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ntai Protection
Office of Toxic Substances
Washington. DC 20460
EPA-560 3-36-002
March 1986
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»EPA New Chemical Review
Process Manual
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EPA-560/3-86-002
March 1986
Office of Toxic Substances
U.S. Environmental Protection Agency
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AWBERC LIBRARY
U.S. EPA
26 W. MARTIN LUFHER KING Off, r«nt««t«
C1AICJNNAIJ, OHIO 45268. Contents
Page
Introduction [[[ 1
I. Pre-Notice [[[ 1-1
A. Pre-Notice Searches of the Inventory ................................................. 1-1
B. Pre-Notice Communications [[[ 1-1
C. Receipt [[[ I-2
II. Pre-IMotice/Receipt to Focus Meeting [[[ 11-1
A. Inventory Procedures [[[ 11-1
B. Chemistry Review and Search Strategy (CRSS) Meeting ............................. 11-1
C. Structure Activity Team (SAT) Meeting ............................................. II-2
D. Exposure Assessment Meeting (EXAM) .............................................. II-2
E. Focus Meeting [[[ II-3
III. Focus to Division Directors' Meeting [[[ Ill- 1
A. Workplan Meeting [[[ 111-1
B. Mid-course Meeting [[[ 111-1
C. CCD Disposition Meeting [[[ III-2
D. ETD Disposition Meeting ........... ................................................. III-2
E. HERD Disposition Meeting [[[ III-2
F. PNMB Options Meeting [[[ III-2
G. Division Directors' Briefing [[[ III-3
IV. Actions . . ; ............. [[[ IV- 1
A . 5(c) Extension Notice [[[ IV- 1
B. 5(e) Order .................... . [[[ IV- 1
C . 5{f ) Action [[[ IV- 1
D. Litigation [[[ ; .......... IV-2
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&EPA
Introduction
The purpose of this manual is to provide an introduction to the new chemical review process as
it takes place in the Office of Toxic Substances (OTS). Organized chronologically, the manual
presents the process in terms of component procedures and meetings. The description of each
meeting includes a discussion of objectives, participants, preparation, and accomplishments (deci-
sions and written output). Divisions and branches that participate in the process are described in
Appendix A, Functions of Divisions and Branches in the New Chemical Review Process. A flow
diagram of the new chemical review process may aid understanding of the text; the New Chemical
Review Process Diagram can be found in Appendix C. Reports are discussed in the context of
preparation for a meeting or as written output resulting from a meeting. The manual also presents
EPA's statutory authority and options for action under §5 of the Toxic Substances Control Act
(TSCA).
New chemical review is mandated by TSCA. Any person who intends to manufacture or import a
new chemical substance is required to provide to EPA available data on the chemical structure, pro-
duction, use, release, exposure, and health and environmental effects. The submitter of new
chemical information may claim that any part of the data supplied to EPA is entitled to confidential
treatment. Confidentiality procedures have been developed to protect such information (see Appen-
dix E). In reviewing and regulating new chemicals, EPA utilizes an integrated approach that draws
on knowledge and experience across disciplinary and organizational lines to identify and evaluate
concerns regarding health and environmental effects, exposure and release, and economic impacts.
Submissions that activate new chemical review may be either a Premanufacture Notice (PMN), a
polymer or low volume exemption notice, or test marketing exemption application. Exemption ap-
plications and notices take certain production or chemical parameters into account that, if verified
to meet requirements, exempt the manufacturer of the substance from being subject to an entire
PMN review process.
The manual contains seven chapters as follows:
Chapter I, "Pre-Notice," describes procedures that take place up to the time that the submission
is received by EPA;
Chapter II, "Pre-Notice/Receipt to Focus Meeting," describes procedures and meetings that take
place up through the Focus Meeting, which is the first point in the process at which a regulatory
decision is made;
Chapter III, "Focus to Division Directors' Meeting," describes the process that guides develop-
ment of cases that remain in review after Focus;
Chapter IV, "Action," describes EPA's options for actions under §5 of TSCA and circumstances
under which EPA will litigate to regulate under §5;
Chapter V, "Exemptions," describes submitter requirements and EPA procedures regarding ex-
emption applications and notices;
Chapter VI, "Follow-Up Review," describes activities to evaluate possible new uses of
chemicals referred by new chemical review and to assess the hazard potential of such chemicals
under changed conditions;
Chapter VII, "Post-Review," describes procedures for Notice of Commencement, substantiation
of confidentiality claims, and generic name development.
Appendices A through G, the Glossary of terms and abbreviations used in the manual, and the
Bibliography, provide additional information pertaining to new chemical review in OTS. Appendix A
is a table, "Functions of Divisions and Branches in the New Chemical Review Process." Appendix
B is an OTS organizational chart, Appendix C is a flow diagram of the new chemical review pro-
cess, and Appendix D is a meeting schedule. Appendix E discusses confidential business informa-
tion, Appendix F provides a list of major databases searched, and Appendix G is the form that sub-
mitters complete for new chemical review. The Bibliography provides citations for background
materials regarding legal authority and regulatory development of new chemical review.
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New Chemical Review Process Manual
I. Pre-IMotice
A. Pre-Notice Searches of the Inventory
Prior to the manufacture or import of a new chemical substance, a person may wish to ascertain
if the substance is already on the unpublished, non-confidential, or confidential sections of the Tox-
ic Substances Control Act Chemical Substance Inventory (TSCA Inventory). Non-confidential
search requests for adequately defined chemical substances may be submitted to the Inventory In-
quiry Service at Chemical Abstracts Service. Non-confidential search requests of a more complex
nature (e.g., tradename products) may be sent to the Chemical Inventory Section (CIS) of the Con-
fidential Data Branch/Information Management Division (CDB/IMD) at EPA.
A manufacturer may also request a search of the confidential section of the TSCA Inventory by
submitting a statement of bona fide intent to manufacture a substance (a bona fide) to EPA (see
40 CFR 710.7 (g) and 720.25).. The bona fide is received by the Confidential Document and
Systems Control Section (CDSCS) of the Confidential Data Branch (CDB/IMD), which logs and
tracks the submission into the Document and Personnel Security System (DAPSS) before routing it
to CIS for processing. See Receipt Section for a description of DAPSS. The general information
contained in the bona fide is reviewed by a CIS staff member to render a judgment of complete or
incomplete according to prescribed requirements. Substance identity information is evaluated by a
chemist in CIS to determine if the chemical name and structure provided by the submitter are ade-
quate to perform an accurate search of the TSCA Inventory. The following information must be
contained in a bona fide:
1 ) Specific chemical identity of the substance,
2) A signed statement of intent,
3) An elemental analysis,
4) Intended use,
5) Analytical data (i.e., infrared spectral analysis), and
6) A description of research and development activities conducted to date on the substance.
CIS coordinates the search of the TSCA Inventory for the substance with the Inventory contrac-
tor, Chemical Abstracts Service (CAS). A CIS chemist assures that the CAS search results are ac-
curate and in keeping with Agency policy concerning Inventory listings. The CIS chemist also con-
tacts submitters of bona fide notices as necessary to resolve problems of chemical nomenclature
and chemical structure. Following this search, CIS prepares a response to the submitter including
the CAS-preferred name and CAS Registry Number or TSCA Inventory accession number. The sub-
mitter is thus given the correct name for use in a future PMN or in future reports to EPA for on-ln-
ventory chemicals. The response letter is returned along with the bona fide submission to CDSCS,
which logs results of the search into DAPSS.
The time required to process a complete bona fide is normally 30 days; however, review time
can be extremely variable for bona fides determined to be incomplete. If the bona fide substance is
on the TSCA Inventory, a PMN or exemption application or notice is not required. If the substance
is not on the TSCA Inventory, manufacturers and importers may consider submitting a PMN,
polymer or low volume exemption notice, or application for a test market exemption if appropriate.
Otherwise, the manufacturer or importer must complete the PMN form for any intended uses of the
chemical subject to new chemical review under §5 of TSCA. See Receipt section for a description
of the information content and processing of the PMN form.
B. Pre-Notice Communications
The Pre-Notice Communications Coordinator in the Premanufacture Notice Management Branch
of the Chemical Control Division (PNMB/CCD) assists persons preparing a notice or considering the
submission of a notice. Pre-Notice inquiries may pertain to the scope of TSCA and Premanufacture
Notification requirements. Questions on subjects such as information requirements for a submis-
sion, §5 exemptions, premanufacture testing, confidentiality, bona fides, generic name development,
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consolidated notices, joint submissions, and notice review procedures are asked of the Pre-
Notice Communications Coordinator. The Pre-Notice Communications Coordinator:
1) Responds to telephone inquiries and letters providing guidance on technical, regulatory, and
procedural issues,
2) Coordinates conferences at the request of industry persons prior to submissions,
3) Serves as an interface between the Agency and persons seeking approval for consolidated
PMN submissions and generic chemical names, and
4) Interacts with other OTS offices (including the Industrial Chemistry Branch of the
Economics and Technology Division (ICB/ETD), Chemical Engineering Branch of the
Economics and Technology Division (CEB/ETD), Confidential Data Branch of
the Information Management Division (CDB/IMD), and Regulatory Program Development
Branch of the Chemical Control Division (RPDB/CCD)) to ensure consistency of technical
and regulatory response.
ICB/ETD and CDB/IMD interact with the Pre-Notice Communications Coordinator in responding to
inquiries regarding technical aspects of reporting requirements, when appropriate.
C. Receipt
On the day of receipt, the PMN or exemption application or notice is reviewed by the Confidential
Document and Systems Control Section of CDB/IMD for completeness. In cases where the submission
is incomplete, the submitter is notified by telephone followed by a formal notice by registered mail.
Day 1 of the review period is then delayed pending submitter response. CDSCS/IMD also
acknowledges receipt of completed submissions through formal letters. A completed PMN form in-
cludes the following information on the new chemical substance:
1) Submitter identity and plant site information,
2) Chemical identity,
3) Production, import, and use data,
4) Human exposure and environmental release data,
5) Test data, e.g., fate, mammalian toxicity, aquatic toxicity, and
6) Sanitized version if any information is claimed confidential.
