SECRETARIAT FOR THE VIENNA CONVENTION AND ITS MONTREAL PROTOCOL   THE OZONE SECRETARIAT P. O. Box 30552, Nairobi, Kenya   Tel: [+ 254 20] 623851  Fax: [+ 254 20] 624691 / 624692 / 624693 Email: ozoneinfo@ unep. org   Http:// www. unep. org/ ozone Your reference:

Our reference: OzL./ MBTOC CUN/ USA/ MS/ lm Date: 16 March 2005 Dear Sir,

Re: Review of Critical Use Nominations for Methyl Bromide Please refer to the on going review process of nominations for critical use exemptions for methyl bromide.

In accordance with this process and based upon the information provided by your Government, the MBTOC reviewers have some questions that I am forwarding for your attention. The questions are on technical issues and on nominations related to structures, commodities and objects. If further questions on economic issues and on nominations related to soil applications arise, they will be communicated to you separately.

I would appreciate it if your response and any questions you may have are directly sent to the Co chairs of the Committee at the addresses provided below with a copy to the Secretariat.

Dr. H. J. Banks Dr. Nahum M. Mendoza 10 Beltana Road and Department of Agricultural Parasites Pialligo, ACT 2609 Autonomic University of Chapingo Australia P. O. Box 56230 Chapingo, Mexico Tel: (+ 61 2) 6248 9228 Tel: (+ 52 595) 954 1646 / 1602 Fax: (+ 61 2) 6248 9228 Fax; (+ 52 595) 954 1646 / 1602 / 40692 E Mail: apples3@ bigpond. com E Mail: nahumm@ correo. chapingo. mx Yours sincerely,

Marco González Executive Secretary Ozone Secretariat Dr. John E. Thompson, Ph. D. International Affairs Officer Office of Environmental Policy U. S. Department of State 2201 C Street N. W. Room 4325 Washington DC 20520, U. S. A.

Fax: (+ 1 202) 647 5947 SECRETARIAT FOR THE VIENNA CONVENTION AND ITS MONTREAL PROTOCOL   THE OZONE SECRETARIAT P. O. Box 30552, Nairobi, Kenya   Tel: [+ 254 20] 623851  Fax: [+ 254 20] 624691 / 624692 / 624693 Email: ozoneinfo@ unep. org   Http:// www. unep. org/ ozone  2

Copy to: Dr. H. J. Banks Fax: (+ 61 2) 6248 9228 Dr. Nahum M. Mendoza Fax: (+ 52) 5954 0692 Ms. Michelle Marcotte Tel: (+ 1 301) 262 9866 Dr. Ian Porter Fax: (+ 61 3) 9800 3521 SECRETARIAT FOR THE VIENNA CONVENTION AND ITS MONTREAL PROTOCOL   THE OZONE SECRETARIAT P. O. Box 30552, Nairobi, Kenya   Tel: [+ 254 20] 623851  Fax: [+ 254 20] 624691 / 624692 / 624693 Email: ozoneinfo@ unep. org   Http:// www. unep. org/ ozone Questions from MBTOC concerning Post harvest CUNs General Issues The U. S. CUNs do not list the structures to be fumigated, do not give specific and individual volumes, types of structure, location, frequency of fumigation, dosage rate and why each is not suited to use of alternatives. Yet, MBTOC has the job of diligently evaluating if the proposed use of MB is critical for the specific circumstances of proposed use of MB. For example, without this information it is not possible for MBTOC to check volume of structure to be fumigated against the dosage rate and the requested amount of MB. Without this information MBTOC can not determine if SF can be used by a particular structure because we do not know if it is located in a state that allows SF use. We can not determine if heat can be used successfully because we do not know location of the structure or its volume.

These questions were also raised during consideration of last year's CUNs relating to fumigation of structures. MBTOC is concerned that it will be unable to assess the particular circumstances of the individual mills, food processing or similar facilities without this information. MBTOC cannot ascertain whether such an analysis has been carried out in order to provide an estimate of the critical need for methyl bromide in the year of the nomination.

MBTOC can not ensure that there is no double counting of establishments and fumigations by fumigators competing for business from the potentially the same customers. Would it be possible for U. S. to explain to MBTOC or assure MBTOC that there is sufficient oversight to ensure the same facility or structure is not included in more than one CUN or by more than one fumigator company?

Questions from MBTOC concerning CUN Commodities 1. Section 5 says that Eco2Fume is the only chemical alternative available for the treatment of dried fruit and nuts. We assume that other forms of phosphine supply are also allowable. However, MBTOC is aware of the registration of propylene oxide ( PPO) for disinfestation of nuts and some other dried commodities in the US. Additionally, the California almond industry has built several suitable chambers and markedly increased its use of PPO on almonds in the past two years ( largely in response to Salmonella contamination but the process used to control Salmonella would also be useful for pests). The CUN Table 12.1 page 12 refers to the registration of PPO for in shell walnuts, but does not inform about the registration for other commodities included in this CUN. Please inform MBTOC of the current registration status of PPO in the US and in California for disinfestation of the dried commodities included in this CUN and reasons for not considering it an available alternative for the various commodities. SECRETARIAT FOR THE VIENNA CONVENTION AND ITS MONTREAL PROTOCOL   THE OZONE SECRETARIAT P. O. Box 30552, Nairobi, Kenya   Tel: [+ 254 20] 623851  Fax: [+ 254 20] 624691 / 624692 / 624693 Email: ozoneinfo@ unep. org   Http:// www. unep. org/ ozone 2. What percentage of walnuts is exported to Europe and is there an EU tolerance for PPO residues in walnuts?

3. Given that registration status and technical issues that might allow or disallow use of a potential alternative shelled versus in shell nuts, can you give MBTOC the percentage of the nut crop to be MB fumigated that is shelled or in shell?

4. Table 6.1 located on Page 8 is incorrect in terms of amount of MB requested and/ or volume to be treated or both. Could you please check this, correct it and return a corrected version to us?

5. Please explain reasons for variation in amount of MB used in various years as reported in Table 6.1. For example, while we note that the 2007 total requested amount is less than use in 2003, it is more than use in 2002 and 1998 and just slightly less than use in year 2000.

6. Why is there an increase in the request for walnuts and pistachios for 2007 over 2006? The CUN indicates that 20% of walnuts are now treated with propylene oxide and other lines of investigation are in progress. Phosphine treatment is available and used for nuts in store and where handling facilities, including temporary storage, allow the longer fumigation period to be applied. Yet increased MB use is nominated. Does this imply the 20% that is treated with PPO is also treated with MB and that there is an increased requirement for methyl bromide in store for some reason? Note that MBTOC understands the need for MB to be used for research and does not include quantities used for research as part of this query.

7. The dosage rate used for walnuts seems to be a mistake. Table 1.9a page 10 indicates a walnut dosage rate of 111kg/ 1000m3, yet MBTOC believes the highest label rate is 48g/ m3. The maximum label rate is higher than the minimum efficient dosage rate for walnuts. Please supply MBTOC with the correct, and minimum effective, intended MB dosage rate for walnuts.

8. Table 12.2 page 14 footnotes refer to vacuum chamber fumigation of walnuts. What percentage of walnuts is MB fumigated in vacuum chambers and is this the reason for the high dosage rate reported? If so, what is the dosage rate used for walnuts that are not fumigated in vacuum chambers? Vacuum chamber fumigation while faster, uses more MB. Please justify the use of vacuum chamber fumigation for MB. 9. MBTOC would like to know more about the marketing pressures on dried beans. Although the CUN discusses marketing pressures on dried fruit and nuts, including factors as the need for quick fumigation before export and domestic pre Christmas sales, but this information is not included for beans. Since beans harvested earlier and used later and with less need for quick sales, might there be less need for quick fumigation and thus slower alternatives, such as phosphine, may be suitable? ( Table B2, Page 10)?

10. Page 20 and page 22 indicate there are no technically feasible alternatives for dried beans. Is phosphine registered federally and in California for use on dried beans? If so, why is it not considered technically feasible? SECRETARIAT FOR THE VIENNA CONVENTION AND ITS MONTREAL PROTOCOL   THE OZONE SECRETARIAT P. O. Box 30552, Nairobi, Kenya   Tel: [+ 254 20] 623851  Fax: [+ 254 20] 624691 / 624692 / 624693 Email: ozoneinfo@ unep. org   Http:// www. unep. org/ ozone 11. Table 9.1( a) Page 10 seems to indicate that the reported dosage rates are used regardless of product temperature. Is this correct? Warmer temperatures, as seem likely in California, can allow for lower MB dosage rates. Can you supply MBTOC with information on product temperature at time of fumigation?

12. Table 9.1( b) says no information on gastightness is available. Fumigators conduct gastightness measurements before and during fumigations. For a critical use, Decision XI/ 6 requires that MB emissions and use are minimized. MBTOC seeks information on gastightness of fumigations to ensure only the minimum amount of MB technically required is used. For this reason, and to ensure due diligence, we need information on gastightness. Failing that, can the US confirm that MB fumigations in this sector will only be conducted in conditions of at least good gastightness ( refer to Handbook for definition of ` good gastightness'). If good gastightness is not currently possible, how will gastightness of fumigation facilities be improved this year and what effect is this expected to have on the potential critical quantity of methyl; bromide in this nomination?

13. Could the US government inform MBTOC if or when SF becomes registered in California for the uses included in this CUN, likely rate of adoption and the effect SF adoption will have on requested amounts of MB?

Questions from MBTOC concerning CUN Food Facilities 1. The amount of MB requested for 2007 represents an increase over 2006 ( 401,889 kg in 2007 versus 394,843 in 2006). MBTOC is aware of increased use of heat, sulfuryl fluoride and increased successes with IPM that decrease frequency of fumigation in addition to much new research that should be helpful to the industry. MBTOC thinks it is reasonable to expect some level of continued adoption of alternatives. Why then will an increased amount of MB be needed in 2007?

