[Federal Register Volume 66, Number 173 (Thursday, September 6, 2001)]
[Notices]
[Pages 46630-46633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22379]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-59378; FRL-6795-1]


Toxic Substances Control Act; Certain Chemicals and 
Microorganisms; Premanufacture Notices; High Production Volume 
Challenge Program; Delay in Processing Due to Move of Offices; 
Extension of Review Periods

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA's Office of Pollution Prevention and Toxics (OPPT) is 
expected to move a number of its offices on November 1, 2001, from the 
current location at 401 M St., SW., to 1200 Pennsylvania Ave., NW., in 
Washington, DC. The move is expected to cause limited delay in OPPT's 
processing of certain documents submitted for review, including notices 
submitted under section 5 of the Toxic Substances Control Act (TSCA). 
EPA is requesting submitters' cooperation in handling this temporary 
interruption in operations. Other units within OPPT will also be moving 
at various times before or after this date. This notice discusses how 
OPPT's move will affect the processing of different types of TSCA 
section 5 notices, as well as certain documents submitted under the 
High Production Volume (HPV) Challenge Program. These documents fall 
into several categories as described below in the notice.

DATES: The anticipated move date is November 1-2, 2001, as of today's 
Federal Register notice, and should this date change, EPA will publish 
another Federal Register notice. For information on other relevant 
dates, see Unit II.B. of SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: For general information contact: 
Barbara Cunningham, Director, Office of Program Management and 
Evaluation, Office of Pollution Prevention and Toxics (7401), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (202) 554-1404; e-mail address: 
[email protected].
    For technical information contact: For the New Chemicals Program: 
Flora Chow, Chief, New Chemicals Notice Management Branch, Chemical 
Control Division (7405), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 
260-3725, facsimile: (202) 260-0118.
    For the HPV Challenge Program: Barbara Leczynski, Chief Existing 
Chemicals Branch, Chemical Control Division (7405), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (202) 260-3945, facsimile: (202) 260-1096.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Document Apply to Me?

    You may be affected by this document if you are, or may in the 
future be, a manufacturer or importer of a chemical substance that 
requires submission of a Premanufacture Notice (PMN), a manufacturer or 
importer of a microorganism that requires submission of a Microbial 
Commercial Activity Notice (MCAN), or the manufacturer, importer or 
processor of a chemical substance for a significant new use that 
requires a Significant New Use Notice (SNUN), under section 5 of TSCA 
(15 U.S.C. 2604), or an exemption from these requirements. Particularly 
affected are submitters of such notices with review periods scheduled 
to expire between October 25, 2001, and November 15, 2001, and persons 
wishing to submit new notices between October 25, 2001, and November 8, 
2001.
    Potentially affected entities may include, but are not limited to 
the following:

[[Page 46631]]



------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS Codes         Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Chemical manufacturers or         325, 32411          Anyone who plans
 importers                                             to manufacture or
                                                       import a new
                                                       chemical
                                                       substance
                                                       (including
                                                       microorganisms),
                                                       or who intends to
                                                       manufacture,
                                                       import or process
                                                       a chemical
                                                       substance for a
                                                       significant new
                                                       use, for a non-
                                                       exempt commercial
                                                       purpose is
                                                       required to
                                                       provide the EPA
                                                       with a PMN or
                                                       MCAN or SNUN at
                                                       least 90 days
                                                       prior to the
                                                       activity. Any
                                                       TSCA chemical
                                                       substance that is
                                                       not on the TSCA
                                                       Inventory is
                                                       classified as a
                                                       new chemical.
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. 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 
questions regarding the applicability of this action to a particular 
entity, consult the technical person listed under FOR FURTHER 
INFORMATION CONTACT.
    This document may also apply to you if you are a sponsor of a HPV 
chemical under the Agency's voluntary HPV Challenge Program.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/. To 
access information about EPA's New Chemicals Program, go directly to 
the Home Page at http://www.epa.gov/oppt/newchems/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPPTS-59378. The official 
record consists of the documents specifically referenced in this 
action, any public comments received, and other information related to 
this action, including any information claimed as CBI. This official 
record includes the documents that are physically located in the 
docket, as well as the 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 submitted, is available for inspection in the TSCA 
Nonconfidential Information Center, North East Mall Rm. B-607, 
Waterside Mall, 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 for the Center is (202) 260-7099.