Following the review for completeness, CDSCS/IMD then reviews the submission for confidentiality
claims. If the submission is judged to be complete, the notice period begins. An ICB/ETD chemist
then reviews the chemical identity and other technical information in PMN submissions and exemp-
tion applications and notices for conformance with §5 rules and policies, generic name develop-
ment, and clarification of proposed uses. PMNs must be reviewed within 90 days of receipt, unless
the Agency, for good cause, extends the review period for up to an additional 90 days. Polymer
exemption notices and low volume exemption applications must be reviewed within 21 days of
receipt, unless EPA extends the review period. The Agency can at any time grant a suspension of
the review period upon request by a submitter, for example, to develop additional data or review
options. Test market exemption applications must be reviewed within 45 days.
On the day that a completed PMN or exemption application or notice is received, tracking pro-
cedures are initiated by the Confidential Document.and Systems Control Section of CDB/IMD.
CDB/IMD attaches a green cover to the CBI submission, assigns a document control number (ap-
propriate to the type of submission) and a case number, and logs the document into several infor-
mation systems. DAPSS, the Document and Personnel Security System, records and monitors the
receipt, tracking, and archiving of all TSCA documents. Every report generated by the new
chemical review process is tracked through DAPSS as well as all submitter input. DAPSS also
maintains the TSCA CBI Access List, which contains clearance information for Federal employees
and contractors. The Management Information Tracking System, MITS, a non-confidential system,
serves many functions throughout the review period including generation of weekly case status
reports, review schedules, and support for reviewers through programmed information retrieval.
Submission data is entered by CDSCS into PENTA, a confidential information system that stores
scientific and regulatory information from all cases submitted under §5 of TSCA and from most
reports generated by new chemical review. One primary use of PENTA is to identify structural,
functional, and/or use analogues. Each submission has a pre-review search by CDSCS in PENTA,
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to locate exact matches or analogues. CIS/CDB/IMD searches the TSCA Inventory to gather
background information (see Inventory Procedures, page 11-1). The results of the IMD searches for
related cases are passed on to the Premanufacture Notice Management Branch/Chemical Control
Division (PNMB/CCD), the Industrial Chemistry Branch/Economics and Technology Division
(ICB/ETD), and to the Exposure Assessment Branch/Exposure Evaluation Division (EAB/EED).
Together these branches narrow the list of possible analogues to those most relevant. PNMB/CCD
then begins preparation of a related case summary for the Focus meeting.
The Confidential Document and Systems Control Section of IMD routes a confidential version of
each submission to the Confidential Business Information Center (CBIC) of OTS for reproduction
and makes submissions available to case reviewers. CDSCS routes a non-confidential version of
each submission (prepared by the submitter or CDSCS) to the OTS public information office and
prepares a Federal Register notice from the non-CBI submission.
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vvEPA
II. Pre-Notice/Receipt To Focus Meeting
A. Inventory Procedures
Concurrent with acknowledgment to the submitter of receipt of a bona fide, PMN, or exemption
application or notice and data entry procedures within IMD, the public and confidential portions of
the TSCA Inventory are searched for the substance by the Chemical Abstracts Service (CAS). In-
formation from CAS is reviewed by chemists in the Chemical Inventory Section (CDB/IMD), who
use this information to verify whether the substance is on the TSCA Inventory. CIS chemists
assure that the Inventory search results are in keeping with Agency policy concerning Inventory
listings and chemical nomenclature. CIS chemists interact with ICB chemists as needed when per-
forming this review; in addition, CIS chemists contact submitters, in coordination with PNMB, as
necessary to resolve problems of chemical nomenclature and chemical structure. If the substance is
on the TSCA Inventory, the PMN, low volume exemption notice, or test market exemption applica-
tion number assigned to the substance is retained and a disposition code is assigned. The submit-
ter is notified of the results of the Inventory search, and no further review work is conducted on
the submission.
CIS ensures that chemical names assigned to non-confidential as well as confidential chemicals
entering the Inventory at the end of new chemical review are accurate and appropriate descriptions
of substances. CIS also develops generic names for the confidential portion of the TSCA Inventory
in cooperation with the submitter.
Chemical names assigned to new substances that have been received under polymer exemptions
are added to the Inventory along with descriptive information about structure (e.g., molecular
weight composition, residual monomer levels). Chemicals that are subjects of test market exemp-
tions are not added to the Inventory. Substances that have been approved under low volume ex-
emption are automatically added to a searchable file, which is not a part of the TSCA Inventory.
Test market and low volume exemptions require no notice of commencement (NOC).
B. Chemistry Review and Search Strategy (CRSS) Meeting
At the CRSS meeting, chemical information is evaluated for all submissions accepted pursuant to
§5 of TSCA. Chemical nomenclature, structure, physical and chemical properties, reactions,
technical aspects of use, and other relevant information is reviewed for completeness, consistency,
and accuracy. Determinations are made as to conformance with technical aspects of §5 rules and
policies. The development of further chemical data, analogous substances, and ambiguous informa-
tion is discussed. This meeting occurs between day 8 and day 12 in the review process.
CRSS is led by a senior staff person from the Industrial Chemistry Branch/Economics and
Technology Division (ICB/ETD). The ICB/ETD provides industrial chemistry and related technical
evaluations to all OTS Divisions to support both risk assessments and non-regulatory decisionmak-
ing. Attending the CRSS meeting are all ICB chemists and the Section Chief of the New Chemicals
Section of ICB.
Prior to the CRSS meeting, an ICB chemist responsible for making assignments will review
copies of PMNs, low volume exemption notices, and test market exemption applications received
by IMD. Specific cases are linked to expedite review. Preliminary estimates of required chemistry
effort are made for each case and group of related cases and the cases are assigned. In addition,
the generic chemical names for substances that have confidential chemical identities are evaluated
for acceptability for publication in the §5(d)(2) Federal Register Notice. The published CRSS
meeting agenda is coordinated with CEB and PNMB assignments to help expedite the evaluation of
related substances.
Two to three working days before the CRSS meeting, chemists begin to: evaluate the chemistry
and related data; seek clarification from submitters; solve any §5(d)(2) generic name problems; pro-
vide technical support to and coordinate with CIS/IMD on TSCA Inventory searches, and initiate
search requests on unusual, associated substances; review routine PENTA searches for analogues
and matches; conduct manual and computer-assisted literature searches; calculate properties using
estimation methods; and prepare draft chemistry reports including large structural representations
used as visual aids in review process meetings.
At the meeting, chemists review chemical nomenclature including the generic name, structure,
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critical physical properties such as vapor pressure and solubility in water, chemical properties such
as hydrolysis rates and extent of dissociation, the practical applications intended, and related data
for the substances under review. The review of some PMNs and exemption notices and applica-
tions may be terminated based on established criteria and professional judgment.
The written output of the CRSS meeting is a partially completed Chemistry report that reflects
CRSS discussions and further information development. The report represents validated chemical
data including the ICB's chemical indexing of the identity for PENTA. A CRSS drop form is com-
pleted for those submissions whose reviews have been terminated.
C. Structure-Activity Team (SAT) Meeting
The structure-activity team (SAT) predicts hazard potential for new chemicals based on such
things as physical/chemical properties, data on analogous chemicals, knowledge of chemical reac-
tivity, and, occasionally, on data on the new chemical itself. The SAT meeting occurs between day
9 and 13 (on the day following the CRSS meeting).
The team is chaired by the SAT coordinator from the Toxic Effects Branch/Health and En-
vironmental Review Division (TEB/HERD). The coordinator, or a HERD senior staff member,
presides at the SAT meeting and is responsible for recording the deliberations of the team.
Members of the SAT are drawn largely from the branches of HERD, but also include represen-
tatives from ICB/ETD, the Exposure Assessment Branch/Exposure Evaluation Division (EAB/EED),
and the Chemical Screening Branch/Existing Chemical Assessment Division (CSB/ECAD).
For each chemical considered at the SAT meeting, a representative from ICB/ETD presents find-
ings from the CRSS meeting and clarifies chemistry questions raised by the SAT. An environmental
fate profile is presented by a representative from EAB/EED. The SAT chair presents information on*
related chemicals from PMN files, PENTA searches, and from published literature. Following
presentation of background data, the team discusses absorption, metabolic fate, and potential
health effects. A representative from the Environmental Effects Branch (EEB/HERD) delivers the
ecotoxicity report.
Based on information presented by meeting participants, the SAT assigns a hazard concern
rating to the substance for potential health and ecological hazards.
The written output produced as a result of the SAT meeting is a SAT report. The discussions
and evaluations of the SAT meeting are summarized in this report. In addition to the meeting sum-
mary, a complete SAT report includes listing of physical/chemical properties, discussion of
chemical fate in wastewater treatment and in the environment, toxicity test data summaries, and
basis for Quantitative Structure-Activity Relationships (QSARs).
D. Exposure Assessment Meeting (EXAM)
EXAM establishes a preliminary profile of exposure and release for new chemicals that are not
under the polymer or low volume exemptions or CRSS drops. Consumer and worker exposure, en-
vironmental release, and environmental fate and possible treatments are evaluated. This meeting
takes place between day 12 and 16.
EXAM is co-chaired by members of the Exposure Assessment Branch/Exposure Evaluation Divi-
sion (EAB/EED) and by the Chemical Engineering Branch/Economics and Technology Division
(CEB/ETD). EAB/EED has the responsibility to estimate physical/chemical properties; evaluate the
fate of the chemical in wastewater treatment, surface water, ground water, soil, sediment, and air;
and estimate all potential human exposures to the chemical except occupational exposure and all
exposures of environmental biota. CEB/ETD reviews PMNs and exemption notices and applications
to determine sources of environmental release, release rate estimates, production technologies,
controls to limit releases and exposures, and occupational exposure. Also attending the EXAM
meeting is a representative from ICB/ETD. Representatives from the Design and Development
Branch/Exposure Evaluation Division (DDB/EED) may also be assigned to cases serving as EED ex-
posure assessors.
Prior to the meeting, EXAM participants review the draft Chemistry report and a brief summary
of the SAT report. The CEB engineer prepares information on worker exposure and environmental
release and controls likely to be used. The EED assessor prepares exposure information that may
pertain to consumer, environmental biota, drinking water, or other exposures. ICB/ETD provides a
brief version of their report to EXAM members.
