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Rule

Revocation of TSCA Section 4 Testing Requirements for Certain High Production Volume Chemical Substances

Action

Direct Final Rule.

Summary

EPA is revoking certain testing requirements for six chemical substances and all the testing requirements for four chemical substances. EPA is basing its decision to take this action on information received since publication of the first test rule for certain high production volume chemical substances (HPV1). HPV1 established testing requirements for those 10 chemical substances. On the effective date of this direct final rule, persons who export or intend to export the four chemical substances for which all the testing requirements are revoked are no longer subject to section 12(b) of the Toxic Substance Control Act (TSCA) export notification requirements triggered by HPV1.

Unified Agenda

High Production Volume (HPV) Chemicals; 1st Group of Chemicals

4 actions from December 26th, 2000 to December 2011

  • December 26th, 2000
  • March 16th, 2006
  • December 8th, 2006
    • Direct Final Action1; Revocation; Coke-Oven Light Oil (Coal)
  • December 2011
    • Direct Final Action 2; Revocation
 

Table of Contents Back to Top

Tables Back to Top

DATES: Back to Top

This direct final rule is effective May 15, 2012 without further notice, unless EPA receives adverse comment in writing, or a request to present comment orally, on or before April 16, 2012. If EPA receives adverse comment, or a written request for an opportunity to present oral comments, EPA will publish a timely withdrawal in the Federal Register informing the public that this direct final rule, or relevant portions of this direct final rule, will not take effect. If you write EPA to request an opportunity to present oral comments on or before April 16, 2012, EPA will hold a public meeting on this direct final rule in Washington, DC. The announcement of the meeting will be published in the Federal Register.

ADDRESSES: Back to Top

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2005-0033, by one of the following methods:

  • Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments.
  • Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
  • Hand Delivery: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. Attention: Docket ID Number EPA-HQ-OPPT-2005-0033. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564-8930. Such deliveries are only accepted during the DCO's normal hours of operation, and special arrangements should be made for deliveries of boxed information.

Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2005-0033. EPA's policy is that all comments received will be included in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or email. The regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: Back to Top

For technical information contact: Catherine Roman, Chemical Control Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-8157; email address: roman.catherine@epa.gov.

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: Back to Top

I. General Information Back to Top

A. Does this action apply to me?

This action is directed to the public in general and may be of particular interest to those persons who manufacture (defined by statute to include import), process, or export the chemical substances identified in this direct final rule. Because other persons may also be interested, the Agency has not attempted to describe all the specific persons that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

B. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

II. Statutory Authority Back to Top

Section 4(a) of TSCA authorizes EPA to require testing if certain findings are made. EPA is amending the chemical testing requirements for certain HPV chemical substances in 40 CFR 799.5085 because some of the findings that EPA made for 10 chemical substances are no longer supported. These findings were that:

1. The chemical substances were produced in substantial quantities.

2. There are insufficient data upon which the effects of manufacture, distribution, processing, use, or disposal of those chemical substances on health or the environment can reasonably be determined or predicted.

3. Testing of the chemical substance with respect to such effects is necessary to develop such data. (See TSCA section 4(a)(1)(B)(i), (ii), and (iii); also, see Ref. 1).

Unit III. discusses which findings are not supported for each specific chemical substance subject to this direct final rule.

III. Amendment to Chemical Testing Requirements Back to Top

EPA is amending the chemical testing requirements for certain HPV chemical substances in 40 CFR 799.5085 by direct final rule. Specifically, this direct final rule revokes the testing requirements for the following four chemical substances: Acetyl chloride (CAS No. 75-36-5); imidodicarbonic diamide (CAS No. 108-19-0); methane, isocyanato- (CAS No. 624-83-9); and urea, reaction products with formaldehyde (CAS No. 68611-64-3). This direct final rule also revokes some of the testing requirements for the following six chemical substances: 9,10-Anthracenedione (CAS No. 84-65-1); 1-chlorododecane (CAS No. 112-52-7); phenol, 4,4′-methylenebis [2,6-bis(1,1-dimethylethyl)]- (CAS No. 118-82-1); methanesulfinic acid, hydroxyl-, monosodium salt (CAS No. 149-44-0); benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]- (CAS No. 1324-76-1); and C.I. Solvent Black 7 (CAS No. 8005-02-5). EPA is basing its decision to revoke all testing requirements for four chemical substances and some of the testing requirements for six other chemical substances on information received since publication of HPV1 (40 CFR 799.5085), as described in this unit.

A. Revocation of All Testing Requirements for Four Chemical Substances

1. Acetyl chloride. EPA is revoking all testing requirements for acetyl chloride (CAS No. 75-36-5) because there is no longer support for the TSCA section 4(a)(1)(B)(i) “substantial production” finding for this chemical substance. “Substantial production” of a chemical substance under TSCA section 4(a)(1)(B)(i) is generally interpreted by EPA to be an aggregate production (including import) volume equaling or exceeding 1 million pounds per year. See EPA's TSCA section 4(a)(1)(B) Final Statement of Policy (“B” policy) (Ref. 2). The “substantial production” finding for this chemical substance was based on reports from several companies to the 2002 TSCA Inventory Update Reporting (IUR) rule. The Albemarle Corporation which manufactured and imported the largest volume of acetyl chloride, without which a finding of substantial production could not have been made, informed EPA in 2007 that its manufacture and importation of acetyl chloride at the time the test rule was promulgated were only for non-TSCA purposes (i.e., for use in pharmaceuticals) (Ref. 3), and was, therefore, not subject to HPV1.

