Preliminary Assessment Information Reporting; Addition of Certain Chemicals

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This final rule, issued pursuant to section 8(a) of the Toxic Substances Control Act (TSCA), will require certain manufacturers (including importers) of 3 chemical substances in the chemical category “Pyridinamines” and 20 chemical substances in the chemical category “Tungsten Compounds” to submit a one-time report on general production/importation volume, end use, and exposure-related information to EPA. The Interagency Testing Committee (ITC), established under section 4(e) of TSCA to recommend chemicals and chemical mixtures to EPA for priority testing consideration, amends the TSCA Section 4(e) Priority Testing List through periodic reports submitted to EPA. The ITC recently added these 2 categories containing 23 chemicals to the Priority Testing List.

In addition, EPA is adding as required under the Paperwork Reduction Act (PRA) the Office of Management and Budget (OMB) approved information collection requirements contained in this final rule to EPA's table of OMB control numbers in the Code of Federal Regulations (CFR).

DATES:

This final rule is effective on January 6, 2005. For purposes of judicial review, this rule shall be promulgated at 1 p.m. eastern daylight/standard time on December 21, 2004. (See 40 CFR 23.5)

For submission of a Preliminary Assessment Information Reporting (PAIR) Form, see Unit III.B. of the SUPPLEMENTARY INFORMATION.

A request to withdraw a chemical from this rule, pursuant to 40 CFR 712.30(c), must be received on or before December 21, 2004. (See Unit IV. of the SUPPLEMENTARY INFORMATION.)

ADDRESSES:

Instructions: Direct your submissions to docket identification (ID) number OPPT-2004-0089. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.epa.gov/edocket/ , 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 EDOCKET, regulations.gov, or e-mail. The EPA EDOCKET and the regulations.gov websites are “anonymous access” systems, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through EDOCKET or regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket visit EDOCKET on-line or see the Federal Register of May 31, 2002 (67 FR 38102) (FRL-7181-7).

Submit your withdrawal requests and PAIR forms, identified by docket ID number OPPT-2004-0089, by one of the following methods:

• Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, Attention: 8(a) Auto-ITC.
• Hand delivery: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: 8(a) Auto-ITC. 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 Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.

Docket: All documents in the docket are listed in the EDOCKET index at http://www.epa.gov/edocket/ . Although listed in the index, some information is not publicly available, i.e., 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 either electronically in EDOCKET or in hard copy at the OPPT Docket, EPA Docket Center, EPA West, Rm. B102, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is (202) 566-1744, and the telephone number for the OPPT Docket, which is located in the EPA Docket Center, is (202) 566-0280.

FOR FURTHER INFORMATION CONTACT:

For general information contact: Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov.

For technical information contact: Joe Nash, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-8886; fax number: (202) 564-4765; e-mail address: ccd.citb@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you manufacture (defined by statute to include import) any of the chemical substances that are listed in 40 CFR 712.30(e) of the regulatory text of this document. Entities potentially affected by this action may include, but are not limited to:

• Chemical manufacturers (including importers), (NAICS 325, 324110), e.g., persons who manufacture (defined by statute to include import) one or more of the subject chemical substances.

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. 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. How Can I Access Electronic Copies of this Document and Other Related Information?

In addition to EDOCKET ( http://www.epa.gov/edocket/ ), you may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR parts 9 and 712 is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ .

C. How Do I Submit CBI Information?

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

II. Background

A. What Action is the Agency Taking?

EPA is issuing a final TSCA section 8(a) PAIR rule which requires certain manufacturers (including importers) of 3 chemical substances in the chemical category “Pyridinamines” and 20 chemical substances in the chemical category “Tungsten Compounds” added to the ITC's TSCA section 4(e) Priority Testing List to submit production and exposure reports. The regulatory text of this rule lists the 23 chemical substances that are being added to the PAIR rule.