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At the EXAM meeting, chemistry is presented by a senior ICB/ETD representative. Following this,
a brief statement on health and ecotoxicity concerns is presented from the SAT report. The CEB
engineer presents findings on worker exposure, environmental release, personal protective equip-
ment, and engineering control options. The EED assessor presents findings on physical/chemical
properties; predictions of environmental fate in wastewater treatment, surface water, septic tanks,
soil and landfills; environmental releases resulting from the use of consumer goods; human ex-
posures to the chemical (except occupational exposure); and all exposures of environmental biota.
Two written outputs are produced as a result of the EXAM meeting: an EXAM report covering
the EED assessment, and an Engineering report covering the CEB assessment.
E. Focus Meeting
The Focus meeting examines the results of the CRSS, SAT, and EXAM meetings to decide which
issues need further investigation. The Focus meeting is the first point in the process at which a
regulatory decision is made based on both hazard and exposure. If no further investigation is war-
ranted, the reviewers may decide to drop the case from further review at Focus. This meeting
takes place between day 15 and 19.
Focus is led by the Branch Chief of the Premanufacture Notice Management Branch/Chemical
Control Division (PNMB/CCD). PNMB is responsible for overseeing and managing the evaluation
and disposition of PMNs and exemption notices and applications within the regulatory time frame
and assigns a Program Manager to coordinate the PMN review. Representatives from the CRSS,
SAT, and EXAM meetings attend Focus to present their findings. Also attending the Focus meeting
are senior staff and managers from EED, HERD, and ETD. The Program Manager may attend but is
not required to be present.
Prior to the Focus meeting, a Focus schedule is prepared. PNMB prepares a regulatory history of
selected analogues (from the PENTA search and the SAT summary). A Regulatory Impacts Branch/
Economics and Technology Division (RIB/ETD) economist does a preliminary assessment of the
case. HERD holds an informal meeting where TEB, the Oncology Branch (OB), and the Chemical
Review and Evaluation Branch (CREB) review the SAT report and information on related cases.
EAB/EED prepares SAT and Initial EXAM Chemical Fate reports on low volume exemptions.
At the meeting, ICB presents chemistry, and HERD presents human and environmental toxicity
evaluations (a SAT meeting summary). The engineer from CEB and exposure assessor from EAB
summarize the Engineering report and the EXAM report, respectively. Based on a preliminary
assessment for some cases (criterion is based on SAT evaluations), a RIB/ETD representative may
recommend that the substance be referred to the Follow-up program if there is evidence indicating
that uses other than those cited in the submissions are possible and/or production volume is likely
to increase.
Based on a consensus of meeting attendees, the Focus meeting leader decides whether to pro-
ceed with further evaluation, or to drop the case. If concerns are identified at the Focus meeting,
the case enters Standard Review. If no concerns are identified, the case is dropped. When ap-
propriate, cases (whether dropped or continuing in review) may be referred to Follow-up. The case
enters Follow-up Review to investigate potential other uses or increased volumes that would lead
to increased exposures if concerns are identified either at Focus or during the review, but are
mitigated by low volume and/or low exposure.
Two written outputs are produced as a result of the Focus meeting: a set of Focus notes and an
Assignment sheet (for those chemicals continuing in review). Focus notes highlight the Focus
meeting and contain results of SAT and EXAM meetings. Case review team members assigned by
support branches and scheduled meetings are listed on a MITS-generated Assignment sheet, which
is distributed by the Program Manager.
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'" FOCUS to Division Directors' Meeting
A. Workplan Meeting
At the Workplan meeting, the objectives of the Standard Review process for each PMN that is
not dropped at Focus are clarified, and assignments and scheduling are discussed. This is the first
time that the case review team meets to address decisions made at the Focus meeting. This
meeting is held between day 23 and 27.
Workplan is led by the PNMB/CCD Program Manager and is always attended by a Technical In-
tegrator (Tl) from CREB/HERD, the Chemical Review and Evaluation Branch of HERD. The Tl
assigned by CREB on the day following the Focus meeting has the primary lead for technical
discussions at the Workplan meeting. The Tl is responsible for technical oversight and integration
of hazard and exposure information to produce risk assessments. The case chemist, economist,
chemical engineer, hazard and exposure assessors, and Information Services Section (ISS)
representative also attend the Workplan meeting.
Prior to the meeting, Focus notes are prepared and all documentation and reports prepared prior
to the Workplan meeting are available for review by Workplan meeting attendees. The Program
Manager is responsible for knowing Focus decisions and issues raised for special attention.
At the meeting, the Program Manager transmits information concerning Focus decisions and
issues of concern to case reviewers. The Tl is responsible for developing questions to resolve
hazard and exposure issues raised at the Workplan meeting. When necessary, ISS is asked to per-
form literature searches.
Following the Workplan meeting, the Tl distributes the results of literature searches to case
reviewers. The Tl works to resolve technical issues with hazard reviewers, exposure assessors, the
engineer, and the chemist. The Tl briefs the Program Manager on progress of the technical com-
ponents of the case. The Program Manager maintains contact with the Tl, exposure assessor,
economist, attorney and PMN submitter during Standard Review, and is responsible for informing
the submitter that the case has entered Standard Review. ISS may retrieve hard copies of the
literature for case review.
Written output is produced within two days of the Workplan meeting; the Tl provides to the Pro-
gram Manager a list of questions developed from the Workplan meeting. The Program Manager
reviews and distributes questions to the relevant case reviewer. Draft reports are due approximate-
ly 1 5 days after the Workplan meeting.
B. Mid-course Meeting
The Mid-course meeting assesses the progress of the case and integrates submitted reports. The
meeting is held to discuss whether the PMN is ready for CCD Disposition and, if not, how much
more work is required. The Program Manager may decide to recommend discontinuing the review
of the case or may choose to continue the review if more in-depth work is needed. This meeting is
held three to four weeks after the Workplan meeting (approximately day 44-48).
Mid-course is led by the Program Manager. The Tl, as well as the case reviewers, attends the
Mid-course meeting.
Prior to the Mid-course meeting, each reviewer is required to submit a draft that contains all in-
formation known up to that point and identifies data gaps. Hazard reports are reviewed and in-
tegrated by the Tl. Exposure, release, chemistry, and economic reports are submitted to the Pro-
gram Manager. The Program Manager is responsible for notifying the Tl of receipt of these reports
and their contents.
At the meeting, the Program Manager and the Tl decide what remains to be done and how much
time is required. The Program Manager may decide to drop the case (or a portion of the case) at
CCD Disposition because of assessments discussed at Mid-course.
Based on information presented at Mid-course, recommendations are made to determine whether
(1) concerns are adequately addressed, (2) concerns require additional resources to be addressed,
or (3) evaluation of issues identified at Focus indicates that regulation should not be pursued. ISS
may conduct more searches to meet the needs for continued case review.
No formal written output results from the Mid-course meeting. However, if a case is continued,
draft reports are revised in response to recommendations made at Mid-course.
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C. CCD Disposition Meeting
The CCD Disposition meeting resolves questions on the need for further review of cases. The
CCD Disposition participants may drop cases or concerns from review if data gaps or inconsisten-
cies can be resolved. A CCD Disposition meeting (and drop) can occur any time after the Mid-
course meeting.
The CCD Disposition meeting is led by the Branch Chief of PNMB. Senior staff persons from
CCD, HERD, ETD, EED, and each supporting branch attend. This meeting is also attended by the
Program Manager and Tl.
Prior to the CCD Disposition meeting, the Program Manager prepares an Analysis of Disposition
Options report based on all of the reports and decisions developed up to this point.
At the meeting, cases may be dropped from further review if issues can be resolved. In some
cases, additional resources will be assigned to a case in order to address concerns.
Written output produced as a result of a CCD Disposition meeting is a Final Disposition Summary
that is written by the Program Manager for cases dropped as a result of decisions made at CCD
Disposition. If a case is dropped at a CCD Disposition meeting, then draft reports become final
reports. Concerns and decision rationales will be reported for those cases that remain in the review
process following CCD Disposition.
D. ETD Disposition Meeting
The ETD Disposition meeting provides an opportunity for ETD management to review
assessments in areas of chemistry, engineering and economics, and prepares the Director of ETD
for the Division Directors' meeting. The ETD Disposition meeting is held between day 57 and 65.
The meeting is chaired by the ETD Director and attended by the Branch Chiefs, Section Chiefs,
and individual case reviewers from CEB, ICB, and RIB. The Program Manager and Tl may attend.
Prior to the ETD Disposition meeting, the first drafts of reports prepared by ICB, RIB, and CEB
are revised as new information on the case surfaces and comments are received from the Program
Manager and Tl.
At the ETD Disposition meeting, the chemist assigned from ICB presents chemistry review
results; the engineer from CEB presents worker exposure, environmental release results, and con-
trol alternatives; and the economist from RIB presents findings on available substitutes and
socioeconomic analyses.
The written output produced as a result of the ETD Disposition meeting is the ETD Disposition
Meeting Summary. This summary covers the conclusion of the ETD review and serves as the ETD
Director's briefing material for the Division Directors' meeting.
E. HERD Disposition Meeting
At the HERD Disposition meeting, the Tl briefs HERD management on the case. The outcome of
the meeting is a decision on whether the new chemical in review presents a potential health or
ecological hazard and, if so, whether there is sufficient exposure to the chemical to pose a poten-
tially significant risk. Recommendations for appropriate tests to address data gaps are also made at
the meeting. The meeting ordinarily falls between day 57 and 65 of the review process.
The HERD Disposition meeting is chaired by the Deputy Director of HERD and is attended by
HERD managers and senior scientists, case reviewers from HERD, the Program Manager, and the
Tl.
Prior to the meeting, the Tl prepares a support document consisting of final assessments from
HERD reviewers, together with a risk assessment summary written by the Tl. The summary con-
sists of background information on the chemical, brief descriptions of potential toxic effects and
exposures, conclusions about potential risk, and testing recommendations. Following the HERD
Disposition meeting, the support document is logged into the CBIC.