Three other companies had reported importing smaller volumes of acetyl chloride in the 2002 IUR, the sum of which would not have provided support for a finding of substantial production. Two of these companies, Tessenderlo Kerley, Inc., and a company, which claimed its name as CBI, have since ceased importation of acetyl chloride. Tessenderlo Kerley ceased importation several years ago, and the other company ceased importation over a year prior to the effective date of HPV1, April 17, 2006 (Ref. 4). Neither of these companies is, therefore, subject to HPV1. The third small importer, Chartkit Chemical Corporation, reported that it imported only a small amount of acetyl chloride after the effective date of HPV1 in 2006, but none since (Ref. 5). EPA's review of data in the 2006 IUR (which required reporting on chemical substances manufactured or imported during calendar year 2005) did not identify any companies manufacturing or importing acetyl chloride. (Chartkit Chemical Corporation did not import acetyl chloride in 2005, making a report to the 2006 IUR unnecessary.) Because the finding for substantial production for acetyl chloride was not supported when HPV1 was promulgated, the Agency is revoking all the testing requirements for acetyl chloride (CAS No. 75-36-5) by removing it from Table 2 in 40 CFR 799.5085(j).

2. Imidodicarbonic diamide. EPA is revoking all the testing requirements for imidodicarbonic diamide (CAS No. 108-19-0), also known as biuret, by removing imidodicarbonic diamide from Table 2 in 40 CFR 799.5085(j). EPA considers the test requirements for this chemical substance unnecessary at this time because sufficient data have been provided to allow the Agency to reverse its finding under TSCA section 4(a)(1)(B)(ii) for “insufficient data.” Information that satisfied HPV1's requirements was voluntarily submitted by The Fertilizer Institute (TFI) on behalf of a member company that manufactures the chemical substance as an impurity in its products. EPA considers a company that manufactures a chemical substance only as an impurity to be a Tier 2 manufacturer with regard to its obligations under HPV1. Although subject to HPV1 and responsible for providing reimbursement to persons in Tier 1, Tier 2 manufacturers do not have to respond to HPV1 with a letter of intent to test or a request for exemption, unless directed to do so by EPA through a document published in the Federal Register. Although EPA did not publish such a document, TFI, acting on behalf of its member company, volunteered to provide information to EPA on the endpoints specified by HPV1 for that chemical substance. This information (Refs. 6-8) was provided to the Agency and found to meet the standards prescribed by EPA (Refs. 9-11) and is being made available in the docket for this direct final rule and will be added to the High Production Volume Information System (HPVIS).

3. Methane, isocyanato. EPA is revoking all the testing requirements for methane, isocyanato- (CAS No. 624-83-9) by removing it from Table 2 in 40 CFR 799.5085(j). On May 11, 2007, Bayer CropScience submitted a test plan and robust summaries of existing data for methane, isocyanato- along with a request that EPA determine if the robust summaries satisfied the Agency's need for data on physical/chemical properties (Ref. 12). In the same letter, Bayer CropScience requested a waiver for the requirement to determine an octanol-water partition coefficient and the requirement to conduct aquatic toxicity tests because of the extreme reactivity in water of methane, isocyanato-. Bayer CropScience also asked EPA to consider, as a substitute for aquatic toxicity studies of methane, isocyanato-, robust summaries of aquatic toxicity studies of dimethyl urea (CAS No. 96-31-1) (DMU), one of the two degradation products of methane, isocyanato- in water, the other being carbon dioxide. EPA concluded that the submitted data satisfied the Agency's need for data on the physical/chemical properties of boiling point, melting point, vapor pressure, and water solubility (Ref. 13). EPA also agreed that methane, isocyanato- hydrolyzes very rapidly and, as a result, an octanol-water partition coefficient is not relevant (Ref. 13). Because of the rapid hydrolysis of methane, isocyanato- to carbon dioxide and DMU, EPA is revoking the requirement to test for aquatic toxicity (fish acute toxicity, Daphnia acute toxicity, and toxicity to algae). EPA believes that the aquatic toxicity studies of DMU, provided by Bayer CropScience, which the Agency reviewed and found adequate, provide information on the aquatic effects of methane, isocyanato- (Ref. 14). Therefore, EPA, in this direct final rule, is revoking the testing requirements for boiling point, melting point, vapor pressure, octanol-water partition coefficient, water solubility, fish acute toxicity, Daphnia acute toxicity, and toxicity to algae for methane, isocyanato- by removing it from Table 2 in 40 CFR 799.5085(j).

4. Urea, reaction products with formaldehyde. EPA is revoking all the testing requirements for urea, reaction products with formaldehyde (CAS No. 68611-64-3) by removing it from Table 2 in 40 CFR 799.5085(j). EPA considers the test requirements for this chemical substance unnecessary at this time because sufficient data have been provided to allow the Agency to reverse its finding under TSCA section 4(a)(1)(B)(ii) for “insufficient data.” Information which satisfied HPV1's requirements was voluntarily submitted by TFI on behalf of its member companies that manufacture this chemical substance as an impurity in their products. EPA considers companies that manufacture a chemical substance only as an impurity to be Tier 2 manufacturers with regard to their obligations under HPV1. Although subject to HPV1 and responsible for providing reimbursement to persons in Tier 1, Tier 2 manufacturers did not have to respond to HPV1 with a letter of intent to test or a request for exemption, unless directed to do so by EPA through a document published in the Federal Register. Despite the lack of an EPA published Federal Register document, TFI, acting on behalf of its member companies, volunteered to provide information to EPA on the endpoints specified by HPV1 for this chemical substance. This information (Refs. 7 and 16) has been provided to the Agency and found to meet the standards for testing prescribed by EPA (Refs. 17-19) and is being made available in the docket for this direct final rule and will be added to HPVIS.

