        AGENDA
                   U.S. ENVIRONMENTAL PROTECTION AGENCY (EPA)
                       TOXIC SUBSTANCES CONTROL ACT (TSCA)
                SCIENCE ADVISORY COMMITTEE ON CHEMICALS (SACC)
                                   PUBLIC MEETING
                               September 10 - 12, 2019

               TSCA SACC WEB SITE: http://www.epa.gov/tsca-peer-review
                     DOCKET NUMBER: EPA - HQ - OPPT - 2019 - 0235
   MEETING LOCATION: Hyatt Regency Crystal City at Reagan National Airport,
            2799 Jefferson Davis Highway, Arlington, Virginia 22202

          [Please note that all times are approximate as noted at the
     end of the Agenda. Agency speakers may change based on availability.]

 Title:  Peer Review for the U.S. EPA Draft Risk Evaluation for                                  1-Bromopropane (1-BP)
                                         Day 1
                             Tuesday, September 10, 2019
                                        Day 1
                             Tuesday, September 10, 2019

                    9:00 A.M. 	Opening of Meeting  -  Tamue Gibson, M.S., Designated Federal Official, Office of Science Coordination and Policy, EPA

  9:10 A.M. 	Introduction and Identification of Committee Members  -  Kenneth Portier, Ph.D., TSCA Science Advisory Committee on Chemicals (SACC) Chair

  9:20 A.M.		Introduction and Welcome - EPA Office of Pollution Prevention and
            Toxics (OPPT) Immediate Office

  9:30 A.M. 	OPPT Technical Presentation  -  Overview of 1-Bromopropane Risk Evaluation - Katherine Anitole, Ph.D., EPA/OPPT/RAD

11:00 A.M.		Break

11:15 A.M.		Public Comments

 Mr. Richard Denison, Ph.D., Lead Senior Scientist, Environmental Defense Fund             [5 minute public comment]

 Ms. Stephanie Schwarz, Legal Fellow, Environmental Defense Fund                                    [5 minute public comment]

 Ms. Lindsay McCormick, Program Manager, Environmental Defense Fund                       [5 minute public comment]
 Mr. Robert Sussman, Safer Chemicals Healthy Families                                                       [5 minute public comment- via telephone]

 Ms. Suzanne Hartigan, Ph.D., American Chemistry Council                                            [5 minute public comment]

 Mr. Jonathan Kalmuss-Katz, J.D., EarthJustice                                                                         [5 minute public comment- via telephone]

 Ms. Swati Rayasam, MSc and Ms. Tracey Woodruff, Ph.D., University of California, San Francisco [10 minute public comment (5 minutes allocated for each presenter)]

12:00 P.M. 	Lunch
  1:00 P.M. 		Charge to the Committee
Systematic Review
Question 1. To meet the TSCA scientific standards, EPA applied systematic review approaches and methods to support the draft risk evaluation of 1-BP. Information on the approaches and/or methods is described in the draft risk evaluation as well as several supplemental documents.

      1.1.	Please comment on the approaches and/or methods used to support and inform the gathering, screening, evaluation, and integration of data/information used in the Draft Risk Evaluation for 1-Bromopropane (1-BP).
      1.2. 	Please also comment on the clarity of the information as presented related to systematic review and suggest improvements as warranted.

Occupational Exposure Assessment

Question 2. EPA evaluated acute and chronic exposures to workers for conditions of use in industrial and commercial settings. For exposure via the inhalation pathway, EPA quantified occupational exposures for both workers and occupational non-users based on a combination of monitoring data and modeled exposure concentrations. For exposure via the dermal route, EPA modeled exposure for workers, accounting for the effect of volatilization and glove use. EPA assumed dermal exposure would not occur for occupational non-users.

EPA assumed that workers and occupational non-users would be adults of both sexes (>16 and older, including women of reproductive age) based on occupational work permits.
      2.1.	Please comment on the approaches and estimation methods, models, and data used in the occupational exposure assessment.

      2.2.	Please provide any specific suggestions or recommendations for alternative data, or estimation methods that could be considered by the Agency for conducting the occupational exposure assessment.

  3:00 P.M. 		Break
  3:15 P.M. 		Charge to the Committee (Continued)
Consumer Exposure Assessment
Question 3.	EPA evaluated acute inhalation exposure to consumers for the following nine product use scenarios: adhesive accelerants, general spray cleaners, spot cleaner/stain
removers, mold cleaning/release, general cleaners-degreasers, degreasers-electronics, coin/scissors cleaner, automobile AC flush products, and insulation, which contain 1-BP. EPA also evaluated acute dermal exposure to consumers using general cleaners-degreasers, coin/scissors cleaner, and automobile AC flush products containing 1-BP. This was based on the assumption that there is a continuous supply of product against the skin during use or a barrier prohibiting evaporation (submersion into a pool of product, or a product-soaked rag covering the skin). Consumer uses of the above listed products are not expected to be chronic in nature and, therefore, EPA did not evaluate chronic inhalation or dermal exposure.

EPA evaluated exposure to consumers in residential settings following acute exposure and considered both users of a product and bystanders within the residence where the product was used. EPA considered users to be either adult (>21 years of age) or youth (16-20 years of age). A second youth group (11-15 years of age) are included in the evaluation although this age group is not expected to be a significant user of most product uses evaluated. Bystanders within a residence where product is used include individuals of any age group (infants, children, youth, adults, elderly).

Three models (CEM, MCCEM, and IECCU) were used to evaluate acute inhalation exposure depending on the condition of use evaluated. These three models are defined and discussed in detail within the 1-BP draft risk evaluation. Dermal exposure was evaluated using CEM.

Product specific consumer monitoring information was not identified during the systematic review process, therefore, model inputs related to consumer use patterns (duration of use, mass of product used, room of use, and similar inputs) are based on survey data found in the literature as described and referenced within the 1-BP draft risk evaluation. Weight fraction of chemical within products are based on product specific safety data sheets (SDS). Default values utilized within the models are based on literature reviewed as part of model development as well as EPA's Exposure Factors Handbook.
      3.1.	Please comment on the approaches, models, exposure or use information (e.g., information on duration, number of user events, amount used) and estimates for the nine consumer uses evaluated for this draft risk evaluation.
      3.2.	Please provide any specific suggestions or recommendations for alternative approaches, models, exposure or use information (e.g., information on duration, number of user events, amount used) that could be considered by EPA in developing and/or refining the exposure assumptions and estimates for the nine consumer uses evaluated for this draft risk evaluation.

      3.3.	Dermal exposure was evaluated using a permeability method within CEM based on the availability of a permeability coefficient found within the literature in a study by NIOSH. The permeability method within CEM does not consider evaporation when estimating exposure which is the primary basis for EPA evaluating dermal exposure only for consumer uses where there is a continuous supply of product against the skin during use or a barrier prohibiting evaporation. Please comment on the chosen approach and provide any suggestions or recommendations for alternative approaches, dermal methods, models, or other information which may guide EPA in developing and refining the dermal exposure estimates.
  4:15 P.M. 		Break
  4:30 P.M. 		Charge to the Committee (Continued)
Environmental Hazard and Risk Characterization
Question 4.	Reasonably available information indicates that 1-BP exhibits a moderate environmental hazard to aquatic species. A screening-level analysis of potential risk to aquatic species indicates that expected environmental concentrations are below hazard thresholds for aquatic species. In addition, a qualitative consideration of physical-chemical properties and the conditions of use in this draft risk evaluation indicate that risks to sediment-dwelling invertebrate species and terrestrial species are not expected.
      4.1.	Only a few environmental test data endpoints (including ECHA) are available in the public domain for 1-BP. Most are from the ECHA website. EPA attempted to obtain the full ECHA studies with no success. Since the studies were in French and Japanese (and no U.S.A. sponsor), EPA decided not to make further attempts to find the studies. Given that the ECHA environmental test data results are in the public domain, EPA decided to use the environmental data. Please comment on the reasonableness of this approach for the environmental hazard assessment of 1-BP.
      4.2.	EPA determined that there are no environmental risks based on a screening-level assessment of risk using environmental hazard data, TRI exposure data, fate information, and physical/chemical properties. Please comment on the approach used in the screening-level assessment. Are there other data that EPA could have considered? If so, please provide specific data and references.

  5:30 P.M.		Adjourn

                                        Day 2
                            Wednesday, September 11, 2019
                                       Day 2
                            Wednesday, September 11, 2019

                    9:00 A.M. 	Opening of Meeting  -  Tamue Gibson, M.S., Designated Federal Official, OSCP, EPA

  9:05 A.M. 	Committee Members: Follow-up from the Previous Day  -  Kenneth Portier, Ph.D., TSCA SACC Chair
  9:15 A.M. 		Charge to the Committee
Human Health Hazard and Dose-Response Assessments
Question 5.	EPA considered the adverse human health effects for 1-BP across organ systems and screened for those that are relevant, sensitive, and found in multiple studies. The 1-BP human health hazard systematic review process screened 813 studies and obtained 29 studies that were relevant and applicable to the PECO statement. Five of these studies were unacceptable based on data evaluation criteria. The remaining database of 24 studies included epidemiological studies that examined associations between 1-BP exposure and endpoints related to effects on the nervous system, as well as repeat-dose experimental animal studies. For hazard identification and dose-response, EPA reviewed the evidence for 1-BP toxicity and selected liver toxicity, kidney toxicity, reproductive/developmental toxicity, neurotoxicity, and cancer. Data on toxicity following acute exposures, and genotoxicity were also considered. From these effects, EPA selected endpoints supported by the weight-of-the-scientific evidence (WOE) for non-cancer and cancer that demonstrated the most robust, sensitive and consistent adverse human health effects for risk characterization and that were amenable to quantitative analysis for dose-response assessment. The appropriate toxicological studies to be used for acute and chronic exposure scenarios were then selected. EPA used benchmark dose (BMD) modeling where practicable and, when BMD values were adequate, they were used to generate the Point of Departure (POD) for characterizing chronic and acute exposure scenarios. EPA determined that using developmental toxicity and neurotoxicity endpoints for dose-response calculation would be protective of the most sensitive life stages, including the developing fetus for non-cancer PODs and risk estimates.
For the non-cancer assessment, EPA identified liver toxicity, kidney toxicity, reproductive/developmental toxicity, and neurotoxicity in the risk assessment as adverse human health effects for risk characterization. EPA used developmental toxicity to calculate PODs to assess non-cancer risks associated with acute inhalation exposures. EPA used all of the endpoints to calculate PODs to assess non-cancer risks associated with chronic inhalation exposures.
      5.1.	As part of the review, please comment on the choice of these endpoints as PODs for assessing risks in humans associated with acute and chronic inhalation exposures to 1-BP. Specifically, are there other data that EPA could have considered for the hazard identification and dose-response associated with acute inhalation exposures? If so, please provide specific data and references. Are there other data that EPA could have considered for the hazard identification and dose response associated with chronic inhalation exposures? If so, please provide specific data and references.
      5.2.	Please comment on the WOE analysis for the choices of non-cancer endpoints for the acute and chronic risk scenarios. Please provide additional data, data interpretation or information that would have informed the WOE analysis and selection of critical studies for the PODs.

