[Dioxin-l] EPA agrees to ITC's voluntary data for APE's
Tony Tweedale
ttweed@wildrockies.org
Fri, 14 Jan 2000 21:57:59 -0700
"II. What is the Purpose of Today's Action?
...Specifically at the request of the ITC in a letter to EPA
dated September 15, 1997, EPA is not issuing a final TSCA section 8(d)
``Unpublished Health and Safety Data'' reporting rule at this time for
the 23 nonylphenol ethoxylates recommended for testing in the 39th ITC
Report so as to give the ITC an opportunity to implement the voluntary
information submission policy that was proposed in the ITC's 40th
Report (62 FR 30580, June 4, 1997) (FRL-5718-3).
...
EPA reserves the right to issue a TSCA section 8(d) rule for some
or all of these 23 nonylphenol ethoxylates if:
...2. The ITC notifies EPA in writing that the ITC did not receive
adequate information via its voluntary information submission activity.
(The ITC's voluntary submission policy can be found on the ITC's[SNIP]"
---
[Federal Register: January 11, 2000 (Volume 65, Number 7)]
[Rules and Regulations]
[Page 1548-1554]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ja00-10]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 712 and 716
[
OPPTS-82050; FRL-5777-2]
RIN-2070-AB08 and 2070-AB11
Preliminary Assessment Information and Health and Safety Data
Reporting; Addition and Removal of Certain Chemicals and Removal of
Stay
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This final rule addresses the recommendations of the 39th TSCA
Interagency Testing Committee (ITC) Report by adding 19 of 23
recommended nonylphenol ethoxylates to the Toxic Substances Control Act
(TSCA) section 8(a) Preliminary Assessment Information Reporting (PAIR)
rule. The TSCA ITC in its 39th Report to EPA revised the TSCA section
4(e) Priority Testing List by recommending testing for 23 nonylphenol
ethoxylates, 19 of which are associated with unique Chemical Abstract
Service (CAS) Registry numbers. The ITC recommendations are given
priority consideration by EPA in promulgating TSCA section 4 test
rules. This PAIR rule will require manufacturers (including importers)
of the 19 CAS-numbered substances identified in this document to report
certain production, use, and exposure-related information to EPA. This
action also removes a stay for TSCA section 8(a) PAIR and section 8(d)
Health and Safety Data Reporting rules issued previously for 18
nonylphenol ethoxylates recommended by the TSCA ITC in its 38th Report
to EPA and removes those 18 chemicals from these reporting rules.
DATES: This rule is effective on February 10, 2000.
FOR FURTHER INFORMATION CONTACT: For general information contact:
Joseph S. Carra, Deputy Director, Office of Pollution Prevention and
Toxics (7401), Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460; telephone numbers: (202) 554-1404 and TDD: (202)
554-0551; e-mail address: TSCA-Hotline@epa.gov.
For technical information contact: David R. Williams, Chemical
Control Division (7405), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460;
telephone numbers: (202) 260-8130; e-mail address: ccd.citb@epa.gov.
SUPPLEMENTARY INFORMATION:
[[Page 1549]]
I. General Information:
A. Does This Action Apply to Me?
You may be affected by this action if you manufacture (defined by
statute to include import) any of the chemical substances that are
listed in section 712.30(e) of the regulatory text portion of this
document. Entities potentially affected by this action may include, but
are not limited to:
--------------------------------------------------------------------------------
--------------------------------
Examples of Potentially
Type of Entity SIC
NAICS Affected Entities
--------------------------------------------------------------------------------
--------------------------------
Chemical manufacturers (including 28, 2911 325, 32411
Persons who manufacture
importers)
(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 Standard Industrial Classification (SIC) codes and the
North American Industrial Classification System (NAICS) codes have been
provided to assist you and others in determining whether or not 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 in the ``FOR FURTHER INFORMATION
CONTACT'' section.
B. How Can I Get Additional Information or Copies of This Document or
Other Documents?
1. Electronically. You may obtain electronic copies of this
document and other documents from the EPA Internet EPA Home Page at
http://www.epa.gov/. On the Home Page select ``Law and Regulations''
and then look up the entry for this document under ``Federal Register--
Environmental Documents.'' You can also go directly to the Federal
Register listings at http://www.epa.gov/fedrgstr/.