B. What is the Agency's Authority for Taking this Action?

EPA promulgated the PAIR rule in 40 CFR part 712 under TSCA section 8(a) (15 U.S.C. 2607(a)). This model TSCA section 8(a) rule establishes standard reporting requirements for certain manufacturers (including importers) of the chemicals listed in the rule at 40 CFR 712.30. These entities are required to submit a one-time report on general production/importation volume, end use, and exposure-related information using the PAIR Form entitled Manufacturer's Report-Preliminary Assessment Information (EPA Form No. 7710-35). (See 40 CFR 712.28.) EPA uses this model TSCA section 8(a) rule to quickly gather current information on chemicals or chemical categories as referenced in TSCA section 26(c) (15 U.S.C. 2625(c)).

This model TSCA section 8(a) rule provides for the addition of TSCA section 4(e) Priority Testing List chemicals. Whenever EPA announces the receipt of an ITC Report, EPA can, and without providing notice or an opportunity for public comment, amend the model information-gathering rule by adding the recommended (or designated) chemicals. The amendment adding these chemicals to the PAIR rule is effective 30 days after the date of publication in the Federal Register.

C. Why is this Action Being Issued as a Final Rule?

EPA is publishing this action as a final rule without prior notice and an opportunity for comment pursuant to the procedures set forth in 40 CFR 712.30(c). EPA finds that there is “good cause” under the Administrative Procedure Act (APA) (5 U.S.C. 553(b)(3)(B)) to make these amendments without prior notice and comment. EPA believes notice and an opportunity for comment on this action are unnecessary. TSCA directs the ITC to add chemicals to the Priority Testing List for which EPA should give priority consideration. EPA also lacks the authority to remove a chemical from the Priority Testing List once it has been added by the ITC. As explained earlier in this rule, pursuant to 40 CFR 712.30(c), once the ITC adds a chemical to the Priority Testing List, EPA in turn is obliged to add that chemical to the list of chemicals subject to PAIR reporting requirements, unless requested not to do so by the ITC. EPA promulgated this procedure in 1985 after having solicited public comment on the need for and mechanics of this procedure. (See the Federal Register of August 28, 1985 (50 FR 34805)). Because that rulemaking established the procedure for adding ITC chemicals to the PAIR rule, it is unnecessary to request comment on the procedure in this action. EPA believes this action does not raise any relevant issues for comment. EPA is not changing the PAIR reporting requirements or the process set forth in 40 CFR 712.30(c). Finally, 40 CFR 712.30(c) does provide EPA with the discretion to withdraw a chemical from the PAIR rule if a chemical manufacturer submits to EPA information showing why a chemical should be removed from the PAIR rule.

III. Final Rule

A. What Chemicals are to be Added ?

In this rule, EPA is adding 3 chemical substances in the chemical category “Pyridinamines” and 20 chemical substances in the chemical category “Tungsten Compounds” to the TSCA section 8(a) PAIR rule as requested by the ITC in its 53^rd Report (Ref. 1).

B. Who Must Report Under this PAIR Rule?

Persons who manufactured (defined by statute to include import) the chemicals identified in the regulatory text of this document during their latest complete corporate fiscal year must submit a PAIR Form for each site at which they manufactured or imported a named substance. Exemptions from this reporting requirement are found at 40 CFR 712.25. A separate form must be completed for each substance and submitted to the Agency as specified in 40 CFR 712.28 no later than March 7, 2005. Persons who have previously and voluntarily submitted a PAIR Form to the ITC may be able to submit a copy of the original report to EPA along with an accompanying letter notifying EPA of the respondent's intent that the submission be used in lieu of a current data submission. Persons who have previously and voluntarily submitted a PAIR Form to EPA may be able to notify EPA by letter of their desire to have this voluntary submission accepted in lieu of a current data submission. (See 40 CFR 712.30(a)(3)).

Details of the PAIR reporting requirements, including the basis for exemptions, are provided in 40 CFR part 712. Copies of the PAIR Form are available from the general information contact person listed under FOR FURTHER INFORMATION CONTACT. Copies of the PAIR Form are also available electronically from the Chemical Testing and Information Branch Home Page on the Internet at http://www.epa.gov/opptintr/chemtest/pairform.pdf/ .