The CSAC Peer Review of the Application of Systematic Review in TSCA Risk Evaluations document (U.S. EPA, 2018a) recommended that while the majority of exposures are occurring via inhalation, and inhalation exposure is the most important, dermal exposures might be an important contributor to overall exposure and an estimate for dermal exposure should be included in the evaluation with gaps/limitations clearly stated to address another potential workplace exposure pathway. Limited toxicological data is available by the oral route, and no repeated-dose toxicity studies by the dermal route were identified on 1-BP. Physiologically based pharmacokinetic/pharmacodynamic (PBPK/PD) models that would facilitate route-to-route extrapolation have not been identified, and there are no relevant kinetic or metabolic information for 1-BP that would facilitate development of dosimetric comparisons. Therefore, when EPA derived HEDs for dermal exposures, the limited oral studies were not used and HEDs for dermal exposures were derived by extrapolating from the inhalation PODs.

      5.3. 	Please comment on the assumptions, strengths, and weaknesses of this approach including using an inhalation study instead of a limited oral study for route-to-route extrapolation for determining dermal PODs in the non-cancer assessment.
10:45 A.M.		Break
11:00 A.M. 		Charge Question 5 (Continued)

In the 2016 Draft Risk Assessment (U.S. EPA, 2016), decreased live litter size (i.e. reduced number of live pups per litter) was the endpoint selected as most relevant for calculating risks associated with developmental toxicity following chronic, exposures (WIL Research, 2001). A BMR of 5% was used to address the severity of this endpoint (U.S. EPA, 2012). This endpoint choice is a combination of reproductive effects where a BMR of 10% relative deviation would be used and developmental effects of post implantation loss which is considered a severe effect, like mortality where a BMR of 1% relative deviation would be used and so an intermediate value of 5% was used. The POD for the decreased live litter size was a BMDL of 43 ppm. The CSAC Peer Review of the 2016 Draft Risk Assessment (U.S. EPA, 2016) recommended using nested modeling on this developmental endpoint to account for intra-litter correlations and litter specific covariates. In response to this recommendation, EPA used the BMDS nested dichotomous model, evaluated multiple covariates of dam weight and number of implantation sites and selected the NCTR model. However, this model can only be applied to increases in effects and therefore, increased post-implantation loss was the endpoint selected as most relevant for calculating risks associated with developmental toxicity following chronic exposures (WIL Research, 2001) using nested modeling. A BMR of 1% was used to address the severity of this endpoint which is considered a severe effect like mortality (U.S. EPA, 2012). The POD for the increased post-implantation loss was a BMDL of 23 ppm.
      5.4. 	Please comment on the nested modeling approach and the selection of endpoints and whether the draft risk evaluation has adequately described the use of this model.
11:45 A.M. 		Lunch
12:45 P.M. 		Charge Question 5 (Continued)

For the cancer risk assessment, EPA derived the inhalation unit risk (IUR) based on lung
tumors in female mice. The precise mechanism(s)/mode(s) of action of 1-BP carcinogenesis are not clearly understood. There are, however, an abundance of data, including in vitro tests, metabolism across species, SAR and other potential mechanisms of action, that provide a basis for a WOE evaluation. The WOE evaluation presented in the draft 1-BP Risk Evaluation proposes a mutagenic, and possibly additional, modes of action for carcinogenesis. Other possible mechanisms of action  -  oxidative stress, immunosuppression, and cell proliferation -- could act synergistically to complete the multi-stage process of carcinogenesis. Per EPA Guidelines for Carcinogen Risk Assessment, overall, reasonably available information and the WOE analysis for the cancer endpoint was sufficient to support a mutagenic mode of action for 1-BP carcinogenesis.
      5.5. 	EPA concluded in the human health risk assessment that 1-BP carcinogenesis occurs through a mutagenic mode of action (MMOA) based on reasonably available information and the WOE. Please comment whether the cancer hazard assessment has adequately described the WOE regarding the MMOA.
      5.6. 	Typically, EPA uses the benchmark dose modeling software (BMDS) with a BMR of 10% and the models are restricted to multistage models or the broader suite of dichotomous models in BMDS and a single best model is chosen for the POD. EPA used an alternative approach to calculate the cancer POD versus the standard approach of choosing best fit model and to assess the impact of model uncertainty. Briefly, EPA used two model averaging approaches (frequentist and Bayesian) considering multiple benchmark dose models to calculate the POD at benchmark response (BMR) levels of 0.1% and 10% and for added and extra risk. Please comment on the assumptions, strengths and weaknesses of the model averaging approach for determining the POD in the cancer assessment.
      5.7. 	In agreement with EPA's long-standing approach, all three tumor types from the NTP study (NTP, 2011) were dose-response modeled with multistage models using the typical constrained model coefficients >=0 (EPA, 2012). Under the U.S. EPA's 2005 cancer guidelines (U.S. EPA, 2005), quantitative risk estimates from cancer bioassay data were calculated by modeling the data in the observed range to estimate a BMCL for a BMR of 10% extra risk, which is generally near the low end of the observable range for standard cancer bioassay data. The BMCs and BMCLs are shown for each of the three cancer datasets. The results for a BMR of 0.1% added risk are presented for comparison. Please comment on the assumptions, strengths and weaknesses of the multistage modeling approach for determining the POD in the cancer assessment.

  2:15 P.M. 		Break

  2:30 P.M. 		Charge Question 6

Human Health Risk Characterization

Question 6.	EPA quantified non-cancer risks based on the Margin of Exposure (MOE), which is the product of dividing the scenario specific exposure into the hazard point of departure which is the no adverse effect level, based on animal and/or human studies. EPA calculated MOEs for acute or chronic exposures separately based on the appropriate noncancer POD and estimated exposure concentrations adjusted for durations. To determine if risks were present for relevant exposure scenarios, the endpoint-specific MOEs were compared to the endpoint-specific benchmark MOEs. The benchmark MOEs were the product of all of the relevant UFs identified for each non-cancer POD. If the MOE estimate was less than the benchmark MOE, the exposure scenario for non-cancer endpoints was interpreted as a human health risk. Cancer risk estimation consisted of multiplying the occupational scenario-specific exposure estimates by the cancer IUR to estimate the extra cancer risk. Extra lifetime cancer risk estimates from 1-BP exposure were compared to benchmark cancer risk levels of 10[-6], 10[-5] and 10[-4] (i.e., 1 in 10,000, 1 in 100,000 and 1 in 1,000,000).

The Frank R. Lautenberg Chemical Safety for the 21st Century Act amended TSCA on
June 22, 2016. TSCA § 6(b)(4)(A) states that relevant "potentially exposed or susceptible subpopulations" (PESS) be considered in the risk evaluation process. "The Administrator shall conduct risk evaluations pursuant to this paragraph to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator, under the conditions of use." Further, TSCA § 3(12) states: "The term `potentially exposed or susceptible subpopulation' means a group of individuals within the general population identified by the Administrator who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, or the elderly."

EPA interpreted the endpoint of decreases in live litter size following exposure to 1-BP before and during gestation, as a surrogate for frank developmental effects, as relevant to humans per EPA's Guidelines for Developmental Toxicity Risk Assessment. EPA used this endpoint to calculate a point of departure (POD) to assess non-cancer risks associated with acute inhalation exposures to 1-BP.

      6.1. 	Please comment on the assumptions, strengths and weaknesses of the MOE approaches used to estimate the non-cancer risks to workers and occupational non-users (e.g., adults of reproductive age) following acute inhalation exposures to 1-BP, including the MOEs presented in the document. Specifically, please suggest alternative data that could be used. Please comment on the selection of uncertainty factor values in deriving the benchmark MOE for acute inhalation exposures.

      6.2. 	Please comment on the assumptions, strengths and weaknesses of the MOE approaches used to estimate the non-cancer risks to consumers following acute inhalation exposures to 1-BP, including the MOEs presented in the document. Specifically, please suggest alternative data that could be used. Please comment on the selection of uncertainty factor values in deriving the benchmark MOE for acute inhalation exposures.

      6.3. 	Please comment on the assumptions, strengths and weaknesses of the MOE approaches used to estimate the non-cancer risks to workers and occupational non-users following chronic inhalation exposures to 1-BP, including the MOEs presented in the document. Please comment on the selection of uncertainty factor values in deriving the benchmark MOE for chronic inhalation exposures.

   4:00 P.M. 		Break

   4:15 P.M. 		Charge Question 6 (Continued)

      6.4. 	Please comment on the assumptions, strengths and weaknesses of the approach used to estimate extra lifetime cancer risks to workers which EPA-derived from an inhalation unit risk based on lung tumors in female mice for estimating incremental or extra individual lifetime cancer risk.

      6.5. 	Please comment on whether the risk characterization has adequately described the assumptions, uncertainties and data limitations in the methodology used to assess risks from 1-BP. Please comment on whether this information and the risk conclusions are presented in a logical, transparent manner and provide suggestions that could increase clarity in the risk characterization.

      6.6. 	Please comment on whether the risk characterization has adequately identified and characterized the "potentially exposed or susceptible subpopulations" (PESS) based on a thorough review of the reasonably available 1-BP exposure and health effects information on both potentially exposed and biologically susceptible subpopulations.

  5:30 P.M.		Adjourn

                                              Day 3
                            Thursday, September 12, 2019
                                     Day 3
                            Thursday, September 12, 2019

                    9:00 A.M. 	Opening of Meeting  -  Tamue Gibson, M.S., Designated Federal Official, OSCP, EPA

  9:10 A.M. 	Committee Members: Follow-up from the Previous Day  -  Kenneth Portier, Ph.D., TSCA SACC Chair

  9:20 A.M.		Charge to the Committee
General Risk Characterization
Question 7. 	After consideration of all information identified by EPA that pertains to 1-BP, EPA preliminarily concluded that 1-BP does not present an unreasonable risk of injury to the environment but does present an unreasonable risk of injury to human health under some of the conditions of use. EPA made these determinations considering risk to potentially exposed and susceptible subpopulations identified as relevant, under the conditions of use without considering costs or other non-risk factors.

