Document ID: EPA-HQ-OPPT-2005-0014-0052
Agency: epa
Document Type: Rule
Title: Removal of Two Chemical Substances from Preliminary Assessment Information Reporting and Health and Safety Data Reporting Rules
Posted Date: 2007-04-30T04:00Z

[Federal Register: April 30, 2007 (Volume 72, Number 82)]
[Rules and Regulations]               
[Page 21119-21123]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap07-12]                         

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 712 and 716

[EPA-HQ-OPPT-2005-0014 and EPA-HQ-OPPT-2005-0055; FRL-8124-9]
RIN 2070-AB08 and 2070-AB11

 
Removal of Two Chemical Substances from Preliminary Assessment 
Information Reporting and Health and Safety Data Reporting Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: This direct final rule the removes chemical substances 
phosphorotrithious acid, tributyl ester, CAS No. 150-50-5, and 
phosphorodithioic acid, O,O-diethyl ester, sodium salt, CAS No. 3338-
24-7, which were inadvertently added to the list of voluntary High 
Production Volume (HPV) Challenge Program orphan (unsponsored) chemical 
substances by EPA. As a result, these chemical substances were 
inadvertently added to two final rules: The Preliminary Assessment 
Information Reporting (PAIR) rule (Toxic Substances Control Act (TSCA) 
section 8(a)) and the Health and Safety Data Reporting rule (TSCA 
section 8(d)), both published in the Federal Register issue of August 
16, 2006. With this removal action, persons who manufacture (including 
import) either of these two chemical substances are no longer subject 
to the reporting requirements imposed by these TSCA section 8(a) and 
8(d) rules.

DATES: This rule is effective on June 29, 2007 without further notice, 
unless EPA receives adverse comment on or before May 30, 2007.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) numbers EPA-HQ-OPPT-2005-0014 and EPA-HQ-OPPT-2005-0055, by one of 
the following methods:
      Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line 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 Numbers EPA-HQ-OPPT-2005-0014 and EPA-HQ-OPPT-
2005-0055. The DCO is open from 8 a.m. to 4 p.m.,

[[Page 21120]]

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 numbers EPA-HQ-
OPPT-2005-0014 and EPA-HQ-OPPT-2005-0055. EPA's policy is that all 
comments received will be included in the docket without change and may 
be made available on-line 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 e-mail. The regulations.gov website is an 
``anonymous access'' system, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an e-mail comment directly to EPA without 
going through regulations.gov, your e-mail 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. For additional information about EPA's public docket, visit 
the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm
.

    Docket: All documents in the docket are listed in the docket index 
available in regulations.gov. To access the electronic docket, go to 
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket 

Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov web 
site to view the docket index or access available documents. Although 
listed in the index, some information is not publicly available, e.g., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, will be publicly 
available only in hard copy. Publicly available docket materials are 
available electronically 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 Federal 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: 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) either of the two chemical 
substances listed in this direct final rule. Entities potentially 
affected by this action may include, but are not limited to:
     Chemical manufacturers (including importers), (NAICS codes 
325, 32411), 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?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this ``Federal Register'' document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. Frequently updated electronic 

versions of 40 CFR parts 712 and 716 are available through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. 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 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 
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.

[[Page 21121]]