C. Economic Analysis

The economic analysis for the addition of the 23 chemicals to the TSCA section 8(a) PAIR rule is entitled Economic Analysis for the Addition of 23 Chemical Abstract Service (CAS)-numbered Chemicals Requested to be added to EPA's Preliminary Assessment Information Reporting (PAIR) Rule in the 53^rd Report of the TSCA Interagency Testing Committee (Ref. 2). A report was located on only one of the 23 chemicals in EPA's 2002 Chemical Update System (CUS) utilizing the ITC-supplied CAS numbers, yielding one company producing that one chemical at one site. Because the threshold for reporting to CUS under the Inventory Update Rule through its most recent reporting cycle in 2002 was 10,000 lbs., and the threshold for PAIR reporting is 500 kilograms (kg) (1,100 lbs.), and because there was no requirement that inorganic chemicals be reported to CUS (the majority of the tungsten compounds are inorganic), EPA assumed that one manufacturer exists per chemical to account for the possibility that there may be manufacturers producing PAIR-reportable amounts that were not captured by CUS. Given the assumptions in this unit, the costs and burden associated with this rule are estimated in the economic analysis (Ref. 2) to be the following:

Reporting Costs (dollars)

23 reports estimated at $345.81 per report = $7,953.63

 Total Cost = $31,162.43

Unit cost of this rule per site/report = $31,162.43

 Total cost/23 total sites/reports = $1,354.89

Reporting Burden (hours)

Form familiarization: 7 hours/site x 23 sites =161 hours

Reporting: 490.71 hours

 Total burden hours = 651.71 hours

Unit burden of this rule per site/report = 651.7

 Total hours/23 total sites/reports = 28.3 hours

EPA Costs (dollars) and Burden (hours)

It is estimated that the annual cost to the Federal Government will be $5,072.24 (23 reports @ $220.53 each), plus 0.0581 Full Time Equivalents (FTEs). At an estimated $97,021 per FTE, the total of 0.0581 FTEs will cost EPA $5,632.35 in salaries, bringing the total costs to the Federal Government to $10,704.59 (i.e., $5,072.24 + $5,632.35).

IV. Requesting a Chemical be Withdrawn from the Rule

As specified in 40 CFR 712.30(c), EPA may remove a chemical substance, mixture, or category of chemical substances from this rule for good cause prior to January 6, 2005 if a chemical manufacturer submits to EPA information showing why a chemical should be removed from the PAIR. Any chemical manufacturer who believes that the reporting required by this rule is not warranted for a chemical listed in this rule, must submit to EPA detailed reasons for that belief. You must submit your request to EPA on or before December 21, 2004 and in accordance with the instructions provided in 40 CFR 712.30(c), which are briefly summarized here. In addition, to ensure proper receipt by EPA, you must identify docket ID number OPPT- 2004-0089 in the subject line on the first page of your submission. If the Administrator withdraws a chemical substance, mixture, or category of chemical substances from the amendment, a Federal Register document announcing this decision will be published no later than January 6, 2005.

V. Materials in the Docket

The official docket for this rule has been established under docket ID number OPPT-2004-0089. The official public docket is available for review as specified in ADDRESSES. The following is a listing of the documents that have been placed in the official docket for this rule:

1. ITC. 2004. Fifty-Third Report of the ITC. Federal Register (69 FR 2468, January 15, 2004) (FRL-7335-2). Available online at http:// www.epa.gov/fedrgstr/ .

2. EPA. 2004. Economic Analysis for the Addition of 23 Chemical Abstract Service (CAS)-numbered Chemicals Requested to be added to EPA's Preliminary Assessment Information Reporting (PAIR) Rule in the 53^rd Report of the TSCA Interagency Testing Committee. April 2, 2004.

VI. Statutory and Executive Order Reviews

A. Executive Order 12866

The Office of Management and Budget (OMB) has exempted actions under TSCA section 8(a) related to the PAIR rule from the requirements of Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act

The information collection requirements contained in TSCA section 8(a) PAIR rules have already been approved by OMB under the provisions of PRA, 44 U.S.C. 3501 et seq., and OMB control number 2070-0054 (EPA ICR No. 0586). The collection activities in this final rule are captured by the existing approval and do not require additional review and/or approval by OMB.

