                  	Office of Chemical Safety and United States	Pollution Prevention
                  Environmental Protection Agency	April 2019

Summary of External Peer Review and Public Comments and Disposition for the Environmental and Human Health Hazards for Persistent, Bioaccumulative and Toxic (PBT) Chemicals

                 Draft to Support Proposed Rule: RIN 2070-AK34

                                  April 2019

This document summarizes the public and external peer review comments that the EPA's Office of Pollution Prevention and Toxics (OPPT) received for the environmental and human health hazards for the persistent, bioaccumulative, and toxic (PBT) chemicals. It also provides EPA/OPPT's response to the comments received from the public and the peer review panel.
EPA/OPPT appreciates the valuable input provided by the public and peer review panel. The input resulted in numerous revisions to the hazard summary.
Peer review charge questions are used to categorize the peer review and public comments into specific issues related to the five main themes.
 Organization and clarity of the document
 Methodology for collecting and summarizing information
 Representativeness and completeness of presented information
 Appropriateness and sufficiency of information
 Reliability and relevance of information
All peer review comments for the nine charge questions are presented first, organized by charge question in the following section. These are followed by the public comments. For each theme, general comments pertaining to all chemicals are presented first, and then additional comments pertaining to only one or several chemicals follows.

Organization and Clarity of the Document - Peer Review Comments
Charge question 1: This information, when finalized will inform a technical support document to support EPA's regulatory activities on PBTs. Please comment on the organization and structure of this document to inform this use. Do you have specific recommendations to improve clarity and presentation of this information?
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Summary of Peer Review Comments for Specific Issues Related to Charge Question 1
                               EPA/OPPT Response
                                       1
Summarization and Conclusions:
 There is no discussion of the data presented. For example, there is no discussion of the weight of the evidence for each endpoint, the possible relevance to humans, or the adequacy of the database.
 The executive summary of this document is just a summary of the purpose of the document and is not a summary of the contents of the document. The executive summary should be expanded to include a short summary of the hazard findings for each of the chemicals.
 A summary that compares the margin of exposure in the animal studies or environmental studies to human exposure (from the Exposure and Use Assessment, if an estimated exposure has been identified) would be useful, particularly because that aspect of the risk assessment is not being completed in this expedited process.
 The addition of a summary table of physical-chemical properties for each chemical would enable the reader to more easily compare exposure dose to solubility, route of exposure and distribution within the organism to log Kow, etc.  Addition of any available persistence information and metabolic pathways would also be important.
 The environmental hazard assessment should be structured similarly to the human health summary, by including explicit NOAELs and LOAELs.
 The Environmental and Human Health Hazard Summary is intended to be a survey of existing hazard data to provide a general characterization of the toxicity profile of the five PBT chemicals, e.g. species, types of effects and the range of toxicity. Hence, the hazard data are reported from the literature with no additional analysis or assessment. EPA did not conduct a systematic review or calculate margins of exposure to characterize hazard (toxicity) for the five PBT chemicals. The Hazard Summary is fit for purpose for the type of analysis performed in support of 6(h) rulemaking.
 Margins of exposure are not necessary to characterize hazards of the five PBT chemicals.
 Physical-chemical properties, as well as exposure and persistence information are available in the Exposure and Use Assessment.  Including this information in the hazards document would be redundant.
 The executive summary now includes a short summary of hazard findings for each of the chemicals.
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Editorial:
 The document should be carefully reviewed for errors (e.g., the environmental hazard summary table has some cells that use "per cent" instead of %). Fixing errors and ensuring consistency will make the document easier to understand for the reader.
 EPA has performed a review of the document to remove errors and ensure consistency in the text.

DecaBDE-specific comments:
 Acute toxicity is reported at levels above the aqueous solubility value listed in Table 4.1.
 Summary text should reflect the key results of Table 4.1
 Many Deca-BDE studies use commercial products that do not specify the percent purity, nor the other components of the product, which may enhance solubility of Deca-BDE. Thus, the commercial product toxicity data may be confounded by the additional chemical ingredients. Section 4.1 discusses instances where the data are from commercial mixtures.
 Summary text was updated to reflect key results of Table 4.1.

HCBD-specific comments:
 No aqueous solubility data is given in the table as was done for decabromodiphenyl ether.
 Aqueous solubility and other physical-chemical properties are available in the exposure and use document.

PIP (3:1)-specific comments:
 The first paragraph on page 20 provides useful information on the chemical identify of PIP. Since the information applies to both the environmental and human health sections, this paragraph should appear before section 6.1.
 The document tried to evaluate a multi-chemical product rather the constituents of the product, and thus the purported hazard was unclear.  Indeed the CASRN is actually isopropyl phenyl phosphate. This is a single compound and not a mixture as reported in the assessment.  Hazard assessments for the specific constituents would provide a better mechanism for regulators to assess the risks of the mixture. Perhaps a strategy for pesticide registration, which selects an "active ingredient" within the product, may improve clarity.
 In the human health hazard summary of PIP (3:1), the first sentence refers to hazard data for "Isopropylated, phosphate (3:1)". If this is a typo, please fix it. If it is intentional, please note whether this is a synonym (although it isn't labeled as such in the exposure and use assessment), or if a different chemical was assessed for hazard data.
 In the environmental hazard summary, the % of PIP (3:1) contained in the test mixture is included in the summary table. This information should also be included for the human health hazard summary. If it is not available, this should be stated in the text or in the table.
 In Table 6-2, there is no information about the dose timing or number of days of dosing for the OECD 422 oral gavage study in Sprague-Dawley rats. This information should be added to the table.
 Comment has been addressed in the editing of the document.
 Hazard data for PIP (3:1) and related compounds is generally scarce. EPA provided all hazard data it located in order to provide as much information as possible regarding the hazards associated with the family of PIP (3:1) structures. EPA agrees that a component-based or `active ingredient' type hazard assessment would be ideal; however, EPA did not locate data that would support such an analysis.
 A review of the document was performed to remove errors and ensure accuracy and consistency in the text and tables.
 OECD 422 is a guideline with a specific dosing protocol. Restating this information is unnecessary for the summary table and has not been done for other guideline studies.
 The percentage of Isopropylated, phosphate (3:1) is generally unavailable because most of the studies used commercial formulations.
 Table 6-2 was edited to include number of days of dosing duration as part of the OECD 422 oral gavage study in Sprague-Dawley rats.

PCTP-specific comments:
 The title of Table 8-2 is misleading. It should indicate that only PCTP metabolites or breakdown products are included.
 Clarifying text was added to Table 8-2.

2,4,6 TTBP-specific comments:
 In the human health hazard summary, the second paragraph contains a sentence that states "One unpublished OECD 422 guideline study report observed reduced body weights in the offspring and increased postnatal." Please finish this sentence to describe what was increased postnatally.
 Clarifying text was added.

Methodology for Collecting and Summarizing Information - Peer Review Comments
Charge question 2: Please comment on the methodology for collecting and summarizing information from secondary sources. Was the approach appropriate? Is the description for how and where the literature was obtained clearly described?
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Summary of Peer Review Comments for Specific Issues Related to Charge Question 2
                               EPA/OPPT Response
                                      11
Specific details needed in description of search:
 Did the search strategy supplement the reviews by searching forward from the date of the review (allowing for suitable overlap)?
 Which chemical identifiers and chemical names and synonyms were used as search terms?
 Did the search strategy include PubMed, ToxNet, or Toxline? What was the rationale for database selection and how were data from different databases weighted? For example, was data from ECOTOX considered as higher value than other sources?
 Did the search strategy include the National Toxicology Program, Report on Carcinogens, or National Academy of Sciences?
 What were the dates of the searches?
 Information on the search strategy is outlined in Section 3: Approach for Surveying the Chemical-Specific Hazard Data. No forward searching was conducted. No restrictions were placed on the search results.
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Recommendations for Scope of Search:
 The assessment should have been a systematic review.
 Specific searches for vulnerable populations should have been included.
 The compilation of information from secondary sources leaves much room for error in the interpretation of the primary literature and in the aggregation of data.  For example an average or median LC or EC value loses ALL of the structure of the underlying data set(s).  Also, the ECHA 2018 references are basically lengthy fact sheets and as such are useless for review purposes.  Actual study data are needed for hazard or risk assessments.  If these are proprietary studies from manufacturers, they still must be made available to US regulators and appropriate reviewers before serious consideration can be given to them.
 It was stated in the review document that Web of Science was utilized as a secondary literature review source. An additional resource should be Scifinder Scholar produced by Chemical Abstract Services (CAS).  Conducting a search using the terms BPE toxicity and refining that to "review," a number of documents were identified that were not included in this search.
 A risk evaluation to support a 6(h) action for PBTs was not conducted. The presented data provide an overview of the range of hazard information available for each category of chemicals. The hazard summary is not a full hazard assessment that would be used for a risk evaluation. Systematic review and additional full searches were not conducted for the purpose of the hazard summary in support of 6(h).
 The literature searches were broad enough to identify vulnerable populations.
 Aggregate data are adequate for a literature survey intended to characterize types and magnitude of effects and not to identify specific points of departure or dose-response analyses.
 The Environmental and Human Health Hazard Summary is intended to be a survey of existing hazard data to provide a general characterization of the toxicity profile of the five PBT chemicals, e.g. species, types of effects and the range of toxicity. Hence, the hazard data are reported from the literature with no additional analysis or assessment. EPA did not conduct a systematic review to characterize hazard (toxicity) for the five PBT chemicals. The Hazard Summary is fit for purpose for the type of analysis performed in support of 6(h) rulemaking.