2. The CUN did not supply a list of mill and food processing facility locations, although the CUN says this information will be sent to MBTOC when available ( page 8). MBTOC would welcome this list as part of understanding the needs for methyl bromide on a case by case basis and ensuring there is no duplication between this CUN and the one involving NPMA treated facilities. Can the US government check this eventual list to ensure that a food processing facility listed as part of one CUN is not also included in another CUN? The list should specifically give reasons why MB alternatives are not feasible and/ or why the dosages and frequency of treatment cannot be ( further) reduced.

3. Table B1 page 9, footnote says that some mills and food processing facilities in cooler locations are fumigated once every three years, whereas those in Southern US locations are fumigated twice a year ( or 2.5 times per year as reported in table 9.1. a). In contrast Table B. 2 page 10 footnote says rice mills are fumigated 5 x per year. The CUN reports that rice mills are in Southern US, where other mills such as wheat flour mills are also located. Flour mills in SECRETARIAT FOR THE VIENNA CONVENTION AND ITS MONTREAL PROTOCOL   THE OZONE SECRETARIAT P. O. Box 30552, Nairobi, Kenya   Tel: [+ 254 20] 623851  Fax: [+ 254 20] 624691 / 624692 / 624693 Email: ozoneinfo@ unep. org   Http:// www. unep. org/ ozone Southern US have been successful in reducing fumigation frequency from 4 6 times per year to current 2.5/ yr ( Part D13 page 16). So, the 5x/ yr fumigation frequency for rice mills is remarkable. What is the technical justification for the higher frequency of fumigation in rice mills? What are the plans to reduce frequency of fumigation?

4. Table 9.1: Page 10 notes variability in the need for fumigation of pet food establishments between 1/ yr to 1/ 3 5 years and that only 80% of pet food establishments require fumigation. What MB alternatives do the other 20% and the pet food plants that do not require frequent fumigation use or are there other factors? MBTOC is aware of the use of spot heat treatment at a very large commercial pet food company. Why is heat, either as a whole site treatment or as a component if an IPM system, not considered technically and economically feasible for pet food establishments?

5. Table 9.1: b Page 11 reports gastightness of the establishments included in this CUN. Rice mills are reported to be poor or very poor gastightness. In each other use category, a significant percentage of establishments are reported as very poor, poor or medium gastightness. Poor, very poor and even medium gastightness results in increased methyl bromide use ( and may also create increased safety hazards from fumigant leakage). For an MB use to be considered critical under Decision XI/ 6, all technically and ecionomically feasible steps should have been taken to minimize the critical use and any associated emissions of MB. MBTOC views gastightness as an important facet of that aspect of assessment. What is the plan to improve gastightness of mills and reduce methyl bromide dosage and frequency for this year of nomination?

6. The CUN implies that heat treatment is unsuitable for bakeries because of the presence of butter and other heat sensitive foods We have assumed the paragraphs on page 5 and page 6 pertain to bakeries because butter and other high fat foods are more likely to be present in bakeries than in mills, rice mills and most food processing establishments but we know that fats are also present in pet food establishments. Butter and similar fats absorb methyl bromide substantially. In commercial practise in the U. S. are butter and similar fats actually present when a bakery is fumigated with methyl bromide? Are there food tolerances for methyl bromide and derived residues in butter and similar fats arising from fumigation? It is possible to remove heat sensitive foods outside of the bakery during a heat treatment, and it seems quite likely that bakeries have the heat capability or could withstand heat to 56 ° C as required. The CUN page 22 notes that some bakeries have already switched to heat and other alternatives. Using figures from the BUNI, bakery MB requested amount for 2007 is only 11   12% less than historical use in 2001   2002. Has the US government calculated its bakery MB requested amount in consideration of the switch to heat that has already occurred according to page 22, and that is likely to continue to occur between now and 2007? SECRETARIAT FOR THE VIENNA CONVENTION AND ITS MONTREAL PROTOCOL   THE OZONE SECRETARIAT P. O. Box 30552, Nairobi, Kenya   Tel: [+ 254 20] 623851  Fax: [+ 254 20] 624691 / 624692 / 624693 Email: ozoneinfo@ unep. org   Http:// www. unep. org/ ozone 7. MBTOC would also like a discussion and justification for the apparent growth in requested MB by bakeries. The 2007 requested amount of 23,814 kg is compared to the 2006 amount of 14,742 kg in 2006. Unlike other BUNI's where growth in MB use is identified ( and usually not allowed), the BUNI associated with this CUN does not identify or discuss this growth in use of MB for bakeries. Why has the need for MB increased from 2006 to 2007, especially since the CUN also says some bakeries are using alternatives? Why does the US, which in BUNI calculations for other CUNs, usually does not allow growth in MB use, seem to allow growth in bakery MB use in this instance?

Questions from MBTOC concerning CUN Dry Cure Pork Products 1. This CUN is for a critical use for 2007, yet historical use data is only submitted for up to 2002. When will recent historical use data be available?

2. Which information on historical use should MBTOC use? Table 6.1 page 7 indicates very low historical use between 1998 and 2002 of about 803   1139 kg, but the BUNI indicates more than 40,000 kg.

3. Industry sources indicate to MBTOC that historical use of MB for dry cure pork is likely less than 40,000 lbs ( not kg). The CUE adopted for this sector at 16 MOP of 67 tonnes for 2005 appears to substantially exceed requirements. What capacity is there for use of stockpiles in place of this particular nomination?

4. Table B1 footnote Page 8 indicates that some facilities have low gastightness. This would result in increased methyl bromide use ( plus the added pest pressure indicated in the CUN). For an MB use to be considered critical under Decision XI/ 6, all technically and economically feasible steps should have been taken to minimize the critical use and any associated emissions of MB. MBTOC views gastightness as an important facet of that aspect of assessment. What is the plan to improve gastightness of dry pork processing establishments that use MB and and for reduction of methyl bromide dosage, frequency and quantity for this year of nomination?

5. Informal survey data available to MBTOC suggests that current MB usage in this industry does not exceed 10 tonnes annually. SECRETARIAT FOR THE VIENNA CONVENTION AND ITS MONTREAL PROTOCOL   THE OZONE SECRETARIAT P. O. Box 30552, Nairobi, Kenya   Tel: [+ 254 20] 623851  Fax: [+ 254 20] 624691 / 624692 / 624693 Email: ozoneinfo@ unep. org   Http:// www. unep. org/ ozone Questions from MBTOC concerning CUN NPMA Foods and Food Processing Facilities 1. The CUN did not supply a list of food facilities, although the CUN says this information will be sent to MBTOC when available ( page 9). MBTOC would welcome this list as part of understanding the needs for methyl bromide on a case by case basis and ensuring there is no duplication between this CUN and the one involving mills and other processing facilities. Table 6.1 page 8 notes that, although not listed, the food facilities are ` not included in other chapters'. Can the US government check this eventual list to ensure that a food processing facility listed as part of one CUN is not also included in another CUN? The list should specifically give reasons why MB alternatives are not feasible and/ or why the dosages and frequency of treatment cannot be ( further) reduced.

2. Page 7 Facilities section indicates that food processing and commodities included in this CUN have decreased MB use through improved IPM, increased use of phosphine and spot heat. Fumigations are reported to have decreased from 4 6 times per year to an average of 2x/ yr in the South and 1x/ 3 5 yr in the North ( Page 8). Yet from Table 6.1 Page 8, reported volumes of MB treated space has remained essentially steady since 1998 ( Volume treated average 1998   2002 was 7535 1000m3 and 2007 volume requested in the CUN is 7,868 1000m3). In terms of MB use, the 2007 request ( BUNI figures) represents 67% of 2002 usage and 76% of 2001 usage. The two sets of information in the CUN do not appear to be in complete agreement. MBTOC finds it difficult to conduct diligent analysis when the historical use data stops at 2002. When will recent historical use data be available?

3. If we ignore 2006 CUN amounts since the Parties have not yet decided them, and look at the amounts of MB granted by the Parties for 2005, we see that the 2007 requested amount shows planned increased MB use for processed foods, cocoa, herbs and spices and cheese; the ` other foods' category represents a decrease. Increases in requested MB for 2007 is not in agreement with the CUN reporting that MB use has decreased through improved IPM, increased use of phosphine and spot heat treatment as reported in the point above. Please comment on why this industry needs increased critical MB in 2007 over 2005 amounts granted by the Parties.

4. Table 9.1. b page 12 indicates that some facilities have low gastightness. This would result in increased methyl bromide use. For an MB use to be considered critical under Decision XI/ 6, all technically and economically feasible steps should have been taken to minimize the critical use and any associated emissions of MB. MBTOC views gastightness as an important facet of that aspect of assessment. What is the plan to improve gastightness of food processing facilities and commodity trailer fumigations this year?

5. Discussions about phosphine on page 7 and page 12 mention concern about phosphine resistant pests. Have phosphine resistant pests been reported in the US and in the facilities or commodities included in this CUN? SECRETARIAT FOR THE VIENNA CONVENTION AND ITS MONTREAL PROTOCOL   THE OZONE SECRETARIAT P. O. Box 30552, Nairobi, Kenya   Tel: [+ 254 20] 623851  Fax: [+ 254 20] 624691 / 624692 / 624693 Email: ozoneinfo@ unep. org   Http:// www. unep. org/ ozone 6. Section 17.1 Research page 20 and 21 does not seem to report research on the food facilities and commodities included in this CUN, but does report research included in the other CUN for food processing facilities also submitted by the US ( e. g. rice milling, bakeries). Is it possible that the appropriate section for this CUN was inadvertently lost or not included? The facilities and commodities included in this CUN are likely to be different than the other CUN in terms of heat generating capacity, improved sanitation and structures ( resulting from operating under HACCP processing for processed foods) and other factors. Has research been conducted on adopting and adapting MB alternatives for the types of facilities and commodities included in this CUN?