The written output produced as a result of this meeting is a HERD Disposition Meeting summary,
which contains issues that bear on determination of potential risk, disposition decisions, and
testing recommendations.
F. PNMB Options Meeting
At the PNMB Options meeting, the Program Manager presents the PMN case, with recommended
options, to the Branch Chief and Section Chiefs of PNMB. Regulatory recommendations are assess-
111-2
-------
ed for feasibility from a legal standpoint. This meeting occurs on about day 72 to 75 (shortly
before the Division Directors' Briefing).
The PNMB Options meeting is chaired by the Branch Chief of PNMB. Attending the meeting are
the Program Manager, the Branch Chief of PNMB, PNMB Section Chiefs, and an attorney from
PNMB.
Written output produced as a result of the Options meeting is the Division Directors' Briefing
Paper, which is prepared by the Program Manager. This briefing paper characterizes the potential
toxicity of the PMN substance and identifies issues of concern regarding the substance.
G. Division Directors' Briefing
The Division Directors' Briefing is held 1) to brief the Division Directors of CCD, EED, ETD, and
HERD, and the Deputy Director of OTS on PMN cases; and 2) to determine what action will be
taken on PMN substances. The meeting takes place between day 79 and 82.
The meeting is chaired by the Deputy Director of OTS and is attended by Directors of CCD, EED,
ETD, HERD, the Program Manager, and the Technical Integrator. Other Branch Chiefs involved in
the review and a representative from the Office of General Counsel (OGC) also attend. The Pro-
gram Manager or the Tl also requests that certain case reviewers attend the Division Directors'
Briefing.
Prior to the meeting, the Division Directors' Briefing paper is made available for review. In the
event that RIB/ETD identifies (a) substitute(s), HERD makes a relative hazard finding of the new
chemical as compared with the substitute(s).
At the meeting, the Program Manager briefs the Division Directors and recommends regulatory
action regarding a PMN substance. Following discussion, the Division Directors decide what the
final action (if any) will be.
As a result of the briefing, the Directors will either 1) initiate a Consent or Unilateral §5(e)/5(f)
order or rule to control, limit, or ban manufacture, processing, distribution in commerce, use, or
disposal of the substance (see Action, page IV-1); 2) enter into a voluntary (or informal) agreement
with the submitter (e.g., upfront testing); 3) refer the case for Follow-up; 4) drop the PMN from
further consideration; or 5) request further case review and revisit at a later Division Directors'
Briefing.
Written output from this meeting is a Division Directors' Briefing Summary that is prepared by
PNMB. The report records all salient points of discussion, the final disposition of the PMN, and in-
cludes rationale and logic for decisions and supporting documentation.
I-3
-------
vvEPA
IV. Action
At the end of the PMN review period, EPA has the authority under TSCA §5 to issue a limitation
or ban on a new chemical substance if the Agency can demonstrate that the manufacture, pro-
cessing, use, distribution in commerce, or disposal of the substance may present an unreasonable
risk of injury to health or the environment and/or the substance may be manufactured in substantial
quantities and either enters the environment in substantial quantities or there may be significant
human exposure to the substance. Section 5(c) of TSCA authorizes certain extensions in the PMN
review period, §5(h)(1) allows exemption of manufacturers and importers of new chemical
substances for test marketing from PMN requirements under new chemical review, and §5(h)(4)
also allows manufacturers/importers of some polymers, low volume chemicals, and other applicable
substances to apply for exemptions. EPA's options for actions under §5 are explained in the follow-
ing sections.
A. §5(c) Extension Notice
The §5(c) Notice is the vehicle by which the new chemical review period can be extended up to
90 additional days. The additional time allows EPA to complete its review, to assess the merits of
the case, and to determine whether a §5(e) Order or §5(f) action is appropriate. (For polymer ex-
emption notices, which have a 21-day review period, EPA can extend the review back to 90 days
and use §5(c) to add up to an additional 90 days.)
B. §5(e) Order
At the end of the review period for a PMN submission, EPA may issue a proposed order pro-
hibiting or limiting the manufacture, processing, distribution in commerce, use, or disposal of a
new chemical substance. EPA may take this action if it is determined that:
Available information on the substance is insufficient to determine its health and/or en-
vironmental effects, and
a) the manufacture, processing, distribution in commerce, use, or disposal of the substance
may present an unreasonable risk, or
b) the substance is or will be produced in substantial quantities and may reasonably be an-
ticipated to enter the environment in substantial quantities or there is or may be significant
or substantial human exposure.
A §5(e) Order may be issued as a "Consent Order" where EPA and the manufacturer or importer
agree to certain conditions, or as a "unilateral order" in which the company does not enter into
agreement on the conditions of the EPA order. These conditions may include testing requirements,
use of protective equipment by workplace employees, or monitoring for exposure and release.
A decision to issue a §5(e) Order is based on an assessment of the hazards and exposure infor-
mation detailed in the documents prepared up to and through the Division Directors' meeting. The
Program Manager, PNMB attorney, case reviewers, and OGC are on the workgroup to participate in
drafting a §5(e) Order which, if adversarial, must be served on the submitter no less than 45 days
before the close of the review period. An abbreviated Red Border review asks for concurrence of
OGC and the Office of Program Planning and Evaluating (OPPE). The Assistant Administrator for
the Office of Pesticides and Toxic Substances mus.t approve and sign the §5(e) Order unless ir-
reconcilable objections have been raised by OGC or OPPE. (In this case, the EPA Administrator
makes the final decision to issue the §5(e) Order.)
C. §5{f) Action
Under §5(f), EPA has the authority to issue an order banning or a rule limiting the manufacture,
processing, distribution in commerce, use, or disposal of a new chemical substance based on a
finding that the manufacture, processing, distribution in commerce, use, or disposal of the
substance will present an unreasonable risk of injury to human health or the environment before a
TSCA §6 rule could be issued to prevent such risk.
The participants and background materials required to process a §5(f) action are the same as
those for a §5(e) Order. However, a §5(f) action must be approved by the EPA Administrator. Thus,
there must be a Red Border review (Agency-wide review procedure).
IV-1
-------
D. Litigation
If the submitter files objections to a unilateral §5(e) or §5(f) proposed Order within 30 days after
it is issued, the Order does not go into effect. Once objections to the §5(e) Order are received, it is
assumed that litigation will take place unless the objections change EPA's conclusion that restric-
tions are necessary. EPA's OGC must go to a U.S. District Court to ask for an injunction to put the
Order into effect. OGC works with the Department of Justice, which assigns an attorney to help
litigate the case. OGC's potential involvement in litigation requires OGC attorneys to be in a posi-
tion to evaluate objections to proposed §5(e) and §5(f) Orders. An OGC representative usually at-
tends the Division Directors' meetings to contribute to decisions regarding possible §5(e) and §5(f)
actions, and OGC reviews all §5(e) and §5(f) Orders that result from the new chemical review pro-
cess.
OGC begins to organize the preparation of affidavits and other materials to support a §5(e) or
§5(f) injunctive action. The following documents may be prepared depending on the nature of the
objections to the §5(e) or §5(f) Order:
1) An affidavit concerning exposure/release potential as well as economic analysis (prepared
by EED and ETD),
2) An affidavit on potential human health and/or environmental effects/toxicity (prepared by
HERD),
3) An affidavit from CCD explaining how the PMN program works and how the PMN was
reviewed, and
4) A revised risk assessment that addresses any new information received in the objections
(prepared by HERD).
OGC assists the OTS divisions in the preparation of the affidavits needed for the injunctive action, if
necessary.
IV-2
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&EPA
V. Exemptions
A. Test Market Exemption
A company that wants to assess the marketability of a new chemical substance may apply for a
test market exemption (TME) under TSCA §5(h)(1). TME applications are responded to within 45
days and are processed in the same manner as PMNs from receipt to the Focus meeting. During
the 45-day period, the test market application is evaluated for the potential to cause an
unreasonable health or environmental risk. If no such finding is made, a decision to grant the test
market exemption is made at the Focus meeting.
There is no maximum production volume limitation for applicability, but the submitter must iden-
tify the chemical substance and define persons who will obtain the substance during the test
market period. A TME is issued for a specified time period; this time varies but is always specified.
Certain enforceable restrictions (such as mandatory worker protective equipment) may be
stipulated as part of the exemption.
Receipt of TME applications and EPA's decision to grant or deny TMEs are published in the
Federal Register. TMEs are effective upon signature by the Director of the Office of Toxic
Substances. If a TME application is denied, the manufacturer or importer can submit a PMN.
B. Polymer Exemption
A manufacturer or importer of certain new polymers may submit a notice under the polymer ex-
emption, which provides for 21-day EPA review (40 CFR 723.250). The submitter must complete
applicable portions of the PMN form (EPA Form 7710-25). A chemist in ICB/ETD determines
whether the composition of the polymer qualifies it for the polymer exemption. Polymer exemp-
tions are effective after day 21 unless the company has been notified by telephone, followed by
written notification, that the substance is ineligible for exemption.
C. Low Volume Exemption
New chemical substances to be manufactured or imported at an annual volume of 1,000 kg or
less may be exempt from PMN review under TSCA (40 CFR 723.50). Manufacturers or importers
of low volume substances may provide a notice to EPA with information on the chemical's struc-
ture and intended uses. The notice, which does not have to be completed on the PMN form, is
reviewed within 21 days. Possible health risk concerns from exposure to the chemical are
evaluated based on information gathered on analogues. The submitter is free to manufacture or im-
port after 21 days unless EPA notifies the submitter by telephone, followed by written notification,
that it may not.
The volume for the substance cannot exceed 1,000 kg. Certain stipulations, such as re-
quirements for worker protection equipment, may be included as part of the notice to EPA and are
binding. Only one company may manufacture or import a specific substance under the low volume
exemption.
V-1
-------
vvEPA
VI. New Chemical Follow-Up Review
Chemicals are referred to the Existing Chemical Control Branch/Chemical Control Division
(ECCB/CCD) for Follow-up by the Premanufacture Notice Management Branch/Chemical Control
Division (PNMB/CCD) because (1) a hazard concern has been identified during PMN review and (2)
exposures/releases different from the PMN exposures/releases are suspected. Referrals to Follow-
up are generally made at the Focus, CCD Disposition, or Division Directors' meeting. ECCB is
responsible for managing Follow-up technical and regulatory evaluations and implementing
regulatory decisions. These evaluations may include a more detailed toxicology review, a new use
and exposure analysis, and technical integration report. Based on the findings of the technical
review, ECCB has the responsibility of determining the appropriate course of regulatory action.