B. Revocation of Some Test Requirements for Six Chemical Substances

1. 9,10-Anthracenedione. In a letter dated July 10, 2006, the Chemical Products Corporation (CPC) requested EPA's permission to submit the values for boiling point and vapor pressure of 9,10-anthracenedione (CAS No. 84-65-1) contained in the International Uniform Chemical Information Database (IUCLID) instead of conducting the tests required by HPV1 (Ref. 20). CPC stated that the ASTM methods specified by HPV1 would not work for 9,10-anthracenedione because the boiling point and vapor pressure listed for that chemical substance in IUCLID and the boiling point listed for that chemical substance in the “Handbook of Chemistry and Physics” (Ref. 21) fell outside the determination ranges of the ASTM methods. EPA agreed and approved CPC's request to submit IUCLID and other existing values because those values matched or were in close agreement with measured values in various literature sources (Ref. 22). CPC also requested a modification of the ASTM method E 324 to determine the melting point for 9,10-anthracenedione (Ref. 23). While evaluating this request, EPA reviewed available data on measured melting points of 9,10-anthracenedione and found the existing data to be in sufficiently close agreement that they could be used to satisfy the Agency's data need for that endpoint (Ref. 22). EPA is, therefore, revoking the requirement that the boiling point, vapor pressure, and melting point of 9,10-anthracenedione be determined by the ASTM methods specified in HPV1 and accepts the submitted existing data as sufficient to satisfy those data needs, making the testing requirements unnecessary. Therefore, EPA is revoking the testing requirements for boiling point, vapor pressure, and melting point for 9,10-anthracenedione by removing those requirements from those listed for 9,10-anthracenedione in Table 2 in 40 CFR 799.5085(j). The test requirements for 9,10-anthracenedione that are not revoked by this direct final rule include tests to determine octanol/water partition coefficient and water solubility, and to screen for reproduction/developmental toxicity. Studies responding to those test requirements have been submitted to the Agency (Ref. 24).

2. 1-Chlorododecane. In a letter dated February 21, 2008, EPA informed Lonza, Inc., that the testing of 1-chlorododecane (CAS No. 112-52-7), which Lonza had committed to sponsor, did not have to include a test for melting point because, in publicly available documents, 1-chlorododecane is reported to be a liquid (Ref. 25). Therefore, EPA is revoking the testing requirement for melting point for 1-chlorododecane by removing that requirement from those listed for 1-chlorododecane in Table 2 in 40 CFR 799.5085(j). The test requirements for 1-chlorododecane that are not revoked by this direct final rule include tests for boiling point, vapor pressure, octanol/water partition coefficient, water solubility, biodegradation, Daphnia chronic toxicity, toxicity to algae, acute mammalian toxicity, mutagenicity, chromosomal damage, and 28-day repeated-dose toxicity with a reproduction/developmental toxicity screen. Studies responding to those test requirements have been submitted to the Agency (Ref. 26).

3. Phenol, 4,4′-methylenebis[2,6-bis(1,1-dimethylethyl)]-. In letters dated May 12, 2006, July 14, 2006, May 1, 2007, and May 16, 2007 (Refs. 27-30), the Albemarle Corporation requested EPA to review existing data that it was submitting for phenol, 4,4′-methylenebis[2,6-bis(1,1-dimethylethyl)]- (CAS No. 118-82-1) to determine if they satisfied the Agency's need for data on water solubility, octanol/water partition coefficient, acute mammalian toxicity, bacterial reverse mutation, and screening level reproduction/developmental toxicity. EPA found that the data satisfied the Agency's data needs for those testing endpoints in HPV1, making the testing requirements unnecessary (Refs. 31-33). Therefore, EPA is revoking the testing requirements for water solubility, octanol/water partition coefficient, acute mammalian toxicity, bacterial reverse mutation assay, and a reproduction/developmental toxicity screen for phenol, 4,4′-methylenebis[2,6-bis(1,1-dimethylethyl)]- by removing those requirements from Table 2 in 40 CFR 799.5085(j). The test requirements for phenol, 4,4′-methylenebis[2,6-bis(1,1-dimethylethyl)]- that are not revoked by this direct final rule include tests for melting point, boiling point, vapor pressure, inherent biodegradation, and chromosomal damage. Studies responding to those test requirements have been submitted to the Agency (Ref. 34).

4. Methanesulfinic acid, hydroxyl-, monosodium salt. On May 14, 2007, the Sodium Formaldehyde Sulfoxylate Consortium (SFS Consortium) formed under the auspices of the Synthetic Organic Chemical Manufacturers Association (SOCMA) submitted existing data to satisfy some of the testing requirements for methanesulfinic acid, hydroxyl-, monosodium salt (CAS No. 149-44-0) (Ref. 35). The submitted studies used the dihydrate form of methanesulfinic acid, hydroxyl-, monosodium salt (CAS No. 6035-47-8) as the test substance to address the endpoints of inherent biodegradation, fish acute toxicity, Daphnia acute toxicity, and toxicity to algae (Ref. 35). Although the hydrated form is identified by a different CAS number, in general, EPA does not recognize a hydrate as a separate entity from the corresponding anhydrous material for TSCA purposes, and accepts studies of the hydrated form of a chemical substance as predictive of the effects of the anhydrous chemical (Ref. 15). EPA found that the submitted study on ready biodegradation satisfied the need for information on biodegradability, making the test requirement for inherent biodegradation unnecessary (Refs. 36 and 37). The existing studies on fish acute toxicity, Daphnia acute toxicity, and toxicity to algae were reviewed by the Agency and found to satisfy EPA's data needs for those endpoints (Ref. 38).

In the test plan submitted with the May 14, 2007 letter, the SFS Consortium requested that EPA revoke the requirement to determine vapor pressure because the chemical substance is an organo-metallic salt that does not volatilize (Ref. 35). The SFS Consortium also requested that EPA revoke the requirement to determine the octanol/water partition coefficient (log K ow) because its estimated value was −6.17 and HPV1 did not require a determination of octanol/water partition coefficient if its estimated value is less than zero (Ref. 35). EPA agreed with the SFS Consortium's position that testing was not needed to determine vapor pressure (Ref. 39) and octanol/water partition coefficient (Ref. 40). Also, in the test plan submitted on May 14, 2007, (Ref. 35), the SFS Consortium reported that in a test to determine boiling point, the test substance decomposed. EPA, therefore, is waiving the test for boiling point (Ref. 41).