7. Please clarify whether the amount requested for herbs and spices is for the herb and spice processing structure or the commodity.

8. The US FDA requires that a large volume of the cocoa beans landing for import to the US be disinfested because of pests found on inspection or because the exporting countries has been found to consistently send infested cocoa to the US ( i. e. mandatory detention by the FDA). Has the US government made a determination that the volume of cocoa beans treated with methyl bromide as a result of its automatic detention by US FDA is not a QPS treatment?

9. Is cheese sometimes present in the stores and sometimes not present? If there are times when cheese is not present in the cheese stores, what avenues are being explored to adapt and adopt other alternatives when the cheese stores do not contain cheese? Are other alternatives registered to be used when the cheese is not in the cheese stores? Can improvements in IPM and use of alternative treatments such as heat be used on the cheese stores when cheese is not present to result ensure the stores stay disinfested when the cheese is present?

10. Foods in the ` other foods' category are reported to include tea on pallets, coffee beans, tomatoes, bell peppers, citrus and cassava ( Table A1 page 8). Are these items all dry commodities? If so, could they be treated with ethylene oxide gas or irradiated under US regulations? If they are dry commodities is there marketing or time pressure that prevents the use of phosphine and is phosphine registered for this use?


[Federal Register: March 21, 2007 (Volume 72, Number 54)]
[Notices]
[Page 13327-13328]
[DOCID:fr21mr07-102]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55463; File No. SR-NASDAQ-2006-041]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing of Amendment No. 1 and Order Granting Accelerated
Approval to Proposed Rule Change as Modified by Amendment No. 1 To
Modify an Aspect of the Definition of Independent Director

March 13, 2007.

I. Introduction

    On October 3, 2006, The NASDAQ Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to modify an aspect of Nasdaq's definition of
``independent director.'' The proposed rule change was published for
comment in the Federal Register on November 28, 2006.\3\ The Commission
received no comment letters on the proposal as published. On March 2,
2007, Nasdaq filed Amendment No. 1 to the proposed rule change. The
Commission is publishing notice of Amendment No. 1 to the proposed rule
change and granting approval to the proposed rule change as modified by
Amendment No. 1 on an accelerated basis.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 54797 (November 20,
2006), 71 FR 68855 (``Notice'').
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II. Description of the Proposed Rule Change

    Under current Nasdaq Rule 4200(a)(15)(B), a director of a listed
issuer is generally precluded from being considered independent if that
director has received more than $60,000 in compensation from the issuer
during any period of twelve consecutive months within the three years
preceding the determination of independence.\4\ The proposed rule
change would raise this amount to $100,000, the same figure specified
by the New York Stock Exchange (``NYSE'') in its comparable
independence standard.\5\
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    \4\ See Nasdaq Rule 4200(a)(15)(b).
    \5\ See Section 303A.02(b)(ii) of the NYSE Listed Company
Manual. See also Amendment No. 1 to the proposed rule change.

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III. Discussion and Commission Findings

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to Nasdaq,\6\ and, in particular, with Section
6(b)(5) of the Act.\7\
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    \6\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. 15 U.S.C. 78c(f).
    \7\ 15 U.S.C. 78f(b)(5).
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    The Commission believes that the proposed rule change is reasonable
and would align Nasdaq's ``bright line'' test with respect to a
director's receipt of compensation from the issuer more closely with
the equivalent rule of the NYSE. The Commission notes that, under the
proposed rule change, a Nasdaq listed issuer's board would still have
the responsibility to make an affirmative determination that an
independent director has no relationship whatsoever with the issuer
that would impair his or her independence, even when the director has
passed the ``bright line'' test of the rule and has not accepted (and
has no family member who has accepted) more than $100,000 in
compensation from the issuer during the relevant period.\8\
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    \8\ See Nasdaq Rule 4200(a)(15) and IM-4200--``Definition of
Independence.'' See also Notice, supra note 3, at note 8.
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IV. Solicitation of Comments Concerning the Proposed Rule Change

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

Electronic Comments

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

File Number SR-NASDAQ-2006-041 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 Number SR-NASDAQ-2006-041.
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 (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 such
filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NASDAQ-2006-041 and should be submitted on or before
April 11, 2007.

V. Accelerated Approval of the Proposed Rule Change

    Nasdaq has requested that the Commission approve the proposed rule
change as modified by Amendment No. 1 on an accelerated basis.\9\
Pursuant to Section 19(b)(2) of the Act,\10\ the Commission may not
approve any proposed rule change, or amendment thereto, prior to the
30th day after the date of publication of notice of the filing thereof,
unless the Commission finds good cause for so doing and publishes its
reasons for so finding.
---------------------------------------------------------------------------

    \9\ See Amendment No. 1.
    \10\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission hereby finds good cause to approve the proposed rule
change as amended by Amendment No. 1 on an accelerated basis. The
proposed rule change as published in the Notice would have raised the
amount of compensation that precludes a director from being an
``independent director'' from $60,000 to $120,000. Amendment No. 1
established the compensation threshold at $100,000. The Commission
believes that this change raises no new regulatory issues and aligns
Nasdaq's rule with the equivalent rule of the NYSE. The Commission
believes that no reasonable purpose would be served by delaying
implementation of the proposal.
    Accordingly, pursuant to Section 19(b)(2) of the Act,\11\ the
Commission finds good cause to approve the proposed rule change as
modified by Amendment No. 1 prior to the 30th day after notice in the
Federal Register.
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    \11\ Id.
---------------------------------------------------------------------------

VI. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\12\ that the proposed rule change (File No. SR-NASDAQ-2006-041),
as modified by Amendment No. 1, be, and it hereby is, approved.
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    \12\ Id.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-5084 Filed 3-20-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 82, Number 128 (Thursday, July 6, 2017)]
[Notices]
[Page 31377]
[FR Doc No: 2017-14143]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81052; File No. SR-IEX-2017-11]

Self-Regulatory Organizations; Investors Exchange LLC; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change To Modify the Manner in Which the Exchange Opens Trading for
Non-IEX-Listed Securities

June 29, 2017.
    On April 13, 2017, the Investors Exchange LLC (``IEX'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to modify the manner in which the Exchange opens
trading for non-IEX-listed securities beginning at the start of Regular
Market Hours and make related changes. The proposed rule change was
published for comment in the Federal Register on April 28, 2017.\3\ On
May 19, 2017, IEX filed Amendment No. 1 to the proposal. On June 9,
2017, IEX consented to an extension of time for the Commission to act
on the proposal until July 5, 2017.\4\ On June 22, 2017, IEX filed
Amendment No. 2 to the proposal, which superseded and replaced
Amendment No. 1 in its entirety. On June 29, 2017, IEX filed Amendment
No. 3 to the proposal, which superseded and replaced Amendment No. 2 in
its entirety.\5\ The Commission received no comments on the proposed
rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C.78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 80514 (April 24,
2017), 82 FR 19763.
    \4\ See letter from Claudia Crowley, Chief Regulatory Officer,
IEX, to Richard Holley, Assistant Director, Division of Trading and
Markets, Commission, dated June 9, 2017.
    \5\ Amendment No. 3 revised the proposal to (i) provide
additional clarity regarding the process for determining the Opening
Match Price; (ii) modify the definition of ``Cross Tie Breaker'' to
account for a scenario involving securities in Test Groups Two and
Three of the Plan to Implement a Tick Size Pilot Program; and (iii)
correct certain typographical errors. Amendment No. 3 also revised
the proposal to fix an error in the proposed rule text in Amendment
No. 2 and correct additional typographical errors.
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    Section 19(b)(2) of the Act \6\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
was June 12, 2017. IEX consented to an extension of time for the
Commission to act on the proposal until July 5, 2017.\7\ The Commission
is further extending the time period for Commission action on the
proposed rule change.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2).
    \7\ See supra note 4.
---------------------------------------------------------------------------

    The Commission finds that it is appropriate to designate a longer
period within which to take action on the proposed rule change so that
it has sufficient time to consider the proposed rule change, as
modified by Amendment No. 3. Accordingly, the Commission, pursuant to
Section 19(b)(2) of the Act,\8\ designates July 27, 2017, as the date
by which the Commission shall either approve or disapprove, or
institute proceedings to determine whether to disapprove, the proposed
rule change (File No. SR-IEX-2017-11), as modified by Amendment No. 3.
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    \8\ 15 U.S.C. 78s(b)(2).
    \9\ 17 CFR 200.30-3(a)(31).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2017-14143 Filed 7-5-17; 8:45 am]
BILLING CODE 8011-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY TESTING CONSENT ORDER FOR ETHYLENE DICHLORIDE Docket No. OPPT  2003 0010 Under the authority of section 4 of the Toxic Substances Control Act ( TSCA), 15 U. S. C.