The Follow-up program has several regulatory options available. One is to issue a Significant
New Use Rule (SNUR) pursuant to §5(a)(2) of TSCA. A SNUR is designed to limit or prohibit certain
activities associated with the substance(s) (e.g., release to water) without prior notice to EPA. A
second option is for OTS to issue a §8(a) rule that requires a manufacturer or processor of a
specified substance to notify the Agency when a certain activity or event has occurred (e.g., pro-
duction volume has reached a certain volume). A third approach is for ECCB to refer a chemical to
another OTS program that can more appropriately evaluate and regulate, if necessary, the
substance. For instance, if the risk case is well defined and considered to be significant the
substance could be referred to §6; a substance may be submitted to Test Rules Development
Branch (TRDB) for data development consideration, or if the chemical is defined as an existing
chemical (chemical on original TSCA Inventory) the substance will be referred to the Existing
Chemical Assessment Division (ECAD). (ECAD manages the Follow-up process for existing
chemicals. Follow-up for existing chemicals is analogous to Follow-up for new chemicals.)
Substances for which a §5(e) Consent Order has been written may also be subject to a SNUR
authored by PNMB.
The current Follow-up process is undergoing re-evaluation. A more detailed description of the
Follow-up program will be added to a later date.
VI-1
-------
&EPA
VII. Post-Review
A. Notice of Commencement
When the review period expires, the submitter may commence manufacture/import of a new
substance if EPA or a Federal court has not banned these activities. The manufacturer/importer of a
new substance must submit a notice of commencement (NOC) of manufacture or import to the
Confidential Document and Systems Control Section on or after the first day of manufacture or im-
port up to 30 days after manufacture or import commences. No specific form is required to be sub-
mitted for a notice of commencement of manufacture or import. However, the submitter is required
to provide the specific chemical identity, case number, and the exact date of commencement.
After reviewing the notice of commencement, CDSDS tracks the document through DAPSS and
enters the NOC date into PENTA and MITS. A CIS chemist obtains the NOC and copies of the
original CIS Inventory search results, PMN, ICB chemistry report and any relevant telephone logs
from the CBIC files. Based on this review the CIS chemist determines the most accurate
nomenclature to reflect the chemical substance as reviewed by OTS, and notifies the Chemical
Abstracts Service to add this substance to the Inventory. Thereafter, any person may produce the
substance without giving notice to the Agency. CDSCS compiles a list of NOC's for monthly
publication in the Federal Register.
If the substance is an exempt polymer, the CIS chemist performs a similar review and provides
CAS with the absolute 'molecular weight and residual monomer values. This information, along
with the chemical name and an exemption flag comprise the Inventory listing for the substance.
In the case of an exempt low volume substance that has not been denied, the chemist performs
a similar review as soon as the 21 day review period has expired and the required documents have
been turned in to the CBIC by ICB/ETD and PNMB/CCD. The chemist then notifies CAS to add this
substance to the low volume exemption list. Although these substances are not technically on the
Inventory they are maintained on the TSCA Inventory with an "L" flag indicating their special
status.
B. CBI Substantiation
Chemical substances whose specific identity is claimed as confidential during new chemical
review do not automatically remain confidential when entered onto the TSCA Inventory after a
NOC is received from the manufacturer or importer. The submitter must substantiate any claim of
confidentiality for the chemical identity in the NOC, reporting to EPA information such as harmful
effects resulting from disclosure of chemical identity and measures already taken to prevent
disclosure. Substantiation of claims must accompany the NOC and are evaluated by CDB attorneys
and CDSCS upon receipt. ETD personnel will aid IMD if IMD requires technical assistance in
reviewing substantiations, preparing letters to companies, making further inquiries, or researching
issues pertinent to substantiation review. Submitters should contact a CDB attorney to find out
what constitutes an approved or denied substantiation. A complete list of questions that must be
answered in order to substantiate chemical identity claims is found in the Federal Register publish-
ed on May 13, 1983, 48 FR 21752.
C. Generic Name Development
Chemical substances whose identities are claimed as confidential prior to new chemical review
are assigned generic names by the submitter. These generic names or generic names that have
been negotiated by ICB/ETD are used for identification purposes in §5(d)(2) notices. When the
substance is placed on the TSCA Inventory, a CIS representative reviews the generic name original-
ly used for 5(d)(2) purposes in light of the chemical identity and the unique features of the
molecule that contribute to its confidential nature. Unless the 5(d)(2) generic name meets Inventory
standards, a more revealing Inventory generic name is negotiated with the submitter.
After CIS receives written confirmation of the submitter's agreement to this name, the CIS staff
sends the approved generic name to CAS for subsequent publication on the TSCA Inventory.
VII-1
-------
Appendix A
Functions of Divisions and Branches
in the New Chemical Review Process
-------
Functions of Divisions and Branches
in the New Chemical Review Process
Chemical Control Division (CCD)
Manages the regulatory evaluation and decisionmaking process for substances subject to manufac-
turing or process notices under §5 of TSCA.
Premanufacture Notice Management Branch of the Chemical Control Division (PNMB/CCD)
Oversees and manages the evaluation and disposition of PMNs and exemption applications
within the regulatory time frame. Communicates with the submitter (through a Program
Manager) to acquire information or to clarify Notice data.
Existing Chemical Control Branch of the Chemical Control Division (ECCB/CCD)
Manages the Follow-up evaluation of substances referred by new chemical review. Develops
Significant New Use Rules (SNURs) to restrict or prohibit specified new uses of a substance.
Economics and Technology Division (ETD)
Provides chemistry, economics, and engineering support for the evaluation of PMNs and other ex-
emption applications required under §5 of TSCA.
Industrial Chemistry Branch of the Economics and Technology Division (ICB/ETD)
Provides industrial chemistry and related technical evaluations to all OTS Divisions to support
both risk assessments and non-regulatory decisionmaking for all new chemicals reported pur-
suant to §5 of TSCA.
Chemical Engineering Branch of the Economics and Technology Division (CEB/ETD)
Reviews PMNs and exemption requests to characterize industrial activities and determine
sources of environmental release, release rate estimates, protective clothing, personal protec-
tive equipment, engineering control options, production technologies, and occupational ex-
posure.
Regulatory Impacts Branch of the Economics and Technology Division (RIB/ETD)
Provides economic, marketing, and socioeconomic analyses in support of PMN and exemp-
tion review. Reviews submissions for availability and cost/performance analyses of
substitutes, potential uses and benefits of the new chemical, and market trends.
Exposure Evaluation Division (EED)
Provides scientific assessments of human and environmental exposure for substances subject to
manufacturing or process notices under §5 of TSCA.
Exposure Assessment Branch of the Exposure Evaluation Division (EAB/EED)
Estimates physical/chemical properties; evaluates chemical fate in wastewater treatment,
surface water, ground water, soil, sediment, and air; and estimates all potential exposures
to the chemical except occupational exposure and all exposures of environmental biota for
all substances evaluated under §5 of TSCA.
Design and Development Branch of the Exposure Evaluation Division (DDB/EED)
May serve as EED exposure assessors in estimating non-occupational exposures and
assessing chemical fate for substances evaluated under §5 of TSCA.
Health and Environmental Review Division (HERD)
Provides expertise for health and ecological effects considered in the scientific evaluation of a PMN
or other exemption application required under §5 of TSCA.
Chemical Review and Evaluation Branch of the Health and Environmental Review Division
(CREB/HERD)
Manages the technical and scientific evaluations of PMNs.
-------
Functions of Divisions and Branches
in the New Chemical Review Process
Page 2.
Oncology Branch of the Health and Environmental Review Division (OB/HERD)
Assesses the chronic human toxicity and oncogenicity of PMN substances.
Toxic Effects Branch of the Health and Environmental Review Division (TEB/HERD)
Assesses the human toxicity of PMN substances with the exception of chronic toxicity and
oncogenicity.
Environmental Effects Branch of the Health and Environmental Review Division (EEB/HERD)
Assesses environmental impact of PMN substances.
Information Management Division (IMD)
Ensures security and control of documents (or other forms of information) that contain CBI. Coor-
dinates CBI and non-CBI information searches for new chemical review and provides systems
development and support operations. Investigates persons applying for TSCA CBI Clearance.
Chemical Information Branch of the Information Management Division (CIB/IMD)
Performs literature searching and retrieval in support of identification, evaluation, and nam-
ing of submissions requiring new chemical review under §5 of TSCA.
Confidential Data Branch of the Information Management Division (CDB/IMD)
Ensures adequate security and control of documents (or other forms of communication)
that transmit CBI. Specifies proper handling of CBI. Manages the TSCA Inventory. Searches
the TSCA Inventory for information in support of identification, evaluation, and naming of
submissions requiring new chemical review under §5 of TSCA. Evaluates confidentiality
claims associated with NOCs and other TSCA submissions.
Data Management Branch of the Information Management Division (DMB/IMD).
Provides development and user support for CBI and non-CBI systems in OTS.