EPA is revoking the testing requirements for boiling point, vapor pressure, octanol/water partition coefficient, biodegradation, fish acute toxicity, Daphnia acute toxicity, and toxicity to algae for methanesulfinic acid, hydroxyl-, monosodium salt by removing those requirements from those listed for that chemical substance in Table 2 in 40 CFR 799.5085(j). The testing requirements for methanesulfinic acid, hydroxyl-, monosodium salt that are not revoked by this direct final rule include tests for melting point, water solubility, chromosomal damage, and 28-day repeated-dose toxicity with a reproduction/developmental toxicity screen. Studies responding to those test requirements, also using the dihydrate form of methanesulfinic acid, hydroxyl-, monosodium salt, were submitted to the Agency (Ref. 42).

5. Benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]-. On July 17, 2006, the Color Pigments Manufacturers Association (CPMA) submitted a test plan for benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]- (CAS No. 1324-76-1), also known as C.I. Pigment Blue 61. CPMA also submitted robust summaries of existing data which CPMA asked EPA to accept as satisfying some of the Agency's data needs for C.I. Pigment Blue 61. Some of the existing data described in the summaries addressed C.I. Pigment Blue 56, a close analog of C.I. Pigment Blue 61, which CPMA requested EPA to accept as satisfying the Agency's data needs for C.I. Pigment Blue 61, providing a structure-activity relationship (SAR) argument in the test plan to justify that request (Refs. 43 and 44). CPMA also asked EPA to accept results for water solubility and octanol/water partition coefficient which were obtained by using an alternative method, due to the extremely low predicted solubility of C.I. Pigment Blue 61, instead of the methods specified by the test rule (Ref. 43). Finally, CPMA asked EPA to accept that determining a melting point for C.I. Pigment Blue 61 was not relevant because the pigment thermally decomposes before it melts (Ref. 43).

EPA reviewed the submitted information on physical/chemical properties and decided that melting point, boiling point, and vapor pressure determinations were not relevant because C.I. Pigment Blue 61 decomposes before it melts and the decomposition temperature had been reported (Ref. 45). EPA accepted the submitted data on water solubility as satisfying the Agency's data needs for that endpoint, but did not accept the calculated value submitted to satisfy the testing requirement for octanol/water partition coefficient (Ref. 45). EPA believes the calculated value would, most likely, underestimate the measured value (Ref. 45) required to be determined by HPV1.

EPA reviewed CPMA's SAR argument concerning C.I. Pigment Blue 61 and C.I. Pigment Blue 56 and agreed that C.I. Pigment Blue 56 is an acceptable surrogate for C.I. Pigment Blue 61, thereby allowing adequate data on C.I. Pigment Blue 56 to satisfy data needs for C.I. Pigment Blue 61 (Ref. 46). As a result, a biodegradation study of C.I. Pigment Blue 56, found adequate by an EPA review, satisfies the need for biodegradation data on C.I. Pigment Blue 61 (Ref. 46). Likewise, a chromosomal damage test of C.I. Pigment Blue 56, which EPA reviewed and found adequate, will satisfy the data need for that endpoint (Ref. 47) for C.I. Pigment Blue 61. EPA's review of the existing data on C.I. Pigment Blue 61 found the studies on fish acute toxicity, mammalian acute toxicity, and bacterial mutation assay to be adequate to satisfy the data needs for those endpoints (Ref. 47). The existing study on repeated-dose toxicity, however, did not satisfy the test requirement for that endpoint (Ref. 47).

Therefore, EPA is revoking the testing requirements for melting point, boiling point, vapor pressure, water solubility, biodegradation, fish acute toxicity, mammalian acute toxicity, bacterial reverse mutation, and chromosomal damage for C.I. Pigment Blue 61 by removing those requirements from those listed for that chemical substance in Table 2 in 40 CFR 799.5085(j). In order to clarify that test requirements for acute toxicity to Daphnia and toxicity to algae had not been satisfied by existing studies, and that the fish acute toxicity test requirement had been satisfied, the test symbol C2 replaces C1 for C.I. Pigment Blue 61 in Table 2 in 40 CFR 799.5085(j). The testing requirements for C.I. Pigment Blue 61 that are not revoked by this direct final rule include tests for octanol/water partition coefficient, acute toxicity to Daphnia, toxicity to algae, and combined 28-day repeated-dose toxicity with a reproduction/developmental toxicity screen. Studies responding to those test requirements were submitted to the Agency. The full studies were claimed to be CBI and are not available to the public, but robust summaries of those studies (Ref. 48) are in the docket.

6. C.I. Solvent Black 7. On July 29, 2006 and August 4, 2006, the Solvent Black 7 Consortium formed under the auspices of SOCMA submitted eight existing studies on C.I. Solvent Black 7 (CAS No. 8005-02-5) and requested EPA to determine if they satisfied some of the Agency's data needs specified in HPV1 (Ref. 49). EPA found that the studies satisfied the need for data on inherent biodegradation, fish acute toxicity, Daphnia acute toxicity, toxicity to algae, acute mammalian toxicity, chromosomal damage, and repeated-dose 28-day oral toxicity in rodents, making those test requirements for C.I. Solvent Black 7 unnecessary (Ref. 50). Although the 28-day oral toxicity study in rodents was accepted, it lacked a required screening test for reproduction/developmental toxicity. Although a test for chronic toxicity to Daphnia was not required for this chemical substance, SOCMA submitted a Daphnia magna reproduction test because the log K ow of C.I. solvent Black 7 is close to 4.2 and a log K ow greater than 4.2 would have made a Daphnia chronic toxicity test a requirement (Refs. 1 and 51). The submitted study was evaluated and was not found adequate to satisfy the objectives of a Daphnia chronic toxicity study because the study was only 10 days long instead of 21 days, and only one concentration was tested and it was lethal, preventing observation of sub-lethal endpoints (Ref. 52).