2603, the United States Environmental Protection Agency ( EPA) issues this testing consent order ( Order) to take effect on the date of publication ofthe notice in the Federal Register announcing the issuance of this Order. This Order incorporates the enforceable consent agreement ( ECA) for Ethylene Dichloride ( EDC).

ate °, Pesticides, Substances RECEIVED OPPT NCIC 2003 MAY27 11: 44AM OPPT 2003 0010 0002 31 pp ENFORCEABLE CONSENT AGREEMENT FOR ETHYLENE BICHLORIDE ( EDC)

CAS No. 107 06 2 Docket No, OPPTS  42197C FINAL May 15, 2003 , o si4~ ENFORCEABLE CONSENT AGREEMENT FOR ETHYLENE DICHLORIDE ( EDC)

Docket No. OPPTS 42197C TABLE OF CONTENTS I. INTRODUCTION 1 II. CHEMICALSUBJECTTOTHEECA 2 ifi. OBLIGATION OF SIGNATORY COMPANIES AND ROLE OF THE HAP TASK FORCE 2 IV. PURPOSE OF THE TESTING PROGRAM 3 V. SCOPE OF THE TESTING PROGRAM 3 VI. DESCRIPTION OF THE TESTING PROGRAM 6 VU. EPA PROGRAM REVIEW OUTCOMES 7 Vifi. STANDARDS FOR CONDUCTING TESTING 9 IX. STUDY PLANS 10 X. MODIFICATIONS TO ENFORCEABLE CONSENT AGREEMENT 11 XI. FAILURE TO COMPLY WITH THE ENFORCEABLE CONSENT AGREEMENT .. 10 XII. EPA MONITORING OF ENFORCEABLE CONSENT AGREEMENT TESTING .... 11 Xffl. SUBMISSIONS TO EPA 11 XIV. PUBLICATION AND DISCLOSURE OF TEST RESULTS 11 XV. CONFIDENTIALITY OF INFORMATION 12 XVI. RESPONSIBILITIES OF THE COMPANIES 12 XVII. SEVERABILITY QE ENFORCEABLE CONSENT AGREEMENT PROVISIONS .. 12 XVIII. FINAL AGENCY ACTTON . 12 XIX. PUBLIC RECORD 13 XX. EFFECTIVENESS 13 XXI. RIGHTS OF THE COMPANIES 13 XXII. IDENTITY OF THE COMPANIES 14 XXIII. SIGNATURE 15 Table 1. REQUIRED TESTING, TEST STANDARDS, REPORTING AND OTHER REQUIREMENTS FOR ETHYLENE DICHLORIDE 25 APPENDICES A. Flow Chart of Testing Program B. TSCA Guidelines with Annotations as Appropriate: B. 1 Acute Inhalation Toxicity with BAL and Histopathology B. 2 Acute Inhalation Neurotoxicity B. 3 Subchronic Neurotoxicity B. 4 Reproductive Toxicity C. PKIMECH Procedures and Route to Route Extrapolation Reporting: C. 1 Pharmacokinetic Studies for F344 Rats C. 2 C. 3 C. 4 C. 5 C. 6 Subchronic Toxicity Subchronic Neurotoxicity Reproductive Toxicity PBPK Model Description and Coding General Outline for Route to Route Extrapolation Reports D. Study Protocols: D. 1 Combined Acute Toxicity with BAL and Histopathology and Acute Neurotoxicity ( Inhalation) D~ 2 Subchronic Neurotoxicity ( Oral) D. 3 Reproductive Toxicity ( Oral)

  11   APPENDICES   continued E. Existing Toxicity Studies: E. 1 Existing Macrophage Function Assay a) Sherwood et at. ( 1987) E. 2 Existing SubchrQnic Toxicity Study a) Daniel et at. ( 1994) E. 3 Existing Developmental Toxicity Studies a) Rao era!. ( 1980) b) Payan et al. ( 1995) E. 4 Existing Reproductive Toxicity Studies a) Alumot et at. ( 1976) b) Rao etal. ( 1980) c) Lane et at. ( 1982)

  111   I. INTRODUCTION Under the authority of section 4 of the Toxic Substances Control Act ( TSCA), 15 U. S. C. 2603, the United States Environmental Protection Agency ( EPA) and The Dow Chemical Company, Vulcan Materials Company, Occidental Chemical Corporation, Oxy Vinyls, LP, Georgia Gulf Corporation, Westlake Chemical Corporation, PPG Industries, Inc., &~ iefI € hemioal8 Pfa~ Iic~. flper~ th1 g Limited P~ sl~ 4~, and Formosa Plastics Corporation, U. S. A. ( hereinafter collectively the Companies") enter into this enforceable consent agreement ( ECA). This ECA takes effect on the date of publication of the notice in the Federal Register announcing the issuance of the testing consent order ( Order) that incorporates this ECA.

In EPA's proposed test rule for hazardous air pollutants ( HAPs) published on June 26, 1996 ( 61 FR 33178), amended on December 24, 1997 ( 62 FR 67466) and on April 21, 1998 ( 63 FR 19694), EPA invited the submission of alternative testing proposals for HAPs that would apply pharmacokinetics studies and mechanistic data ( PKIMECH) to inform route to route extrapolation of data from studies acceptable to EPA that were performed by a route ofexposure other than inhalation. Such proposals would be used to develop a tailored testing program to provide the data needs identified by EPA in the proposed HAPs rulemaking via an ECA process. This ECA resulted from negotiations conducted as a part of an ECA process for the HAP ethylene dichloride ( 62 FR 66626; December 19, 1997). The official record for this ECA, including the public version, is established under EPA docket control number OPPTS 42197C. The procedures for ECA negotiations are described at 40 CFR 790.22( b).

On December 26, 2000 ( 65 FR 81700) EPA announced the Voluntary Children's Chemical Evaluation Program ( VCCEP) which is intended to provide data to enable the public to understand the potential health risks to children associated with certain exposures to commercial chemicals. EDC and some 22 other chemicals have been selected for inclusion in a pilot of VCCEP. Under the VCCEP, EPA asks that companies which manufacture andlor import chemicals selected for this pilot of VCCEP volunteer to sponsor Tier 1 of the program. The VCCEP pilot consists of three tiers, which a sponsor may commit to separately. EDC producers ( sponsors), as represented by the American Chemistry Council Vinyl Chloride Health Committee ( Health Committee), intend to voluntarily sponsor EDC in Tier 1 of the VCCEP pilot. Part of this commitment is being executed and implemented via this ECA through the HAP Task Force. The relationship between the Health Committee and the HAP Task Force is described in the June 25, 2001 letter of commitment to the VCCEP Tier 1 for ethylene dichloride, which is available in the EPA OPPTS Docket No. 42197B.

In the commitment letter EDC producers proposed to complete this ECA testing program before submitting risk and exposure assessments under the VCCEP. Results from this HAPs ECA testing program would provide data needed for the VCCEP and, where possible, could avert some or all of the overlapping requirements between the two initiatives. A concern expressed by the EDC producers was whether scheduled deliverables for the VCCEP will be considered timely if, due to the time needed for completing the ECA testing, the VCCEP 1 deliverables extended beyond the expected VCCEP timelines. EPA has accepted that the VCCEP Tier I deliverables could he submitted within twelve months following the completion of all testing to be conducted under this ECA. EPA understands that the test schedule set forth in this ECA includes some higher tier VCCEP toxicity studies and may also depend in part on EPA performing certain actions in a timely manner during the course of the testing. Additionally, events could occur that would cause the ECA test schedule to be extended beyond what is contemplated in the ECA. Any schedule changes would occur via the ECA modification procedures at 40 CFR 790.68 ( b), see also Part X. of this ECA. If the schedule for RCA testing is extended, the schedule for VCCEP commitments would be likewise extended.

II. CHEMICAL SUBJECT TO THE RCA The subject of this ECA is the chemical substance ethylene dichioride ( EDC), CAS No. 107 06 2. The ethylene dichioride to be tested must he as pure as can be reasonably attained, hut must be at least 99.0 percent pure.

III. OBLIGATION OF SIGNATORY COMPANIES ANDROLE OF THE HAP TASK FORCE A. Testing will be sponsored by the Companies, which are responsible for complying with this RCA.

B. The Companies recognize that to implement this ECA, EPA will issue an Order under section 4 of TSCA that incorporates the terms of this ECA. The Companies agree that all terms of this ECA will take effect on the date of publication of the notice in the Federal R~ gister announcing the issuance of the Order that incorporates this RCA, and all applicable time periods will be treated as beginning on that publication date.

C. The Companies are members of the HAP Task Force, which represents the manufacturers of ethylene dichioride. The HAP Task Force will be responsible for coordinating and administering testing under this ECA and communicating with EPA about study plans, protocols, test standards, and other aspects of the testing program. In performing these functions, the HAP Task Force will be acting as the agent of the Companies for purposes of compliance and communication with EPA. EPA and the Companies recognize that, except for its role as agent as specified in this ECA, the HAP Task Force has no legal responsibility for complying with this ECA. Responsibility for complying with the ECA rests at all times with the individual Companies. IV. PURPOSE OF THE TESTING PROGRAM The purpose of the testing program specified in this RCA is to supplement available information in order to further characterize the potential for acute toxicity, subchronic toxicity. neurotoxicity, developmental toxicity and reproductive toxicity effects of ethylene dichloride from inhalation exposures. One component of this testing program will develop PKIMECH data directed at characterizing the mode of action of ethylene dichloride. Such information, along with data from health effects studies acceptable to EPA and/ or from health effects studies to be conducted as part of this ECA testing program for ethylene dichioride, will be used to inform the route to route extrapolations that are specified in Table 1. EPA will also use the PKJMECH data to provide the basis for determining the feasibility and appropriateness of using a tailored approach to testing and whether route to route extrapolations can be used to meet inhalation testing requirements for ethylene dichioride that are identified in the proposed HAPs test rule, as amended.

