Source: https://www.federalregister.gov/documents/2001/09/06/01-22379/toxic-substances-control-act-certain-chemicals-and-microorganisms-premanufacture-notices-high
Timestamp: 2018-04-20 03:23:16
Document Index: 256777454

Matched Legal Cases: ['art 720', 'art 725', 'art 721', 'art 725', 'art 725', '§\u2009725', 'art 725', 'art 725', 'art 725']

Federal Register :: 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
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
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.
46630-46633 (4 pages)
OPPTS-59378
FRL-6795-1
B. What Action is the Agency Taking in Regard to TSCA Section 5, and Which Notices are Affected by this Action?
C. Are Only TSCA Section 5 Notices Affected?
D. Which Notices Will Not Be Affected?
E. If I Am the Submitter of an Affected PMN, MCAN, SNUN, or Exemption Application, What Do I Need to Do?
F. What Happens If I Submit a TSCA Section 5 Notice During this 15-Day Period?
G. What Effect Will this Action Have on Submissions to the Agency Under the HPV Challenge Program?
H. Was this Action Submitted to Congress and the Comptroller General?
https://www.federalregister.gov/d/01-22379 https://www.federalregister.gov/d/01-22379
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.
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.
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:Start Printed Page 46631
Chemical manufacturers or importers 325, 32411 Anyone who plans 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 document may also apply to you if you are a sponsor of a HPV chemical under the Agency's voluntary HPV Challenge Program.
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.
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 (§§ 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.
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 Start Printed Page 46632November 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.
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.
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.
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.
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.
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/​Start Printed Page 46633chemrtk) 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.
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).
[FR Doc. 01-22379 Filed 9-5-01; 8:45 am]