Therefore, EPA is revoking the testing requirements for inherent biodegradation, fish acute toxicity, Daphnia acute toxicity, toxicity to algae, acute mammalian toxicity, chromosomal damage, and repeated-dose 28-day oral toxicity in rodents for C.I. Solvent Black 7 (CAS No. 8005-02-5) by removing those requirements from those listed for that chemical substance in Table 2 in 40 CFR 799.5085(j). In order to clarify that the requirement for a reproduction/developmental toxicity screening test had not been satisfied, but that the requirement for a repeated-dose 28-day oral toxicity test had been satisfied, the test symbol F2 replaces F1 for C.I. Solvent Black 7 in Table 2 in 40 CFR 799.5085(j). The testing requirements not revoked by this direct final rule include the tests to determine five physical/chemical properties and to screen for reproduction/developmental toxicity. Studies responding to those test requirements have been submitted to the Agency (Refs. 51 and 53).

IV. Economic Analysis Back to Top

In the economic impact analysis of this direct final rule, the Agency estimated the total testing cost to industry to be $4.03 million for all 17 chemical substances, with an average of approximately $237,000 per chemical substance (Ref. 54). This total included an additional 25% in administrative costs. An amendment to HPV1 revoking testing requirements for Coke-Oven Light Oil (Coal) reduced the total cost to industry to an estimated $3.7 million for the remaining 16 chemical substances, with an average compliance cost of approximately $232,000 per chemical substance. This direct final rule would have the effect of further reducing the total testing cost by an estimated $1.5 million (approximately 41%), by eliminating all the testing requirements for acetyl chloride; imidodicarbonic diamide; methane, isocyanato-; and urea, reaction products with formaldehyde; as well as some of the testing requirements for 9,10-anthracenedione; 1-chlorododecane; phenol, 4,4′-methylenebis [2,6-bis (1,1-dimethylethyl)]-; methanesulfinic acid, hydroxy-, monosodium salt; benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-(phenylmino)-2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]-; and C.I. Solvent Black 7 (Ref. 55). In addition, the 25% administrative costs would be eliminated for these tests. The reduced total cost for the remaining 12 chemical substances with testing requirements is estimated to be $2.2 million (i.e., $3.7 million minus $1.5 million), with an average compliance cost per chemical substance of approximately $184,000 (Ref. 55).

V. Export Notification Back to Top

On the effective date of the revocations in this direct final rule of the TSCA section 4 testing requirements for acetyl chloride (CAS No. 75-36-5); imidodicarbonic diamide (CAS No. 108-19-0), methane, isocyanato- (CAS No. 624-83-9); and urea, reaction products with formaldehyde (CAS No. 68611-64-3), persons who export or intend to export those chemical substances will no longer be subject to any TSCA section 12(b) export notification requirements triggered by HPV1 (See 40 CFR part 707, subpart D). The export notification requirements remain the same for the other six chemical substances discussed in the preamble of this direct final rule that are listed as subject to the requirements of HPV1 (Ref. 1); these chemical substances are 9,10-anthracenedione (CAS No. 84-65-1); 1-chlorododecane (CAS No. 112-52-7); phenol, 4,4′-methylenebis[2,6-bis(1,1-dimethylethyl)]- (CAS No. 118-82-1); methanesulfinic acid, hydroxy-, monosodium salt (CAS No. 149-44-0); benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]- (CAS No. 1324-76-1); and C.I. Solvent Black 7 (CAS No. 8005-02-5).

VI. Direct Final Rule Procedures Back to Top

EPA is publishing this direct final rule without prior proposal because the Agency views this as a non-controversial amendment and anticipates no adverse comment as this action simply revokes testing which is not feasible, or testing for which the substantial production finding was not supported, or testing for which EPA has adequate data at this time. This direct final rule is effective May 15, 2012 without further notice, unless EPA receives adverse comment or a written request for an opportunity to present oral comments on or before April 16, 2012. If EPA receives adverse comment or a written request for an opportunity to present oral comments on one or more distinct amendments, paragraphs, or sections of this direct final rule, the Agency will publish a timely withdrawal in the Federal Register indicating which provisions will become effective and which provisions are being withdrawn due to adverse comment or a written request for an opportunity to present oral comments. Any distinct amendment, paragraph, or section of this direct final rule for which the Agency does not receive adverse comment or a request for an opportunity to present oral comments is effective May 15, 2012, notwithstanding any adverse comment or request on any other distinct amendment, paragraph, or section of this direct final rule. For any distinct amendment, paragraph, or section of this direct final rule that is withdrawn due to adverse comment or a request for an opportunity to present oral comments, EPA will publish a notice of proposed rulemaking in a future issue of the Federal Register. The Agency will address the comment or request for an opportunity to present oral comments on any such distinct amendment, paragraph, or section as part of that notice of proposed rulemaking.

VII. References Back to Top

Each reference listed in this unit has a docket ID number (EPA-HQ-OPPT-2005-0033) followed by a four-digit document ID number. All document ID numbers are listed in numerical order in the docket. To access a particular document in the docket, go to http://www.regulations.gov and follow the online instructions.

1. EPA. Testing of Certain High Production Volume Chemicals; Final Rule. Federal Register (71 FR 13708, March 16, 2006) (FRL-7335-2). (Document ID number EPA-HQ-OPPT-2005-0033-0001).

2. EPA. TSCA Section 4(a)(1)(B) Final Statement of Policy; Criteria for Evaluating Substantial Production, Substantial Release, and Substantial or Significant Human Exposure; Notice. Federal Register (58 FR 28736, May 14, 1993) (FRL-4059-9). (Document ID number EPA-HQ-OPPT-2005-0033-0060).

3. Albemarle Corporation. Letter from M.G. Clisby to Catherine Roman, Chemical Information and Testing Branch (CITB), Chemical Control Division (CCD), Office of Pollution Prevention and Toxics (OPPT), EPA. April 16, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0344).