EPA believes that the PKIMECH studies designed to construct quantitative dosimetric characterization of the disposition and relevant response mechanisms with regard to ethylene dichioride, in conjunction with the studies and route to route extrapolation reporting that are specified in Table 1 and described in Appendices C through E to this ECA, will generate data needed by EPA to determine whether ethylene dichioride presents an unreasonable risk of injury to human health from inhalation exposures. The data will also be used to implement several provisions of section 112 of the Clean Air Act, including determination of residual risk, estimation of the risks associated with accidental releases of ethylene dichloride, and determinations regarding whether substances should he removed from the Clean Air Act section 1 12( b)( 1) list of hazardous air pollutants. In addition, the data will also be used by other Federal agencies ( e. g., the Agency for Toxic Substances and Disease Registry ( ATSDR), the National Institute for Occupational Safety and Health ( NIOSH), the Occupational Safety and Health Administration ( OSHA), and the Consumer Product Safety Commission ( CPSC)) in assessing chemical risks and in taking appropriate actions within their programs. It is intended that the data generated under this ECA will satisfy the toxicological data needs for acute toxicity, subchronic toxicity, neurotoxicity, developmental toxicity and reproductive toxicity effects of ethylene dichloride identified in the amended proposed HAPs rulemaking.

V. SCOPE OF THE TESTING PROGRAM The Companies, through the HAP Task Force, will jointly conduct or provide for the performance of the testing program specified in this ECA. This testing program will consist of: 1) conducting the testing listed in Table I in accordance with the test standards specified in Table I and described in Appendix B( l 4) as annotated in Appendix D( l 3) to this ECA (" Test Standards"), and performing the PBPK studies and route to route extrapolations specified in Table 1 and described in Appendix C( l 6) to this ECA; and 2) submitting the reports and documents specified in Table I in accordance with the deadlines set forth in Table 1.

3 The use of PK! MECH data to support quantitative route to route extrapolation is a new approach for EPA's Office of Pollution Prevention and Toxics ( OPPT) in the TSCA section 4 Chemical Testing Program. It is essential to the success of this ECA testing program for EPA to ensure that the data used to inform the route to route extrapolations are of the highest quality. For this reason, aprogram review requirement has been incorporated into this ECA testing program ( see Part VI. C. and Part VII. A.  D. of this RCA).

EPA notes that the generation of PKIMECH data to support development of dosimetry ( e. g.; physiologically based pharmacokinetics  PBPK) models should he chemical specific and based on an understanding, to the degree possible. of the mode of action for the various endpoint toxicitics. Modeling is an iterative process. The nature of chemical reactions between a xenobiotic agent and biological tissues, and the degree to which they are understood, have a profound influence on the scope of the modeling effort. A degree of uncertainty regarding the model structure can be clarified by validation of the predications of the PBPK dosimetry model with appropriately designed experiments. New insights on important parameters and processes can then be additionally tested and used to further refine the mode!. Because these chemical and toxicity specific attributes can affect both the type of PKJMECH data necessary to characterize disposition of a chemical and the type of model structure that would be adequate to describe it, EPA does not have guidelines available for the HAP Task Force to utilize. General guidance is available in a number of references ( Woodruff et at., 1992'; Ultrnan, 19942; Andersen et at., l995~: Kohn, l997~ Buchanan et at.. l997~). Key considerations for model structure include the degree of parameterization and whether the model is to be used to extrapolate ( e. g., across species or across routes) versus interpolate data ( Woodruff etat., 1992).

The source of each model parameter value should be described, indicating whether it was: I) obtained from prior literature ( copy of references cited to be provided by the HAP Task Force), 2) determined directly by a separate experiment described in the submitted report or peerreviewed paper, or 3) estimated by the fitting of model output to experimental data. Parameter estimates derived independently of tissue time course or dose response data are preferred ( Andersen et at.. 1995). Determination by separate experiment is preferred, particularly for Woodruti. T. J.. F. Y. Bois. D. Austander and R. Spear. 1992. . Structure and pararneterization ofpharmacokinetics models: Their impact on model predictions. Risk Anal. 12: 189 201.

2 Ultman, J. S. 1994. Dosimetry modeling: Approaches and issues. Inhal. Toxlcol. 6: 5971 Andersen. M. E.. H. J. Clewell, Ill and C. 13. Frederick. 1995. Applying simulation modeling to problems in toxicology and risk assessment . A short perspective. Tar. App!. Phann. 133 187.

~` Kohn, M. C. 1997. The importance of anatomical realism for validation of physiological models of disposition of inhaled toxicants. Tax. App!. Pharm. 147: 448 458.

~ Buchanan. JR.. L. T. Burka. and R. L, Melnick. 1997. Purpose and guidelines for toxicoki netic studies within the National Toxicology Program. Em'iron. H/ rh. Perspecr. 105( 5): 468 471.

4 critical target tissue parameters, such as partition coefficients. Model verification, the process of evaluating the sufficiency of the model for its intended purpose, should be demonstrated by showing the ability of the model to predict the behavior of experimental data different from those on which it was based. Model validation should demonstrate the ability of the model to predict the behavior of the system under conditions which test the principal aspects of the underlying hypothetical structure. Objective measures of variance ( e. g., statistical goodness of fit) that can be compared to residual variance are preferred, but accurate prediction of the general behavior of the data for the intended application ( e. g., a given range) may be a more important consideration. For this latter consideration, however, a factor of 2 fold ( on average) will be a general criterion applied to determine " reasonable" agreement of the model with the experimental data.

The choice of which dose metric to use in the model to characterize a given endpoint toxicity should be based on some knowledge of the mode of action by which the toxic effects are induced. The mechanistic information does not necessarily have to be exhaustive hut can rather be related to general aspects of the nature and causes of a particular toxic interaction. Certainly route specific toxicity needs to he characterized, both the effects in the portal of entry as well as modulation of systemic dose at remote sites. PKIMECH data must be developed that correspond to the species, dose level, exposure regimen and vehicle ( e. g., intermittent corn oil gavage versus drinking water ad lib versus diet) of the toxicity data that are the object of the extrapolation. For the extrapolation of the chronic endpoint data, demonstration of periodicity during the experiments used to generate the PKIMECH data is required. Periodicity, as defined in U. S. EPA ( l994)~, is achieved when the internal concentration of the dose metric of interest ( e. g., parent venous concentration) versus time profile is the same for 90% of the exposure period. The rationale for the choice of various dose metrics should be provided.

Andersen eta!. ( 1995) published a table of characteristics of a good modeling paper and documentation; EPA will utilize these same reporting requirements. These include: ( 1) clear presentation of all equations; ( 2) clear definition of all variables and parameters; ( 3) clear definition of units to ensure proper dimensions; ( 4) definition of criteria to evaluate predictions or fits; ( 5) specification of the time, species. and exposure domain where the model is valid; and ( 6) discussion of the hypothesis testing and model discrimination as necessary. Graphical display of model fits to data are required; including both parent and metaholite( s) blood and target tissue time course data. A sensitivity analysis of the model must be conducted and documentation of model code with comment fields must be provided. Computer hardware and software actually used in the application must be described. If specialized software functions must be referred to, they should be described sufficiently to enable someone unfamiliar withthe software to understand their operation. Standard mathematical forms are preferred to software language functional forms.

6 U. S. EPA. 1994. Methods for derivation of inhalation reference concentrations and application of inhalation dosimetry. Office of Research and Development. Environmental Criteria and Assessment Office, Research Triangle Park, NC. EPAI600/ 8 90/ 066F. VI. DESCRIPTION OF THE TESTING PROGRAM The testing program has four segments as follows: Tier I HAPs Testing; Tier I Program Review Testing; EPA Program Review; and Tier II Testing.

A. Tier I HAPs Testing: This testing will consist of the following endpoint testing, conducted by inhalation exposure, that EPA has deemed necessary to meet certain data needs identified in the proposed HAPs test rule, as amended: I) acute toxicity testing with BAL and histopathology, and 2) acute neurotoxicity testing. EPA will not finalize the testing requirements for these Tier I HAPs Testing endpoints for ethylene dichloride as specified in the proposed HAPs test rule, as amended, because such testing will be conducted under this RCA. Furthermore, EPA considers the existing study by Sherwood et at. ( 1987), adequate to fulfill the macrophage function assay portion of the acute toxicity testing requirement ( see Appendix E. 1). In addition, EPA considers the existing studies by Rao eta!. ( 1980) and Payan et at. ( 1995), adequate to characterize the developmental toxicity of ethylene dichioride under the proposed HAPs rulemaking, as amended ( see Appendix E. 3). Thus, EPA will not finalize the testing requirements for the developmental toxicity and macrophage function assay Tier I HAPs testing endpoints for EDC as specified in the HAPs proposed rule as amended, because available studies are acceptable for HAPs purposes. Tier 1 testing for acute toxicity and acute neurotoxicity and the extant data for macrophage function assay and developmental toxicity testing are specified in the " Tier I HAPs Testing" segment of Table 1 and described in Appendix B( 1,2) as annotated in Appendix D( 1), and Appendix E( 1,3).

B. Tier I Program Review Testing: This testing, specified in the " Tier I Program Review Testing" segment of Table I and described in Appendix C. 1, will develop PK/ MECH data needed to inform about the acceptability of an alternate route to inhalation for Tier II testing. It will also develop and validate the dosimetry model of ~ 9g~ et at. ( 1987; 1988) in rats and verify the ability of the model to perform quantitative route to route extrapolations, as described ( in Appendix C( 2 5) and as will be reported following guidance provided in Appendix C. 6. Data from this testing will be the subject of discussions at the EPA Program Review. While EPA believes that it is best to obtain this type of PKIMECH data in conjunction with the testing specified in the Tier I HAPs Testing ( see Part VI. A.), these PK/ MECH data may also be obtained independently from stand alone studies. Specifically, the PKIMECH data will support: 1) oral to inhalation extrapolation of existing subchronic toxicity data in rats administered ethylene dichloride via corn oil gavage ( Daniel et at., l994)( see Appendix E. 2); 2) oral toinhalation extrapolation of subchronic neurotoxicity data in rats administered ethylene dichloride via drinking water ( see Tier H testing); and 3) oral to inhalation extrapolation of reproductive toxicity data in rats administered ethylene dichloride via drinking water ( see Tier II testing) and each dosing paradigm of existing reproductive toxicity studies by Alumot eta!. ( 1976), Rao et at. ( 1980), and Lane et at. ( 1982)( see Appendix E. 4). The PKIMECH data will also support model simulations to demonstrate validation and verification of PBPK models for route to route extrapolation in order to evaluate acceptability of oral drinking water exposure in rats in the Tier H testing for subchronic neurotoxicity and reproductive toxicity.