-------
Appendix B
OTS Organizational
Structure
-------
Office of Program
Management
and Evaluation
Existing Chemical
Assessment
Division
Health and
Environmental
Review Division
Chemical
Screening
Branch
Oncology
Branch
Risk
Management
Branch
Toxic
Effects
Branch
Test Rules
Development
Branch
Environmental
Effects Branch
Chemical Review
and Evaluation
Branch
Office Director
Deputy Office
Director
Office of
TSCA
Assistance
Exposure
Evaluation
Division
Chemical
Control
Division
Economics
and Technology
Division
Design and
Development
Branch
Existing
Chemical
Control Branch
Regulatory
Impacts
Branch
Field
Studies
Branch
Regulatory Program
Development
Branch
Industrial
Chemistry
Branch
Exposure
Assessment
Branch
Premanufacture
Notice
Management
Branch
Chemical
Engineering
Branch
Chemical
Regulation
Branch
Information
Management
Division
Chemical
Information
Branch
Data
Management
Branch
Confidential
Data
Branch
-------
Appendix C
New Chemical Review Process Diagram
-------
New Chemical Review Process
Standard Review
DAY 1
DAY 8-12
DAY 9-13
DAY 12-16
PMN
RECEIPT
C
po
i
CRSS
MEETING
»-
SAT
MEETING
EXAM
MEETING
rop for some
ymers meeting
select criteria
DAY 15-19
STANDARD REVIEW
(for additional concerns)
FOCUS
MEETING
I
I
L
I
PMNs - DROP OR
DROP/FOLLOW UP
TEST MARKET EXEMPTIONS
GRANT OR DENY
POLYMER EXEMPTIONS
GRANT OR DENY
LOW VOLUME EXEMPTIONS
GRANT OR DENY
' ' DAY 23-27
WORKPLAN
MEETING ~7
If
(1st DRAFT
DAY 38-43)
XDAY 44-48 DAY 57-65
MID COURSE ^ HERD/ETD
^ MEETING ^ BRIEFING
\
\ <
(2nd DRAFT (1
DAY 56-58) D
' DA
REQUEST ADDITIONAL C
RESOURCES TO
ADDRESS CONCERNS
i
r
DISPOSITION MEETING
DROP or DROP/
FOLLOW-UP
DAY 72-75
PNMB OPTIONS
"* MEETING
:inal DRAFT / \
AY 66-711 / \
* 74-78 ff \ DAY 79-82
MSPOSITION MEETING DIVISION
DROP or DROP DIRECTORS'
FOLLOW-UP BRIEFING
\ !
POST DDs (H
Regulatory
Action)
-------
Appendix D
New Chemical Review Process
Meeting Schedule
-------
New Chemical Review Process Meeting Schedule
MONDAY
TUESDAY
WEDNESDAY
THURSDAY
FRIDAY
8:00
HERD DISPO (8:30-10:00)
CRSSMTG (8:45-10:00)
SAT MTG (8:45-10:30)
CRSSMTG (8:45-10:00)
SAT MTG (8:45-10:30)
9:00
10:00
MID-COURSE MTG
(10:00-12:00/45" intervals)
WORKPLAN MTG
(10:30-12:00/30"
intervals)
MID COURSE MTG
(10:00-12:00/45" intervals)
WORKPLAN MTG
(10:30-12:00/30"
intervals)
11:00
ETD DISPO
(11:00-12:30)
12:00 Noon-Lunch
1:00
FOCUS MTG
(1:00-2:30)
PNMB OPTIONS MTG
(1:00-2:00)
EXAM MTG (1:00-2:00)
HERD DISPO
(1:30-3:00)
FOCUS MTG
(1:00-2:30)
PNMB OPTIONS MTG
(1:00-2:00)
EXAM MTG
(1:00-2:30)
2:00
CCD DISPO MTG (2:30-3:00)
DD BRIEFING
(2:00-3:00)
CCD DISPO MTG (2:30-3:00)
3:00
DD BRIEFING
(3:00-4:00)
-------
Appendix E
Confidential Business Information
-------
Confidential Business Information (CBI)
Confidential Business Information (CBI) is defined as proprietary or trade secret information sub-
mitted under the Toxic Substances Control Act (TSCA) and claimed confidential by the submitter
under §14 of the Act (5 U.S.C. 552(b)(4)). PMNs and exemption applications and notices usually
contain TSCA CBI.
The Confidential Data Branch, Information Management Division, provides security and control of
documents, whether in hardcopy or any other form. CDB/IMD maintains proper control and handl-
ing of TSCA CBI documents during storage, use, transmittal, document reproduction, and destruc-
tion.
The TSCA Security Staff, Information Management Division, establishes policy and standards for
control and accountability of TSCA CBI documents for Federal employees and contractor
employees performing work that requires the use of CBI information. This includes performing in-
spections of Federal and contractor facilities as well as initiating background investigations of per-
sons requiring access to TSCA CBI. The TSCA Security Staff also investigates any inadvertent
unauthorized disclosure of TSCA CBI and violations of TSCA CBI handling procedures as outlined
in the TSCA Confidential Business Information Security Manual.
-------
Appendix F
Major Databases
Searched
-------
Major Databases Searched for PMN Literature Review
The primary databases searched for PMN Literature Review follow. Additional databases are
searched as needed.
Database
Searched On
Chemical Substance Identification
CAS ONLINE REGISTRY FILE
CHEMLINE
CHEMNAME
CHEMSIS
CHEMZERO
SANSS (Substructure and Nomenclature
Search System)
Chemical Structures
CAS ONLINE REGISTRY FILE
SANSS (Substructure and Nomenclature
Search System)
Environmental Effects
APTIC (Air Pollution Technology Information
Center)
BIOSIS PREVIEWS
CA SEARCH
CAS ONLINE CA FILE
ENVIROLINE
ENVIRONMENTAL BIBLIOGRAPHY
HAZARDOUS SUBSTANCES DATABANK
POLLUTION ABSTRACTS
SPHERE (Scientific Parameters in Health and
the Environment: Retrieval and Estimation
ACQUIRE
ENVIROFATE
TOXLINE
Exposure
APTIC (Air Pollution Technology
Information Center)
AQUALINE
BIOSIS PREVIEWS
CANCERLIT
CA SEARCH
CAS ONLINE CA FILE
CHEMICAL EXPOSURE
EMBASE (Excerpta Medical
HAZARDOUS SUBSTANCES DATABANK
STN International
MEDLARS National Library of Medicine
DIALOG Information Services, Inc.
DIALOG Information Services, Inc.
DIALOG Information Services, Inc.
Chemical Information System, Inc.
or Information Consultants, Inc.
STN International
Chemical Information System, Inc.
or Information Consultants, Inc.
DIALOG Information Services, Inc.
DIALOG Information Services, Inc.
DIALOG Information Services, Inc.
STN International
DIALOG Information Services, Inc.
DIALOG Information Services, Inc.
MEDLARS National Library of Medicine
DIALOG Information Services, Inc.
Chemical Information System, Inc.
or Information Consultants, Inc.
MEDLARS National Library of Medicine
DIALOG Information Services, Inc.
DIALOG Information Services, Inc.
DIALOG Information Services, Inc.
MEDLARS National Library of Medicine
DIALOG Information Services, Inc.
STN International
DIALOG Information Services, Inc.
DIALOG Information Services, Inc.
MEDLARS National Library of Medicine
-------
Major Databases Searched for PMN Literature Review (continued)
Database
Searched On
MEDLINE
MED80, MED77, MED66
(Backfiles)
NIOSH
POLLUTION ABSTRACTS
SPHERE (Scientific Paramters in Health and
the Environment: Retrieval and Estimation
ENVIROFATE
TOXLINE
Health Effects
CANCERLIT
EMBASE (Excerpta Medical
GLOBAL INDEXING SYSTEM
HAZARDOUS SUBSTANCES DATABANK
MEDLINE
MED80, MED77, MED66
(Backfiles)
NIOSH
RTECS (Registry of Toxic Effects of
Chemical Substances)
SPHERE (Scientific Paramters in Health and
the Environment: Retrieval and Estimation
DERMAL
GENETOX
TOXLINE
Physical/Chemical Properties
HAZARDOUS SUBSTANCES DATABANK
RTECS (Registry of Toxic Effects of
Chemical Substances)
SPHERE (Scientific Parameters in Health and
the Environment: Retrieval and Estimation
ACQUIRE
ENVIROFATE
ISHOW
Production/Processing
BIOSIS PREVIEWS
CA SEARCH
CAS ONLINE CA FILE
HAZARDOUS SUBSTANCES DATABANK
MEDLARS National Library of Medicine
DIALOG Information Services, Inc.
DIALOG Information Services, Inc.
Chemical Information System, Inc.
or Information Consultants, Inc.
MEDLARS National Library of Medicine
MEDLARS National Library of Medicine
DIALOG Information Services, Inc.
USEPA Office of Toxic Substances
Database
MEDLARS National Library of Medicine
MEDLARS National Library of Medicine
DIALOG Information Services, Inc.
MEDLARS National Library of Medicine
Chemical Information System, Inc.
or Information Consultants, Inc.
MEDLARS National Library of Medicine
MEDLARS National Library of Medicine
MEDLARS National Library of Medicine
Chemical Information System, Inc.
or Information Consultants, Inc.
DIALOG Information Services, Inc.
DIALOG Information Services, Inc.
STN International
MEDLARS National Library of Medicine
-------
Major Databases Searched for PMN Literature Review (continued)
Database Searched On
Regulation/Control
CASR (Chemical Activities Status Report) USEPA Office of Toxic Substances
Database
Use/Disposal
BIOSIS PREVIEWS DIALOG Information Services, Inc.
CA SEARCH DIALOG Information Services, Inc.
CAS ONLINE CA FILE STN International
GLOBAL INDEXING SYSTEM USEPA Office of Toxic Substances
Database
HAZARDOUS SUBSTANCES DATABANK MEDLARS National Library of Medicine
NIOSH DIALOG Information Services, Inc.
POLLUTION ABSTRACTS DIALOG Information Services, Inc.
-------
Appendix G
Premanufacture Notice for New Chemical
Substances, EPA Form 7710-25
-------
Form Approved. O.M.B. No. 2070^0012. Approval Expires 1-31-94.
U. S. ENVIRONMENTAL PROTECTION AGENCY
f/EPA
PREMANUFACTURE
NOTICE
FOR NEW CHEMICAL SUBSTANCES
When
completed
send this
form to
DOCUMENT CONTROL OFFICER
OFFICE OF TOXIC SUBSTANCES, TS-790
U.S. EJ»A.
401 M STREET, SW
WASHINGTON, D.C. 20460
Enter the total number of pages
in the Premanufacture Notice
AGENCY USE ONLY
Date of receipt
Document control number
EPA case number
GENERAL INSTRUCTIONS
You must provide all information requested in this form to the extent that it is known to or reasonably ascertainable by you.
Make reasonable estimates if you do not have actual data.
Before you complete this form, you should read the "Instructions Manual for Premanufacture Notification" (Instructions Manual).
