ day the MOEs are : 25 Estimation of Dermal and Respiratory Exposures or Risksof Workers Planting Wheat and Canola Seed Treated with Lindane Dermal Exposure (mg/ kg/ day) Respiratory Exposure (mg/ kg/ day) MOE Dermal Respiratory Wheat 0.0013 0.00011 920 1200 Canola 0.0015 0.00013 800 1000 Examination of the data from the revised assessment, derived from a planting study (not included in PHED) and the previous assessment from PHED indicates that there are a large number of non detect samples in both of the data sets. Since the original PHED derived estimates, which separated loading from planting showed large numbers of non detects for the planting function, it is evident that the loading contributes the majority of the exposure and that the actual planting task contributes relatively little to the total exposure.

3.0 CALCULATION OF EXPOSURES In order to estimate the exposures of workers planting seed treated with lindane a number of assumptions regarding amount of seed planted and other parameters were required.

6) It is assumed that 250 acres of wheat or canola can be planted in a day (2).

7) An average worker has a body weight of 60 kg (a change from the previous assessment due to changes in the toxicological parameters) for dermal assessment. A weight of 70 kg is used for inhalation assessments.

8) Wheat is planted at a rate of 120 lbs of seed per acre. Canola is planted at a rate of 4 lbs seed per acre.

9) The application rate of lindane on wheat seed is 0.68 oz/ cwt (0.043 lb/ cwt). For canola the rate is 23.3 oz/ cwt (1.5 lb ai/ cwt). See Appendix B.

10) The dermal absorption of lindane is 10 percent (1).

3.1 Exposure Assessment for Wheat Amount of lindane handled per day: 26 Lbs ai/ day = 250 A/ day x 120 lb seed/ A x 0.043 lb ai/ 100 lbs seed = 12.9 lb ai/ day The resulting dermal exposure using arithmetic mean values from Appendix A is:

Dermal Exposure (mg/ kg/ day) = 0.0597 mg/ lb ai x 12.9 lb ai/ day x 0.1 (abs) ÷ 60 kg bw = 0.0013 mg/ kg/ day The resulting dermal MOE using a NOAEL of 1.2 mg/ kg/ day is:

MOE = 1.2 mg/ kg/ day/ 0.0013 mg/ kg/ day = 920 The respiratory exposure is:

Respiratory Exposure (mg/ kg/ day) = 12.9 lb ai/ day x 0.0006 mg/ lb ai ÷ 70 kg = 0.00011 mg/ kg/ day The resulting respiratory MOE using a NOAEL of 0.13 mg/ kg/ day is:

MOE = 0.13 mg/ kg/ day/ 0.00011 mg/ kg/ day = 1200 3.1 Exposure Assessment for Canola Amount of lindane handled per day:

Lbs ai/ day = 250 A/ day x 4 lb seed/ A x 1.5 lb ai/ 100 lbs seed = 15 lb ai/ day The resulting dermal exposure using arithmetic mean values from Appendix A is:

Dermal Exposure (mg/ kg/ day) = 0.0597 mg/ lb ai x 15 lb ai/ day x 0.1 (abs) ÷ 60 kg bw = 0.0015 mg/ kg/ day The resulting dermal MOE using a NOAEL of 1.2 mg/ kg/ day is:

MOE = 1.2 mg/ kg/ day/ 0.0015 mg/ kg/ day = 800 The respiratory exposure is:

Respiratory Exposure (mg/ kg/ day) = 15 lb ai/ day x 0.0006 mg/ lb ai ÷ 70 kg = 0.00013 mg/ kg/ day The resulting respiratory MOE using a NOAEL of 0.13 mg/ kg/ day is: 27 MOE = 0.13 mg/ kg/ day/ 0.00013 mg/ kg/ day = 1000 28


[Federal Register Volume 88, Number 186 (Wednesday, September 27, 2023)]
[Notices]
[Page 66467]
[FR Doc No: 2023-20999]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4652-DR; Docket ID FEMA-2023-0001]

New Mexico; Amendment No. 15 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster for the
State of New Mexico (FEMA-4652-DR), dated May 4, 2022, and related
determinations.

DATES: This amendment was issued August 8, 2023.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated August 8, 2023, the President amended the cost-sharing
arrangements regarding Federal funds provided under the authority of
the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42
U.S.C. 5121 et seq. (the ``Stafford Act''), in a letter to Deanne
Criswell, Administrator, Federal Emergency Management Agency,
Department of Homeland Security, under Executive Order 12148, as
follows:

    I have determined that the damage in certain areas of the State
of New Mexico resulting from wildfires, straight-line winds,
flooding, mudflows, and debris flows during the period of April 5 to
July 23, 2022, is of sufficient severity and magnitude that special
cost sharing arrangements are warranted regarding Federal funds
provided under the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford Act'').
    Therefore, I amend my declarations of May 4, 2022, June 9, 2022,
June 27, 2022, and August 24, 2022, to authorize Federal funds for
Public Assistance, including direct Federal assistance, at 100
percent of the total eligible costs for projects undertaken in
response to the Cerro Pelado Fire in Los Alamos and Sandoval
Counties.
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-20999 Filed 9-26-23; 8:45 am]
BILLING CODE 9111-23-P