6 C. EPA Program Review: A program review will be conducted by EPA to review the data collected from the Tier I Program Review Testing segment ( see Part VI. B. of this ECA) and other studies acceptable to EPA that would be applied to route to route extrapolations. as indicated in footnotes 4, 6, and 8 of Table 1.

The purpose of the EPA Program Review will be to determine: ( 1) whether it is feasible and appropriate to apply Tier I Program Review Testing data and data from other studies acceptable to EPA to inform route to route extrapolations for endpoints listed in the Tier II Testing segment; ( 2) whether the data from the Tier I Program Review Testing segment ( see Part VI. B. of this ECA) provide a sufficient basis for conducting the endpoint testing and/ or the route to route extrapolations specified in the Tier II Testing segment; andlor ( 3) the nature and Scope of any additional work that may he required prior to the commencement of Tier II Testing and extrapolation reporting ( e. g., additional PKIMECH data as described in Part VII. of this RCA).

Opportunity for public participation in the EPA Program Review will be provided either by a request for written comments or through an announcement of a public meeting. EPA will publish the request for public comments andlor the announcement of a public meeting in the Federal Realster. Following the EPA Program Review, EPA will place in the record for this action a summary describing the EPA Program Review meeting, if such a meeting is held, a copy of comments received, and a copy of the letter sent to the HAP TASK FORCE informing it of the conclusions of EPA's Program Review.

D. Tier II Testing: This segment will consist of additional endpoint testing not included in the Tier I HAPs Testing segment, as specified in Table I and described in Appendix B ( 3 4) as annotated in Appendix D( 2 3). Specifically this testing will consist of oral subchronic neurotoxicity testing and oral reproductive effects testing. Tier II will also consist of route toroute extrapolation reporting for existing subchronic toxicity data of Daniel eta!. ( 1994), the suhchronic neurotoxicity and reproductive toxicity data obtained from Tier II testing, and extant data from reproductive toxicity studies by Alumot ci at. ( 1976), Rao eta!. ( 1980), and Lane et dil.

( 1982), as specified in Table 1 and Appendix C( 2 4) and reported following guidance provided in Appendix C. 6. Following a successful outcome of the EPA Program Review ( see Section VII. A. and B. l. a.), EPA will not finalize inhalation testing requirements for these Tier II testing endpoints for ethylene dichloride, as specified in the amended proposed HAPs test rule, because the data required under the HAPs rulemaking will be developed under this ECA.

VII. E~ PROGRAM REVIEW OUTCOMES The EPA Program Review segment can result in several possible outcomes, described below.

7 A. EPA Accepts Tier I Program Review Testing Data: EPA may determine that the Tier I Program Review Testing data can be used to inform and support Tier H testing for any or all of the endpoints and/ or associated route to route extrapolation reporting for ethylene dichloride that are specified in Table 1. In such an instance, EPA will notify the Companies in writing that Tier II endpoint testing and route to route extrapolation reporting must be conducted for: subchronic toxicity, subchronic neurotoxicity, and reproductive toxicity for ethylene dichloride. In addition, EPA will not finalize the testing requirements for these endpoints for ethylene dichloride as specified in the proposed HAPs test rule, as amended.

B. EPA Identifies Limitations in the Tier I Program Review Testin. g Data: EPA may determine that additional Tier I Program Review Testing is needed before any or all of the Tier II endpoint testing and/ or associated route to route extrapolation reporting that are specified in Table 1 for ethylene dichloride can be conducted. In such an instance, EPA will inform the Companies by letter that additional Tier I Program Review Testing is needed and a copy of this letter will be placed in the record for this action. EPA may initiate technical discussions with the Companies on this matter.

( I) Agreement on Additional Tier I Pro.~' ramReview Testing: If EPA and the Companies agree to the additional testing, modifications to the relevant Test Standards specified in the Tier I Program Review Testing section of Table 1 and described in the associated appendices for the relevant Test Standards may be made according to the procedures contained in 40 CFR 790.68 ( see Part X of this ECA). The additional Tier I Program Review Testing will be conducted in accordance with these modifications. The data resulting from this additional testing will be reviewed to determine if such data meet EPA needs. This review may include one or more meeting( s) between the Companies and EPA. Opportunity for public participation will be provided either by a request for written comments and/ or through an announcement of a public meeting. Following such meeting( s), EPA will place in the record for this action asummary of each meeting along with a copy of the comments received.

( a) Additional Tier I Pro. gram Review Testin. g Meets Data Needs: If and when the Tier I Program Review Testing data are determined to be acceptable to EPA, EPA will inform the Companies by letter that the data from the Tier I Program Review Testing can be used as a basis to inform and support Tier II Testing for any or all of the endpoints and associated route to route extrapolation reporting for ethylene dichioride that are specified in Table 1. In addition, the letter will indicate that EPA will not finalize the inhalation testing requirements for these Tier II Testing endpoints for ethylene dichloride as specified in the proposed HAPs test rule, as amended. A copy of the letter will be placed in the record for this action.

( b) Additional Tier I Program Review TestinR Does Not MeetData Needs: If, at any point, EPA determines that the Tier I Program Review Testing data, as supplemented by the additional Tier I Program Review Testing data, cannot be used to inform and support Tier H testing for any or all of the endpoints and/ or associated route to route extrapolations for 8 ethylene dichioride that are specified in Table 1, then the outcome described in Part. VH . C. below will apply to these endpoints.

( 2) Failure to Agree on Additional Needed Tier I Program Review Testing~ If the Companies and EPA do not agree to the additional Tier I Program Review Testing that EPA has determined to be needed, the outcome described in Part VII. C. below will apply to these endpoints.

C. EPA Determines TaitoredApproach to HAPs Testing is not Feasibte: EPA may determine that the tailored approach to HAPs testing set forth in this ECA, for any or all Tier I Program Review Testing as applied to any or all Tier H endpoint testing and associated route toroute extrapolations, is not feasible. In such an instance, EPA will notify the Companies by certified letter or Federal Register notice. The notification will include the reason( s) for the determination and will be placed in the record for this action. If EPA issues such a notification for any endpoint( s), the Companies' obligations to conduct testing or associated route to route extrapolations for that endpoint( s) as described under this RCA are terminated. EPA may pursue testing for such endpoint( s) under the HAPs rulemaking, a new rulemaking , or develop a separate ECA for the purpose of obtaining the needed data, as appropriate.

D. Other Possibte Outcomes: If the EPA Program Review or Tier H endpoint testing and associated route to route extrapolations do not result in any of the outcomes described above, EPA and the Companies may modify this ECA according to the procedures contained in 40 CFR 790.68 ( see Part X. of this RCA).

VIII. STANDARDS FOR CONDUCTING TESTING A. Testing for specific toxicity endpoints ( acute toxicity, neurotoxicity, and reproductive toxicity) must be conducted in accordance with the Test Standards listed in Table 1 and described in Appendix B( 1 4) as annotated in Appendix D( 1 3) to this ECA. Certain provisions of these Test Standards are considered to be mandatory and are referred to as ` requirements". These requirements are identified by the use of the word " shall" in the text of the Test Standard.

Provisions that are not mandatory, and are therefore only recommended, are identified by the use of " should" statements. In the event such " should" provisions are not followed, the Companies will not be deemed by EPA to be in violation of this ECA and will not be subject to penalties or other enforcement actions, as described in Part XI. of this ECA. However, in such cases, EPA will use its professional judgement to determine the scientific adequacy and validity of the test results and any repeat testing that is determined by EPA to be necessary will be required either under a separate RCA or pursuant to a rule promulgated under section 4( a) of TSCA, 15 U. S. C. 2603( a).

9 For the purpose of this ECA, the words " will" and " must," if they appear in the Test Standards, are considered equivalent to the word " shall" and therefore delineate a test requirement to be followed or met.

B. The development of PKIMECH data to be used in this RCA testing program must be conducted in accordance with the guidance outlined in Appendix C( 1 4) of this ECA. The development and application of PKJMECH data is expected to be an iterative process and, as such, the final details of the testing may not be included in the presently available Test Standard( s). For the purposes of this ECA, Appendix C( 1 4) will be the " Test Standard( s)" for testing specified in Table 1 under Tier I Program Review Testing and Tier II Route to Route Extrapolation Reporting. The PK/ MECH data development under this ECA will be the subject of discussions at the EPA Program Review, described in Part VI. C. and Pan VII. A.  D. of this RCA.

C. The Companies, through the HAP Task Force, and EPA will consult in a good faith effort to consider the need for Test Standard modifications if either EPA or the Companies desire such modifications. Modifications to this RCA will be governed by 40 CFR 790.68 ( see Part X. of this RCA).

D. All testing required by this RCA must be conducted in accordance with the EPA Good Laboratory Practice ( GLP) Standards contained in 40 CFR part 792.

E. All final reports must be submitted by the Companies to EPA by the dates specified in Table 1 unless otherwise authorized by EPA pursuant to 40 CFR 790.68. Interim status reports describing the status of all studies to be performed under this RCA testing program must be submitted by the Companies to EPA every six months beginning six months from the effective date of this ECA and until the end of the ECA testing program. These interim reports should contain information such as a summary of the interim status of each study being performed under this ECA testing program, a description of significant activities and/ or difficulties experienced during the interim, and an explanation of the actions taken in response to difficulties. See Pan Xffl. of this ECA regarding submissions to EPA.