      7.1. 	Please comment on the objectivity of the underlying data used to support the risk characterizations and the sensitivity of EPA's conclusions to analytic assumptions.

      7.2. 	Please comment on the characterization of uncertainties and assumptions including whether EPA has presented a clear explanation of underlying assumptions, accurate contextualization of uncertainties and, as appropriate, the probabilities associated with both optimistic and pessimistic projections, including best-case and worst-case scenarios.

      7.3. 	Please provide information on additional uncertainties and assumptions that EPA has not adequately presented.

      7.4.	Please comment on whether the information presented supports the findings outlined in the draft risk characterization section. If not, please suggest alternative approaches or information that could be used to develop a risk finding in the context of the requirements of EPA's Final Rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR 33726).

11:20 A.M.		Break
11:40 A.M. 	Charge Question 8

Content and Organization

Question 8.	EPA's Final Rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR 33726) stipulates the process by which EPA is to complete risk evaluations under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. To that end, EPA has completed a draft risk evaluation for 1-BP.
As part of this draft risk evaluation for 1-BP, EPA conducted an assessment of potential environmental, occupational and consumer exposures. The evaluation considered reasonably available information, including manufacturing, import, processing, distribution in commerce, use, and disposal information. It is important that the information presented in the draft risk evaluation and accompanying documents are clear and concise and describe the process in a scientifically credible manner.

      8.1. 	Please comment on the overall content, organization, and presentation of the draft risk evaluation of 1-BP.

      8.2. 	Please provide suggestions for improving the clarity of the information
      presented in the documents.
                  12:45 P.M. 	Closing Remarks  -  Kenneth Portier, Ph.D., TSCA Science Advisory Committee on Chemicals (SACC) Chair
  1:00 P.M. 		Adjourn

Please be advised that agenda times are approximate; when the discussion for one topic is completed, discussions for the next topic will begin. For further information, please contact the Designated Federal Official for this meeting, Tamue Gibson, M.S., via telephone:<PHONE_NUMBER>; or email<EMAIL_ADDRESS>


[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Page 693]
[FR Doc No: 2019-00461]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Citation Change for Commision Rulemakings

    Take notice that on January 1, 2019, the Commission will be
changing its official citation format for orders in rulemaking
proceedings. Because Commission orders in rulemaking proceedings
currently are published in a variety of sources (posting on eLibrary
and the Commission website, and distribution through LexisNexis,
Westlaw, Commerce Clearing House, and the Federal Register), adoption
of a standard citation format will permit citation uniformity across
all sources and simplify the citation of Commission rulemakings.
    Accordingly, citations to rulemakings must use the FERC citation
assigned by the Commission when issuing orders, e.g., 162 FERC ]
61,001, at P 1 (2018). The FERC citation format alone suffices for
future rulemaking proceedings, and also for those past rulemaking
proceedings in which the paragraphs of the order are individually
numbered and can be used for pinpoint citation. If, however, a pinpoint
page citation is provided to a past rulemaking proceeding that does not
contain individual paragraph numbers, both the FERC citation and a
pinpoint citation to FERC Stats. & Regs. (or to the Federal Register)
should be used.\1\
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    \1\ The Commission encourages participants, wherever possible,
to provide in their pleadings pinpoint citations to the relevant
paragraphs or pages.

    Dated: December 31, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-00461 Filed 1-30-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 180 (Monday, September 19, 2022)]
[Proposed Rules]
[Pages 57161-57165]
[FR Doc No: 2022-20135]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2021-0318; FRL-10004-01-R9]

Air Plan Approval; California; San Diego Air Pollution Control
District; San Joaquin Valley Unified Air Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: Under the Clean Air Act (CAA or ``Act''), the Environmental
Protection Agency (EPA) is proposing full approval of revisions to the
San Diego County Air Pollution Control District (SDCAPCD) and San
Joaquin Valley Unified Air Pollution Control District (SJVUAPCD)
portions of the California State Implementation Plan (SIP). These
revisions concern emissions of volatile organic compounds (VOC) from
architectural coating operations. We are proposing a full approval of
the amended SDCAPCD and SJVUAPCD architectural coatings rules because
they meet all the applicable requirements. We are taking comments on
this proposal and plan to follow with a final action.

DATES: Comments must be received on or before October 19, 2022.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2021-0318 at https://www.regulations.gov. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. 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, please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section. For 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. If you need assistance in a
language other than English or if you are a person with disabilities
who needs a reasonable accommodation at no cost to you, please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Arnold Lazarus, EPA Region IX, 75
Hawthorne St., San Francisco, CA 94105. By phone:<PHONE_NUMBER> or by
email at [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. The State's Submittals
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rule revisions?
II. The EPA's Evaluation and Action
    A. How is the EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. What are the rule deficiencies?
    D. The EPA's Recommendations to Further Improve the Rules
    E. Proposed Action and Public Comments
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. The State's Submittals

A. What rules did the State submit?

    Table 1 lists the rules addressed by this proposal with the dates
that they were adopted by the local air agency and submitted by the
California Air Resources Board (CARB).

                                             Table 1--Submitted Rule
----------------------------------------------------------------------------------------------------------------
                                                                              Adopted/amended/
     Local agency          Rule No.                  Rule title                   revised           Submitted
----------------------------------------------------------------------------------------------------------------
SDCAPCD...............          67.0.1  Architectural Coatings.............  2/10/2021          4/20/2021, as an
                                                                              (effective for     attachment to a
                                                                              state law          letter dated 4/
                                                                              purposes on 1/1/   16/2021.
                                                                              2022).
SJVUAPCD..............            4601  Architectural Coatings.............  4/16/2020          4/23/2020, as an
                                                                              (effective upon    attachment to a
                                                                              adoption but the   letter of the
                                                                              new or revised     same date.
                                                                              VOC content
                                                                              limits were
                                                                              effective 1/1/
                                                                              2022).
----------------------------------------------------------------------------------------------------------------

    The submittal for SDCAPCD Rule 67.0.1 became complete by operation
of law on October 20, 2021. On June 29, 2020, the EPA determined that
the submittal for SJVUAPCD Rule 4601 met the completeness criteria in
40 CFR part 51, appendix V.\1\
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    \1\ Letter from Elizabeth J. Adams, Director, Air and Radiation
Division, EPA Region IX, to Richard W. Corey, Executive Officer,
CARB, dated June 29, 2020.
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B. Are there other versions of these rules?

    We approved an earlier version of SDCAPCD Rule 67.0.1 into the SIP
on October 4, 2016 (81 FR 68320). The SDCAPCD adopted revisions to Rule
67.0.1 on February 10, 2021, and the revisions became effective as a
matter of state law on January 1, 2022. CARB submitted the amended rule
to the EPA on April 20, 2021, as an attachment to a letter dated April
16, 2021. If we take final action to approve the February 10, 2021
version of Rule 67.0.1, it will replace the previously-approved version
of the rule in the SDCAPCD portion of the applicable California SIP.
    We approved an earlier version of SJVUPACD Rule 4601 into the SIP
on November 8, 2011 (76 FR 69135). The SJVUAPCD adopted revisions to
Rule 4601 on April 16, 2020 (effective upon adoption), and CARB
submitted the amended rule to us on April 23, 2020, as an attachment to
a letter of the same date. If we take final action to approve the April
16, 2020 version of Rule 4601, it will replace the previously-approved
version of the rule in the SJVUAPCD portion of the applicable
California SIP.

C. What is the purpose of the submitted rule revisions?

    Emissions of VOCs contribute to the production of ground-level
ozone, smog and particulate matter, which harm human health and the
environment. Section 110(a) of the CAA requires states to submit
regulations that control VOC emissions. Architectural coatings are
coatings that are applied to stationary structures and their
accessories. They include house paints, stains, industrial maintenance
coatings, traffic coatings, and many other products. VOCs are emitted
from the coatings during application and curing, and from the
associated solvents used for thinning and clean-up.
    SDCAPCD Rule 67.0.1 and SJVUAPCD Rule 4601 regulate VOC emissions
from architectural coatings. The rules were updated to conform to
CARB's Suggested Control Measures (SCM) for Architectural Coatings, May
2019. More specifically, to conform with CARB's 2019 update of the SCM
for architectural coatings, SDCAPCD and SJVUAPCD added certain new
categories of coatings, tightened VOC limits for certain other
categories of coatings, added new limits for colorants, updated test
methods, and clarified and tightened certain definitions and
administrative requirements. SDCAPCD estimates that aligning Rule
67.0.1 with the CARB 2019 SCM for architectural coatings will reduce
VOC emissions by approximately 0.22 tons per day (tpd) in San Diego
County.\2\ SJVUAPCD estimates that aligning Rule 4601 with the CARB
2019 SCM will reduce VOC emissions in San Joaquin Valley by
approximately 0.30 tpd.\3\
---------------------------------------------------------------------------

    \2\ SDCAPCD, Agenda Item, February 10, 2021, Subject: Noticed
Public Hearing--Adoption of Amendments to Rule 67.0.1--Architectural
Coatings (Districts: All), Attachment C, Incremental Cost-
Effectiveness Analysis, Proposed Amended Rule 67.0.1--Architectural
Coatings, page C-1.
    \3\ SJVUAPCD, Final Draft Staff Report, Proposed Amendments to
Rule 4601 (Architectural Coatings) April 16, 2020, pages 13-14.
---------------------------------------------------------------------------

    Both rules were also amended to include provisions to address
contingency measure requirements for nonattainment areas with respect
to ozone national ambient air quality standards (NAAQS). With respect
to contingency provisions, the air districts amended their respective
architectural coatings rules to include new sections that would remove
the rules' small container exemptions (SCE) (i.e., one liter or less)
for certain types of coatings within 60 days of the EPA's determination
that the area failed to meet a reasonable further progress (RFP)
milestone or to attain the ozone national ambient air quality standards
(NAAQS) by the applicable attainment date. As originally submitted, the
contingency provision in the SJVUAPCD architectural coatings rule
(section 4.3 of Rule 4601) included language that was inconsistent with
the requirements for contingency measures in CAA sections 172(c)(9) and
182(c)(9) and inconsistent with the intent of the SJVUAPCD's Board in
adopting the provision. However, the SJVUAPCD has subsequently made an
administrative correction to the rule text to clarify the contingency
measure provision consistent with the SJVUAPCD's Board's intent and has
submitted the revised rule to the EPA to replace the earlier submitted
version.\4\ For this proposed action, we are basing our evaluation on
the SJVUAPCD architectural coatings rule as corrected.
---------------------------------------------------------------------------

    \4\ Letter from Sheraz Gill, Deputy Air Pollution Control
Officer, SJVUAPCD, to Doris Lo, Manager, EPA Region IX, dated August
5, 2022. CARB submitted the corrected version of the rule to EPA
electronically on August 11, 2022, to replace to earlier version of
the rule.
---------------------------------------------------------------------------

    SDCAPCD estimates that removing the SCE for certain coatings will
reduce VOC emissions by approximately 0.72 tons per day (tpd) in San
Diego County.\5\ SJVUAPCD estimates that removing the SCE for certain
coatings will reduce VOC emissions in San Joaquin Valley by
approximately 0.65 tpd.\6\ The EPA's technical support documents (TSDs)
have more information about these rules.
---------------------------------------------------------------------------

    \5\ SDCAPCD, 2020 Plan for Attaining the National Ambient Air
Quality Standards for Ozone in San Diego County (October 2020),
Attachment O (Contingency Measures for San Diego County), page O-1.
    \6\ SJVUAPCD, Final Draft Staff Report, Proposed Amendments to
Rule 4601 (Architectural Coatings) April 16, 2020, pages 12-13.
---------------------------------------------------------------------------

II. The EPA's Evaluation and Action

A. How is the EPA evaluating the rules?

    Rules in the SIP must be enforceable (see CAA section 110(a)(2)),
must not interfere with applicable requirements concerning attainment
and reasonable further progress or other CAA requirements (see CAA
section 110(l)), and must not modify certain SIP control requirements
in nonattainment areas without ensuring equivalent or greater emissions
reductions (see CAA section 193). We are also evaluating whether the
rules meet the requirements for contingency measures specified in CAA
sections 172(c)(9) and 182(c)(9).