Recommendations for Presentation of Search:
 The search strategy should explain the general procedure for the collection and organization of the literature data for the first chemical and mention only differences or unique cases for all the other compounds.
 Information on the search strategy is outlined in Section 3: Approach for Surveying the Chemical-Specific Hazard Data.

PIP (3:1)-specific comments:
 Many of the references, especially the human health summary, refer to dossiers prepared by the manufacturer. These references adequately support the conclusion that PIP is toxic. However, it is preferable to review and cite original references for key studies if they are readily available, such as data reported to EPA (TSCATS).
 For this particular agent(s), it was very unclear which compound was being evaluated.  Although an alkylated phosphate, triphenyl phosphate is structurally different than 68937-41-7 and has a host of adverse developmental effects already reported (van der Veen and de Boer 2012).  It also would likely undergo significantly different biotransformation and disposition. In the exposure and use assessment the CASRN is 2502-15-0. The CASRN being used for this assessment of PIP (3:1) should be clarified.
 The search strategy collected publicly available hazard information and did not apply quality or source limitations on the search results. Whenever possible, original references were cited, however, many of the studies were accessed from databases containing only summaries of the data.
 Hazard data on PIP (3:1) as a discrete substance is largely unavailable. Most studies tested PIP (3:1) that also contains triphenyl phosphate (TPP) in commercial product.  TPP is mentioned because of its presence in a majority of the publicly available studies with PIP (3:1).  Comments for the exposure and use assessment are not applicable here.
 Hazard data for PIP (3:1) and related compounds are generally scarce. EPA presented all hazard data it located to provide as much information as possible regarding the hazards associated with the family of PIP (3:1) structures.

PCTP-specific comments:
 Using studies of pentachloronitrobenzene as a surrogate for 133-49-3 is unacceptable.  Renner and Nguyen 1982 clearly show that 133-49-3 is 16 times higher in toxicity than Pentachloronitrobenze. Additional software Scifinder Scholar should be an additional source for publically available literature.
 The Renner and Nguyen data were obtained from acute intraperitoneal exposures. Intraperitoneal exposure is not an appropriate route of administration for toxicity testing.
 Per TOXNET, pentachlorothiophenol (CAS 133-49-3) has a rat oral LD50 of 11,900 mg/kg/bw and a mouse oral LD50 of 1,000-4000 mg/kg/bw. According to Extoxnet, oral LD50 values for pentachloronitrobenzene (the surrogate cited in the human health hazard summary) varies in rats and range from 1500 mg/kg/bw when administered in oil to-12,000 mg/kg/bw when administered in water. These data suggest both chemicals are category 4 acute toxicity hazards and are appropriate analogues. Thus, looking at the relevant oral exposure pathway, the two chemicals have similar acute toxicity.
 Information on the search strategy is outlined in Section 3: Approach for Surveying the Chemical-Specific Hazard Data; Scifinder would not identify additional information from the abovementioned hazard endpoints.

Representativeness and Completeness of Presented Information - Peer Review Comments
Charge question 3: Please comment on the representativeness and adequacy of the selected literature used in the evidence tables and described in the text to summarize the hazard concerns. Are there additional primary peer-reviewed and publicly available literature that warrant further consideration? If so, please identify or provide these sources and comment on whether acquisition and summarization of this additional information would change the hazard characterization already provided in the existing summaries? Does the information presented clearly and accurately represent the hazards associated with each chemical? Are there any studies that should be removed from the summary and evidence tables due to study quality or data transparency concerns?
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Summary of Peer Review Comments for Specific Issues Related to Charge Question 3
                               EPA/OPPT Response
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Overall comments about representativeness of data:
 There are more studies available for some of the chemicals (e.g., decaBDE) than are provided in the summary tables. This is consistent with the stated purpose of providing a summary, not a comprehensive literature review. However, it is not clear how the studies that were put into the summary tables were chosen. The reason for study choice should be explicitly stated.
 A better description should be provided explaining why only repeat-dose studies are relevant to these chemicals ("given the PBT nature of the chemicals of interest"  -  page 1 of the charge question document). Not all the studies listed for the human health assessment are repeat-dose studies  -  e.g., for decaBDE Johansson et al. (2008) or Viberg et al. (2007).
 The nature of this document as a hazard summary, instead of a comprehensive hazard assessment, makes it very likely that there will be additional studies that were not identified in the summary. The most important consideration is to ask whether enough studies have been identified in order to perform an adequate weight-of-evidence evaluation to determine the hazards. Looking at a single study can lead to erroneous conclusions about hazard. It is important to collect all key studies for a chemical and evaluate all the findings from those studies to reach a balanced conclusion about hazard.
 A full systematic review process was not used or required under 6(h) for the development of the hazard summaries. The studies identified by panelists were incorporated in the document.
 The sentence containing the phrase "given the PBT nature..." was amended to clarify that acute studies were used to document hazard concerns for the PBTs.
 The Environmental and Human Health Hazard Summary is intended to be a survey of existing hazard data to provide a general characterization of the toxicity profile of the five PBT chemicals, e.g. species, types of effects and the range of toxicity. Hence, the hazard data are reported from the literature with no additional analysis or assessment. EPA believes that an adequate number of key studies across hazard endpoints have been identified and summarized to characterize the hazards for DecaBDE and HCDB.
 Other chemicals were so data poor that EPA has presented all the information it identified to gauge reproducibility, concordance and/or qualitative weight of evidence, if possible, in characterizing hazards.

DecaBDE-specific comments:
 The current human health hazard summary is not representative of the literature for decaBDE hazard identification, because available summary documents were not used, and a primary literature search was not conducted. Since this decaBDE hazard summary does not complete a full review of the primary literature, there are many studies not cited here (e.g., ATSDR (2017) cites 91 studies on decaBDE for human health-related toxicity, whereas this hazard summary cites 14). As noted above, the reason for EPA's choice of these 14 particular studies is unclear and should be explained.
 Additional studies:
             The National Research Council assessed the health risks of flame retardant chemicals including Decabrom (NRC 2000). This assessment includes a review of the health effects of Decabrom.
             Reviews by Hardy et al. 2009, Xu et al. 2018, and Lu et al. 2018.
             Missing key studies identified by Health Canada (2012) and ATSDR (2017) that pass study quality criteria.
 Acquisition of this information and assessment of study quality and weight-of-evidence does change the hazard characterization. In this hazard summary EPA concludes that "Oral repeated dose animal data for DecaBDE indicate developmental neurological effects, developmental immunological effects, general developmental toxicity, and liver effects." And "Dose-related brain effects were reported in adult rats as well, which was demonstrated by a decrease in brain weight following 28-days of oral gavage (Van der Ven et al., 2008)."  The reviewer provides an alternate interpretation of the evidence based on their own search and review.
 Based on study quality review Liang et al. (2010) and Viberg et al. (2003) should be removed, because their study quality is unacceptable. Hsu et al. (2006) and raw results from van der Ven et al. (2008) were not available, so these should be removed. Several of the key studies identified in the Health Canada (2012) and ATSDR (2017) assessments should also be removed because of unacceptable study quality (Zhang et al. (2013), Xing et al. (2009)).
 The additional studies cited in this comment have been added to the document.
 A study quality analysis was not conducted for this hazard summary.
 The fact that well recognized, authoritative peer-reviewed assessments such as those by Health Canada and ATSDR have relied on certain studies that the commenter finds unacceptable highlights that differences in interpretation may occur depending on the context or specific purpose of an assessment in which they are used. Because the commenter does not provide information on what purpose nor the approach or criteria by which the cited studies were deemed unacceptable, EPA cannot comment on the basis for these assertions. The purpose of EPA's Environmental and Human Health Hazard Summary is intended to be a survey of existing hazard data to provide a general characterization of the toxicity profile of the five PBT chemicals, e.g. species, types of effects and the range of toxicity. The inclusion of the studies cited aid in accomplishing this goal.