     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. Background

A. What Action is the Agency Taking?

    The chemical substances phosphorotrithious acid, tributyl ester, 
CAS No. 150-50-5, and phosphorodithioic acid, O,O-diethyl ester, sodium 
salt, CAS No. 3338-24-7, are being removed from the table in 40 CFR 
712.30(e) of the TSCA section 8(a) PAIR rule published in the Federal 
Register of August 16, 2006 (Ref. 1), and the table in 40 CFR 
716.120(d) of the TSCA section 8(d) Health and Safety Data Reporting 
rule published in the Federal Register of August 16, 2006 (Ref. 2). On 
August 16, 2006, EPA published a final PAIR rule under TSCA section 
8(a) (40 CFR part 712), which requires manufacturers (including 
importers) of chemical substances in the category of voluntary HPV 
Challenge Program orphan (unsponsored) chemical substances on the ITC's 
TSCA section 4(e) Priority Testing List to submit a one-time report on 
general production/importation volume, end use, and exposure-related 
information to EPA. Also on August 16, 2006, EPA published a final 
Health and Safety Data Reporting rule under TSCA section 8(d) (40 CFR 
part 716), which requires manufacturers (including importers) of 
chemical substances in this category of voluntary HPV Challenge Program 
orphan (unsponsored) chemical substances to submit certain unpublished 
health and safety data to EPA. On September 15, 2006, EPA published a 
final rule (Ref. 3) that revised the effective date of the two rules 
published on August 16, 2006. The effect of this action is that persons 
who manufacture (including import) either of the two chemical 
substances are not subject to the reporting requirements imposed by the 
final TSCA section 8(a) and 8(d) rules published on August 16, 2006, 
and the rule published on September 15, 2006 (Ref. 3), that changed the 
effective date for these two rules.

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

    EPA promulgated the PAIR rule under TSCA section 8(a) (15 U.S.C. 
2607(a)), and it is codified at 40 CFR part 712. This model TSCA 
section 8(a) rule establishes standard reporting requirements for 
certain manufacturers (including importers) of the chemical substances 
listed in the rule at 40 CFR 712.30. The final rule published by EPA on 
August 16, 2006, amended the model TSCA section 8(a) rule by adding the 
ITC category of certain voluntary HPV Challenge Program orphan 
(unsponsored) chemical substances (Ref. 1).
    EPA promulgated the model Health and Safety Data Reporting rule 
under TSCA section 8(d) (15 U.S.C. 2607(d)), and it is codified at 40 
CFR part 716. The TSCA section 8(d) model rule requires past, current, 
and prospective manufacturers, importers, and (if specified by EPA in a 
particular notice or rule under TSCA section 8(d)) processors of listed 
chemical substances to submit to EPA copies and lists of unpublished 
health and safety studies on the listed chemical substances that they 
manufacture, import, or (if specified by EPA in a particular notice or 
rule under TSCA section 8(d)) process. The final rule published by EPA 
on August 16, 2006, amended the model TSCA section 8(d) rule by adding 
the ITC category of certain voluntary HPV Challenge Program orphan 
(unsponsored) chemical substances (Ref. 2).

C. Why is EPA Using a Direct Final Rule?

    EPA is publishing this direct final rule without a prior proposed 
rule because we view this as a non-controversial action and anticipate 
no adverse comment. If EPA receives adverse comment, we will publish a 
timely withdrawal in the Federal Register informing the public that the 
direct final rule will not take effect. Any parties interested in 
commenting must do so on or before May 30, 2007.

D. Why are These Two Chemical Substances Being Removed?

    The chemical substances phosphorotrithious acid, tributyl ester, 
CAS No. 150-50-5, and phosphorodithioic acid, O,O-diethyl ester, sodium 
salt, CAS No. 3338-24-7, were inadvertently added by EPA to the list of 
HPV orphan orphan (unsponsored) chemical substances. This list was the 
source of the category of ``Voluntary HPV Challenge Program orphan 
(unsponsored) chemicals'' that was the subject of the TSCA section 8(a) 
PAIR rule and TSCA section 8(d) Health and Safety Data Reporting rule 
published in the Federal Register of August 16, 2006 (Refs. 1 and 2). 
These two chemicals were originally sponsored in the HPV Challenge 
Program by Bayer CropScience on March 15, 1999 (Ref. 4). Subsequently, 
in a letter dated December 29, 2003, Bayer CropScience requested that 
EPA ``designate the two chemicals as `no longer HPV' on the HPV 
Challenge Program Chemical List'' because Bayer CropScience considered 
the chemicals to be ``non-isolated intermediates'' (Ref. 5). In a 
letter dated December 3, 2004, EPA responded that, based on a review of 
the information submitted by Bayer CropScience, EPA had determined that 
the two substances were ``isolated intermediates'' and, consequently, 
did not meet the `no longer HPV' criteria and that ``they will remain 
in the HPV Challenge Program and should continue to be reported'' (Ref. 
6). In a letter dated December 15, 2005, Bayer CropScience clarified 
the status of the two chemicals (Ref. 7). In that letter, Bayer 
``recommit[ed] to sponsoring'' both chemicals in the HPV Challenge 
Program and proposed to include the two chemicals into two categories. 
This record demonstrates that Bayer CropScience did not withdraw its 
commitment to sponsor these two chemicals in the HPV Challenge Program. 
Consequently, EPA is removing these two chemicals from the table in 40 
CFR 712.30(e) of the TSCA section 8(a) PAIR rule published in the 
Federal Register of August 16, 2006 (Ref. 1), and the table in 40 CFR 
716.120(d) of the TSCA section 8(d) Health and Safety Data Reporting 
rule published in the Federal Register of August 16, 2006 (Ref. 2).
    This action does not preclude the future listing of these two 
chemical substances under the TSCA section 8(a) PAIR rule or the TSCA 
section 8(d) Health and Safety Data Reporting rule should the 
information be reasonably required.