4. Tessenderlo Kerley, Inc. Email from Dawn Kominski to Catherine Roman, CITB, CCD, OPPT, EPA. March 23, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0342).

5. Charkit Chemical Corporation. Letter from Bryant Hinnant to Document Control Office, OPPT, EPA. December 7, 2006. (Document ID number EPA-HQ-OPPT-2005-0033-0220).

6. TFI. Submission for fulfillment of data requirements for biuret under TSCA section 4. July 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0343).

7. Organisation for Economic Co-operation and Development (OECD). Screening Information Data Set (SIDS), Urea, CAS No.: 57-13-6. Also, a supporting document for biuret. 1994. (Document ID number EPA-HQ-OPPT-2005-0033-0360).

8. IUCLID Data Set, Biuret, CAS No. 108-19-0. March 7, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0359).

9. EPA. Memorandum from Tracy Williamson, Industrial Chemistry Branch (ICB), Economics, Exposure, and Technology Division (EETD), OPPT, to Greg Schweer, CITB, CCD, OPPT. Review of the physical-chemical endpoints for HPV orphan chemical biuret (CAS No. 108-19-0). Sept 17, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0356).

10. EPA. Email from Robert Boethling, Exposure Assessment Branch (EAB), EETD, OPPT, to Greg Schweer, CITB, CCD, OPPT. Review of TFI submission on biuret. August 20, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0347).

11. EPA. Email from David Brooks, High Production Volume Chemical Branch (HPVCB), Risk Assessment Division (RAD), OPPT, to Greg Schweer, CITB, CCD, OPPT. Review of biuret (CAS No. 108-19-0). October 2, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0358).

12. Bayer CropScience. Letter to Document Control Office, OPPT, EPA, submitting a test plan and request for review of existing data on physical chemical properties and aquatic toxicity. May 11, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0249).

13. EPA. Email from Tracy Williamson, ICB, EETD, OPPT, to Catherine Roman, CITB, CCD, OPPT. June 18, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0281).

14. EPA. Email and attached review of aquatic studies of methane, isocyanato from David Brooks, HPVCB, RAD, OPPT, to Greg Schweer, CITB, CCD, OPPT. August 29, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0284).

15. EPA. Emails on acceptability of studies on dihydrate form of CAS No. 149-44-0. August 18, 2009. (Document ID number EPA-HQ-OPPT-2005-0033-0357).

16. TFI. Submission for Fulfillment of Data Requirements for Urea, Reaction Products with Formaldehyde under TSCA Section 4. Revised March 2008. (Document ID number EPA-HQ-OPPT-2005-0033-0361).

17. EPA. Memorandum from Kathryn Schechter, ICB, EETD, OPPT, to Greg Schweer, CITB, CCD, OPPT. September 13, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0345).

18. EPA. Email from David Brooks, HPVCB, RAD, OPPT, to Mike Mattheisen and Catherine Roman, CITB, CCD, OPPT. April 23, 2008. (Document ID number EPA-HQ-OPPT-2005-0033-0346).

19. EPA. Email from Robert Boethling, EAB, EETD, OPPT, to Greg Schweer, CITB, CCD, OPPT. August 14, 2007. Includes copyrighted attachment: Ahapir, Nir, et al. Purification and Characterization of TrzF: Biuret Hydrolysis by Allophanate Hydrolase Supports Growth. Applied and Environmental Microbiology. 72(4):2941-2495 (2006). (Document ID number EPA-HQ-OPPT-2005-0033-0363).

20. CPC. Letter from Jerry A. Cook to Document Control Office, OPPT, EPA, concerning existing data on boiling point and vapor pressure. July 10, 2006. (Document ID number EPA-HQ-OPPT-2005-0033-0182).

21. CRC Handbook of Chemistry and Physics. 85th Edition. David R. Lide, ed., CRC Press. Boca Raton, FL. 2004.

22. EPA. Letter from Greg Schweer, CITB, CCD, OPPT, to Jerry A. Cook, CPC, concerning acceptance of existing data on boiling point, vapor pressure, and melting point. August 30, 2006. (Document ID number EPA-HQ-OPPT-2005-0033-0211).

23. CPC. Email from Jerry Cook to Catherine Roman, CITB, CCD, OPPT, EPA, concerning determination of melting point. July 24, 2006. (Document ID number EPA-HQ-OPPT-2005-0033-0348).

24. CPC. Studies submitted for 9,10-anthracenedione on octanol/water partition coefficient, water solubility, and a screen for reproduction/developmental toxicity. Submitted on February 15, 2007. (Document ID numbers EPA-HQ-OPPT-2005-0033-0222.1, EPA-HQ-OPPT-2005-0033-0222.1, and EPA-HQ-OPPT-2005-0033-0222.2, respectively).

25. EPA. Letter from Mike Mattheisen, CITB, CCD, OPPT, to John Van Miller, Toxicology/Regulatory Services, Charlottesville, VA. February 21, 2008. (Document ID number EPA-HQ-OPPT-2005-0033-0291).

26. Lonza, Inc. Studies submitted for 1-chlorododecane on boiling point, vapor pressure, octanol/water partition coefficient, water solubility, biodegradation, Daphnia chronic toxicity, toxicity to algae, acute mammalian toxicity, mutagenicity, chromosomal damage, and 28-day repeated-dose toxicity with a reproduction/developmental toxicity screen. Submitted on September 17, 2008. (Document ID numbers EPA-HQ-OPPT-2005-0033-0314.6, EPA-HQ-OPPT-2005-0033-314.10, EPA-HQ-OPPT-2005-0033-0314.8, EPA-HQ-OPPT-2005-0033-0314.11, EPA-HQ-OPPT-2005-0033-0314.9, EPA-HQ-OPPT-2005-0033-0314.7, EPA-HQ-OPPT-2005-0033-0314.5, EPA-HQ-OPPT-2005-0033-0314.1, EPA-HQ-OPPT-2005-0033-0314.2, EPA-HQ-OPPT-2005-0033-0314.3, and EPA-HQ-OPPT-2005-0033-0314.4, respectively).