HCBD-specific comments:
   ::	There is no Health Canada (2012) assessment of HCBD  -  the study cited in the hazard summary is the decaBDE assessment. Presumably the Health Canada (2000) study was intended to be cited  -  "Priority Substances List Assessment Report: Hexachlorobutadiene".
   ::	Additional reviews/assessments to consider (including their key studies):
             US EPA Office of Water 2003 Health Effects Support Document on Hexachlorobutadiene.
             Taylor et al. 2003
  ::	Acquisition of this information and assessment of study quality and weight-of-evidence does change the hazard characterization. The reviewer provides an alternate interpretation of the evidence based on their own search and review.
  ::	Based on study quality review, Gage (1970) (identified in US EPA 2007) should be removed because the study quality is unacceptable, and Field et al. (1990) should be removed, because this study does not appear to be available.
 The additional studies cited in this comment have been added to the document.
 A study quality analysis was not conducted for this hazard summary.

PIP (3:1)-specific comments:
 The database on PIP is relatively data poor. Read-across methods were used to assess PIP exposure. A similar approach might be considered for the human health or ecological effects document, as well.  At a minimum, the toxicity of the class of aryl phosphates should be acknowledged.
 Because TPP is generally included in the mixture with PIP (3:1) and TPP has its own known toxicological effects, data should be presented that describes hazard assessments of TPP so that the hazards from each can be compared to determine what may be a PIP (3:1)-specific effect.
 The hazard summary references both ECHA 2018a and 2018b for PIP (3:1). However, only 2018b should be referenced  -  2018a is for 2,4,6 TTBP.
 Additional reviews/assessments to consider (including their key studies):
             UK  2009: Environmental risk evaluation report: Isopropylated triphenyl phosphate (CAS nos. 28108-99-8, 26967-76-0 & 68937-41-7)
 Acquisition of this information and assessment of study quality and weight-of-evidence does change the hazard characterization. The reviewer provides an alternate interpretation of the evidence based on their own search and review.
 Based on study quality review, Patisaul et al. (2013) (identified in US EPA 2015) should be removed because the compound tested (FireMaster 550) seems to contain mostly non-PIP (3:1) chemicals.
 The chemicals identified under 6(h) are identified by CAS nos. and the hazard summary focuses specifically on those CAS nos. with other information used as needed.
 The hazard summary references were updated so that only ECHA 2018b is referenced for PIP (3:1).
 UK  2009: Environmental risk evaluation report: Isopropylated triphenyl phosphate (CAS nos. 28108-99-8, 26967-76-0 & 68937-41-7) were incorporated.
 Assessing the hazard of TPP is beyond the scope of this assessment as EPA is not using a `read-across' approach for characterizing hazards for PIP (3:1), however it is mentioned because it is contained in many studies with PIP (3:1), i.e., it provides transparency in interpreting results
 Patisaul et al. (2013) was removed.

PCTP-specific comments:
 The exposure and use assessment Section 8.2 stated that PCTP has been banned in most parts of the world because it forms several teratogenic decomposition products. The information about PCTP's decomposition products and their potential teratogenic properties is very important to include in this hazard assessment.
 The ToxNet Hazardous Substances Database (referenced in the Exposure and Use Assessment) provides some toxicological information about PCTP. Many of the references are for studies in the ECHA IUCLID database.
 Acquisition of this information and assessment of study quality and weight-of-evidence could completely change the hazard characterization of PCTP, because the current characterization is not based on PCTP data.
 No relevant repeated-dose animal toxicity studies or human data were available for PCTP, thus analogous chemicals that are known to metabolize or degrade into PCTP were included in the hazard summary.  Characterization of the hazards of decomposition products is outside the scope of this assessment since the 6(h) action is specific to PCTP. However, any actions to reduce exposure to PCTP would commensurately reduce the possibility of formation of decomposition products. The studies identified by panelists were incorporated in the document.
 The Hazard Summary is fit for purpose for the type of analysis performed in support of 6(h) rulemaking. A hazard summary was developed under 6(h) while a full hazard assessment and risk evaluation were not completed.

2,4,6 TTBP-specific comments:
 Acquisition of additional primary and summary information and assessment of study quality and weight-of-evidence does not change the hazard characterization.
 The aquatic studies indicate that TTBP is quite toxic. The document states: "No toxicity data for terrestrial species were identified." The paucity suggests further investigation of exposure and toxicity are warranted.  Perhaps some structure activity relationship work or investigation of the effects of other butylated or alkylated phenols is merited.

 The Hazard Summary is fit for purpose for the type of analysis performed in support of 6(h) rulemaking.
 The Hazard Summary focuses on the specific PBT chemicals such as 2,4,6 TTBP and is fit for purpose for the type of analysis performed in support of 6(h) rulemaking. A full hazard assessment and risk evaluation were not conducted for this rulemaking.

Appropriateness and Sufficiency of Information - Peer Review Comments
Charge question 4: Has appropriate and sufficient information been obtained from the literature to support the identification of hazards?
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Summary of Peer Review Comments for Specific Issues Related to Charge Question 4
                               EPA/OPPT Response
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Overall comments about the sufficiency of the data:
 Appropriate and sufficient information was not obtained from the literature to support a weight-of-evidence evaluation of the hazards. Many of the studies use compounds that have similar structures but do not use the chemical being considered.  Some of the studies compiled are from databases where the primary literature or reports are not identified, which should disqualify them from consideration.
 The current summary does not present the hazards with enough detail to accurately portray the nuances of the data. Different levels of confidence could be expressed in the endpoints, for example strong evidence of hepatoxicity from adult or developmental exposure; moderate evidence for thyroid impacts; limited evidence of immunotoxicity. That would help provide more information to the audience about the confidence of the hazard identification.
 The Hazard Summary is fit for purpose for the type of analysis performed in support of 6(h) rulemaking. hazard assessment for a risk evaluation A full hazard assessment and risk evaluation were not conducted for this rulemaking. When available, EPA obtained data on the chemical itself. However, as noted by the reviewer, the available dataset for some of the chemicals lacked chemical-specific data, so EPA presented data for analogs and metabolites to fill data gaps.
 While EPA acknowledges that the literature summary presented is not exhaustive, for data rich chemicals EPA has presented an adequate number and characterization of toxicity studies to characterize types and magnitude of toxicity endpoints. For data poor chemicals, EPA has presented all the information it identified to gauge reproducibility, concordance and/or qualitative weight of evidence, if possible in characterizing hazards.

DecaBDE-specific comments:
 The studies summarized by the Agency end at 2014. While there have been additional studies on DecaBDE since 2014, in general, most of the studies and endpoints summarized by the Agency are relevant to the hazards under consideration and there are a sufficient number to draw conclusions regarding DecaBDE-induced hazards subject to the PBT assessment.
 EPA incorporated additional studies published after 2014 for DecaBDE.

HCBD-specific comments:
 The review reports that EPA considers HCBD a "possible" human carcinogen based on kidney adenomas and carcinomas. What exactly does this mean? Is "possible carcinogen" sufficient to support a regulation?
 This language is a weight of evidence determination using the Guideline for Carcinogen Risk Assessment (1986), and can specifically address chemical agents that have limited animal evidence and human data (web accessible at: http://ofmpub.epa.gov/eims/eimscomm. getfile?p_download_id=439779).

PIP (3:1)-specific comments:
 Although not all of the available data are cited, the toxicity of PIP, especially neurotoxicity, is well established.
 As a class, triaryl phosphates are generally neurotoxic, and structure-activity relationships have been identified. This raises the question as to whether other aryl phosphates, including triphenyl phosphate, should be included in this rulemaking process.
 TPP is not one of the identified PBTs under 6(h), so a hazard summary was not specifically developed, however it is mentioned because it is contained in many studies with PIP (3:1).
 This is consistent with the hazard summary EPA presents in Section 6.2: Human Health Hazard Summary (Phenol, Isopropylated, Phosphate (3:1)), of this document.
 The scope of the TSCA section 6(h) rulemaking is determined according to specific criteria outlined in the statute and summarized in the Background section of this document. Evidence for neurotoxic effects for PIP (3:1) are presented in section 6.2 of this document.