2. In person. The official record for this proposed rule, which
includes the public version, has been established under docket control
number OPPTS-82050. The official record consists of the documents
referenced in this preamble, as well as any public comments, and other
information related to this rulemaking, including information claimed
as Confidential Business Information (CBI). This official record
includes the documents that are physically located in the docket, as
well as all documents that are referenced in those documents. The
public version of the official record does not include any information
claimed as CBI. The public version of the official record, which
includes printed, paper versions of any electronic comments that may be
submitted as described in Units I.C. and D. of this preamble, is
available for inspection in the TSCA Nonconfidential Information
Center, Rm. NE-B607, 401 M St., SW., Washington, DC. The Center is open
from noon to 4 p.m., Monday through Friday, excluding legal holidays.
The telephone number of the Center is (202) 260-7099.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, your comments must
identify docket control number OPPTS-82050 in the subject line on the
first page of your response.
1. By mail. Submit comments to: Document Control Office (7407),
Office of Pollution Prevention and Toxics, Environmental Protection
Agency, 401 M St., SW., East Tower, Rm. G-099, Washington, DC 20460.
2. In person or by courier. Deliver comments to: Document Control
Office, Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 401 M St., SW., East Tower, Rm. G-099, Washington,
DC. The telephone number for the OPPT Document Control Office is (202)
260-7093.
3. Electronically. Submit your comments electronically by e-mail
to: oppt.ncic@epa.gov, or you may mail or deliver your computer disk to
the addresses identified in Units I.C.1. or 2. of this preamble. Do not
submit any information electronically that you consider to be CBI.
Submit comments as an ASCII file, avoiding the use of special
characters and any form of encryption. Comments will also be accepted
on standard disks in WordPerfect 6.1/8.0 or ASCII file format. All
copies of electronic comments must be identified by docket control
number OPPTS-82050. Electronic comments may be filed online at many
Federal Depository Libraries.
D. How Should I Handle CBI Information That I Want To Submit To The
Agency?
Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit in response to this
document as CBI by marking any part or all of that information as CBI.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2. In addition to one complete
version of the comments that include any information claimed as CBI, a
copy of the comments that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record. Information not marked confidential will be included
in the public version of the official record by EPA without prior
notice. If you have any questions about CBI or the procedures for
claiming CBI, consult the technical person identified in ``FOR FURTHER
INFORMATION CONTACT''at the beginning of this preamble.
II. What is the Purpose of Today's Action?
In today's action, EPA is issuing a final TSCA section 8(a)
``Preliminary Assessment Information Reporting'' (PAIR) rule for 19 of
23 nonylphenol ethoxylates recommended for testing in the 39th TSCA ITC
Report to the EPA Administrator (62 FR 8578, February 25, 1997) (FRL-
5580-9). Specifically at the request of the ITC in a letter to EPA
dated September 15, 1997, EPA is not issuing a final TSCA section 8(d)
``Unpublished Health and Safety Data'' reporting rule at this time for
the 23 nonylphenol ethoxylates recommended for testing in the 39th ITC
Report so as to give the ITC an opportunity to implement the voluntary
information submission policy that was proposed in the ITC's 40th
Report (62 FR 30580, June 4, 1997) (FRL-5718-3). Also in today's
action, EPA is removing the ``stay'' (61 FR 65186, December 11, 1996)
(FRL-5577-6) that was issued for the TSCA section 8(a) and TSCA section
8(d) rules (61 FR 55871, October 29, 1996) (FRL-5397-9) promulgated by
the Agency for the 18 nonylphenol ethoxylates recommended for testing
in
[[Page 1550]]
the ITC's 38th Report (61 FR 39832, July 30, 1996) (FRL-5379-2).
Further, EPA is revoking those TSCA section 8(a) and TSCA section 8(d)
rules issued on October 29, 1996.
III. What is the Basis for Today's Action?
On May 31, 1996, EPA received the 38th Report of the TSCA Section
4 ITC. In the 38th Report, the ITC recommended 18 nonylphenol
ethoxylates for testing under section 4 of TSCA (61 FR 39832, July 30,
1996). In response to the ITC's 38th Report, EPA promulgated final TSCA
section 8(a) ``Preliminary Assessment Information Reporting'' (PAIR)
and TSCA section 8(d) ``Unpublished Health and Safety Data'' reporting
rules (61 FR 55871, October 29, 1996) (FRL-5397-9) for the 18
nonylphenol ethoxylates listed in the ITC's 38th Report.
Shortly after the effective date for these TSCA rules, EPA became
aware of the fact that the ITC's use of some alternate CAS numbers and
several unclear chemical names in the 38th Report had resulted in
confusion among U.S. producers, importers, and processors about the
exact identities of the chemical substances for which TSCA section 8(a)
and 8(d) reporting was being required. In order to eliminate further
confusion within the regulated community about the actual identities of
the subject chemicals, EPA formally ``stayed'' the TSCA section 8(a)
and 8(d) rules for the 18 nonylphenol ethoxylates recommended in the
ITC's 38th Report. EPA issued this stay on December 11, 1996 (61 FR
65186) and also requested the ITC to clarify the identities of the
nonylphenol ethoxylates recommended in its 38th Report.