IX. STUDY PLANS The Companies, through the HAP Task Force, will submit a study plan to EPA for each test conducted pursuant to this ECA prior to the initiation of testing in accordance with 40 CFR 790.62. ( For this ECA, EPA will not require the study plans to be submitted " no later than 45 days prior to the initiation of testing," as specified at 40 CFR 790.62( a)). The content of the study plans submitted to EPA will comply with 40 CFR 790.62( b). Modifications to the study plans will be governed by the procedures of 40 CFR 790.62( c). All study plans will become pan of the official record ( Docket Control Number OPPTS 42l97C).

10 X. MODIFICATIONS TO ENFORCEABLE CONSENT AGREEMENT EPA and the Companies recognize that in some instances modifications to the schedule in Table I may be needed in view of uncertainties in developing PK/ MECH data. Modifications to this ECA, if any, will be made according to the procedures contained in 40 CFR 790.68.

XI. FAILURE TO COMPLY WITH THE ENFORCEABLE CONSENT AGREEMENT The Companies acknowledge that a violation of the requirements of this RCA will constitute a " prohibited act" under section 15( 1) of TSCA, 15 U. S. C. 2614( 1), and will trigger all provisions applicable to a section 15 violation. In addition, noncompliance with any term of this ECA by any Company will constitute conduct " in violation of this Act" under section 20( a)( 1) of TSCA, 15 U. S. C. 2619( a)( l), and could result in a citizen's civil action.

Under the penalty provisions of section 16 of TSCA, 15 U. S. C. 2615, and the Federal Civil Penalties Inflation Adjustment Act of 1990, 28 U. S. C. 2461 note, as amended by the Debt Collection Improvement Act of 1996, 31 U. S. C. 3701 note, as implemented by 61 FR 69360 ( December 31, 1996), a non complying Company could be subject to acivil penalty of up to $ 27,500 per violation, with each day in violation potentially constituting a separate violation under section 15. Knowing or willful violations may lead to the imposition of criminal penalties, or a fine of not more than $ 27,500 for each day of violation, or imprisonment for not more than one year, or both. In addition, EPA could enforce this RCA pursuant to section 17 of TSCA, 15 U. S. C. 2616, by seeking an injunction to compel adherence to the requirements of this RCA.

XII. EPA MONITORING OF ENFORCEABLE CONSENT AGREEMENT TESTING EPA may conduct monitoring activities of the testing conducted under this ECA such as laboratory inspections and study audits, as permitted under section 11 of TSCA, 15 U. S. C. 2610.

XIII. SUBMISSIONS TO EPA All data submitted to EPA under this ECA will be identified by the Docket Number: OPPTS 42197C and the name: ethylene dichloride. Six ( 6) copies of all submissions under this ECA will be provided to EPA at the address specified in 40 CFR 790.5( b).

XIV. PUBLICATION AND DISCLOSURE OF TEST RESULTS All results of testing conducted pursuant to this RCA will be announced to the public by EPA in accordance with the procedures specified in section 4( d) of TSCA, 15 U. S. C. 2603( d).

11 Disclosure by EPA of data generated by such testing will be governed by section 14( b) of TSCA, 15 U. S. C. 26 13( b), and 40 CFR part 2.

XV. CONFIDENTIALITY OF INFORMATION Any claims of confidentiality for information submitted under this RCA will be made under the terms of 40 CFR 790.7. If no claim of confidentiality is made by the submitter of the information at the time of submission, the information will be deemed by EPA, in accordance with 40 CFR 790.7, to be public, and may be made available to the public without further notice to the submitter. Information claimed as confidential will be treated in accordance with the procedures in 40 CFR pan 2 established pursuant to section 14 of TSCA, 15 U. S. C. 2613.

XVI. RESPONSIBILITIES OF THE COMPANIES A. The Companies are bound by the terms of this RCA and the provisions of 40 CFR 790.62 and 790.65.

B. The Companies will comply with the notification requirements of section l2( b)( 1) of TSCA, 15 U. S. C. 261 1( b)( l), and 40 CFR part 707, subpart D, if they export or intend to export ethylene dichloride. Any other person who exports or intends to export ethylene dichloride will be subject to these export notification requirements upon promulgation of an export notification rule for ethylene dichloride under section 12( b)( 1) of TSCA.

C. If ethylene dichloride becomes subject to a rule promulgated under TSCA section 5( a)( 2), 15 U. S. C. 2604( a)( 2), governing significant new uses of ethylene dichloride, then the Companies will be subject to the data submission requirements imposed by section 5( b)( l)( A) of TSCA, 15 U. S. C. 2604( b)( l)( A), as if the testing under this RCA had been required by a TSCA section 4 test rule.

XVII. SEVERABILITY OF ENFORCEABLE CONSENT AGREEMENT PROVISIONS In the event that one or more provisions of this ECA are determined by a court decision to be unenforceable, the remaining provisions of this ECA will not be presumed to be valid, and EPA will either initiate a rulemaking proceeding to require testing or publish in the Federal Register the reasons for not initiating such a proceeding.

XVIII. FINAL AGENCY ACTION Issuance of this RCA by EPA constitutes final EPA action for purposes of 5 U. S. C. 704.

12 XIX. PUBLIC RECORD EPA has established a public record which will contain this RCA, the Order that incorporates this ECA, the Federal Register notice announcing issuance of the Order incorporating this ECA, and any and all relevant information, subject to the confidentiality provisions of section 14( h) of TSCA and 40 CFR part 2. The official record for this RCA, including the public version, which does not include any information claimed as CBI, has been established under docket control number OPPTS 42197C.

XX. EFFECTIVENESS This ECA may be signed in separate counterparts. This ECA will not be effective unless signed by each of the Companies and by EPA. This ECA will take effect on the date of publication of the Federal Register notice announcing the issuance of the Order that incorporates this ECA.

XXI. RIGHTS OF THE COMPANIES By signing this RCA, the Companies waive their right to challenge EPA's authority to assess penalties for violations of the terms of this ECA. This waiver does not affect any other rights that the Companies may have under TSCA, including the right to dispute the amount of any penalty or to dispute factually whether a violation of the terms of this ECA has occurred, or to seek judicial review of any rule that may he adopted by EPA that imposes requirements to test ethylene dichioride.

13 XXII. IDENTITY OF THE COMPANIES The Companies subject to this ECA are:

The Dow Chemical Co. I~ th~ afl~ Hwy t ~ D2~ ~ M(~ J( 1 ML ~ ~ T A 7r~ 7~ Westlake Chemical Corporation 2801 Post Oak Blvd. Suite 600 Houston, TX 77056 Vulcan Materials Company 1200 Urban Center Drive Birmingham, AL 35242 Occidental Chemical Corporation 5005 LBJ Freeway Dallas, TX 75244 PPG Industries, Inc. One PPG Place Pittsburgh, PA 15272 e~ t~? fl~~& Na~ ü&~, ~ e~ ating Limi~ e~~

Oxy Vinyls, LP Suite 500, LB3O 5005 LBJ Freeway Dallas, TX 75244 Georgia Gulf Corporation 26100 LA 45 Plaquemine, LA 70764 Formosa Plastics Corporation, U. S. A.

9 Peach Tree Hill Road Livingston, NJ 07039 14 XXIII. SIGNATURE TEST SPONSOR The Dow Chemical Company Date: ~ ae1R. Gambre1l Business Vice President The Dow Chemical Company 2020 Dow Center Midland, MI 48674 The Dow Chemical Company agreed to sponsor ethylene dichioride in Tier I of the Voluntary Children's Chemical Evaluation Program as a member of the American Chemistry Council Vinyl Chloride Health Committee. XXIII. SIGNATURE TEST SPONSOR Vulcan Materials Company Date: ~ C/~ 2~~) ~ Brad C. Rosenwald President Vulcan Chemicals Division Vulcan Materials Company 1200 Urban Center Drive Birmingham, AL 35242 Vulcan Materials Company agreed to sponsor ethylene dichloride in Tier I of the Voluntary Children's Chemical Evaluation Program as a member of the American Chemistry Council Vinyl Chloride Health Committee. XXIII. SIGNATURE Date: ~ I TEST SPONSOR Occidental Chemical Corporation c~ Q~ Q~ Chuck Anderson Senior Vice President   Basic Chemicals Occidental Chemical Corporation 5005 LBJ Freeway Dallas, TX 75244 Occidental Chemical Corporation agreed to sponsor ethylene dichloride in Tier I of the Voluntary Children's Chemical Evaluation Program as a member of the American Chemistry Council Vinyl Chloride Health Committee. XXIII. SIGNATURE TEST SPONSOR Oxy Vinyls, LP Date: / ames M. Lienert Senior Vice President and General Manager Oxy Vinyls, LP 5005 LBJ Freeway Dallas, TX 75244 Oxy Vinyls, LP agreed to sponsor ethylene dichloride in Tier I of the Voluntary Children's Chemical Evaluation Program as a member of the American Chemistry Council Vinyl Chloride Health Committee. XXIII. SIGNATURE TEST SPONSOR Georgia Gulf Corporation Date: 0. Edward A. Schmitt President and CEO Georgia Gulf Corporation 26100 LA 45 Plaquemine, LA 70764 Georgia Gulf Corporation agreed to sponsor ethylene dichloride in Tier I of the Voluntary Children's Chemical Evaluation Program as a member of the American Chemistry Council Vinyl Chloride Health Committee. XXIII. SIGNATURE TEST SPONSOR Westlake Chemical Corporation Date:~

\~ Wayne Senior Vi~ ePresident, Vinyls Westlake Chemical Corporation 2801 Post Oak Blvd., Suite 600 Houston, TX 77056 XXIII. SIGNATURE TEST SPONSOR PPG Industries, Inc.