PCTP-specific comments:
 In the human health hazards summary, it is noted that PCTP is a metabolite and/or breakdown product of other chemicals. Only data on the parent compounds were identified. Is there any evidence that PCTP is more toxic than the parent compounds or that it is the active metabolite responsible for toxicity? Otherwise, the toxicity of PCTP in humans has not been established.
 The studies and endpoints summarized by the Agency are relevant to the hazards under consideration. However, given the limitations in the database of studies, it will be especially important for the Agency to provide a thorough uncertainty analysis in its risk characterization for PCTP.
 The use of surrogate compounds is highly uncertain for human health assessment and few ecological endpoints for 133-49-3 suggest uncertain information for hazard assessments.
 No relevant repeated-dose animal toxicity studies or human data were available for PCTP, thus analogous chemicals that are known to metabolize or degrade into PCTP were included in the hazard summary.  Decomposition products of the PBT chemicals are not being evaluated in the hazard document.  Likewise, surrogate compounds are not being used to assess the human health or ecological hazard for the PBT chemicals.
 The hazard summary is not supporting a risk evaluation for a which an uncertainty analysis would be conducted.

2,4,6 TTBP-specific comments:
 GLP studies support the identification of hazardous chemical to ecological receptors.  Bioaccumulation data was not present.   For human health assessment, one peer-reviewed study and few ECHA documents suggested hazard, but confirmation with peer-reviewed literature is uncertain.
 Identification of hazards associated with 2,4,6-TTBP is consistent with the information presented in Section 7.2: Human Health Hazard Summary (2,4,6-Tris(tert-butyl) Phenol) of this document.

Reliability and Relevance of Information - Peer Review Comments
Charge question 5: Please comment on the reliability and relevance of the identified data sets for each chemical and on the strengths and weaknesses of individual data sets that will help to better inform future regulatory actions.
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Summary of Peer Review Comments for Specific Issues Related to Charge Question 5
                               EPA/OPPT Response
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Overall comments about the reliability of the data:
 Additional information on the selection process for these chemicals is needed. Why are data on persistence and bioaccumulation not included in the reviews? Why were these selected over other chemicals?
 There is no assessment provided of the study quality and methods that might impact interpretation, such as test material purity, solubility and stability, and study design, e.g., guideline study, GLP, and other methodological considerations affecting study quality.
 The health effects summary should be strengthened to include a discussion of weight of the evidence with some conclusions.
 The scope of the TSCA section 6(h) rulemaking is determined according to specific criteria outlined in the statute and summarized in the Background section of this document and the NPRM. Persistence and bioaccumulation characteristics of the chemicals are such criteria and were considered in identifying the chemicals subject to the 6(h) action, as outlined in the Background section of this document.  Further details regarding how the PBT chemicals were evaluated to be listed in the TSCA Work Plan can be found in EPA's TSCA Work Plan for Chemical Assessments: 2014 Update (web accessible at: https://www.epa.gov/sites/production/files/2015-01/documents/tsca_work_plan_chemicals_2014_update-final.pdf).
 The Environmental and Human Health Hazard Summary is intended to be a survey of existing hazard data to provide a general characterization of the toxicity profile of the five PBT chemicals, e.g. species, types of effects and the range of toxicity. EPA did not conduct a systematic review, or calculate margins of exposure to characterize hazard (toxicity) for the five PBT chemicals. The Hazard Summary is fit for purpose for the type of analysis performed in support of 6(h) rulemaking.

DecaBDE-specific comments:
 The Agency should consider that most of the identified studies are not guideline studies conducted under good laboratory practices and so it is often not possible to confirm in these non-GLP studies key critical considerations for establishing an accurate dose or exposure response relationship for observed effect. Therefore, in its weight-of-evidence assessment, the Agency should place more consideration on those studies conducted following established guidelines and conducted under good laboratory practices.
 Many of the decaBDE studies treated animals with oral gavage using a lipophilic medium. This both increased the acute dose (a gavage dose is administered all at once so the body has more difficulty recovering from it), and it increases bioavailability in a manner that may not be relevant to exposure in the general public (with the possible exception of breast feeding babies). This should be addressed in decisions about hazards from decaBDE.
 The Environmental and Human Health Hazard Summary is intended to be a survey of existing hazard data to provide a general characterization of the toxicity profile of the five PBT chemicals, e.g. species, types of effects and the range of toxicity. Because TSCA does not require a risk evaluation be conducted to support a 6(h) action for PBTs, EPA does not deem it necessary to conduct systematic review, weight of evidence analyses to characterize hazard (toxicity) for the five PBT chemicals.
 Analyzing the pharmacokinetic differences between exposure methods and study quality analysis is outside the scope the hazard summary. Because the hazard data presented herein will not be used to conduct dose-response analyses or identify points-of-departure, PBPK differences introduced by dosing regimens is not critical to hazard identification.

HCBD-specific comments:
 The dataset for HCBD is sufficiently comprehensive for the desired review. The Agency should consider that most of the identified studies are not guideline studies conducted under good laboratory practices and so it is often not possible to confirm in these non-GLP studies key critical considerations for establishing an accurate dose or exposure response relationship for observed effects. Therefore, in its weight-of-evidence assessment, the Agency should place more consideration on those studies and technical reports conducted following established guidelines and conducted under good laboratory practices (GLP) or principles of GLP for older studies and reports conducted prior to implementation of GLP.
 Peer-reviewed, government and manufacturer-based data were provided and used to provide necessary NOEC, NOAEL and other thresholds that could be used to derive hazard.  Strengths of the data sets were the numerous sources of data that have presumably been vetted by the Agency. However, a noticeable weakness would be the lack of description of inclusion/exclusion criteria for non-governmental documents or the peer-reviewed literature.
 Bioaccumulation description was not present.
 The Environmental and Human Health Hazard Summary is intended to be a survey of existing hazard data to provide a general characterization of the toxicity profile of the five PBT chemicals, e.g. species, types of effects and the range of toxicity. Hence, the hazard data are reported from the literature with no additional analysis or assessment. EPA did not conduct a systematic review or calculate margins of exposure to characterize hazard (toxicity) for the five PBT chemicals. The Hazard Summary is fit for purpose for the type of analysis performed in support of 6(h) rulemaking.
       Persistence and bioaccumulation characteristics of the chemicals are criteria that were considered previously in identifying the chemicals subject to the 6(h) action, as outlined in the Background section of this document.  Further details regarding how the PBT chemicals were evaluated to be listed in the TSCA Work Plan can be found in EPA's TSCA Work Plan for Chemical Assessments: 2014 Update (web accessible at: https://www.epa.gov/sites/production /files/201501/documents/tsca_work_plan_ chemicals_2014_update-final.pdf). EPA agrees that the dataset for HCBD is sufficient for the desired purpose.

PIP (3:1)-specific comments:
 The dataset for environmental and human health hazards for PIP includes a large number of guideline studies conducted under GLP and is sufficiently comprehensive for the desired review.  However, the Agency should obtain copies of the original study reports to review the accuracy of the data and information reported in the ECHA database.
 Limited strengths are present for this assessment.  There is only one peer-reviewed study provided on a product that was 28% triphenylphosphate.  Thus, the literature is extremely limited.
 The data used is what was publicly available during the initial data extraction; original study reports, especially those from other jurisdictions, are not always readily attainable.
 EPA agrees that the dataset for PIP (3:1) is sufficient for the desired purpose. The Environmental and Human Health Hazard Summary is intended to be a survey of existing hazard data to provide a general characterization of the toxicity profile of the five PBT chemicals, e.g. species, types of effects and the range of toxicity. Hence, the hazard data are reported from the literature with no additional analysis or assessment. EPA did not conduct a systematic review or calculate margins of exposure to characterize hazard (toxicity) for the five PBT chemicals. The Hazard Summary is fit for purpose for the type of analysis performed in support of 6(h) rulemaking.
 EPA agrees the data are limited for PIP (3:1); however, as noted by another commenter, neurotoxicity of PIP (3:1) is well established, consistent with the reports summarized in this document.