If a user fee has been remitted for this notice (40 CFR 700.45), indicate in the TS boxes above the TS-user fee identification
number you have generated. Remember, your user fee ID number must also appear on your corresponding fee remittance.
Part I - GENERAL INFORMATION
You must provide the chemical identity of the new chemical
substance, even if you claim the identity as confidential. You may
authorize another person to submit the identity for you, but your
submission will not be complete and review will not begin until
EPA receives this information. A letter of support from another
person should reference your TS user fee Identification number.
Part U - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE
You may need additional copies of part II, sections A and B if there
are several manufacture, processing, or use operations that you will
describe in the notice. You should reproduce these sections as needed.
Part HI - LIST OF ATTACHMENTS
You should attach additional sheets if yon do not have enough space
on the form to answer a question fully. Label each continuation sheet
with the corresponding section heading. In part in, list these attachments,
any test data or other data and any optional information that yon include
in the notice.
OPTIONAL INFORMATION
You may include in the notice any Information that yon want EPA to
consider in evaluating the new substance The Instructions Manual
identifies categories of optional information that you may want EPA to
review. On page 11 of this form, space has been provided for you to
describe pollution prevention and recycling information you may have
regarding the new substance.
Binding Options: In order to effectively implement risk management
options, EPA may wish to exercise its authority under section 5(e) to make
certain statements in your notice such as use, production volume, protective
equipment and/or process description legally binding and enforceable.
If you wish to initiate such discussions with the EPA, precisely describe those
aspects in this notice deliberately designed to protect against unreasonable risk
to human health or the environment and indicate your willingness to be bound
to the appropriate statements by marking (X) in the boxes provided. Should the
Agency wish to pursue this option, yon will be contacted by an EPA staff person.
CONFIDENTIALITY CLAIMS
Yon may claim any information in this notice as confidential. To assert a
claim on the form, mark (X) the confidential box next to the information
that yon claim as confidential. To assert a claim in an attachment, drde
or bracket the information yon claim as confidential. If yon daim
information in the notice as confidential, yon must provide a sanitized
version of the notice, including attachments, to EPA with your
submission. For additional Instructions on claiming information as
confidential, read the Instructions Manual.
I I Mark (X) if any information in this notice is claimed as confidential
TEST DATA AND OTHER DATA
You are required to submit all test data in your possession or control
and to provide a description of all other data known to or reasonably
ascertainable by you if these data are related to the health and
environmental effects of the manufacture, processing, distribution
in commerce, use, or disposal of the new chemical substance. Standard
literature citations may be submitted for data in the open scientific
literature. Complete test data (written in English), not summaries of data,
must be submitted if they do not appear in the open literature. Following
are examples of test data and other data. Yon should submit these
data according to the requirements of §720.50 of the Premanufacture
Notification Rule (40 CFR Part 720).
Test Data (See Appendix A of the Instructions Manual and the Physical and
Chemical Properties Worksheet on the last page of this form for examples of
data to be submitted).
Environmental fate data
Health effects data
Environmental effects data
Physical/Chemical Properties
n
QYe,
nYe*
nYe*
n Y»
n
n
n
n
Other data I I Yes
Risk assessments
Structure/activity relationships
Test data not in the possession or control of the submitter
TYPE OF NOTICE
LH PMN
(Check Only One)
CONSOLIDATED PMN - f OF CHEMICALS
(Prenotice Communication I required, enter * on page 3)
|~| SNUN (Significant New Use Notice)
LJ INTERMEDIATE PMN - AS DEFINED AT 40 CFR 700.43
QTMEA (Test Marketing Exemption)
|~| LVE (Low Volume Exemption)
l~l POLYMER EXEMPTION- LJe(l) or LJeU)
|~| OTHER EXEMPTION - SPECIFY ^
EPA FORM 7710-25 (Rev. 1-91)
Replaces previous editions of EPA Form 7710-25.
Printed on Recycled Paper
-------
Public reporting burden for this collection of information is estimated to average 110 hours per response, including time for reviewing instructions,
searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send
comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden,
to Chief, Information Policy Branch, PM-223, U.S. Environmental Protection Agency, 401 M. St., S.W.,, Washington, D.C. 20460; and to the Office of
Management and Budget Paperwork Reduction Act (2070-0012), Washington, D.C 20503.
CERTIFICATION
I certify that to the best of my knowledge and belief:
1. The company named in Part I, section A, subsection la of this notice form intends to manufacture or import for a
commercial purpose, other than in small quantities solely for research and development, the substance identified in
Part I, Section B.
2. All information provided in this notice is complete and truthful as of the date of submission.
3. I am submitting with this notice all test data in my possession or control and a description of all other data known to
or reasonably ascertainable by me as required by §720.50 of the Premanufacture Notification Rule.
Additional Certification Statements:
If you are submitting a PMN, (including a polymer exemption notice in accordance with 40 CFR 723.250), Intermediate
PMN, Consolidated PMN, or SNUN, check the following user fee certification statement that applies:
Q The Company named in Part I, Section A has remitted the fee specified in 40 CFR 700.45 (b), or
n The Company named in Part I, Section A is a small business concern under 40 CFR 700.43 and has remitted
a fee of $100 in accordance with 40 CFR 700.45 (b).
If you are submitting a polymer exemption notice in accordance with 40 CFR 723.250, check the following:
I I The new chemical substance meets the definition of polymer, is not specifically excluded from the exemption,
and meets the conditions of the exemption.
If you are submitting a low volume exemption application in accordance with 40 CFR 723.50, check the following
certification statements:
I | The manufacturer submitting this notice intends to manufacture or import the new chemical substance for
commercial purposes, other than in small quantities solely for research and development, under the terms
of 40 CFR 723.50.
|~) The manufacturer is familiar with the terms of this section and will comply with those terms; and
I I The new chemical substance for which, the notice is submitted meets all applicable exemption conditions.
The accuracy of the statements you make in this notice should reflect your best prediction of the anticipated facts regarding the chemical
subtance described herein. Any knowing and willful misinterpretation is subject to criminal penalty pursuant to 18 USC1001.
Confidential
Signature and title of Authorized Official (Original Signature Required)
Signature of agent - (if applicable)
Date
Date
FORM EPA 7710-25
(Rev. 1-91)
Page 2
-------
Part I - GENERAL INFORMATION
Section A - SUBMITTER IDENTIFICATION
Mark (X) the "Confidential" box next to any subsection you claim as confidential
la. Person
Submitting
Notice
(in US.)
Name of authorized officlal
Company
Mailing address (number and street)
City, State, ZIP Code
b. Agent (if Name of authorized official
applicable)
Company
Mailing address (number and street)
City, State, ZIP Code
| Area Code !
Telephone | ,
1 1
I |
Number
c If you are submitting this notice as part of a joint submission, mark (X) this box.
Joint Name of authorized official
Submitter
(if applicable)
Title
Company
Mailing address (number and street)
City, State, ZIP Code
Technical
Contact
(in US.)
Name
| Area Code |
Telephone | |
1 1
Number
Title
Company
Mailing address (number and street)
City, State, ZIP Code
Telephone
Area Code
Number
3. If you have had a prenob'ce communication (PC) concerning this notice
and EPA assigned a PC Number to the notice, enter the number.
Mark(X)
if none
4. If you have submitted an exemption notice/application for
the chemical substance covered by this notice, enter the exemption
number assigned by EPA. If you have withdrawn a previously
submitted PMN enter the PMN number.
MarkOO
if none
n
5. If you have submitted a bona fide request for the chemical substance
covered by this notice, enter the bona fide request number assigned
by EPA. >
Mark(X)
if none
Type of Notice - Mark (X)
1.
Manufacture I
Only I
2.
Binding Option
Mark(x)
D
Import
Only
BindingOption
Mark (x)
n
Both
FORM EPA 7710-25 (Rev. 1-91)
Page3
-------
Part I - GENERAL INFORMATION - Continued
> Section B - CHEMICAL IDENTITY INFORMATION
Mark (X) the "Confidential" box next to any item you claim as confidential.
I Complete either item 1 (Class 1 or 2 substances) or 2 (Polymers) as appropriate. Complete all other items.
If another person will submit chemical identity information for you (for either item 1 or 2), mark (X) the box at the right, i i
Identify the name, company, and address ot that person in a continuation sheet. ^" ' 1
1. Class 1 or 2 chemical substances (for definitions of class 1 and class 2 substances, see the Instructions Manual)
a. Class of substance- Mark (X) 1 | | Qassl or 2 | | dass2
b. Chemical name (preferably CAS or IUPAC nomenclature)
\
Confi-
dential
c. Molecular formula and CAS Registry Number (if known)
CAS*
d. For a class 1 substance, provide a structural diagram. For a class 2 substance - (1) List the immediate, precursor substances with their
respective CAS Registry Numbers. (2) Describe the nature of the reaction or process. (3) Indicate the range of composition and the
typical composition (where appropriate). (4) Provide a representative structural diagram (if possible).
I I Mark (X) this box if you attach a continuation sheet.
FORM EPA 7710-25 (Rev. 1-91) Page 4
-------
Part I - GENERAL INFORMATION - Continued
^ Section B - CHEMICAL IDENTITY INFORMATION - Continued
r Polymers (For a definition of polymer, see the Instructions Manual)
a. Indicate the number-average weight of the lowest molecular weight composition of the polymer y
Indicate maximum weight percent of low molecular weight species (not including residual monon
500 and below 1,000 absolute molecular weight of that composition. Describe the methods of mea
estimates. GPC |~| Other Q (Specify)
Confi-
dential
lers, reactants, or solvents) below
isurement or the bases for your
- lowest number average molecular weight:
- maximum weight % below 500 molecular weight:
- maximum weight ft below 1000 molecular weight:
1 1 Mark (X) this box if you attach a continuation sheet. '
b. You must make separate confidentiality claims for monomer or other reactant identity, composition information, and residual
information. Mark (X) the "Confidential'' box next to any item you claim as confidential.
(1) Provide the chemical name and CAS Registry Number of each monomer or other reactant used in the manufacture of the polymer.
(2) Mark (X) this column if entry in column (1) is confidential.
(3) - Indicate the typical weight percent of each monomer or other reactant in the polymer.