    Generally, SIP rules must require Reasonably Available Control
Technology (RACT) for each category of sources covered by a Control
Techniques Guidelines (CTG) document as well as each major source of
VOCs in ozone nonattainment areas classified as Moderate or above (see
CAA section 182(b)(2)). San Diego County and San Joaquin Valley have
been designated as Severe or Extreme nonattainment areas for the 2008
and 2015 8-hour ozone National Ambient Air Quality Standards (see 40
CFR 81.305).\7\ Because there is no relevant EPA CTG document for
architectural coatings and because there are no major architectural
coating sources within San Diego County or San Joaquin Valley,
architectural coatings are not subject to RACT requirements. However,
as nonattainment areas for ozone, San Diego County and San Joaquin
Valley are subject to the requirement to implement all reasonably
available control measures (RACM) as needed to attain the 2008 and 2015
ozone NAAQS by the applicable attainment dates. Guidance and policy
documents that we used to evaluate enforceability, revision/relaxation
and rule stringency requirements for the applicable criteria pollutants
include the following:
---------------------------------------------------------------------------

    \7\ San Joaquin Valley is also designated as Moderate
nonattainment for the 2012 PM2.5 NAAQS and Serious
nonattainment for the 1997 and 2006 PM2.5 NAAQS and is
thus subject to the requirement to implement reasonably available
control measures (RACM) and best available control measures (BACM).
However, VOC emissions do not contribute significantly to ambient
PM2.5 levels that exceed the PM2.5 NAAQS. See
85 FR 17382, at 17394 (March 27, 2020) (proposed approval of state's
precursor demonstration for the 2006 PM2.5 NAAQS in San
Joaquin Valley), finalized at 85 FR 44192 (July 22, 2020); and 86 FR
49100, at 49109 (September 1, 2021) (proposed approval of state's
precursor demonstration for the 2012 PM2.5 NAAQS in San
Joaquin Valley).Thus, submitted SJVUAPCD Rule 4601 does not need to
meet the requirements for RACM or BACM with respect to the
PM2.5 NAAQS
---------------------------------------------------------------------------

    1. ``State Implementation Plans; General Preamble for the
Implementation of Title I of the Clean Air Act Amendments of 1990,'' 57
FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992).
    2. ``Issues Relating to VOC Regulation Cutpoints, Deficiencies, and
Deviations,'' EPA, May 25, 1988 (the Bluebook, revised January 11,
1990).
    3. ``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies,'' EPA Region 9, August 21, 2001 (the Little Bluebook).
    4. National Volatile Organic Compound Emission Standards for
Architectural Coatings, 40 CFR 59, Subpart D.
    5. California Air Resources Board (CARB) Suggested Control Measure
for Architectural Coatings, May 2019.

B. Do the rules meet the evaluation criteria?

    We have evaluated the enforceability of submitted SDCAPCD Rule
67.0.1 and SJVUAPCD Rule 4601 with respect to applicability and
exemptions; standard of conduct and compliance dates; sunset
provisions; discretionary provisions; and test methods, recordkeeping
and reporting, and have concluded that both rules continue to be
enforceable for the purposes of CAA section 110(a)(2)(A).
    We have also determined that the submitted rules implement RACM-
level controls for this particular area source because the VOC content
limits are more stringent than the corresponding federal requirements
in Table 1 to Subpart D of 40 CFR part 59, ``Content Limits for
Architectural Coatings,'' and are consistent with CARB's 2019 SCM.
    Third, we have found that, because the submitted rules tighten VOC
content limits for certain coating categories and restrict certain
existing exemptions, they would not interfere with any applicable
requirement concerning attainment or reasonable further progress (RFP)
or any other requirement of the CAA, and as such, may be approved under
CAA sections 110(l) and 193.
    Lastly, we have reviewed the specific new provisions in submitted
SDCAPCD Rule 67.0.1 (paragraph (b)(6)) and submitted SJVUAPCD Rule 4601
(section 4.3) that are intended to address contingency measure
requirements for ozone nonattainment areas. As noted previously, the
contingency measure in both rules is the removal of the SCE for certain
coating categories within 60 days if the EPA makes certain final
determinations.
    Under the CAA, ozone nonattainment areas classified under subpart 2
as ``Serious'' or above must include in their SIPs contingency measures
consistent with sections 172(c)(9) and 182(c)(9). CAA section 172(c)(9)
requires states with nonattainment areas to provide for the
implementation of specific measures to be undertaken if the area fails
to make RFP or to attain the NAAQS by the applicable attainment date.
Such measures must be included in the SIP as contingency measures to
take effect in any such case without further action by the state or the
EPA. Section 182(c)(9) requires states to provide contingency measures
in the event that an ozone nonattainment area fails to meet any
applicable RFP milestone.
    Contingency measures are additional controls or measures to be
implemented in the event the area fails to make RFP or to attain the
NAAQS by the attainment date. Contingency measures must be designed so
as to be implemented prospectively; already-implemented control
measures may not serve as contingency measures even if they provide
emissions reductions beyond those needed for any other CAA purpose.\8\
The SIP should contain trigger mechanisms for the contingency measures,
specify a schedule for implementation, and indicate that the measure
will be implemented without significant further action by the state or
the EPA.\9\
---------------------------------------------------------------------------

    \8\ See Bahr v. EPA, 836 F.3d 1218, at 1235-1237 (9th Cir.
2016).
    \9\ See 70 FR 71612 (November 29, 2005); see also 2008 Ozone
SRR, 80 FR 12264 at 12285 (March 6, 2015).
---------------------------------------------------------------------------

    Neither the CAA nor the EPA's implementing regulations establish a
specific amount of emissions reductions that implementation of
contingency measures must achieve, but the 2008 Ozone SIP Requirements
Rule (SRR) reiterates the EPA's guidance recommendation that
contingency measures should provide for emissions reductions
approximately equivalent to one year's worth of RFP, thus amounting to
reductions of 3 percent of the baseline emissions inventory for the
nonattainment area.\10\ In a decision published in August 2021 in the
AIR v. EPA case, the U.S. Court of Appeals for the Ninth Circuit
remanded the EPA's approval of ozone contingency measures for the San
Joaquin Valley and held that, under EPA's current guidance, the surplus
emissions reductions from already-implemented measures cannot be relied
upon to justify the approval of a contingency measure that would
achieve far less than one year's worth of RFP as sufficient by itself
to meet the contingency measure requirements of CAA sections 172(c)(9)
and 182(c)(9) for the nonattainment area.\11\
---------------------------------------------------------------------------

    \10\ 80 FR 12264 at 12285 (March 6, 2015).
    \11\ Association of Irritated Residents v. EPA, 10 F.4th 937
(9th Cir. 2021) (``AIR v. EPA'' or ``AIR'').
---------------------------------------------------------------------------

    Based on our review of the submitted rules in light of the
requirements for contingency measures summarized above, we find that
the contingency measure in paragraph (b)(6) of submitted SCDAPCD Rule
67.0.1 meets the applicable requirements for such measures in CAA
sections 172(c)(9) and 182(c)(9) because the removal of the SCE for
certain coating categories is not required as RACT or RACM or for any
other CAA purpose; paragraph (b)(6) includes an appropriate triggering
mechanism (i.e., EPA final

determinations of failures to meet an RFP milestone or to attain the
NAAQS by the applicable attainment dates); paragraph (b)(6) specifies a
schedule for implementation (i.e., the SCE for the subject coatings
expires 60 days after EPA final determination); and paragraph (b)(6) is
designed to take effect (once triggered) without further significant
action by the District, CARB or the EPA.
    We have conducted a similar review of section 4.3 of submitted
SJVUAPCD Rule 4601 and find that it meets the applicable requirements
for contingency measures in CAA section 172(c)(9) and 182(c)(9). That
is, we find that removal of the SCE as provided in section 4.3 of
submitted SJVUAPCD Rule 4601 is not otherwise required under the CAA
and thus is eligible as a contingency measure and that section 4.3
specifies an appropriate schedule for implementation (i.e., 60 days
from EPA final rulemaking) and is designed to take effect (once
triggered) without further significant action by the District, CARB or
the EPA.
    Lastly, we have reviewed the Districts' estimate of the emissions
reductions that can be expected if the contingency measure provisions
(paragraph (b)(6) of submitted SDCAPCD Rule 67.0.1 and section 4.3 of
submitted SJVUAPCD Rule 4601) are triggered and find the estimates to
be reasonable and adequately documented. The emissions reductions
associated with the contingency measure provisions can be taken into
account by the EPA when determining whether the State and Districts
have fully met the requirements for San Diego County and the San
Joaquin Valley with respect to the contingency measure requirements
under CAA sections 172(c)(9) and 182(c)(9). The EPA expects to make the
determinations with respect to the area-wide contingency measure SIP
requirements in separate rulemakings.
    The TSDs have more information on our evaluation of the two
submitted architectural coatings rules.

C. What are the rule deficiencies?

    We have not identified any deficiencies that would prevent approval
of the two amended architectural coatings rules.

D. The EPA's Recommendations To Further Improve the Rules

    The TSDs include the EPA's recommendations for the next time the
local agencies modify the rules.