PCTP-specific comments:
 The dataset for environmental and human health hazards for PCTP is minimal and appears limited. The Agency should obtain original study reports to assess the quality and validity of the information in order to determine the most reliable data for hazard and risk assessment. In its weight-of-evidence assessment, the Agency should place more consideration on those studies and reports conducted following most closely established guidelines and principles of GLP.
 EPA agrees that the dataset for PCTP is limited, but believes it is sufficient for the desired purpose. The Environmental and Human Health Hazard Summary is intended to be a survey of existing hazard data to provide a general characterization of the toxicity profile of the five PBT chemicals, e.g. species, types of effects and the range of toxicity. Hence, the hazard data are reported from the literature with no additional analysis or assessment. EPA did not conduct a systematic review or calculate margins of exposure to characterize hazard (toxicity) for the five PBT chemicals. The Hazard Summary is fit for purpose for the type of analysis performed in support of 6(h) rulemaking.

2,4,6 TTBP-specific comments:
 The dataset for environmental and human health hazards for 2,4,6 TTBP includes both guideline GLP studies and non-guideline studies.  In its weight-of-evidence assessment, the Agency should place more consideration on those studies and reports conducted following established guidelines and conducted under GLP or following GLP principles with adequate information and data provided to confirm such.  In addition, the Agency should obtain copies of the original study reports to review the accuracy of the data and information reported in the ECHA database.
 GLP studies indicate hazard, but because few peer-reviewed studies have been performed with this specific compound, there is significant uncertainty with regard to hazard.
 The Environmental and Human Health Hazard Summary is intended to be a survey of existing hazard data to provide a general characterization of the toxicity profile of the five PBT chemicals, e.g. species, types of effects and the range of toxicity. Hence, the hazard data are reported from the literature with no additional analysis or assessment. EPA did not conduct a systematic review or calculate margins of exposure to characterize hazard (toxicity) for the five PBT chemicals. The Hazard Summary is fit for purpose for the type of analysis performed in support of 6(h) rulemaking. EPA agrees that the dataset for 2,4,6 TTBP somewhat limited, but believes it is sufficient for the desired purpose.

Organization and Clarity of the Document - Public Comments
Charge question 1: This information, when finalized will inform a technical support document to support EPA's regulatory activities on PBTs. Please comment on the organization and structure of this document to inform this use. Do you have specific recommendations to improve clarity and presentation of this information?
                                       #
  Summary of Public Comments for Specific Issues Related to Charge Question 1
                               EPA/OPPT Response
                                       1
Editorial:
 ACC Recommendation: EPA should establish the human health and ecological health thresholds for each chemical in order to be able to determine what level of exposure represents an unreasonable risk in order to ascertain what exposure reduction is practicable.
 Establishing human health and ecological health thresholds as to demonstrate unreasonable risk for each chemical would be conducted in a risk evaluation. Risk evaluations are not required under 6(h). The Environmental and Human Health Hazard Summary is intended to be a survey of existing hazard data to provide a general characterization of the toxicity profile of the five PBT chemicals, e.g. species, types of effects and the range of toxicity. Hence, the hazard data are reported from the literature with no additional analysis or assessment. EPA did not conduct a systematic review or calculate margins of exposure to characterize hazard (toxicity) for the five PBT chemicals. The Hazard Summary is fit for purpose for the type of analysis performed in support of 6(h) rulemaking.

B. EPA should leverage information generated from the first 10 chemicals for risk evaluation where it can.
 ACC Recommendation: EPA should leverage the information generated from the first 10 chemicals for risk evaluation where it can. For example, it was noted that hexachlorobutadiene (HCBD) is primarily generated as a by-product of the manufacture of chlorinated hydrocarbons, particularly perchloroethylene, trichloroethylene and carbon tetrachloride -- each of which is the subject of one of the first ten risk evaluations. EPA should consider information associated with relevant risk evaluations where appropriate.
 EPA did not conduct risk evaluations of these chemicals for this rulemaking.
 EPA did leverage information generated from the first 10 chemicals where it was possible.

Methodology for Collecting and Summarizing Information - Public Comments
Charge question 2: Please comment on the methodology for collecting and summarizing information from secondary sources. Was the approach appropriate? Is the description for how and where the literature was obtained clearly described?
                                       #
  Summary of Public Comments for Specific Issues Related to Charge Question 2
                               EPA/OPPT Response
                                      12
Recommendations for Scope of Search:
 EPA should apply a similar structural and analytical approach to the Section 6(h) PBT chemicals even though EPA is not required to conduct a risk evaluation on those chemicals.
 ACC Recommendation: Many useful lessons may be learned from the draft risk evaluations prepared by EPA on the initial 10 chemicals for risk evaluation under TSCA. It would be useful for EPA to apply a similar structural and analytical approach to the Section 6(h) chemicals regardless of the fact that EPA is not required to conduct a risk evaluation on those chemicals.
 EPA is required to address the risks of injury to health or the environment that may be presented by these chemicals. Consequently, many aspects of the TSCA risk evaluation process may be valuable in determining those risks. For example, before EPA can identify appropriate risk management for Section 6(h) PBT chemicals, EPA should consider controls already in place under other EPA regulatory programs implementing other EPA-administered statutes. To do so, EPA should review exposure pathways of these chemicals and the risks associated with those.
 EPA should apply a similar structural and analytical approach to the Section 6(h) PBT chemicals even though EPA is not required to conduct a risk evaluation on those chemicals.
 ACC Recommendation: EPA should ensure that it understands how other federal laws not administered by EPA may already be managing the risks of these PBT chemicals for certain exposure pathways. Again, EPA should assess the risks associated with these chemicals under certain exposure pathways in order to do so.
 Risk evaluations were not conducted for the PBTs. A hazard summary was developed to address the hazards of each chemical identified under 6(h).
 The Environmental and Human Health Hazard Summary is intended to be a survey of existing hazard data to provide a general characterization of the toxicity profile of the five PBT chemicals, e.g. species, types of effects and the range of toxicity. Hence, the hazard data are reported from the literature with no additional analysis or assessment. EPA did not conduct a systematic review or calculate margins of exposure to characterize hazard (toxicity) for the five PBT chemicals. The Hazard Summary is fit for purpose for the type of analysis performed in support of 6(h) rulemaking.
 The Environmental and Human Health Hazard Summary is intended to be a survey of existing hazard data to provide a general characterization of the toxicity profile of the five PBT chemicals, e.g. species, types of effects and the range of toxicity. Hence, the hazard data are reported from the literature with no additional analysis or assessment. EPA did not conduct a systematic review or calculate margins of exposure to characterize hazard (toxicity) for the five PBT chemicals. The Hazard Summary is fit for purpose for the type of analysis performed in support of 6(h) rulemaking.

Representativeness and Completeness of Presented Information - Public Comments
Charge question 3: Please comment on the representativeness and adequacy of the selected literature used in the evidence tables and described in the text to summarize the hazard concerns. Are there additional primary peer-reviewed and publicly available literature that warrant further consideration? If so, please identify or provide these sources and comment on whether acquisition and summarization of this additional information would change the hazard characterization already provided in the existing summaries? Does the information presented clearly and accurately represent the hazards associated with each chemical? Are there any studies that should be removed from the summary and evidence tables due to study quality or data transparency concerns?
                                       #
  Summary of Public Comments for Specific Issues Related to Charge Question 3
                               EPA/OPPT Response
                                      19
Overall comments about representativeness of data:
 As was noted in the Environmental Hazard Summary for PIP (3:1), much of the environmental hazard data was collected using commercial mixtures with significant fractions (>5%) of triphenyl phosphate (TPP) which appears to drive toxicity. When the PIP (3:1) commercial mixtures have less than 5% TPP, aquatic toxicity appears to be much lower.
 ACC Recommendation: Greater clarity regarding the environmental toxicity of PIP (3:1) is needed.
 The purpose of the hazard document is not to evaluate the hazard of chemicals typically present in mixtures containing the PBT chemicals. The percentage of TPP was provided (as reported) so the reader is aware that a mixture may have been used in the study.