In an attempt to eliminate the ambiguities resulting from the ITC's
use of alternate CAS numbers and unclear chemical names for the 18
nonylphenol ethoxylates recommended in its 38th Report, the ITC, in its
39th Report to the EPA Administrator, recommended for testing a revised
list comprised of 23 nonylphenol ethoxylates (62 FR 8578, February 25,
1997). According to the 39th Report, the ITC had re-examined its use of
alternate CAS numbers for several of the 18 nonylphenol ethoxylates
recommended in the 38th Report and determined that 5 of those CAS
numbers were not associated with any of the 18 chemical substances.
For the 23 nonylphenol ethoxylates recommended in the 39th Report,
the ITC provided where possible more accurate CAS numbers and more up-
to-date chemical names (using 9th Collective Index chemical
nomenclature where possible). In a letter addressed to the EPA
Administrator dated September 15, 1997, the ITC formally requested that
EPA:
1. Revoke the TSCA section 8(a) PAIR and TSCA section 8(d) rules
issued by EPA on October 29, 1996 (61 FR 55871) for the 18 nonylphenol
ethoxylates that were recommended in the ITC's 38th Report and
``stayed'' by EPA on December 11, 1996 (61 FR 65186).
2. Issue a final TSCA section 8(a) PAIR rule for the 19 nonylphenol
ethoxylates with CAS numbers of the 23 total nonylphenol ethoxylates
recommended in the ITC's 39th Report.
3. Not issue a TSCA section 8(d) rule for the 23 recommended
nonylphenol ethoxylates in order to allow the ITC the opportunity to
implement its voluntary information submission policy proposed in the
ITC's 40th Report (62 FR 30580, June 4, 1997).
EPA reserves the right to issue a TSCA section 8(d) rule for some
or all of these 23 nonylphenol ethoxylates if:
1. EPA believes that such a rulemaking is necessary to gather data
to determine if testing is needed for, or otherwise support the
assessment of, the subject chemical(s); or
2. The ITC notifies EPA in writing that the ITC did not receive
adequate information via its voluntary information submission activity.
(The ITC's voluntary submission policy can be found on the ITC's
Internet Homepage under Voluntary Information Submission Innovative
Online Network or ``VISION'' (http://www.epa.gov/opptintr/itc/vision).
Hard copies of the ITC's voluntary information submission policy are
available from the TSCA Environmental Assistance Division at the
address listed under ``FOR FURTHER INFORMATION CONTACT.'')
IV. What is the Preliminary Assessment Information Reporting (PAIR)
Rule?
EPA promulgated the PAIR rule in 40 CFR part 712 under section 8(a)
of TSCA (15 U.S.C. 2607(a)). This model section 8(a) rule establishes
standard reporting requirements for 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
Preliminary Assessment Information Manufacturer's Report (EPA Form No.
7710-35). EPA uses this model section 8(a) rule to quickly gather
current information on chemicals.
This model rule provides for the automatic addition of ITC Priority
Testing List chemicals. Whenever EPA announces the receipt of an ITC
report, EPA may, at the same time and without providing notice and
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 February 10, 2000.
V. Chemicals To Be Deleted
The following 18 nonylphenol ethoxylates that were recommended in
the ITC's 38th Report are being deleted as a result of today's
revocation of the TSCA section 8(a) PAIR and TSCA section 8(d) rules
that were issued by EPA on October 29, 1996 (61 FR 55871) and stayed by
the Agency on December 11, 1996 (61 FR 65186).
------------------------------------------------------------------------
Chemical Name CAS Number
------------------------------------------------------------------------
Nonylphenol ethoxylates
alpha-(p-Nonylphenol)-omega- NA
hydroxypoly(oxyethylene).
Decaethylene glycol, isononylphenyl ether. 65455-72-3
Ethanol, 2-[2-(p-nonylphenoxy)ethoxy]-.... 20427-84-3
Ethanol, 2-[2-[2-[2-(p- 7311-27-5
nonylphenoxy)ethoxy]ethoxy]ethoxy]-.