III. Economic Analysis

    In the economic analysis conducted for the final TSCA section 8(a) 
PAIR rule, the Agency estimated the total reporting cost to industry to 
be $644,000 for all 243 chemical substances, or approximately $2,650 
per chemical substance (Ref. 1). The Agency is estimated to incur an 
additional $248,000 or $1,021 per chemical substance to provide public 
support for the TSCA section 8(a) PAIR rule and to process the data 
(Ref. 1). The total cost of the TSCA section 8(a) rule, per chemical 
substance, is estimated to be approximately $3,671. This direct final 
rule removes two chemical substances from the TSCA section 8(a) PAIR 
rule. Therefore, costs are estimated to be reduced by $7,342 (two 
chemical substances x $3,671 per chemical substance).
    Furthermore, this direct final rule will also remove two chemical 
substances

[[Page 21122]]

from the TSCA section 8(d) Health and Safety Data Reporting rule. The 
economic analysis conducted for the TSCA section 8(d) Health and Safety 
Data Reporting rule estimates that the total cost to industry is 
$110,000 and to the Agency is $79,000, or $453 and $325 per chemical 
substance, respectively, for a total of $778 per chemical substance 
(Ref. 2). Because this direct final rule removes two chemical 
substances from the TSCA section 8(d) Health and Safety Data Reporting 
rule, the costs of the TSCA section 8(d) Health and Safety Data 
Reporting rule are estimated to be reduced by $1,556 (two chemical 
substances x $778).
    Therefore, the removal of two chemical substances from the TSCA 
section 8(a) and TSCA section 8(d) rules is estimated to result in a 
total reduction in costs of $8,898.

IV. References

    The dockets for this direct final rule are the dockets established 
for the TSCA section 8(a) PAIR rule (docket ID number EPA-HQ-OPPT-2005-
0014) (Ref. 1) and the TSCA section 8(d) Health and Safety Data 
Reporting rule (docket ID number EPA-HQ-OPPT-2005-0055) (Ref. 2). These 
dockets are available for review as specified in ADDRESSES. The 
following is a listing of the materials referenced in this document 
that have been placed in the dockets:
    1. EPA. Preliminary Assessment Information Reporting; Addition of 
Certain Chemicals. Federal Register (71 FR 47122, August 16, 2006) 
(FRL-7764-9). Available on-line at: http://www.epa.gov/fedrgstr.

    2. EPA. Health and Safety Data Reporting; Addition of Certain 
Chemicals. Federal Register (71 FR 47130, August 16, 2006) (FRL-7764-
7). Available on-line at: http://www.epa.gov/fedrgstr.

    3. EPA. Preliminary Assessment Information Reporting Rule and 
Health and Safety Data Reporting Rule; Revision of Effective Dates. 
Federal Register (71 FR 54434, September 15, 2006) (FRL-8094-8). 
Available on-line at: http://www.epa.gov/fedrgstr.