Appropriateness and Sufficiency of Information - Public Comments
Charge question 4: Has appropriate and sufficient information been obtained from the literature to support the identification of hazards?
                                       #
  Summary of Public Comments for Specific Issues Related to Charge Question 4
                               EPA/OPPT Response
                                      25
Overall comments about the sufficiency of the data:
 ACC Recommendation: EPA should consider the application of New Approach Methodologies (NAMs) particularly in those cases where the available data is limited. For example, at least two of the PBTs had limited hazard data. The use of NAMs may help establish a threshold for risk management that could be appropriate.
 PCTP is both a metabolite and biodegradation product of pentachloronitrobenzene (PCNB) (Khan et al., 2011) and a metabolite of hexachlorobenzene (WHO, 1997). EPA used data on these compounds because there was little publicly available data on PCTP.
 The Environmental and Human Health Hazard Summary is intended to be a survey of existing hazard data to provide a general characterization of the toxicity profile of the five PBT chemicals, e.g. species, types of effects and the range of toxicity. Hence, the hazard data are reported from the literature with no additional analysis or assessment. EPA did not conduct a systematic review or calculate margins of exposure to characterize hazard (toxicity) for the five PBT chemicals. The Hazard Summary is fit for purpose for the type of analysis performed in support of 6(h) rulemaking. Because TSCA does not require a risk evaluation be conducted to support a 6(h) action for PBTs, EPA does not deem it necessary to establish a threshold for the five PBT chemicals.

Reliability and Relevance of Information - Public Comments
Charge question 5: Please comment on the reliability and relevance of the identified data sets for each chemical and on the strengths and weaknesses of individual data sets that will help to better inform future regulatory actions.
                                       #
  Summary of Public Comments for Specific Issues Related to Charge Question 5
                               EPA/OPPT Response
                                      26
Overall comments about the reliability of the data:
 ACC Recommendation: EPA is not required to conduct a risk evaluation for Section 6(h) PBT chemicals, nor is it required to apply systematic review to the data associated with the Section 6(h) PBT chemicals. EPA should apply, however, the data quality criteria from its Application of Systematic Review in TSCA Risk Evaluations to the environmental and human health hazard data to enable the public to understand which data may be of sufficient reliability and relevance for regulatory decision-making.
 A number of the acute and chronic environmental hazard endpoint values for the PBT chemicals exceed the water solubility limit which raises questions about the reliability of those data. For example, it is reported for DecaBDE that "[a]cute toxicity to fish varies among species, with acute effects reported in the range of 0.01 to >500 mg/L" (p.8) when water solubility is reported in the Use and Exposure Assessment as 0.02 mg/L (p. 21).
 ACC Recommendation: EPA should re-evaluate the reliability of the acute and chronic environmental hazard data for the PBT chemicals. As part of this, EPA should include the details of the test article, materials, and methods of each acute fish study and water solubility study cited by EPA since these parameters may explain the variation of toxicity in different fish species. ACC also urges EPA to apply its Systematic Review principles to the data that will be used as part of the risk evaluation and risk management decisions on the five PBTs.
  Study details are listed in the hazard document as reported to provide further insight on potential study limitations.
 Publicly available information on the PBT chemicals were provided in the hazard document, and the study details were provided as reported.


[Federal Register: May 2, 2007 (Volume 72, Number 84)]
[Notices]
[Page 24349-24350]
[DOCID:fr02my07-111]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55672; File No. SR-NASDAQ-2007-029]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing of Proposed Rule Change and Amendment No. 1 Thereto To
Require That Companies Submit Material News to Nasdaq Using Nasdaq's
Electronic Disclosure System, Except in Emergency Situations

April 26, 2007.

    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 27, 2007, the NASDAQ Stock Market LLC (``Nasdaq'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II, and III below, which Items
have been prepared substantially by Nasdaq. Nasdaq filed Amendment No.
1 to the proposed rule change on April 25, 2007. The Commission is
publishing this notice to solicit comments on the proposed rule change,
as amended, from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq proposes to amend Nasdaq Rule 4120, ``Trading Halts,'' and
IM-4120-1, ``Disclosure of Material Information,'' to require Nasdaq-
listed companies to submit material news to Nasdaq using Nasdaq's
electronic disclosure submission system, except in emergency
situations. To allow Nasdaq sufficient time to communicate with listed
companies about the new requirement, Nasdaq will not implement the
proposed rule change until approximately 90 days after the proposal is
approved. Nasdaq's communication with companies regarding this proposed
change will provide notice of the implementation date. The text of the
proposed rule change is available at Nasdaq, in the Commission's Public
Reference Room, and at http://www.nasdaq.com.

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

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

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

1. Purpose
    Pursuant to Nasdaq Rules 4310(c)(16) and 4320(e)(14), a Nasdaq-
listed company is required, except in unusual circumstances, to make
prompt disclosure to the public through any Regulation FD compliant
method (or combination of methods) of disclosure of any material
information that would reasonably be expected to affect the value of
its securities or influence investors' decisions. These rules also
require that the company provide prior notice of certain disclosures to
Nasdaq's MarketWatch Department (``MarketWatch'').
    Current methods to provide prior notification to MarketWatch
include electronic submission using Nasdaq's Electronic Disclosure
submission service, fax, and phone. While the Electronic Disclosure
submission service was introduced to companies in 2004, the majority of
companies still rely primarily on fax submission to MarketWatch.\3\ The
material information from fax-delivered documents and telephonic
notifications must be manually retyped into MarketWatch's database
systems. Nasdaq notes that this uses staff time with no added
regulatory benefit, introduces error risk, and results in a less robust
audit trail. To reduce this administrative burden, Nasdaq has recently
taken steps to make the Electronic Disclosure submission system more
accessible to listed companies \4\ and is now proposing to require that
companies submit material news to Nasdaq using the Electronic
Disclosure submission system, except in emergency situations.
---------------------------------------------------------------------------

    \3\ Nasdaq notes, for example, that of approximately 4,200
material news notifications submitted to MarketWatch in January
2007, over 70% were submitted by fax.
    \4\ According to Nasdaq, although the system was previously on a
portion of the Nasdaq Online issuer Web site that offered limited
access, it now resides on an area of Nasdaq Online that can be more
easily and directly accessed by companies and their representatives.
---------------------------------------------------------------------------

    Using the Electronic Disclosure submission system, company
employees and representatives can transmit disclosures to Nasdaq using
a secure, encrypted connection. Upon receipt, Nasdaq reviews these
disclosures to determine if a trading halt is appropriate. If Nasdaq
believes that a halt may be appropriate, Nasdaq will confirm all
disclosures with a company source before taking any action. Nasdaq does
not disseminate any information received over the Electronic Disclosure
submission system.
    Companies would still be required to notify Nasdaq before
disseminating material news, even if an emergency situation prevented
them from accessing the Electronic Disclosure submission system. Nasdaq
would accept notification by phone or fax in these situations. Examples
of the types of situations where Nasdaq believes this could occur
include: Lack of computer or internet access; a technical problem on
either the issuer or Nasdaq system, or an incompatibility between those
systems; and a material development such that no draft disclosure
document exists, but immediate notification to MarketWatch is important
based on the event.
    Nasdaq believes that companies should be familiar with electronic
submission of documents, given that most reports to the Commission must
be

submitted electronically over the Commission's EDGAR system.
Furthermore, the Electronic Disclosure submission system has been
designed to be simple to operate. As such, Nasdaq does not believe that
the required use of the Electronic Disclosure submission system will be
a burden on companies.
    If a company repeatedly fails to either notify Nasdaq prior to the
distribution of material news, or to use the electronic disclosure
submission system when Nasdaq finds no emergency situation existed,
Nasdaq may issue a Staff Determination, pursuant to the Nasdaq Rule
4800 Series,\5\ that is a public reprimand letter or, in extreme
situations, a Staff Determination to delist the company's securities.
In determining whether to issue a public reprimand letter, Nasdaq will
consider whether the issuer has demonstrated a pattern of failures,
whether the issuer has been contacted concerning previous violations,
and whether the issuer has taken steps to assure that future violations
will not occur.
---------------------------------------------------------------------------

    \5\ See Amendment No. 1.
---------------------------------------------------------------------------

2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
Section 6(b) of the Act,\6\ in general, and furthers the objectives of
Section 6(b)(5) of the Act,\7\ in particular. Nasdaq believes that the
proposed rule change would enhance its ability to timely review issuer
disclosures, thereby facilitating the operation of a free and open
market and protecting investors and the public interest.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    Nasdaq does not believe that the proposed rule change will impose
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    Written comments were neither solicited nor received.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which Nasdaq consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form http://www.sec.gov/rules/sro.shtml.
; or     Send an e-mail to<EMAIL_ADDRESS>Please include

File No. SR-NASDAQ-2007-029 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE,
Washington, DC 20549-1090.