27. Albemarle Corporation. Letter from Ronald Zumstein to Document Control Office, OPPT, EPA, concerning existing data on water solubility and octanol-water partition coefficient. May 12, 2006. (Document ID number EPA-HQ-OPPT-2005-0033-0163).

28. Albemarle Corporation. Letter from Kim Boudreaux to Document Control Office, OPPT, EPA, concerning existing data on acute toxicity, gene mutation, and reproductive/developmental toxicity. July 14, 2006. (Document ID numbers EPA-HQ-OPPT-2005-0033-0181, EPA-HQ-OPPT-2005-0033-0181.1, EPA-HQ-OPPT-2005-0033-0181.2, and EPA-HQ-OPPT-2005-0033-0181.3).

29. Albemarle Corporation. Letter from Kim Boudreaux to Document Control Office, OPPT, EPA, concerning an existing Ames study. May 1, 2007. (Document ID numbers EPA-HQ-OPPT-2005-0033-0250, EPA-HQ-OPPT-2005-0033-0250.1, and EPA-HQ-OPPT-2005-0033-0250.2).

30. Albemarle Corporation. Letter from Kim Boudreaux to Document Control Office, OPPT, EPA, concerning existing data on repeated-dose toxicity and reproduction/developmental toxicity screening. May 16, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0247).

31. EPA. Letter from Greg Schweer, CITB, CCD, OPPT, to Ronald Zumstein and Kim Boudreaux, Albemarle Corporation, concerning EPA's acceptance of existing data on water solubility and octanol-water partition coefficient. August 9, 2006. (Document ID number EPA-HQ-OPPT-2005-0033-0210).

32. EPA. Letter from Greg Schweer, CITB, CCD, OPPT, to Kim Boudreaux, Albemarle Corporation, concerning EPA's acceptance of existing data on mammalian acute toxicity. April 5, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0237).

33. EPA. Letter from Greg Schweer, CITB, CCD, OPPT, to Kim Boudreaux, Albemarle Corporation, concerning EPA's acceptance of existing data on bacterial reverse mutation and reproductive/developmental toxicity. October 23, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0285).

34. Albemarle Corporation. Studies submitted for phenol, 4,4'-methylenebis[2,6-bis(1,1-dimethylethyl)]- on melting point, boiling point, vapor pressure, inherent biodegradation, and chromosomal aberration. Submitted on October 31, 2007 and November 1, 2007. (Document ID numbers EPA-HQ-OPPT-2005-0033-0274, EPA-HQ-OPPT-2005-0033-0274, EPA-HQ-OPPT-2005-0033-0274, EPA-HQ-OPPT-2005-0033-0275.1, and EPA-HQ-OPPT-2005-0033-0257, respectively).

35. SFS Consortium, SOCMA. Letter to Document Control Office, OPPT, EPA, submitting a test plan and request for review of existing data on biodegradation and aquatic toxicity. May 14, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0238).

36. EPA. Memorandum from Robert Boethling, EAB, EETD, OPPT, to Greg Schweer, CITB, CCD, OPPT, concerning biodegradation test requirement. July 6, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0277).

37. EPA. Memorandum from Jed Costanza, EAB, EETD, OPPT, to Mike Mattheisen,CITB, CCD, OPPT. October 9, 2008. (Document ID number EPA-HQ-OPPT-2005-0033-0352).

38. EPA. Email from David Brooks, HPVCB, RAD, OPPT, to Catherine Roman, CITB, CCD, OPPT. Review of CAS No. 149-44-0. August 13, 2009. (Document ID number EPA-HQ-OPPT-2005-0033-0349).

39. EPA. Memorandum from Daniel Lin, ICB, EETD, OPPT, to Greg Schweer, CITB, CCD, OPPT, concerning vapor pressure requirement. June 19, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0278).

40. EPA. Letter from Charles Auer, OPPT, to Tucker Helmes, SOCMA. May 28, 2008. (Document ID number EPA-HQ-OPPT-2005-0033-0307).

41. EPA. Memorandum from Greg Fritz, ICB, EETD, OPPT, to Mike Mattheisen, CITB, CCD, OPPT. August 25, 2008. (Document ID number EPA-HQ-OPPT-2005-0033-0351).

42. SOCMA. Studies submitted for methanesulfinic acid, hydroxyl-, monosodium salt on melting point, water solubility, chromosomal damage, and 28-day repeated-dose toxicity with a reproduction/developmental toxicity screen. Submitted on June 16, 2008. (Document ID number EPA-HQ-OPPT-2005-0033-0309).

43. CPMA. Letter to Document Control Office, OPPT, EPA, from J. Lawrence Robinson concerning existing data and test plan. July 17, 2006. (Document ID number EPA-HQ-OPPT-2005-0033-0185).

44. CPMA. Letter to Document Control Office, OPPT, EPA, from J. Lawrence Robinson concerning existing data and test plan. May 9, 2007. (Document ID EPA-HQ-OPPT-2005-0033-0246).

45. EPA. Memorandum from Diana Darling, ICB, EETD, OPPT, to Greg Schweer, CITB, CCD, OPPT. Testing requirements and existing data for physical/chemical properties of the HPV test rule chemical, C.I. Pigment Blue 61 (CAS No. 1324-76-1). May 17, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0280).

46. EPA. Memorandum from Robert Boethling, EAB, EETD, OPPT, to Greg Schweer, CITB, CCD, OPPT. Review of SAR argument and a biodegradation test concerning an HPV test rule chemical, C.I. Pigment Blue 61 (CAS No. 1324-76-1). May 15, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0279).

47. EPA. Email and attached review from David Brooks, HPVCB, RAD, OPPT, to Greg Schweer and Catherine Roman, CITB, CCD, OPPT. Review of C.I. Pigment Blue (CAS No. 1324-76-1). August 22, 2007. (Document ID number EPA-HQ-OPPT-2005-0033-0286).