    4. Bayer Corporation. Letter from Ron Fuchs (Bayer Corporation) to 
Carol Browner (EPA) RE: Sponsorship of chemicals in the HPV Challenge 
Program. March 15, 1999.
    5. Bayer Corporation. Letter from Janet M. Mostowy (Bayer 
Corporation) to Michael Leavitt (EPA) RE: Request to designate 
chemicals as `no longer HPV.' December 29, 2003.
    6. EPA. Letter from Diane Sheridan (EPA/OPPT) to Janet M. Mostowy 
(Bayer Corporation) RE: EPA response to December 29, 2003 letter from 
Bayer Corporation. December 3, 2004.
    7. Bayer CropScience. Letter from George S. Goodridge to Oscar 
Hernandez (EPA/OPPT) RE: Clarification of status of chemicals appearing 
on EPA's 9/16/05 orphan list. December 15, 2005.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    The Office of Management and Budget (OMB) has exempted actions 
under TSCA sections 8(a) and 8(d) related to the PAIR and Health and 
Safety Data Reporting rules from the requirements of Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). In addition, this direct final rule does not impose any new 
requirements and will result in a burden and cost reduction; therefore, 
it is not subject to OMB review under the Executive order.

B. Paperwork Reduction Act

    The information collection requirements contained in TSCA sections 
8(a) PAIR and 8(d) Health and Safety Data Reporting rules have already 
been approved by OMB under the provisions of the Paperwork Reduction 
Act (PRA), 44 U.S.C. 3501 et seq., and OMB control numbers 2070-0054 
(EPA ICR No. 0586) and 2070-0004 (EPA ICR No. 0575). The collection 
activities in this direct final rule are captured by the existing 
approval and do not require additional review and/or approval by OMB.

C. Regulatory Flexibility Act

    Because this direct final rule eliminates reporting 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 adverse economic 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 direct final 
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 direct final rule will not significantly or 
uniquely affect small governments. Accordingly, the direct final rule 
is not subject to the requirements of UMRA sections 202, 203, 204, or 
205.

E. Executive Order 13132: Federalism

    This direct final rule has no Federalism implications because it 
will not have substantial direct effects on States, on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government, 
as specified in Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999).

F. Executive Order 13175: Consultation and Coordination with Indian 
Tribal Governments

    This direct final rule has no tribal implications because it will 
not have substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and Indian tribes, nor 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes as specified in Executive Order 13175, 
entitled Consultation and Coordination with Indian Tribal Governments 
(59 FR 22951, November 6, 2000).

G. Executive Order 13045: Protection of Children from Environmental 
Health Risks and Safety Risks

    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 direct final rule because this is not 
an economically significant regulatory action as defined under 
Executive Order 12866, and it does not concern an environmental health 
or safety risk that may have a disproportionate effect on children.

H. Executive Order 13211: Actions that Significantly Affect Energy 
Supply, Distribution, or Use

    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.

I. National Technology Transfer and Advancement Act

    Because this action does not involve any technical standards, 
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), does not apply to this action.

[[Page 21123]]

J. Executive Order 12898: Federal Actions to Address Environmental 
Justice in Minority Populations and Low-Income Populations

    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).

VI. Congressional Review Act

    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 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 in 40 CFR Parts 712 and 716

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

    Dated: April 23, 2007.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 712--[AMENDED]

0
1. The authority citation for part 712 continues to read as follows:

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

Sec.  712.30  [Amended]

0
2. In Sec.  712.30, in the table under the heading ``Voluntary HPV 
Challenge Program orphan (unsponsored) chemicals'' in paragraph (e), 
remove the entries CAS No. 150-50-5, Phosphorotrithious acid, tributyl 
ester and CAS No. 3338-24-7, Phosphorodithioic acid, O,O-diethyl ester, 
sodium salt.

PART 716--[AMENDED]

0
3. The authority citation for part 716 continues to read as follows:

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

Sec.  716.120  [Amended]

0
4. In Sec.  716.120, in the table under the heading ``Voluntary HPV 
Challenge Program orphan (unsponsored) chemicals in paragraph (d), 
remove the entries Phosphorotrithious acid, tributyl ester, CAS No. 
150-50-5 and Phosphorodithioic acid, O,O-diethyl ester, sodium salt, 
CAS No. 3338-24-7.

[FR Doc. 07-2104 Filed 4-27-07; 8:45 am]

BILLING CODE 6560-50-S