E. Proposed Action and Public Comment

    Pursuant to section 110(k)(3) of the Act, and for the reasons given
above, the EPA is proposing a full approval of submitted SDCAPCD Rule
67.0.1 and SJVUAPCD Rule 4601. For both submitted rules, our proposed
action is based on our finding that the non-contingency-related
amendments meet all applicable CAA requirements. With respect to the
contingency measure provisions in the submitted rules, our proposed
action is based on our finding that the provisions have the necessary
attributes of contingency measures under the CAA. Thus, we are
approving the provisions as contingency measures for the two areas for
the 2008 ozone NAAQS.
    We are not making any determination at this time as to whether
these individual contingency measures are sufficient in themselves for
their respective nonattainment areas to fully comply with the
contingency measure requirements under CAA sections 172(c)(9) and
182(c)(9). We will be taking action on the contingency measure SIP
elements for these areas in separate rulemakings and will be taking
into account the emissions reductions associated with the contingency
provisions in the submitted rules at that time. Regardless of whether
the contingency measure SIP elements are subsequently approved or
disapproved, we find that the contingency provisions in the submitted
rules strengthen the SIP for their respective nonattainment areas. We
will accept comments from the public on this proposal until October 19,
2022.
    If finalized as proposed, this action would incorporate the
submitted architectural coatings rules into the SIP and the submitted
rules would replace the corresponding existing SIP versions of the
rules in the California SIP.

III. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference SDCAPCD Rule 67.0.1 and SJVUAPCD Rule 4601, which regulate
VOC emissions from architectural coatings. The EPA has made, and will
continue to make, these materials available through https://www.regulations.gov and at the EPA Region IX Office (please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information).

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. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
proposed action 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, this proposed 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);
     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 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
     The state did not evaluate environmental justice
considerations as part of its SIP submittal. There is no information in
the record inconsistent with the stated goals of E.O. 12898 of
achieving environmental justice for people of color, low-income
populations, and indigenous peoples.
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the proposed 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 in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Particulate matter,
Reporting and recordkeeping requirements, Volatile organic compounds.

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

    Dated: September 12, 2022.
Martha Guzman Aceves,
Regional Administrator, Region IX.
[FR Doc. 2022-20135 Filed 9-16-22; 8:45 am]
BILLING CODE 6560-50-P


Chlorine Dioxide Dietary Risk Assessment Case 4023 A. Najm Shamim, Ph. D. Office of Pesticide Programs Antimicrobials Division U. S. Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC 20460 April 6, 2006 Page 2 of 18 Executive Summary The Antimicrobials Division has determined that dietary exposures from chlorine dioxide/ sodium chlorite use on direct and indirect food contact surfaces, disinfectant use in drinking water, slimcide use in paper/ pulp, washes for fruits and vegetables, and postharvest treatment for potatoes. AD has determined that there are chronic risks concerns for infants less than one year old (% cPAD = 145.1%) and non nursing infants (% cPAD = 179.8%) from chlorine dioxide treated drinking water.

Background:

In this document, the Antimicrobials Division has assessed the dietary exposure and risks due to the uses of chlorine dioxide and sodium chlorite in the residential scenarios; the exposure and risks also include those from uses on direct or indirect food contact hard surfaces, paper/ pulp slimicide use, and chlorine dioxide treated drinking water exposure and risks.

Table 1 summarizes the use/ site/ application rates for chlorine dioxide and sodium chlorite.

Table 1 Use Sites and Application Rates for Chlorine Dioxide and Sodium Chlorite Use Site EPA Reg. No. Method of Application Application Rates Mushroom facilities ( food contact) 74602 2, 9150 2, 9150 3, 9804 1 Flush equipment with sanitizing solution 100 200 ppm total available chlorine dioxide Potato storage: Potato rinse and humidification 9804 5, 5335 20, 21164 Spray, mist and fogger 200 400 ppm Poultry house disinfection: poultry chiller water/ carcass spray 74602 2, 74602 3, 9150 2, 9150 3, 9150 7, 9150 8 Dip carcass For chiller water: 50 150 ppm; For carcass spray: 500 1200 ppm Egg room/ hatching area, incubator room, tray washing room and loading platform 9150 2, 9150 3, 74602 2 High pressure spray 20 ppm for pre wash with sprayer Chick room, chick grading box and sex room 9150 2, 9150 3, 74602 2, Fogger, mop 1000 ppm with fogger Food processing plants ( poultry, meat, fish) Food contact surfaces 9150 2, 9150 3, 9150 7, 9804 1, 9804 9 53345 14, 53345 19, 53345 20, 70060 6 1 minute contact time 200 ppm total available chlorine dioxide Page 3 of 18 Dairies, breweries, and bottling plants Food contact surface sanitizer 9150 2, 9150 3, 9150 7, 9150 8, 53345 14,19, 20, 21, 21164 6,8,9, 9804 9, 74602 2, 5382 46, 74517 1, 1 minute contact time 200 ppm total available chlorine dioxide Fruits, vegetables 9150 8 Spray or dip 500 1200 ppm Fruits and vegetable rinses 9150 2, 9150 3, 9804 1, 9150 7, 9150 8, 45631 22, 45631 19, 53345 20, Immersion, spray 3 ppm Pulp/ paper mills 9150 2, 9150 3, 9804 1, 9804 9, 53345 22, 69151 3, 4, 21164, 6,8, 9, 21 None stated 4.5 gallons product per 100 tons of paper: 1.25 5 ppm ( 3.2 12.8 fluid ounces per 1000 gallons of water) Potable drinking water 69151 3,5, 21164 6,8,9,21 Metering pump: 1 mg/ L ( 1 ppm) or less 1 gallon per 100,000 of treated water None stated 1 mg/ l or less 5 ppm 1. Mushroom House Treatment A number of AD use labels ( EPA Reg. Nos. 74602 2, 9150 2, 9150 3, 9804 1) indicate the application of chlorine dioxide in mushroom facilities ( application rate varies between 100 200 ppm and the method of application is flush equipment); however, residue level is not indicated. The Agency, at this time, has not established any tolerances or exemptions from the requirement of tolerance for chlorine dioxide on mushroom uses. The Agency has not, at this time, conducted any dietary risk assessment for chlorine dioxide use for mushrooms.

2. Fruits and Vegetable Washes A chlorine dioxide/ sodium chlorite chronic dietary exposure assessment on fruit and vegetable washes was conducted using the DEEM FCID   , Version 2.0 software ( EPA, 2000), which incorporates consumption data from USDA's CSFII, 1994 1996 and 1998. The 1994 96, 98 data are based on the reported consumption of more than 20,000 individuals over two non consecutive survey days. Foods " as consumed" ( e. g., apple pie) are linked to EPA defined food commodities ( e. g. apples, peeled fruit  cooked; fresh or N/ S; baked; or wheat flour  cooked; fresh or N/ S, baked) using publicly available recipe translation files developed jointly by USDA/ ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U. S. population and within population subgroups. Based on analysis of the 1994 96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED ( OPP's Health Effects Division) concluded that it is most appropriate to report risk for the following Page 4 of 18 population subgroups: the general U. S. population, all infants (< 1 year old), children 1 2, children 3 5, children 6 12, youth 13 19, adults 20 49, females 13 49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food form ( e. g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/ food form. The resulting residue consumption estimate for each food/ food form is summed with the residue consumption estimates for all other food/ food forms on the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/ kg body weight/ day and as a percent of the cPAD ( chronic population adjusted dose). This procedure is performed for each population subgroup.

AD conducted a chronic risk assessment for the fruit and vegetable washes ( post harvest) with chlorine dioxide and sodium chlorite using 1 ppm as the input level for DEEM. Although label rates are allow use up to 5 ppm, AD believes that significant degradation of the sodium chlorite will occur by the time the fruits and vegetables reach the consumers and that 1 ppm is sufficiently conservative. The model parameters included all fresh fruits and vegetables, as well as juices. Chronic risks based on the DEEM exposure values are below the Agency's level of concerns. The highest risks were for children ages one to two years old ( 42.4% of the cPAD).

Table II Fruit and Vegetable Wash Exposures and Risks Population Subgroup Total exposure ( mg/ kg body wt./ day) % cPAD U. S. Population 0.003292 11 Infants < 1 year 0.003493 12 Children 1 6 years 0.009933 33 Children 7 12 years 0.004208 14 Females 13 50 0.002689 9 3. Drinking Water Exposures and Risks In a memo from Pat Fair of the EPA's Office of Water, exposure to chlorine dioxide from drinking water was characterized. Chlorine dioxide is used as a disinfectant in water treatment plants in the USA. Chlorite ion ( ClO2 ) is present in drinking water, and there are two possible ways it ends up in the drinking water: First, chlorine dioxide is produced via sodium chlorite used as a starting material and incomplete conversion of sodium chlorite into chlorine dioxide leaves residual chlorite ion in water, and second, a major breakdown product of chlorine dioxide in water is chlorite ion. Because of the health concerns of the presence of chlorite ion and its subsequent conversion to chlorate ion, the Agency wanted to make sure that the presence of chlorite ion did not exceed certain limits. In 1996, EPA instituted the Information Collection Rule ( ICR), and the most Page 5 of 18 extensive monitoring data on the occurrence of chlorite ion in drinking water was collected between July 1997 and December 1998.

Public Water Systems ( PWSs) serving a population of at least 100,000 report, under the ICR, treatment plant design and operational data and to conduct monitoring for specific microbial contaminants and disinfection byproducts, like chlorite ion. Chlorine dioxide treating plants conducted monthly monitoring for chlorite ion concentration in samples of finished water leaving the plant, as well as three sample points in the distribution system: near the first customer, an average residence time and a maximum residence time.

Monitoring data were collected from 22 water systems using chlorine dioxide treatment ( 29 treatment plants). The minimum reporting level ( MRL) was established at 20 µ g/ L. All samples below this value were considered zero. Data from 418 samples ( point of entry to the distribution) showed chlorite ion concentrations ranged from 20 µ g/ L to 2,029 µ g/ L. Data from 1,115 samples ( collected from within the distribution system) showed the concentration of chlorite ion between 20 µ g/ L to 1,850 µ g/ L. The average concentration of chlorite ion from 27/ 29 treatment plants, when averaged from the three distribution system sample points ( first customer, average residence time and maximum residence time), ranged from 20 µ g/ L to 801 µ g/ L.

Based on the results from this ICR monitoring data, the Agency in 1998 established a Stage 1 Disinfectants and Disinfection Byproduct Rule ( Stage 1 DBPR), which established a maximum contaminant level goal ( MCLG) and maximum contaminant level ( MCL) for chlorite ion: 0.8 mg/ L and 1.0 mg/ L respectively.