EPA estimates that the information collection activities related to PAIR reporting for all chemicals in this final rule will result in an annual public reporting burden of 28.3 hours per chemical, for a total of 651.7 hours for the 23 chemicals (Ref. 2). As defined by the PRA and 5 CFR 1320.3(b), “burden” means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal Agency. This includes the time needed to: Review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements which have subsequently changed; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

Under PRA, an agency may not conduct or sponsor, and a person is not required to respond to, an information collection request unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and included on the related collection instrument. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this final rule. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This ICR was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(B) of the APA, 5 U.S.C. 553(b)(B), to amend this table without further notice and comment.

C. Regulatory Flexibility Act

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., the Agency hereby certifies that this final rule will not have a significant adverse economic impact on a substantial number of small entities. The factual basis for the Agency's determination is presented in the small entity impact analysis prepared as part of the economic analysis for this rule (Ref. 2), and is briefly summarized here.

For this final rule, EPA has analyzed the potential small business impacts using the size standards established under the default definition of “small business” established under section 601(3) of RFA, which basically uses the definition used in section 3 of the Small Business Act, 15 U.S.C. 632, under which the Small Business Administration (SBA) establishes small business size standards for each industry sector (13 CFR 121.201). The SBA size standards, which are primarily intended to determine whether a business entity is eligible for government programs and preferences reserved for small businesses (13 CFR 121.101), “seek to ensure that a concern that meets a specific size standard is not dominant in its field of operation” (13 CFR 121.102(b)). (See section 632(a)(1) of the Small Business Act.)

The small business size standards promulgated by SBA (61 FR 3280, 3289-3291, January 31, 1996) for chemical manufacturers are based solely on the number of employees, with a base threshold of 1,000 employees for the ultimate corporate parent, under which all businesses are considered small. Of the 23 businesses assumed to be affected by this rule, it is unknown how many meet this definition of small business. To estimate the impact of the rule on a business, the preferred method is the “sales test,” wherein costs for any individual firm are measured as a percent of annual sales. At a maximum cost for any one firm of $1,511.78, the firm's total sales would have to be less than $160,000 for this rule to have an impact of even 1% of sales. Thus, EPA has determined that this rule will not impose a significant impact on a substantial number of small entities.

D. Unfunded Mandates Reform Act

Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, EPA has determined that this rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any 1 year. In addition, EPA has determined that this rule will not significantly or uniquely affect small governments. Accordingly, the rule is not subject to the requirements of UMRA sections 202, 203, 204, or 205.

E. Executive Order 13132 and 13175

Based on EPA's experience with past TSCA section 8(a) rules, State, local, and tribal governments have not been impacted by these rules, and EPA does not have any reasons to believe that any State, local, or tribal government will be impacted by this rule. As a result, these rules are not subject to the requirements in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) or Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000).

F. Executive Order 13045

Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23,1997), does not apply to this rule, because it is not “economically significant” as defined under Executive Order 12866, and does not concern an environmental health or safety risk that may have a disproportionate effect on children. This rule requires the one-time reporting on general production/importation volume, end use, and exposure-related information to EPA by certain manufacturers (including importers) of certain chemicals requested by the ITC to be added to the PAIR rule in its 53^rd Report (Ref. 1).

G. Executive Order 13211

This rule is not subject to Executive Order 13211, entitled Actions that Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use.

H. National Technology Transfer and Advancement Act

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Section 12(d) of NTTAA directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

I. Executive Order 12898

This action does not involve special considerations of environmental justice-related issues pursuant to Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

J. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this 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

40 CFR Part 9

Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 712

Environmental protection, Chemicals, Hazardous substances, Health and safety, Reporting and recordkeeping requirements.

Therefore, 40 CFR chapter I is amended as follows:

PART 9—[AMENDED]

1. By amending part 9 as follows:

a. The authority citation for part 9 continues to read as follows:

Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342,1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048.

b. In § 9.1, the table is amended by removing the entries under the undesignated center heading “Chemical Information Rules” and adding in their place the entry below to read as follows:

PART 712—[AMENDED]

2. By amending part 712 as follows:

a. The authority citation for part 712 continues to read as follows:

Authority: 15 U.S.C. 2607(a).

b. In § 712.30, the table in paragraph (e) is amended by adding in alphabetical order the category “Pyridinamines” containing 3 chemicals in ascending CAS number order and the category “Tungsten Compounds” containing 20 chemicals in ascending CAS number order to read as follows:

(e) * * *