Date: t~* (~~ o~ L_ a / J~ mesA. Barter, Ph. D. ( ~ irector, Environmental Health Sciences ~ 4PG Industries, Inc. One PPG Place Pittsburgh, PA 15272 PPG Industries, Inc. agreed to sponsor ethylene dichioride in Tier I of the Voluntary Children's Chemical Evaluation Program as a member of the American Chemistry Council Vinyl Chloride Health Conmiittee. t XXIII. SIGNATURE TEST SPONSOR Formosa Plastics Corporation, U. S. A.

Date: ___ , p%~ 44 Robert F. Kelly Vice President for Environment, Health, Safety and Communication Formosa Plastics Corporation, U. S. A. 9 Peach Tree Hill Road Livingston, NJ 07039 Formosa Plastics Corporation, U. S. A. agreed to sponsor ethylene dichloride in Tier I of the Voluntary Children's Chemical Evaluation Program as a member of the American Chemistry Council Vinyl Chloride Health Committee. XXIII. SIGNATURE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY Date:________

Address: Substances U. S. Environmental Protection Agency Office of Pollution Prevention And Toxic Substances Ariel Rios Building 1200 Pennsylvania Avenue, N. W. Washington, DC 20460 Table 1 REQUIRED TESTING, TEST STANDARDS, REPORTING AND OTHER REQUIREMENTS FOR ETHYLENE DICHLORIDE Test Standard Deadline TIER I ( citations are to 40 CFR; for Final HAPs Testing for EDC appendices are attached to this ECA) Report ( Months)'

Acute Toxicity with BAL and § 799.9135 ( as annotated in 18 histopathology ( inhalation) 2 appendix D. 1)

Acute Neurotoxicity ( inhalation) 2 § 799.9620 ( as annotated in appendix D. 1) 18 Developmental Toxicity Appendix E. 33 Number of months after the effective date of the Order that incorporates this ECA when final report is due.

Interim status reports, describing the status of all testing to be performed under this ECA, must be submitted by the Companies to EPA every 6 months beginning six months from the effective date of this ECA until the end of the ECA testing program ( see Part VIII. B. and Part XIII. of this ECA).

2 Acute toxicity and acute neurotoxicity testing to be conducted under a combined protocol following § 799.9135 and § 799.9620 as annotated in appendix D. 1. As specified in Part VI. A. of this ECA, EPA has determined that the macrophage function assay reported by Sherwood et at. ( 1987) adequately fulfills the macrophage function assay portion of the acute toxicity testing requirement. A copy of this report is included as Appendix E. I.

` As specified in Part VI. A. of this ECA, EPA has determined that the developmental toxicity studies reported by Payan et at. ( 1995), in rats, and Rao et at. ( 1980), in rabbits, adequately fulfill the HAPs rulemaking testing requirement for developmental toxicity testing for ethylene dichioride. A copy of these reports is included as Appendix E. 3. TIER I Test Standard Deadline Program Review Testing ( citations are to 40 CFR; for Final ° for EDC4 appendices are attached to this ECA) Report ( Months)

PKJMECH data to support model Appendix C ( 1 4) 21 validation and verification of oralto inhalation extrapolation for the following data needs in the F344 rat5: a. Subchronic toxicity6 b. Subchronic neurotoxicity7 c. Reproductive toxicity8 PBPK model simulations9 Appendix C ( 1 5) 21 `~ As described in Part VI. C. of this ECA, before work under the Tier II testing segment is conducted, EPA will conduct a Program Review of the Tier I Program Review Testing data and data from other studies acceptable to EPA that could be used in performing quantitative route to route extrapolations.

~ Previously published inhalation PBPK model ( D' Souza eta!., 1987; 1988) to be extended and validated to ( I) periodic inhalation exposures based on PK/ MECH data to be acquired as part of the " Tier I Inhalation Toxicity" and ( 2) oral administration via corn oil gavage and drinking water.

6 Relevant to existing data in rats administered EDC via corn oil gavage ( Daniel, eta!. ( 1994)

Relevant to drinking water administration in rats 8 Relevant to drinking water administration and capable to inform route to route extrapolation from each dosing paradigm of extant data by Alumot, eta!. ( 1976), Rao, eta!. ( 1980), and Lane, eta!. ( 1982)

~ The model simulations are to provide point and uncertainty estimates of internal dose metrics ( parent chemical peak and area under the curve ( AUC) concentrations in blood and brain, and 24 hour total glutathione dependent metabolism) in rats and humans to allow quantitative route to route extrapolations. These simulations will be used to evaluate the acceptability of: ( 1) subchronic neurotoxicity testing of oral exposure via drinking water in rats; ( 2) extant oral subchronic toxicity data of Daniel eta!. ( 1994) in rats via corn oil gavage, and ( 3) reproductive toxicity testing of oral exposure via drinking water in rats. Tier II Testing and/ or Extrapolation Reporting for EDC Test Standard ( citations are to 40 CFR; appendices are attached to this ECA) Deadline for Final Report ( Months)

Subchronic toxicity ( route toroute extrapolation of extant data)' ° Subchronic neurotoxicity: a) testing by the oral route b) route to route extrapolation1'

Reproductive toxicity:' 2 a) testing by the oral route b) route to route extrapolation' 3 Appendix C. 2 and C. 6 § 799.9620 ( as annotated in Appendix D. 2)

Appendix C. 3 and C. 6 § 799.9380 ( as annotated in Appendix D. 3)

Appendix C. 4 and C. 6 36 42 52 42 52 Quantitative route to route extrapolation of extant data of Daniel et at. ( 1994) documented graphically and with tabular data using point estimates and uncertainty measures for parentcompound ( peak and AUC) and total amount metabolized by glutathione dependent pathways to develop the dose metric.

~ Quantitative route to route extrapolation of subchronic toxicity testing developed under Tier II Testing, documented graphically and with tabular data using point estimates and uncertainty measures for parent compound ( peak and AUC) in blood and brain and total amount metabolized by glutathione dependent pathways to develop the dose metric. Ability to characterize blood and CNS time course data, if possible, for both oral and inhalation routes must be demonstrated.

12 Control and high dose groups will be evaluated for fertility index, gestation index, gross necropsy, organ weight and histopathology to confirm lack of effect reported in extant studies by Alumot et a!., 1976; Rao et at.. 1980; and Lane et a!., 1982. Observation of an effect in the high dose will trigger detailed evaluation of low dose and middose groups for the above mentioned effects. Estrous cycle, sperm evaluation ( vaginal opening, preputial separation) will be evaluated for all dose groups.

13 Quantitative route to route extrapolation of reproductive toxicity testing developed under Tier II Testing and extant data from Alumot, eta!. ( 1976), Rao, eta!. ( 1980), and Lane, eta!. ( 1982) documented graphically and with tabular data using point estimates and uncertainty measures for parent compound ( peak and AUC) and total amount metabolized by glutathione dependent pathways to develop the dose metric.


[Federal Register Volume 85, Number 138 (Friday, July 17, 2020)]
[Rules and Regulations]
[Pages 43431-43432]
[FR Doc No: 2020-15364]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0377; Airspace Docket No. 20-AGL-20]
RIN 2120-AA66

Amendment of Class E Airspace; Winner, SD

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends the Class E airspace extending upward from
700 feet above the surface at Winner Regional Airport, Winner, SD. This
action as the result of an airspace review caused by the
decommissioning of the Winner VHF omnidirectional range (VOR)
navigation aid as part of the VOR Minimum Operational Network (MON)
Program. The name and geographic coordinates of the airport are also
being updated to coincide with the FAA's aeronautical database.

DATES: Effective 0901 UTC, November 5, 2020. The Director of the
Federal Register approves this incorporation by reference action under
Title 1 Code of Federal Regulations part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11D, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11D at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends the Class E airspace extending upward from 700 feet above
the surface at Winner Regional Airport, Winner, SD, to support
instrument flight rule operations at this airport.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (85 FR 27339; May 8, 2020) for Docket No. FAA-2020-0377 to
amend the Class E airspace extending upward from 700 feet above the
surface at Winner Regional Airport, Winner, SD. Interested parties were
invited to participate in this rulemaking effort by

submitting written comments on the proposal to the FAA. No comments
were received.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11D, dated August 8, 2019, and effective September 15,
2019, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11D, Airspace Designations and
Reporting Points, dated August 8, 2019, and effective September 15,
2019. FAA Order 7400.11D is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11D lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to Title 14 Code of Federal Regulations (14 CFR)
part 71 amends the Class E airspace extending upward from 700 feet
above the surface by removing the Winner VOR and all associated
extensions associated with the Winner Regional Airport, Winner, SD,
from the airspace legal description; removes the city associated with
the airport to comply with changes to FAA Order 7400.2M, Procedures for
Handling Airspace Matters; and updates the name and geographic
coordinates of the Winner Regional Airport (previously Bob Wiley Field)
to coincide with the FAA's aeronautical database.
    This action is the result of an airspace review caused by the
decommissioning of the Winner VOR, which provided navigation
information for the instrument procedures this airport, as part of the
VOR MON Program.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11D,
Airspace Designations and Reporting Points, dated August 8, 2019, and
effective September 15, 2019, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AGL SD E5 Winner, SD [Amended]

Winner Regional Airport, SD
    (Lat. 43[deg]23'22'' N, long. 99[deg]50'28'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of the Winner Regional Airport.

    Issued in Fort Worth, Texas, on July 13, 2020.
Martin A. Skinner,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2020-15364 Filed 7-16-20; 8:45 am]
BILLING CODE 4910-13-P