Based on the ICR Rule for the MCL of chlorite ion, treatment plants using chlorine dioxide as the disinfectant treatment are required to: 1) conduct monthly monitoring at three sample points in the distribution system. Compliance is met if the average chlorite ion concentration does not exceed 1.0 mg/ L. Compliance is determined monthly. 2) Water plants, in addition to monthly monitoring, must also analyze daily samples of water entering the distribution system. Chlorite ion concentration must not exceed 1.0 mg/ L. If the entry point data shows an exceedence over 1.0 mg/ L, the water treatment system must sample at three distribution system sample points within 24 hours and verify that the chlorite ion concentration has not exceeded 1.0 mg/ L.

In the original ICR monitoring data a number of samples and distribution systems showed large exceedences based on the MCL and MCLG. At present, water systems have indicated that treatment is generally designed to meet a level of at least 20% below the MCL in order to ensure compliance. Based on this assumption, the Agency has readjusted all reported concentrations over 1000 µ g/ L to 800 µ g/ L and recalculated the data. Table 1 shows the adjusted values of chlorite concentrations. Page 6 of 18 Table III Chlorite Concentrations1 ( µ g/ L)  ICR Data Adjusted for MCL Compliance Chlorine Dioxide Water Treatment Plants ( WTPs)

Distribution System Entry Point Near First Customer Average Residence Time Maximum Residence Time Distribution System Average2 10th Percentile 60 52 58 30 45 20th Percentile 99 79 87 81 84 50th Percentile 440 380 360 310 390 80th Percentile 590 580 600 510 550 90th Percentile 660 660 640 650 630 Maximum 800 740 680 680 700 # WTPs 29 27 27 27 27 # PWSs 22 21 21 21 21 1The average chlorite concentration was calculated for each sample point at each WTP over the entire ICR monitoring program. The distribution of these averages is presented in this table. 2The distribution system average chlorite concentration was calculated for each WTP using the three distribution system sample points. The distribution of these averages is presented in this column.

The Agency conducted a drinking water risk assessment using the maximum, 90th percentile, and median annual averages of chlorite concentrations of 0.700, 0.630, and 0.390 mg/ L, respectively. The DEEM Model was again used to determine the exposure values ( Memo from David Hrdy, HED, to Jennifer Slotnick, AD). Table IV presents the exposures and corresponding risks. The 90th percentile exposure values will be used in the aggregate risk assessments. Children will be represented by the 1 6 year old age category. The only subpopulation that Agency has concerns for is infants ( less than one year old) when exposed to chlorine dioxide treated water. All other subpopulations and the general population have risks below the Agency's level of concern.

Table IV Drinking Water Exposure and Risks Maximum Concentration 90th Percentile Concentration Median Concentration Population subgroup Total exposure ( mg/ kg/ day) % cPAD Total exposure ( mg/ kg/ day) % cPAD Total exposure ( mg/ kg/ day) % cPAD U. S. Population 0.014754 49 0.013279 44 0.008220 27 Infants < 1 year 0.048372 161 0.043535 145 0.026950 90 Children 1 6 years 0.020613 69 0.018552 62 0.011485 38 Children 7  12 years 0.013402 45 0.012062 40 0.007467 25 Females 13 50 0.014274 48 0.012846 43 0.007952 27 Page 7 of 18 4. Poultry Hatcheries:

AD label searches ( EPA Reg. Nos. 9150 2, 9150 3) indicate that chlorine dioxide is used in poultry hatching areas, incubator rooms, tray washing room and loading platforms as a disinfectant. A high pressure sprayer is used to deliver the chemical at the rate of 20 ppm.

In these poultry hatcheries, eggs are produced for the production of chicks and not for human consumption. Although it is likely that some sanitizer/ disinfectant chemicals may penetrate the egg shells and bioaccummulate in the developing chicks, at this time, the Agency believes that the amount of the chemical transferred to the developing chicks is not likely to adversely affect the development of chicks and will have an even smaller transfer into humans.

A similar label search ( EPA Reg No. 74602 2) indicates the same uses for sodium chlorite at the same application rate. The Agency has no concerns for this use.

The use of chlorine dioxide and sodium chlorite in poultry hatcheries can be classified as non food use. Agency has no dietary risk concerns at this time for this use.

5. Food Handling Establishments ( Hard Surface Indirect Food Contact Surfaces):

Use of chlorine dioxide and sodium chlorite on sites where there is a likelihood of exposure ( and migration) of these chemicals into food is being assessed. An example of direct food contact would be post harvest treatment of fruits and vegetables. Sanitizing and or disinfecting use of antimicrobials on hard non porous surfaces which come into contact with food are classified as indirect food contact surfaces. Eating establishments ( food tables), kitchen counter tops, etc. fall in this category.

Using FDA methodology, EPA has calculated the Estimated Daily Intake ( EDI) of a chemical by using the relationship:

EDI ( mg/ kg/ day) = AR x SA x F/ BW       ..( 1)

Where: SA = Surface area of the treated hard surface which comes into contact with food ( fruits, vegetables, meats) = 2000 cm2 AR = 1 mg/ cm2 of dilute product x a. i. ( active ingredient) = application rate F = Fraction of the pesticide transferred or migrated from the treated surface into food. It is assumed to be 100% as there is no residue data to indicate otherwise and risks from this conservative screening level assessment are not of concern. If refinements are necessary, a 10% factor may be assumed while the Agency calls in confirmatory data from the registrants. BW = Body weight: adult = 70 kg; child = 15 kg. Page 8 of 18 Maximum application rate ( EPA Reg. Nos. 9150 2, 9150 3, 53345 14, 53345 19, and 53345 20) = 200 ppm of chlorine dioxide or sodium chlorite = 200 µ g/ 1000 mg ( ppm)

Using eq. 1:

EDI = 200 µ g/ 1000mg( ppm) x 0.10 mg/ cm2 x 2000 cm2/ BW = 40 µ g a. i. / BW Estimated Daily Dietary Dose for an adult = 40 µ g/ 70kg x 1mg/ 1000 µ g = 0.000571 mg/ kg/ day  ( 1)

Estimated Daily Dietary Dose for a child = 40 µ g/ 15kg x 1mg/ 1000 µ g = 0.00266 mg/ kg/ day  ( 2)

The cPAD for chlorine dioxide and sodium chlorite is 0.03 mg/ kg/ day.

% PAD = exposure / cPAD x 100% ( 3)

For an adult, the % cPAD = 0.000571 mg/ kg/ day / 0.03 mg/ kg/ day x 100% = 1.90%

For a child, the % cPAD = 0.00266 mg/ kg/ day / 0.03mg/ kg/ day x 100% = 11.1%

The Agency does not have any concerns from this exposure, as the % cPAD is below 100% for both age groups.

6. Post   Harvest Potato Treatment:

The Agency has allowed the use of chlorine dioxide in the form of a spray, mist and fogger with the application rate limit of 200 400 ppm in the post harvest treatment of potatoes in the storage area before they are sent out for retail market ( EPA Reg. No. 9804 5). AD had asked the States of Idaho and Washington to collect the analytical data on the residues on the chlorine dioxide treated post harvest potatoes ( AD Memo by Tim McMahon, and A. Najm Shamim, March, 1998).

A six month residue monitoring study from chlorine dioxide treatment on stored potatoes ( February through July 1999) was submitted in August/ September, 1999 by Analytical Sciences Laboratory, a contracting lab. 42 samples ( duplicate) were analyzed: 1) All 42 samples showed chlorite to be non detect ( at the practical quantitation limit of 0.1 ppm level); and 2) 39/ 42 samples showed the presence of chlorate below the quantitation limit of 0.1 ppm and only three samples showed the chlorate level between 0.97 and 1.1 µ g/ g. Both chlorate and chlorite are considered the breakdown products of chlorine dioxide. The Agency did not see any concerns for the presence of chlorate at these levels in a few samples. Page 9 of 18 A memo by the Health Effects Division ( Christina Swartz, 1994) noted: " Residue Chemistry data reviews of data submitted in support of existing tolerance exemptions concluded that there is no likelihood of transfer of residues ( of sodium chlorate) to meat/ milk/ poultry/ eggs)." It also noted that " based on the likelihood of reduction of sodium chlorate residues through hydrolysis on cooking, and based on a lack of toxicity concern, and residue levels found on crops during field trials, CBRS ( HED's Branch), continues to support the existing tolerance exemption."

The Agency has no concerns at this time for use of chlorine dioxide and sodium chlorite for stored potato treatment and subsequent interstate commerce of this commodity.

7. Poultry House Disinfection, Poultry Chiller Water/ Carcass Spray or Dip Several AD products ( EPA Reg Nos. 74602 2, 74602 3, 9150 7, 9150 8) are used in carcass sprays or dips with application rates from 500 1200 ppm and poultry chiller water with application rates from 50 150 ppm. The same application rate and method of application was submitted to FDA for risk assessment. FDA did assess the risks involved for this use ( FDA Memo: FAP: 4A4433, 1994). FDA extensively reviewed the efficacy and analytical chemistry data on the residues of chlorate/ chlorite or possibly chlorine dioxide for the scenarios listed. Residues of chlorite and chlorates were measured on poultry carcasses after pre chiller and chiller water treatments. Acidified sodium chlorite, with pH maintained between 2.4 2.9 ( at which condition, HClO2 is formed and slowly released to the treating system). The duration of exposure was between 5 seconds and 5 minutes. After the pre chiller treatment the carcasses were dipped in water for rinsing at temperature   5 o C. Neither chlorite nor chlorate was detected between 0.009 ppm and 0.011 ppm levels of detection.

In the chiller water treatment, poultry carcasses were chilled an hour (  5 o C) at the application rate of 150 ppm with acidified sodium chlorite solution. Samples were allowed to drip for minutes. Drip samples were analyzed at time, 0, 10 minutes, 1 hour, 2, 4 and 20 hours. Chlorite detection was at 0.54 ppm at time zero, 0.09 ppm at 10 minutes and at 0.021 ppm after one hour. LOD was set at 0.016 ppm. Chlorite was non detect after 2 hours. Chlorate was non detect even at time zero. It is likely that the residual chlorate/ chlorite on the poultry may be going through oxidative processes to form chlorinated organics. FDA asked and industry conducted the studies on the formation of chlorinated organics; no evidence was found for the formation of chlorinated organics. However, some PCBs were detected at the background levels. Open literature studies support the results that with acidified sodium chlorate treatment of poultry no chlorinated organics are formed. FDA accepted the studies and concurred with the results. AD concurs with FDA. At this time, the Agency does not have any concerns with the use of acidified sodium chlorite solution on carcasses. Page 10 of 18 8. Food Contact Surface Sanitizer Use of Chlorine Dioxide and Sodium Chlorite: Food Processing Plants ( Meat, Fish)

Several AD products ( EPA Reg. Nos. 74602 2, 53345 14, 53345 19, 53345 20, 21164 3, 9150 7) are used as food contact surface sanitizers in food processing plants at application rates of 200 ppm. For the application method of a fogger, 1 minute of contact time is required.