II. Background

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

    Section 5 of TSCA and 40 CFR part 720 require any person who 
intends to manufacture (defined by statute to include import) a new 
chemical substance (i.e., a chemical not on the TSCA section 8(b) 
Inventory) to notify EPA at least 90 days before commencing non-exempt 
commercial manufacture in the form of a Premanufacture Notice (PMN). At 
least 90 days advance notice for manufacture of new microorganisms is 
required under 40 CFR part 725 in the form of a Microbial Commercial 
Activity Notice (MCAN). Under section 5 of TSCA and 40 CFR part 721, 
any person intending to manufacture or process a chemical substance for 
a significant new use, as designated by EPA in a Significant New Use 
Rule (SNUR), must also give EPA at least 90 days advance notice in the 
form of a SNUN. SNURs for microorganisms appear at 40 CFR part 725, 
subpart M.
    There are a number of exemptions from the above-described 90-day 
PMN, MCAN and SNUN notice requirements. Several of these exemptions 
require submitting to EPA a written notice or application, which is 
subject to a review period shorter than 90 days. For example, pursuant 
to TSCA section 5(h)(1), EPA has promulgated a Test Market Exemption 
(TME) from all three of the 90-day notice requirements. The TME from 
the PMN requirement appears at 40 CFR 720.38; the TME from the MCAN 
requirement is codified in 40 CFR part 725, subpart F (Secs. 725.300-
725.370); and the TME from the SNUN requirement appears at 40 CFR 
721.45(a). Under TSCA section 5(h)(4), EPA promulgated at 40 CFR 721.50 
a Low Volume Exemption (LVE) and a Low Release/Low Exposure (LOREX) 
Exemption from the PMN requirement. The rule in 40 CFR part 725 
pertaining to genetically engineered microorganisms provides several 
exemptions from the 90-day MCAN requirement, including the TSCA 
Experimental Release Application (TERA) in 40 CFR part 725, subpart E, 
and the Tier I and Tier II Exemptions in 40 CFR part 725, subpart G.
    A submitter may, with EPA's agreement, voluntarily suspend the 
review period for all these types of notices. Suspensions longer than 
15 days must be documented in writing. Suspensions for PMNs, SNUNs, and 
exemptions therefrom are authorized at 40 CFR 720.75(b). Suspensions 
for MCANs and exemptions therefrom are authorized at 40 CFR 725.54.
    TSCA section 26(c) authorizes EPA to take action with respect to a 
category of chemical substances. Under TSCA section 5(c), EPA has 
authority to unilaterally extend the notice review period for PMNs, 
MCANs and SNUNs. (See also 40 CFR 720.75(c) for PMNs and SNUNs, and 40 
CFR 725.56 for MCANs.) However, extensions of the review period for an 
individual TSCA section 5 notice shall not total more than 90 days. 
Because the extension described in this Federal Register notice is for 
less than 90 days, EPA reserves the right under TSCA section 5(c) to 
issue, for good cause, future additional extensions for individual 
cases up to a total of 90 days.