All submissions should refer to File No. SR-NASDAQ-2007-029. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site at http://www.sec.gov/rules/sro.shtml.
 Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of the filing
also will be available for inspection and copying at the principal
office of Nasdaq. All comments received will be posted without change;
the Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File No. SR-NASDAQ-
2007-029 and should be submitted on or before May 23, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-8313 Filed 5-1-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: June 28, 2007 (Volume 72, Number 124)]
[Proposed Rules]
[Page 35375-35376]
[DOCID:fr28jn07-15]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 60

[EPA-HQ-OAR-2007-0011; FRL-8332-4]
RIN 2060-AN72

Standards of Performance for Petroleum Refineries

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of public comment period.

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SUMMARY: EPA is announcing that the comment period on the proposed rule
amendments for the Standards of Performance for Petroleum Refineries,
published on May 14, 2007, is being extended until August 27, 2007.

DATES: Comments. Comments on the proposed amendments must be received
on or before August 27, 2007.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2007-0011, by one of the following methods:
     http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: U.S. Postal Service, send comments to: EPA Docket
Center (6102T), Docket No. EPA-HQ-OAR-2007-0011, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
Please include a total of two copies. In addition, please mail a copy
of your comments on the information collection provisions to the Office
of Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attn: Desk Officer for EPA, 725 17th St., NW., Washington, DC
20503.
     Hand Delivery: In person or by courier, deliver comments
to: EPA Docket Center (6102T), EPA West Building, Room 3334, 1301
Constitution Ave., NW., Washington, DC 20004. Such deliveries are only
accepted during the Docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information. Please
include a total of two copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2007-0011. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information provided,

unless the comment includes information claimed to be confidential
business information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-mail.

The http://www.regulations.gov Web site is an ``anonymous access'' system,

which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://www.regulations.gov,

your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

    Docket: All documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
through http://www.regulations.gov or in hard copy at the EPA Docket Center

(6102T), EPA West Building, Room 3444, 1301 Constitution Ave., NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the EPA Docket Center is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Lucas, Office of Air
Quality Planning and Standards, Sector Policies and Programs Division,
Coatings and Chemicals Group (E143-01), Environmental Protection
Agency, Research Triangle Park, NC 27711; telephone number: (919) 541-
0884; fax number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Regulated Entities. Categories and entities potentially regulated
by this action include:

----------------------------------------------------------------------------------------------------------------
                                                   NAICS*
                    Category                        code         Examples of potentially  regulated entities
----------------------------------------------------------------------------------------------------------------
Industry.......................................      32411  Petroleum refiners.
Federal government.............................  .........  Not affected.
State/local/tribal government..................  .........  Not affected.
----------------------------------------------------------------------------------------------------------------
* North American Industrial Classification System.

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. To determine whether your facility is regulated by this action,
you should examine the applicability criteria in 40 CFR 60.480 and 40
CFR 60.590. If you have any questions regarding the applicability of
the proposed amendments to a particular entity, contact the person
listed in the preceding FOR FURTHER INFORMATION CONTACT section.
    Submitting CBI. Do not submit information that you consider to be
CBI electronically through http://www.regulations.gov or e-mail. Send or

deliver information identified as CBI only to the following address:
Roberto Morales, OAQPS Document Control Officer (C404-02), U.S. EPA,
Office of Air Quality Planning and Standards, Research Triangle Park,
NC 27711, Attention Docket ID EPA-HQ-OAR-2007-0011. Clearly mark the
part or all of the information that you claim to be CBI. For CBI
information in a disk or CD-ROM that you mail to EPA, mark the outside
of the disk or CD-ROM as CBI and then identify electronically within
the disk or CD-ROM the specific information that is claimed as CBI. In
addition to one complete version of the comment that includes
information claimed as CBI, a copy of the comment that does not contain
the information claimed as CBI must be submitted for inclusion in the
public docket. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
    If you have any questions about CBI or the procedures for claiming
CBI, please consult the person identified in the FOR FURTHER
INFORMATION CONTACT section. Worldwide Web (WWW). In addition to being
available in the docket, an electronic copy of the proposed amendments
is available on the WWW through the Technology Transfer Network (TTN).
Following signature, a copy of the proposed amendments will be posted
on the TTN's policy and guidance page for newly proposed or promulgated
rules at http://www.epa.gov/ttn/oarpg. The TTN provides information and

technology exchange in various areas of air pollution control.

Comment Period

    We received several requests to extend the public comment period to
August 27, 2007. We agreed to this request, therefore, the public
comment period will now end on August 27, 2007, rather than July 13,
2007.

How can I get copies of the proposed amendments and other related
information?

    The proposed rule amendments for the Standards of Performance for
Petroleum Refineries, published on May 14, 2007 (72 FR 27178). EPA has
established the official public docket for the proposed rulemaking
under Docket ID No. EPA-HQ-OAR-2007-0011. Information on how to access
the docket is presented above in the ADDRESSES section.

    Dated: June 20, 2007.
Robert J. Meyers,
Acting Assistant Administrator for Air and Radiation.
[FR Doc. E7-12584 Filed 6-27-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 49 (Tuesday, March 13, 2012)]
[Rules and Regulations]
[Pages 14679-14681]
[FR Doc No: 2012-5859]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

Federal Register / Vol. 77, No. 49 / Tuesday, March 13, 2012 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-1087; Directorate Identifier 2011-NM-032-AD;
Amendment 39-16967; AD 2012-04-11]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are superseding two existing airworthiness directives (AD).
One existing AD is for Airbus Model A319, A320, and A321 series
airplanes without Airbus modification 26017. That AD currently requires
replacing the flight warning computers (FWCs). The other existing AD is
for Airbus Model A320 and A321 series airplanes on which Airbus
modification 24612 or Airbus Service Bulletin A320-31-1080 has not been
accomplished. That existing AD currently requires revising the
limitations section of the airplane flight manual. This new AD requires
replacing both FWC units with certain FWC units. This AD was prompted
by in-service events of thrust lever mismanagement and a manufacturer
analysis on the failure to follow procedure or heed existing cockpit
cues. The analysis of the thrust lever management issue showed two
categories of scenarios that could lead to thrust asymmetry during
landing, with controllability and deceleration consequences. We are
issuing this AD to prevent thrust asymmetry conditions which could
result in loss of control of the airplane during landing.

DATES: This AD becomes effective April 17, 2012.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of April 17,
2012.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of June 24,
2002 (67 FR 35425, May 20, 2002).

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Tim Dulin, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-2141; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on October 19, 2011 (76
FR 64854), and proposed to supersede AD 97-22-13, Amendment 39-10185
(62 FR 58891, October 31, 1997); and AD 2002-10-06, Amendment 39-12752
(67 FR 35425, May 20, 2002). That NPRM proposed to correct an unsafe
condition for the specified products. The MCAI states:

    Following in-service experience, analyses of the failure to
follow procedure or heed existing cockpit cues were conducted to
assess the consequences of mismanagement of thrust levers during
landing.
    The investigation results identified the need for improvements
in the identification of throttle mis-positioning and so providing
further opportunity for the flight crew to identify an incorrect
thrust lever configuration and to correct this. For the A320 family
of aeroplanes this being IDLE or REVERSE, which is necessary to
enable ground spoiler (G/S) extension and auto-brake (A/BRK)
functions. In addition, the analysis of the thrust lever management
issue shows two categories of scenarios that could lead to thrust
asymmetry during landing with controllability and deceleration
consequences:

--One thrust lever kept in forward thrust when the other is put in
IDLE or REVERSE. This has been seen in cases of dispatch with one
thrust reverser inoperative; and
--One thrust lever moved in forward position after landing, usually
when bringing the thrust lever back from REVERSE to IDLE.

    These thrust asymmetry conditions, if not corrected, could
result in loss of control of the aeroplane during landing.
    This [EASA] AD supersedes DGAC France AD 94-211-059(B) R2 and
96-079-079(B) [which corresponds to FAA AD 97-22-13 (62 FR 58891,
October 31, 1997], mandating Aircraft Flight Manual Temporary
Revision reference 9.99.99/20 and the installation of FWC P/N
350E017248685 (H1D2) as terminating action for both ADs.
    This [EASA] AD retains the requirements of DGAC France AD 2000-
320-147(B) [which corresponds to FAA AD 2002-10-06 (67 FR 35425, May
20, 2002)], which is also superseded, which required the
installation of FWC P/N 350E017271616 (H1E2).
    For the reasons described above, this [EASA] AD requires the
replacement of both FWC units with minimum FWC P/N 350E053020909
(H2F5) units, introducing ``Enhanced RETARD'' logic.