As the application rates are similar to the section 7 scenario above, exposure would also be similar. Therefore, the Agency does not currently have any dietary risk concerns for this use.

9. Dairies, Breweries, Bottling Plants, Food Contact Surfaces:

The use scenario for this application ( on labels for EPA Reg. Nos. 53345 14, 19, 20, 21; 9150 7, 8; 21164 6, 8, 9; 74602 2; 5382 46; 74517 1; 73139 1) includes sanitizing foodcontact surfaces; processing equipments; and utensils in dairies, breweries, canning operations, and meat and vegetable processing plants at application rates of 200 ppm. FDA reviewed a similar application and made a few assumptions ( FDA Memo by Susan Carberry, Ph. D: HFS 247, Chemistry Review Branch, Document Number 2B4334, 1993). We have used the FDA assumptions for residues and also calculated the EDI, DDDs, and percent cPADs based on our toxicity numbers.

FDA Assumptions: 1) residue exposure = 1 mg/ cm2; 2) major exposure scenarios and foods from this application are: brewery, beverage, egg/ mayonnaise industries; 3) at consumers level, the following foods will have the residues: beer, beverages, egg/ mayonnaise products, and milk. Weight of food/ surface area ratios ( in g/ cm2) for some foods are as follows: Milk ( dairy): 6.6 Egg/ mayonnaise: 64 Beer, beverages: 150; 4) FDA used the intake data [ 14 day average from MRCA ( 1982 87) menu census survey and USDA/ NFCS survey data ( 1987 1988)] for portion sizes. The following represents the average eaters only food category and food intake averages ( in grams/ person/ day): Beverages, alcoholic/ beer: 182 g/ p/ d Beverages, non alcoholic: 240 g/ p/ d Egg products: 9 g/ p/ d Salad dressing/ mayonnaise: 6 g/ p/ d Milk: 124 g/ p/ d; 5) FDA also assumed that there is no loss of chlorine dioxide as a gas, and the treatment is 100% with the product present in the formulation.

Calculations:

Using the maximum application rate of 200 ppm: Page 11 of 18 200ppm = 200 mg/ kg x 1 kg/ 1000g x 200 µ g/ 1 mg = 1000 µ g/ g = 200 µ g/ 1000 mg. Using assumptions 1 through 4 and data inputs from above:

a. Beverages, alcoholic , beer: Estimated Daily Intake ( EDI) = 1000 µ g/ 1000mg x 1 mg/ cm2 x 182 g/ person/ day x 1 cm2/ 150 g = 0.24 µ g/ person/ day ( 1) b. Beverages, non alcoholic: EDI = 0.32 µ g/ person/ day ( 2) c. Egg products, salad dressing, mayonnaise: EDI = 0.28 µ g/ person/ day ( 3) d. Milk: EDI = 3.76 µ g/ person/ day ( 4)

From ( 1): Adult Daily Dietary Dose = 0.24 µ g/ person/ day x mg/ 1000 µ g = 2.4 x 10 4 mg/ person/ day x person/ 70 kg = 3.4 x 10 6 mg/ kg/ day ( 1a) Child DDD is not calculated, as children are not expected to consume alcoholic beverages From ( 2) Adult Daily Dietary Dose = 0.32 µ g/ person/ day x mg/ 1000 µ g = 3.2x 10 4mg/ person/ day x person/ 70 kg = 4.57x 10 6 mg/ kg/ day  ( 2a) Child DDD = 3.1x 10 5 mg/ kg/ day ( 2b)

From ( 3) Adult Daily Dietary Dose = 0.028 µ g/ person/ day x mg/ 1000 µ g = 2.8x10 5 mg/ person/ day x person/ 70 kg = 4.0 x 10 7 mg/ kg/ day ( 3a) Child DDD = 1.86 x 10 7 mg/ kg/ day ( 3b)

From ( 4) Adult Daily Dietary Dose = 3.76 µ g/ person/ day x mg/ 1000 µ g = 3.76 x 10 3 mg/ person/ day x person/ 70 kg = 5.37 x 10 5 mg/ kg/ day  ( 4a) Child DDD = 2.5 x 10 4 mg/ kg/ day ( 4b)

For chlorine dioxide and sodium chlorite the cPAD is 0.03 mg/ kg/ day. The values are presented in Table V. None of the % cPADs exceed 100, and hence, the Agency does not have any concern for uses at these sites at the current application rates.

Table V Dietary Doses and Risks from Food Consumption following use of Chlorine Dioxide/ Sodium Chlorite in Food and Beverage Processing Plants Food Type Daily Dietary Dose ( DDD) ( mg/ kg/ day) % cPAD = Exposure ( DDD) / cPAD x 100% Beverages, alcoholic, beer Adult: 3.4x10 6 Child: Not Applicable Adult: 0.11% Child: Not Applicable Beverages, nonalcoholic Adult: 4.0x10 6 Child: 2.0x10 5 Adult: 0.016% Child: 0.066% Egg products, mayonnaise Adult: 4.0x10 5 Child: 2.6x10 4 Adult: 0.00177% Child: 0.0062% Page 12 of 18 Milk Adult: 5.4x10 5 Child: 2.6x10 5 Adult: 0.132% Child: 0.84% 10. Dietary Exposures and Risks Resulting From Use of Chlorine Dioxide/ Sodium Chlorite as Slimicides in Paper/ Pulp Products ( Indirect Food Additives).

Chlorine dioxide and sodium chlorite's antimicrobials uses include slimicide use in paper/ pulp, paper coatings, polymer slurries ( as a filler in paper), and paper adhesives. AD has, therefore, assessed the potential dietary exposure to such uses applying the FDA methodologies.

AD's label searches identified a number of chlorine dioxide and/ or sodium chlorite products use as slimicides in the manufacture of pulp/ paper products. The label of SLEME TROL RX 33 ( EPA Reg. No. 74655 2) showed the highest concentration of sodium chlorite ( 25%) at use level. The application rate is 2 lbs/ ton of finished paper. The same label shows that in polymer slurries preservative in paper coatings and as adhesives in paper products, the maximum amount of chlorine dioxide / sodium chlorite is 1000 ppm of the active. The Agency has noted that at the use sight, sodium chlorite generates chlorine dioxide. Hence, whether the label is that of chlorine dioxide or sodium chlorite, these are treated as one and the same.

The FDA methodology makes a number of assumptions for calculating migration of active ingredients ( chlorine dioxide/ sodium chlorite) from food contact surfaces ( paper): 1) Food contact surface ( paper) can be a one time use/ day or a repeat use material; 2) Consumption factor ( CF) or fraction of daily food which comes in to contact with the packaging surface ( paper) represents the actual weight of food that comes into contact with the paper to the weight of all food packaged with paper; 3) The CF varies from one type of packaging ( type of paper) to another ( type of paper). FDA methodology of migration of active assumes a 100% migration to the food commodities. This represents a worst case scenario.

Data Input Parameters for Chlorine Dioxide and Sodium Chlorite Used as Paper Slimicide:

1. Rate of Application of Active: Maximum of 2 lbs of product/ ton of paper ( = 1.0 kg/ 1000 kg of paper) 2. Paper slurry: Prior to entering paper manufacturing machine: 1% ( 99% water and 1% pulp) ( FDA assumption) 3. Concentration of Slurries Entering Driers: 33% pulp and 67% water ( FDA Assumption) 4. Standard Paper Weight: 50 mg/ in2 ( FDA Assumption) 5. Finished Paper: 8% water and 92% pulp ( RASSB Memo by Bob Quick, based on FDA Assumption) 6. Mass of Food in Contact with Surface Area of Treated Paper: 10 g/ in2 ( FDA Assumption) 7. Consumption Factor ( CF) for Treated Paper: 0.10 ( FDA Assumption) 8. Daily Average Food Intake ( Adult) = 3000 g Page 13 of 18 9. Daily Average Food Intake ( Child) = 1500 g Calculations:

a. As the active is only 25%, from parameters 1 & 2 above, 2 lb/ ton paper = 0.25 lbs/ 1000 lbs paper or 1 lb active = 4000 lbs paper = 400,000 lb slurry x 1% paper slurry = 1 lb/ 4000 lbs of finished paper = 2.5 ppm of active in the paper slurry. ( This is derived from FDA assumption). b. From in put parameter 3, the concentration of the active ( Chlorine dioxide/ sodium chlorite) present in the pulp prior to entering the driers: Application Rate x % water/ % pulp = 2.5 ppm active = 2. 5 : g active/ g pulp slurry x 0.67 water/ 0.33 g pulp = 5 µ g active/ g pulp.