B. What Action is the Agency Taking in Regard to TSCA Section 5, and 
Which Notices are Affected by this Action?

    EPA's Office of Pollution Prevention and Toxics is moving its 
offices from the current location at 401 M St., SW., to 1200 
Pennsylvania Ave., NW., in Washington, DC. Prior to a move scheduled to 
occur on November 1, 2001, EPA will conduct an inventory of documents 
containing CBI in the current location. After relocation, the holdings 
will be re-inventoried to verify the complete transfer to the new 
offices. Because of these activities, EPA is taking the following 
actions and is requesting the assistance of notifiers as described in 
this unit:
    Category 1--TSCA section 5 notices and exemptions submitted to EPA 
between October 25, 2001, and

[[Page 46632]]

November 8, 2001. OPPT will not process any new documents during the 
15-day period centered around the November 1, 2001, move date, that is 
from October 25, 2001, to November 8, 2001. Therefore, the review 
period for any TSCA section 5 notice submitted between October 25, 
2001, and November 8, 2001, will not begin until OPPT resumes normal 
operations and the TSCA Document Control Office (DCO) receives the 
document on November 9, 2001, or as soon thereafter as practicable. EPA 
strongly discourages companies from submitting new notices or exemption 
applications to OPPT during this time. Also during this period, 
companies should refrain from submitting any related documents, such as 
notice of commencement (NOC), prenotice correspondence, consolidation 
requests, notice of bona fide intent to manufacture, amendments to 
notices, etc.
    Category 2--TSCA section 5 exemptions scheduled to expire between 
October 25, 2001, and November 15, 2001. For any exemption applications 
for which the review period is scheduled to expire between October 25, 
2001, and November 15, 2001, and which have not been granted by EPA, 
EPA is requesting submitters to voluntarily suspend the review period 
until after November 15, 2001. EPA needs to receive these suspensions 
before October 25, 2001. An additional week is required for these 
ememptions in Category 2 to ensure there is suffiecient time to 
dertimine that the exemptions will not present unreasonalbe risk.
    Category 3--TSCA section 5 PMNs, MCANs, and SNUNs scheduled to 
expire between October 25, 2001, and November 8, 2001. Under the 
authority of TSCA sections 5(c) and 26(c), EPA is hereby extending the 
notice review period an additional 15 days for any PMN, MCAN or SNUN 
for which the review period is scheduled to expire between October 25, 
2001, and November 8, 2001, and which are not voluntarily suspended 
beyond November 8, 2001, except those notices that will not be 
regulated by EPA, as described in Unit II.D. However, EPA encourages 
submitters of any notices due to expire between October 25, 2001, and 
November 8, 2001, to provide voluntary suspensions of the review period 
beyond November 8, 2001, so that the 15-day unilateral extension under 
TSCA section 5(c) will not apply to those notices.

C. Are Only TSCA Section 5 Notices Affected?

    No, there is another category of documents that will be affected by 
OPPT's move:
    Category 4--Chemical Right-to-Know documents. It is also expected 
that the move may affect the initial completeness review and posting on 
the Chemical Right-to-Know (ChemRTK) website (www.epa.gov/chemrtk) of 
test plans and robust summaries submitted to the Agency under the HPV 
Challenge Program, as well as the review of submissions for which the 
120-day public review period has already begun. Additional information 
on this program and any delays that may occur can be found at the above 
ChemRTK website and in Unit II.G. below.

D. Which Notices Will Not Be Affected?

    The review period will not be affected for the following notices 
and exemption applications:
    1. PMNs, MCANs, SNUNs, and Low Volume Exemptions for which ``Drop'' 
or ``Grant'' decisions have been posted on the New Chemicals Program 
``Current Status of PMNs'' webpage (http://www.epa.gov/oppt/newchems/dropstat.htm) before October 25, 2001.
    2. Low Release and Exposure (LOREX) Exemptions and TMEs for which 
an EPA representative has orally informed the submitter that EPA has 
made a ``Grant'' decision for the case.
    For these TSCA section 5 notices and exemption applications, 
because no further review or regulatory action is anticipated, EPA 
expects to allow the review period to expire without further suspension 
or extension.