You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comment received. The commenter supports the
NPRM (76 FR 64854, October 19, 2011).

Explanation of Changes Made to This AD

    We have redesignated paragraph (g) and Note 1 of the NPRM (76 FR
64854, October 19, 2011) to paragraphs (g)(1) and (g)(2) in this AD,
respectively. We have revised certain headings throughout this AD. We
have also revised the wording in paragraphs (g)(2) and (j) of this AD;
this change has not changed the intent of those paragraphs.

Conclusion

    We reviewed the available data, including the comment received, and
determined that air safety and the public interest require adopting the
AD with the changes described previously and minor editorial changes.
We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (76 FR 64854, October 19, 2011) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (76 FR 64854, October 19, 2011).

Costs of Compliance

    We estimate that this AD will affect about 729 products of U.S.
registry. The actions that are required by AD 2002-10-06, Amendment 39-
12752 (67 FR 35425, May 20, 2002) and retained in this AD take about 7
work-hours per product, at an average labor rate of $85 per work hour.
Required parts would cost about $0 per product. Where the service
information lists required parts costs that are covered under warranty,
we have assumed that there will be no charge for these parts. As we do
not control warranty coverage for affected parties, some parties may
incur costs higher than estimated here. Based on these figures, the
estimated cost of the currently required actions is $595 per product.
    We estimate that it would take about 4 work-hours per product to
comply with the new basic requirements of this AD. The average labor
rate is $85 per work-hour. Required parts would cost about $0 per
product. Based on these figures, we estimate the cost of this AD on
U.S. operators to be $247,860, or $340 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ''significant regulatory action'' under Executive Order
12866;
    2. Is not a ''significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM (76 FR 64857, October 19,
2011), the regulatory evaluation, any comments received, and other
information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing AD 97-22-13, Amendment 39-
10185 (62 FR 58891, October 31, 1997); and AD 2002-10-06, Amendment 39-
12752 (67 FR 35425, May 20, 2002); and adding the following new AD:

2012-04-11 Airbus: Amendment 39-16967. Docket No. FAA-2011-1087;
Directorate Identifier 2011-NM-032-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective April 17,
2012.

(b) Affected ADs

    This AD supersedes AD 97-22-13, Amendment 39-10185 (62 FR 58891,
October 31, 1997); and AD 2002-10-06, Amendment 39-12752 (67 FR
35425, May 20, 2002).

(c) Applicability

    This AD applies to Airbus Model A318-111, -112, -121, and -122
airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and -
133 airplanes; Model A320-111, -211, -212, -214, -231, -232, and -
233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -
231, and -232 airplanes; certificated in any category; all serial
numbers; if equipped with a flight warning computer (FWC) with a
part number (P/N) listed in table 1 of this AD.

          Table 1--List of FWC Part Numbers Affected by This AD
------------------------------------------------------------------------
                              FWC Part No.
-------------------------------------------------------------------------
        350E017238484 (H1D1)
        350E016187171 (C5)
        350E017248685 (H1D2)
        350E017251414 (H1E1)
        350E017271616 (H1E2)
        350E018291818 (H1E3CJ)
        350E018301919 (H1E3P)
        350E018312020 (H1E3Q)
        350E053020202 (H2E2)
        350E053020303 (H2E3)
        350E053020404 (H2E4)
        350E053020606 (H2F2)
        350E053020707 (H2F3)
        350E053021010 (H2F3P)
        350E053020808 (H2F4)
------------------------------------------------------------------------

(d) Subject

    Air Transport Association (ATA) of America Code 31: Indicating
and Recording Systems.

(e) Reason

    This AD was prompted by in-service events of thrust lever
mismanagement and a manufacturer analysis on the failure to follow
procedure or heed existing cockpit cues. The analysis of the thrust
lever management issue showed two categories of scenarios that could
lead to thrust asymmetry during landing, with controllability and
deceleration consequences. We are issuing this AD to prevent thrust
asymmetry conditions which could result in loss of control of the
airplane during landing.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Restatement of Requirements of AD 2002-10-06, Amendment 39-12752
(67 FR 35425, May 20, 2002): Modification

    (1) For Model A319, A320, and A321 series airplanes without
Airbus modification 26017: Within 18 months after June 24, 2002 (the
effective date of AD 2002-10-06, Amendment 39-12752 (67 FR 35425,
May 20, 2002)), replace the flight warning computers (FWCs) in
accordance with Airbus Service Bulletin A320-31-1106, Revision 04,
dated December 21, 1999; or Airbus Mandatory Service Bulletin A320-
31-1106, Revision 05, dated September 21, 2000.
    (2) This paragraph provides credit for replacement of the FWCs
required by

paragraph (g)(1) of this AD, if the replacement was done before June
24, 2002 (the effective date of AD 2002-10-06, Amendment 39-12752
(67 FR 35425, May 20, 2002)), using Airbus Service Bulletin A320-31-
1106, dated January 3, 1997; Revision 01, dated April 16, 1997;
Revision 02, dated January 20, 1998; or Revision 03, dated July 9,
1999.

(h) Restatement of Requirements of AD 2002-10-06, Amendment 39-12752
(67 FR 35425, May 20, 2002): Optional Method of Compliance

    Installation of a FWC standard in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A320-31-1141,
Revision 04, dated February 14, 2002, is an acceptable method of
compliance with the replacement required by paragraph (g) of this
AD.

(i) New Requirements of This AD: Flight Warning Computer Replacement

    Within 48 months after the effective date of this AD: Replace
both FWC units with FWC part number 350E053020909, in accordance
with the Accomplishment Instructions of Airbus Mandatory Service
Bulletin A320-31-1334, Revision 04, including Appendix 01, dated
September 12, 2011.

(j) Credit for Previous Actions

    (1) For all airplanes, except for Model A319 series airplanes on
which modifications 28238, 28162, and 28342 have been incorporated:
This paragraph provides credit for replacing both FWCs, as required
by paragraph (i) of this AD, if the replacements were performed
before the effective date of this AD using Airbus Service Bulletin
A320-31-1334, dated July 30, 2009; Revision 01, dated December 14,
2009; Revision 02, dated September 13, 2010; or Revision 03, dated
March 15, 2011.
    (2) This paragraph provides credit for replacing both FWCs in
lieu of the installation specified in paragraph (h) of this AD, if
the replacements were performed before the effective date of this AD
using Airbus Service Bulletin A320-31-1141, dated March 6, 2000;
Revision 01, dated May 25, 2000; Revision 02, dated January 22,
2001; or Revision 03, dated June 12, 2001.

(k) Parts Installation

    As of the effective date of this AD, and after accomplishing the
actions in paragraph (i) of this AD, no person may install a FWC
with a part number listed in table 1 of this AD on any airplane.

(l) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Tim Dulin,
Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, Washington
98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information
may be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(m) Related Information

    Refer to MCAI EASA Airworthiness Directive 2011-0001, dated
January 10, 2011; Airbus Service Bulletin A320-31-1106, Revision 04,
dated December 21, 1999; Airbus Mandatory Service Bulletin A320-31-
1106, Revision 05, dated September 21, 2000; Airbus Service Bulletin
A320-31-1141, Revision 04, dated February 14, 2002; and Airbus
Mandatory Service Bulletin A320-31-1334, Revision 04, including
Appendix 01, dated September 12, 2011; for related information.

(n) Material Incorporated by Reference

    (1) You must use the following service information to do the
actions required by this AD, unless the AD specifies otherwise. The
Director of the Federal Register approved the incorporation by
reference (IBR) of the following service information under 5 U.S.C.
552(a) and 1 CFR part 51 on the date specified.
    (2) The following service information was approved for IBR on
April 17, 2012.
    (i) Airbus Mandatory Service Bulletin A320-31-1106, Revision 05,
dated September 21, 2000.
    (ii) Airbus Service Bulletin A320-31-1141, Revision 04, dated
February 14, 2002.
    (iii) Airbus Mandatory Service Bulletin A320-31-1334, Revision
04, including Appendix 01, dated September 12, 2011.
    (3) The following service information was approved for IBR on
IBR June 24, 2002 (67 FR 35425, May 20, 2002).
    (i) Airbus Service Bulletin A320-31-1106, Revision 04, dated
December 21, 1999.
    (4) For service information identified in this AD, contact
Airbus, Airworthiness Office--EAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com.
    (5) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (6) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at an NARA facility, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on January 24, 2012.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-5859 Filed 3-12-12; 8:45 am]
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