OUTPUT:

Based on input parameters 1 through 7 and calculations a and b, the outputs are:

1a. Concentration of chlorine dioxide/ sodium chlorite in food: µ g of chlorine dioxide/ sodium chlorite/ mass of pulp x mass of pulp/ mass of paper x standard mass of paper x mass of food/ surface area ( i)

5 µ g chlorine dioxide/ sodium chlorite/ mass of pulp x 0.92 g pulp/ g of paper x 0.05 g/ in2 x 1 in2 / 10 g food = 0.023 µ g of chlorine dioxide/ sodium chlorite/ g food Taking into account of CF of 0.10, the actual dietary concentration of chlorine dioxide/ sodium chlorite in daily diet would be: 0.023 µ g chlorine dioxide/ sodium chlorite/ g food x 0.10 = 0.0023 µ g of active/ g food ( ii)

1b. Estimated Daily Intake ( EDI) for an Adult = 0.0023 µ g of chlorine dioxide/ sodium chlorite/ g food x 3000 g food = 6.9 µ g chlorine dioxide/ sodium chlorite/ person/ day ( iii)

1c. Estimated Daily Intake ( EDI) for a Child = 0.0023 µ g of chlorine dioxide / sodium chlorite/ g food x 1500 g food = 3.45 µ g chlorine dioxide/ sodium chlorite/ person/ day ( iv)

Estimated Daily Dietary Dose = EDI/ Body Weight: Adult: 6.9 µ g x mg/ 1000 µ g / 70 kg/ day = 9.8 x 10 5 mg/ kg/ day Child: 3.45 µ g x mg/ 1000 µ g / 15 kg / day = 2.3 x 10 4 mg/ kg/ day 11. Chlorine Dioxide and Sodium Chlorite Use in Polymer Slurries As a Filler in Paper The label ( EPA Reg No. 74655 2) indicates that no higher than 1000 ppm of the product be used for polymer slurries for preservation of paper. Since the active is only 25%, the active concentration = 250 ppm. Page 14 of 18 Data Input Parameters for Chlorine Dioxide and Sodium Chlorite as a Preservative in Paper, with Polymers Slurries as Fillers:

1. Rate of Application of the Active: 250 ppm 2. Standard Paper Weight: 50 mg/ in2 ( FDA Assumption) 3. Mass of Food in Contact With Surface Area of Paper Treated with Preservative ( chlorine dioxide/ sodium chlorite) = 10 g food/ in2 4. Consumption Factor ( CF) for Paper Treated With Preservative ( chlorine dioxide/ sodium chlorite) = 0.10 5. Finished Preservative ( chlorine dioxide/ sodium chlorite) Treated Paper = 8% Water and 92% Pulp ( FDA Assumption) 6. Daily Average Food Intake ( Adult) = 3,000 g 7. Daily Average Food Intake ( Child) = 1,500 g Calculations:

a. Concentration of chlorine dioxide/ sodium chlorite in paper/ pulp FDA assumes that 0.1lbs of polymer slurries = 1 lb of paper, that is polymer slurry represents 10% as fillers Rate of Application x 10% filler = 250 ppm x 0.10 = 25 ppm ( i)

If the pulp is 5% in the slurry water ( FDA assumption), the amount of chlorine dioxide/ sodium chlorite is: 0.05 x 25 = 1.25 ppm of chlorine dioxide/ sodium chlorite in slurry water ( ii)

If mass of water to mass of pulp is 67%/ 33% ( 2: 1), the amount of chlorine dioxide/ sodium chlorite/ g pulp is: 1.25 ppm x 2 = 2.50 ppm = 2.5 µ g chlorine dioxide/ sodium chlorite/ g pulp ( iii)

b. Concentration of chlorine dioxide/ sodium chlorite in food:

Mass of chlorine dioxide/ sodium chlorite/ g paper x mass of pulp/ g paper x standard mass of paper/ in2 paper x mass of food/ in2 paper:

2.5 µ g chlorine dioxide/ sodium chlorite/ g paper x 0.92 g pulp/ g paper x 0.05 g paper/ in2 paper x 1 in2 paper/ 10 g food = 0.0115 µ g chlorine dioxide/ sodium chlorite/ g food = 0.0115 ppm of chlorine dioxide/ sodium chlorite ( iv)

If CF factor = 0.10, amount of chlorine dioxide/ sodium chlorite in food = 0.10 x 0.0115 µ g chlorine dioxide/ sodium chlorite/ g food = 0.00115 µ g / g food ( v)

Estimated Daily Intake ( EDI) for an Adult: 0.00115 µ g/ g food x 3000 g food = 3.45 µ g food/ person/ day ( vi) Page 15 of 18 Estimated Daily Intake ( EDI) for a Child: 0.000115 µ g/ g food x 1500 g of food = 1.725 µ g/ person/ day ( vii)

Estimated Daily Dietary dose = EDI/ Body Weight: Adult: 3.45 µ g x mg/ 1000 µ g / 70 kg BW/ day = 4.9 x 10 5 mg/ kg/ day Child: 1.75 µ g mg/ 1000 µ g / 15 kg BW/ day = 1.16 x 10 4 mg/ kg/ day 12. Chlorine Dioxide and Sodium Chlorite as Paper Adhesive Preservative Use Some AD labels claim FDA clearance for use as preservative use in paper adhesives in accordance with the limitations of 21CFR 175.105, which states: " migration levels for the substance generally will be assumed to be no greater than 50 ppb". Applying a consumption factor ( CF) of 0.14 for adhesives gives a dietary concentration of 7 ppb. It should be noted that FDA derives the consumption factor ( CF) from the possible percentage of daily diet expected to contact the paper adhesives.

Calculations:

Estimated Daily Intake ( EDI): ( Dietary conc. X Daily food consumption) Adult: ( 0.007 µ g ai/ g food) x ( 3000 g food/ day) = 21 µ g ai/ person/ day Child: ( 0.007 µ g ai/ g food) x ( 1500 g food/ day) = 10. 5 µ g ai/ person/ day Estimated Daily Dietary Dose = EDI/ Body Weight: Adult: ( 21 µ g ai/ day) x ( mg/ 1000 µ g)/( 70 kg) = 0.00030 mg/ kg/ day Child: ( 10.5 µ g ai/ day) x ( mg/ 1000 µ g)/( 15 kg) = 0.0007 mg/ kg/ day 13. Chlorine Dioxide and Sodium Chlorite as a Paper Coating Preservative Use:

As indicated by various labels for chlorine dioxide/ sodium chlorite as actives, they are added as preservatives to paper coating formulations at a maximum application rate of 1000 ppm, and as the active is 25%, the actual application rate is 250 ppm.

Assumptions: 1. The resulting paper coating is approximately 10% by weight of the paper. 2. The standard basis weight of paper is 50 mg/ in2. 3. The amount of food contacting the coated paper packaging is 10 g of food/ in2. 4. The standard consumption factor ( CF) for coated paper is 0.20 ( fraction of daily diet expected to contact paper coatings). 5. A 100% migration of chlorine dioxide/ sodium chlorite is assumed from the coated paper to the food. 6. Standard adult food consumption is 3 kg/ day and for a child it is 1.5 kg/ day. 7. Adult body weight is 70 kg and child body weight is 15 kg. Page 16 of 18 Output:

Using the equation: Application Rate x % of paper coated x basis paper wt. x surface area in contact with food x CF x % migration 250 µ g ai/ g coating x 0.10 g coating/ g paper x 0.05 g paper/ in2 x in2 paper / 10 g food x 0.2 x 100% = 0.025 µ g ai/ g food or 25 ppb Estimated Daily Intake ( EDI) = Dietary Conc. x Daily food consumption: Adult: 0.025 µ g / g food x 3000 g food/ day = 75 µ g ai/ person/ day Child: 0.025 µ g/ g food x 1500 g food/ day = 37.5 µ g ai/ person/ day Estimation of Daily Dietary Dose = EDI/ Body Weight: Adult: ( 75 µ g ai/ day) x mg/ 1000) / 70 kg = 0.0011 mg ai/ kg/ day Child: ( 37.5 µ g ai/ day) x mg/ 1000 µ g / 15 kg = 0.0025 mg ai/ kg/ day From toxicological data, AD has determined that the chronic PAD from antimicrobials uses for chlorine dioxide/ sodium chlorite is 0.030 mg/ kg/ day. % cPAD = exposure / cPAD x 100%. From data above, the % PADs are calculated. None of the chronic PADs exceed the Agency level of concern.

Table VI Cumulative ( Paper/ Pulp Uses 10 13) Estimated Dietary Intake of Chlorine Dioxide and Sodium Chlorite Use EDI ( µ g/ person/ day) Daily Dietary Dose( mg/ kg BW/ day) Paper Slimicide 6.9 Adult 3.45 Child 9.8 x 10 5 Adult 2.3 x 10 4 Child Aqueous Mineral Slurries 3.45 Adult 1.75 Child 4.9 x 10  5 Adult 1.2 x 10 4 Child Paper Adhesive Preservative 21.0 Adult 10.5 Child 3 x 10 4 Adult 7 x 10 4 Child Paper Coating Preservative 75 Adult 37.5 Child 1.1 x 10 3 Adult 2.5 x 10 3 Child Cumulative 106.25 Adult 53.20 Child 1.54 x 10 3 Adult 3.55 x 10 3 Child Page 17 of 18 Table VII Dietary Risks of Chlorine Dioxide and Sodium Chlorite from Paper/ Pulp Uses ( Sections 10 13) Use Daily Dietary Dose ( mg/ kg BW / day) % PAD Pulp/ Paper Slimicide 9.8 x 10 5 Adult 2.3 x 10 4 Child 0.33 Adult 0.77 Child Aqueous Mineral / Slurries 4.9 x 10 5 Adult 1.2 x 10 4 Child 0.16 Adult 0.40 Child Paper Adhesive Preservative 3 x 10 4 Adult 7 x 10 4 Child 1.00 Adult 2.33 Child Paper Coating Preservative 1.1 x 10 3 Adult 2.5 x 10 3 Child 3.67 Adult 8.33 Child Cumulative 1.54 x 10 3 Adult 3.55 x 10 3 Child 5.13 Adult 11.83 Child BIBLIOGRAPHY 1. AD Memo by Tim McMahon, and A. Najm Shamim to Norm Cook, March, 1998. 2. FDA Memo: 1994, FAP: 4A4433 3. FDA Memo, 1993 by Susan Carberry, Ph. D: HFS 247, Chemistry Review Branch, Document Number 2B4334 4. David Hrdy, 2006. A Memo from David Hrdy ( HED) to Jennifer Slotnick( AD) on Fruits and Vegetable Washes for Chlorine Dioxide Use. 5. David Hrdy, 2006. A Memo from David Hrdy to Jennifer Slotnick ( AD) on Drinking Water Risks from Chlorine Dioxide Treated Water 6. Pat Fair, 2006. A Memo from Office of Water to Jennifer Slotnick, OPP ( AD) on Monitoring Data of Chlorine Dioxide Disinfectant Use by Water Treatment Plants in the USA. 7. Tim McMahon et al., 2005ADTC Memo on Hazard Identification ( End Point Selection) for Chlorine Dioxide and Sodium Chlorite. 8. A. Najm Shamim: AD Document on: Dietary Risk Assessment for Dihalogen Dialkyl and Methylol Hydantoins, 2003. This document lists the FDA assumptions of pesticide migration form paper to food through indirect food contact. 9. A. Najm Shamim, 2005, AD Document on Dietary Risk Assessment for 1,2 Benzisothaizolin 3 one. 10. Bob Quick, 2001 AD Memo on Review of Lonza Registration Request for 5,5 Dimethylhydantoins as Slimicide and Preservative in Paper Manufacture. Additional FDA assumptions on pesticide migration into food from treated paper. 11. RASSB Memo by Bob Quick, 2001, with additional comments on February 2001 Document ( Reference 10) 12. Lonza Document op cit reference 4. 13. EPA, 2000. Available Information on Assessing Exposure from Pesticides, A User's Guide, 6/ 21/ 2000, http:// www. epa. gov/ fedrgstr/ EPA PEST/ 2000/ July/ Day 12/ 6061. pdf. Page 18 of 18