E. If I Am the Submitter of an Affected PMN, MCAN, SNUN, or Exemption 
Application, What Do I Need to Do?

    If you have submitted a notice or notices that fall into any of the 
categories for which EPA is requesting a voluntary suspension, and you 
wish to submit such a suspension, you should send a written suspension 
to the TSCA DCO in accordance with 40 CFR 720.75(b) or 40 CFR 725.54 
for microorganisms. You should also contact the OPPT Program Manager 
assigned to your notice or exemption. If you do not know how to contact 
the Program Manager, you should contact Flora Chow, Chief, New 
Chemicals Notice Management Branch, at (202) 260-3725.
    There is a possibility that the chemical substances submitted for 
review in the TSCA section 5 notices in Category 3 (i.e., PMNs, MCANs 
or SNUNs for which the review period is scheduled to expire between 
October 25, 2001, and November 8, 2001, and which are not dropped or 
voluntarily suspended beyond November 8, 2001) may be regulated by EPA 
under TSCA. EPA requires an extension of the review periods to complete 
its risk assessment, to examine its regulatory options, and to prepare 
the necessary documents, should regulatory action be required. 
Therefore, EPA has determined that good cause exists to extend, under 
TSCA section 5(c) and 40 CFR 720.75(c), the review period for each such 
TSCA section 5 notice. Pursuant to 40 CFR 720.75(c)(2)(i), EPA will 
notify each submitter of such notices that the notice review period 
will be extended for the reasons set forth in this notice.

F. What Happens If I Submit a TSCA Section 5 Notice During this 15-Day 
Period?

    Any notices submitted to the TSCA DCO between October 25 and 
November 8 will not be ``received'' by the Agency and the 90-day review 
period will not commence until the document is processed by the TSCA 
DCO. (See e.g., 40 CFR 720.75(a) and 40 CFR 725.50.) Because no 
document processing activities will occur during this 15-day period, 
all companies are encouraged to refrain from submitting any TSCA 
section 5 notices or exemption applications, or related actions, such 
as notice of commencement (NOC), prenotice correspondence, 
consolidation requests, notice of bona fide intent to manufacture, 
amendments to notices, etc., to the Agency. The Agency intends to 
expeditiously process documents after the 15th day, when normal 
operations resume. However, depending on the number of documents 
pending on November 9, 2001, it may take several days before all these 
documents are officially ``received'' and the review period commenced.

G. What Effect Will this Action Have on Submissions to the Agency Under 
the HPV Challenge Program?

    OPPT's move, which will be phased over several months, may affect 
the review of submissions under the HPV Challenge Program. Sponsors of 
chemicals in the voluntary HPV Challenge Program submit test plans and 
robust summaries of existing data to the Agency for a 120-day review. 
EPA conducts an initial review of such submissions to determine whether 
all materials needed for the technical review are included. All 
submissions under the HPV Challenge Program are then made publicly 
available on the EPA Chemical Right-to-Know (ChemRTK) website 
(www.epa.gov/

[[Page 46633]]

chemrtk) for a 120-day review period prior to the start of any new 
testing. The Agency completes its technical evaluation of the complete 
submission during the 120-day period, and forwards its comments to the 
sponsor and posts them on the website. However, the initial 
completeness review and posting on the ChemRTK website of newly 
submitted test plans and robust summaries may be delayed as a result of 
the move. Submissions for which the 120-day review period has already 
started may also be affected. Additional information on this program 
and any delays that may occur can be found at the ChemRTK website.

H. Was this Action Submitted to Congress and the Comptroller General?

    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 the Agency can impose binding requirements like 
those contained in a rule, the Agency must submit a report, which 
includes a copy of the document, to each House of the Congress and to 
the Comptroller General of the United States. Although this document is 
not a rule, it is binding in the sense that the suspensions announced 
in here are binding. EPA will submit a report to the U.S. Senate, the 
U.S. House of Representatives, and the Comptroller General of the 
United States prior to its publication in the Federal Register. This 
action is not ``major'' as defined by 5 U.S.C. 804(2).

List of Subjects

    Environmental protection, Chemicals, Chemical right-to-know, High 
Production Volume, Microorganisms, Premanufacture notices, Test 
marketing exemptions.

    Dated: August 17, 2001.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.
[FR Doc. 01-22379 Filed 9-5-01; 8:45 am]
BILLING CODE 6560-50-S