Nonoxynol-2............................... NA
Nonoxynol-3............................... NA
Nonoxynol-7............................... NA
Nonylphenol hepta(oxyethylene)ethanol..... 27177-05-5
Nonylphenol octa(oxyethylene)ethanol...... 26571-11-9
Nonylphenol polyethylene glycol ether..... 9016-45-9, 20636-48-0, 26027-
38-3, 26064-02-8, 27177-01-
1, 37205-87-1, 127087-87-0
[[Page 1551]]
Nonylphenol polyethylene glycol ether..... 27177-08-8
Nonylphenolnona(oxyethylene) ethanol...... 27986-36-3
Nonylphenoxy ethanol...................... 27176-93-8
Nonylphenoxydiglycol...................... 68412-54-4
Nonylphenoxypolyoxyethanol................ 152143-22-1, 26027-38-3
p-Nonylphenol polyethylene glycol ether... 27986-36-3, 37205-87-1,
98113-10-1
Poly(oxy-1,2-ethanediyl), alpha- 37205-87-1
(isononylphenyl)-omega-hydroxy-.
Poly(oxy-1,2-ethanediyl), alpha-(2- 51938-25-1
nonylphenyl)-omega-hydroxy-.
------------------------------------------------------------------------
VI. Chemicals To Be Added
In its 39th Report to EPA, the ITC recommended a group of 23
nonylphenol ethoxylates. These chemicals can be automatically added to
the PAIR and TSCA section 8(d) Health and Safety Data Reporting rules
unless requested otherwise by the ITC to implement its voluntary
information submission policy. In a letter dated September 15, 1997,
the ITC requested that a TSCA section 8(d) Health and Safety Data
Reporting rule not be promulgated for these 23 nonylphenol ethoxylates.
Therefore, these substances will not be added to Sec. 716.120.
The regulatory text (Sec. 712.30(e)) of this document lists the 19
nonylphenol ethoxylates that are being added to the PAIR rule as a
result of today's action. The other 4 nonylphenol ethoxylates
recommended in the ITC's 39th report are not being added to the PAIR
rule because they are not associated with unique CAS numbers.
VII. Reporting Requirements
A. Who Must Report Under this PAIR Rule?
All persons who manufactured (defined by statute to include import)
the 19 nonylphenol ethoxylates identified in the regulatory text
(Sec. 712.30(e)) of this rule during their latest complete corporate
fiscal year must submit a Preliminary Assessment Information
Manufacturer's Report (EPA Form No. 7710-35) for each site at which
they manufactured or imported a named substance. A separate form must
be completed for each substance and submitted to the Agency as
specified in 40 CFR 712.28 no later than April 10, 2000. Persons who
have previously and voluntarily submitted a Manufacturer's Report to
the ITC or EPA may be able to submit a copy of the original Report to
EPA or to notify EPA by letter of their desire to have this voluntary
submission accepted in lieu of a current data submission. See
Sec. 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 form are
available from the TSCA Environmental Assistance Division at the
address listed under ``FOR FURTHER INFORMATION CONTACT.'' Copies of the
PAIR form are also available electronically from the Chemical Testing
and Information Gathering Home Page on the Internet at http://
www.epa.gov/opptintr/chemtest/.
B. Removal of Chemical Substances from the PAIR Rule
Any person who believes that section 8(a) reporting required by
this rule is not warranted, should promptly submit to EPA on or before
January 25, 2000, detailed reasons for that belief. EPA, in its
discretion, may remove the substance from this rule (40 CFR 712.30(c)).
When withdrawing a chemical from the rule, EPA will publish a rule
amendment in the Federal Register.
VIII. Public Record
The following documents constitute the public record for this rule
(docket control number OPPTS-82050). All of these documents are
available to the public in the TSCA Nonconfidential Information Center
(NCIC), from noon to 4 p.m., Monday through Friday, excluding legal
holidays. The TSCA NCIC is located at EPA Headquarters, Rm. NE-B607,
401 M St., SW., Washington, DC.
1. This final rule.
2. The Economic Analysis for this rule, December 15, 1999.
3. The 39th Report of the ITC, (62 FR 8578, February 25, 1997).
4. The 38th Report of the ITC, (61 FR 39832, July 30, 1996).
5. Stay of the TSCA section 8(a) and 8(d) rules issued in response
to the 38th Report of the ITC, (61 FR 65186).
6. Letter from the ITC to EPA, September 15, 1997.
IX. 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 to comment because the Agency believes that
providing notice and an opportunity to comment is unnecessary. This
final rule makes modifications needed to clarify the identities of
certain chemicals subject to the TSCA section 8(a) PAIR regulations and
removes certain chemicals from the TSCA section 8(d) regulations. EPA
therefore finds that there is ``good cause'' under section 553(b)(3)(B)
of the Administrative Procedure Act (APA) (5 U.S.C. 553 (b)(3)(B)) to
make these amendments without prior notice and comment.
X. Economic Analysis [SNIP]