48. SOCMA. Robust summaries submitted for C.I. Pigment Blue 61 on octanol/water partition coefficient, acute toxicity to Daphnia, toxicity to algae, and combined 28-day repeated-dose toxicity with a reproduction/developmental toxicity screen. Submitted on November 14, 2008. (Document ID number EPA-HQ-OPPT-2005-0033-0318).

49. SOCMA. Letters from C. Tucker Helmes to Document Control Office, OPPT, EPA. Submission of existing data on C.I. Solvent Black 7. June 29, 2006 and August 4, 2006. (Document ID numbers EPA-HQ-OPPT-2005-0033-0168, EPA-HQ-OPPT-2005-0033-0169, EPA-HQ-OPPT-2005-0033-0170, EPA-HQ-OPPT-2005-0033-0171, EPA-HQ-OPPT-2005-0033-0172, EPA-HQ-OPPT-2005-0033-0173, EPA-HQ-OPPT-2005-0033-0174, EPA-HQ-OPPT-2005-0033-0175, EPA-HQ-OPPT-2005-0033-0176, and EPA-HQ-OPPT-2005-0033-0184).

50. EPA. Memorandum from Mark Townsend, HPVCB, RAD, OPPT, to Greg Schweer, CITB, CCD, OPPT. November 27, 2006. (Document ID number EPA-HQ-OPPT-2005-0033-0283).

51. SOCMA. Letter from C. Tucker Helmes to Document Control Office, OPPT, EPA. Justification for providing Daphnia reproduction study for C.I. Solvent Black 7. February 28, 2008. (Document ID number EPA-HQ-OPPT-2005-0033-0290).

52. EPA. Email from David Brooks, HPVCB, RAD, OPPT, to Mike Mattheisen, CITB, CCD, OPPT. July 15, 2008. (Document ID number EPA-HQ-OPPT-2005-0033-0353).

53. SOCMA. Studies submitted for C.I. Solvent Black 7 on physical/chemical properties and prenatal developmental toxicity. Submitted on February 28, 2008. (Document ID numbers EPA-HQ-OPPT-2005-0290.2 and EPA-HQ-OPPT-2005-0033-0290.4).

54. EPA, EPAB, EETD, OPPT. Economic Analysis for the Final Section 4 Test Rule for High Production Volume Chemicals. October 28, 2005. (Document ID number EPA-HQ-OPPT-2005-0033-0131).

55. EPA. Email from Stephanie Suazo, EPAB, EETD, OPPT, to Catherine Roman, CITB, CCD, OPPT. RE: “Revised Economic Analysis for Revocation of Testing Requirements” with attached economic analysis. December 14, 2009. (Document ID number EPA-HQ-OPPT-2005-0033-0350).

VIII. Statutory and Executive Order Reviews Back to Top

This direct final rule only eliminates existing requirements; it does not otherwise impose any new or revised requirements. As such, this action is not subject to review by the Office of Management and Budget (OMB) as a “significant regulatory action” under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Nor does it impose or change any information collection burden that requires additional review by OMB under the provisions of the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq.).

Because this direct final rule eliminates existing requirements without imposing any new or revised requirements, the Agency certifies pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), that this action will not have a significant economic impact on a substantial number of small entities.

For the same reasons, it is not subject to the requirements of sections 202 and 205 of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1531-1538), and does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of UMRA. This direct final rule does not have tribal implications, as specified in Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), or federalism implications as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999).

Since this action is not economically significant under Executive Order 12866, it is not subject to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), and 13211, “Actions concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001).

This action does not involve technical standards; thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.

This direct final rule does not involve special consideration of environmental justice related issues as specified in Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

IX. Congressional Review Act Back to Top

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 799 Back to Top

Dated: March 9, 2012.

James Jones,

Acting Assistant Administrator, Office of Chemical Safety and Pollution Prevention.

Therefore, 40 CFR chapter I is amended as follows:

begin regulatory text

PART 799—[AMENDED] Back to Top

1.The authority citation for part 799 continues to read as follows:

Authority:

15 U.S.C. 2603, 2611, 2625.

2.In § 799.5085, revise the section heading and Table 2 of paragraph (j) to read as follows:

§ 799.5085 Chemical testing requirements for first group of high production volume chemicals (HPV1).

* * * * *

(j) * * *

Table 2—Chemical Substances and Testing Requirements Back to Top
CAS No. Chemical name Class Required tests (see table 3 of this section)
74-95-3 Methane, dibromo- 1 A, C1, E2, F2.
78-11-5 1,3-Propanediol, 2,2-bis[(nitrooxy)methyl]-, dinitrate (ester) 1 A4, A5, B, C6, F2.
84-65-1 9,10-Anthracenedione 1 A4, A5, F2.
110-44-1 2,4-Hexadienoic acid, (E,E)- 1 A, C4.
112-52-7 1-Chlorododecane 1 A2, A3, A4, A5, B, C3, D, E1, E2, F1.
118-82-1 Phenol, 4,4'-methylenebis[2,6bis(1,1-dimethylethyl)]- 1 A1, A2, A3, B, E2.
149-44-0 Methanesulfinic acid, hydroxy-, monosodium salt 1 A1, A5, E2, F1.
409-02-9 Heptenone, methyl- 2 A, B, C1, D, E1, E2, F1.
594-42-3 Methanesulfenyl chloride, trichloro- 1 A, B, C1, E1, E2, F2.
1324-76-1 Benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]- 2 A4, C2, F1.
2941-64-2 Carbonochloridothioic acid, S-ethyl ester 1 A, B, C1, E2, F1.
8005-02-5 C.I. Solvent Black 7 2 A, F2.

* * * * *

end regulatory text

[FR Doc. 2012-6430 Filed 3-15-12; 8:45 am]

BILLING CODE 6560-50-P

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