(4) Mark (X) the identity column if you want a monomer or other reactant used at two weight percent or less to be listed as part of the
polymer description on the TSCA Chemical Substance Inventory.
(5) - Mark (X) this column if entries in columns (3) and (4) are confidential
(6) Indicate the maximum weight percent of each monomer or other reactant that may be present as a residual in the polymer as
manufactured for commercial purposes.
(7) - Mark (X) this column if entry in column (6) is confidential.
Monomer or other reactant and CAS Registry Number
(1)
[ | Mark (X) this box if you attach a continuation sheet.
c. Provide a representative structural diagram of the polymer, if possible.
I 1 Mark (X) this box if you attach a continuation sheet.
Confi-
dential
(2)
Typical
composition
(3)
%
%
%
%
%
%
%
Identity Confi- Maximum Confi-
Mark(X) dential residual dential
(4) (5) (6) (7)
%
%
%
%
%
%
%
r
FORM EPA 7710-25 (Rev. 1-91)
PageS
-------
Part I - GENERAL INFORMATION - Continued
Section B - CHEMICAL IDENTITY INFORMATION - Continued
3. Imparities
(a) - Identify each impurity that may be reasonably anticipated to be pretest in the chemical substance as manufactured for commercial purposes.
Provide the CAS Registry Number if available. If there are unidentified impurities, enter "unidentified.'
(b) -Estimate the maximum weight % of each impurity. If there are unidentified impurities, estimate their total weight 7..
Impurity and CAS Registry Number
.. (a)
Maximum
percent
(b)
Confi-
dential
Mark (X) this box if you attach a continuation sheet.
4. Synonyms - Enter any synonyms for the new chemical substance identified in subsection 1 or 2.
Confi-
dential
| | Mark (X) this box if you attach a continuation sheet.
5. Trade identification - List trade names for the new chemical substance identified in subsection 1 or 2.
I | Mark (X) this box if you attach a continuation sheet.
6. Generic chemical name If you claim chemical identity is confidential, you must provide a generic chemical name for your substance
that reveals the specific chemical identity of the new chemical substance to the maximum extent possible.
Refer to the TSCA Chemical Substance Inventory, 1985 Addition, Appendix B for guidance on developing
generic names.
Mark (X) this box if you attach a continuation sheet.
7. Byproducts Describe any byproducts resulting from the manufacture, processing, use, or disposal of the new chemical substance at sites
you control. Provide the CAS Registry Number if available
Byproduct
(1)
CAS Registry Number
(2)
Confi-
dential
D
Mark (X) this box if you attach a continuation sheet.
FORM EPA 7710-25 (Rev. 1-91)
Page 6
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Part I - GENERAL INFORMATION - Continued
Section C - PRODUCTION/IMPORT, AND USE INFORMATION
1. Production volume - Estimate the maximum production volume during the first 12 months of production. Also estimate
the maximum production volume for any consecutive 12-month period during the first three years of production.
Maximum first 12-month production (ke/vr)
Maximum 12-month production (ke/vr)
Confi-
dential
Binding
Option
Maiktx)
Mark (X) the "Confidential" box next to any item you daim as confidential
2. Use Information - You must make separate confidentiality claims for the description of the category of use, the percent of production volume
devoted to each category, the formulation of the new substance, and other use information. Mark (X) the "Confidential" Box next to any item you
claim as confidential
a. (1) Describe each intended category of use of the new chemical substance by function and application.
(2) - Mark (X) this column if entry in column (1) is confidential business information (CBD.
(3) - Indicate your willingness to have the information provided in column (1) binding.
(4) - Estimate the percent of total production for the first three years devoted to each category of use.
(5) Mark (X) this column if entry in column (4) is confidential business information (CBD.
(6) Estimate the percent of the new substance as formulated in mixtures, suspensions, emulsions, solutions, or gels as manufactured
for commercial purposes at sites under your control associated with each category of use.
(7) - Mark (X) this column if entry in column (6) is confidential business information (CBD.
(8) Mark (X) whether the use is site-limited, industrial, commercial and/or consumer. Mark more than one box if appropriate. 'Mark
(X) to indicate your willingness to have the information provided in (8) binding.
(9) - Mark (X) this column if entryfies) in column (8) is (are) confidential business information (CBD.
Category of use
(1)
CB1
(2)
Binding
Option
MaikU)
(3)
Produc-
tion %
(4)
%
%
%
%
%
CBI
(5)
%in
Form-
ulation
(6)
%
%
%
%
%
CBI
m
Mark (X) appropriate column(s)
(8)
Site-
limited
Con-*
sumer
Indus-
trial
Com-
merria
Binding
Option
CBI
(9)
"If you have identified a "consumer" use, please provide on a continuation sheet a detailed description of the use(s) of this
chemical substance in consumer products. In addition include estimates of the concentration of the new chemical substance as
expected in consumer products and describe the chemical reactions by which this substance loses its identity in the consumer
product.
LjMaik (X) this box if you attach a continuation sheet. .
b. Generic
use
description
If you claim any category of use description in subsection 2a as confidential, enter a generic description of that
category. Read the Instructions Manual for examples of generic use descriptions.
Mark (X) this box if you attach a continuation sheet.
3. Hazard Information Include in the notice a copy of reasonable facsimile of any hazard warning statement, label, material safety data sheet,
or other information which will be provided to any person who is reasonably likely to be exposed to this substance regarding protective
equipment or practices for the safe handling, transport, use, or disposal of the new substance. List in part III hazard information you indude.
11 I Mark (X) this box if you attach hazard information.
Binding
Option
Mu-kbc)
FORM EPA 7710-25 (Rev. 1-91)
Page 7
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I Fart II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE
^ Section A - INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER
Complete section A for each type of manufacture, processing, or use operation involving the new chemical
substance at industrial sites yon control.
Mark (X) the "Confidential" box next to any item you claim as confidential.
1. Operation description
a. Identity - Enter the identity of the site at which the operation will occur.
Name
Site address (number and street)
City, County, State, ZIP Code
If the same operation will occur at more than one site, enter the number of sites.
Identify the additional sites on a continuation sheet.
| | Mark (X) this box if you attach a continuation sheet.
b. Type-
Mark (X)
n
Manufacturing
I I Processing
c. Amount and Duration - Complete 1 or 2 as appropriate
1. Batch
2. Continuous
Maximum kg/batch
Hours/batch
Batches/year:
Maximum kg/ day
Hours/day
Days/year
d. Process description {""] Mark (X) to indicate your willingness to have your process description binding.
(1) Diagram the major unit operation steps and chemical conversions.
(2) Provide the identity, the approximate weight (by kg/day or kg/batch), and entry point of all feedstocks (including reactants,
solvents, and catalysts, etc.).
(3) Identify by number the points of release to the environment of the new chemical substance.
| | Mark (X) this box if you attach a continuation sheet.
FORM EPA 7710-25 (Rev. 1-91)
PageS
-------
Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE - Continued
Section A - INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER - Continued
Occupational Exposure You must make separate confidentiality claims for the description of worker activity, physical form of the new chemical
substance, number of workers exposed, and duration of activity. Mark (X) the "Confidential" box next to any item you claim as confidential.
(1) Describe the activities in which workers may be exposed to the new chemical substance.
(2) Mark (X) this column if entry in column (1) is confidential business information (CBI).
(3) Describe any protective equipment and engineering controls used to protect workers.
(4) and (6) Indicate you willingness to have the information provided in column (3) or (5) binding.
(5) Indicate the physical form(s) of the new chemical substance at the time of exposure.
(7) Mark (X) this column if entry in column (5) is confidential business information (CBI).
(8) Estimate the maximum number of workers involved in each activity.
(9) Mark (X) this column if entry in column (8) is confidential business information (CBI).
(10) and (11) Estimate the maximum duration of the activity for any worker in hours per day and days per year.
(12) - Mark (X) this column if entries in columns (10) and (11) are confidential business information (CBI).
Worker activity
(1)
CBI
(2)
Protective Equipment/
Engineering Controls
(3)
Binding
Option
MarkU)
(4)
Physical
form(s)
(5)
Binding
Option
MufcU)
(6)
CBI
(7)
#OT
Workers
Exposed
(8)
CBI
(9)
Maximum duration
Mrs/day
(10)
Days/yr
(11)
CBI
(12)
Mark (X) this box if you attach a continuation sheet.
3. Environmental Release and Disposal You must make separate confidentiality claims for the release number and the amount of the new
chemical substance released and other release and disposal information. Mark (X) the "Confidential" box next to each item you claim as
confidential.
(1) - Enter the number of each release point identified in the process description, part II, section A, subsection ld(3).
(2) Estimate the amount of the new substance released (a) directly to the environment or (b) into control technology (in kg/day or kg/batch).
(3) - Mark (X) this column if entries in columns (1) and (2) are confidential business information (CBI).
(4) Identify the media (air, land, or water) to which the new substance will be released from that release point.
(5) - a. Describe control technology, if any, ,and control efficiency that will be used to limit the release of the new substance to the environment.
For releases disposed of on land, characterize the disposal method and state whether it is approved for disposal of RCRA hazardous waste.
On a continuation sheet, for each site describe any additional disposal methods that will be used and whether the waste is subject to
secondary or tertiary on-site treatment, b. Estimate the amount released to the environment after control technology (in kg/day).
(6) Mark (X) this column if entries in columns (4) and (5) are confidential business information (CBD.
(7) - Identify the destination(s) of releases to water. Please supply NPDES (National Pollutant Discharge Elimination System) numbers for direct
dischargers or NPDES numbers of the POTW (Publicly Owned Treatment Works). Mark (X) if the POTW name or NPDES # is confidential
business information (CBI).
Release
Number
(1)
Amount of new sub
released
stance
(2a)
(2b)
CBI
(3)
Media of
release
(4)
Control technology and efficiency
(5a)
Binding
Mark (xl
<5b)
CBI
(6)
(7) Mark (X) the
destination(s) of
releases to water.
POTW provide name(s) below:
CBI
Navigable
waterway
Other - Specify
NPDES #
CBI
| j Mark (X) this box if you attach a continuation sheet.
FORM EPA 7710-25 (Rev. 1-91)
Page 9
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Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -- Continued
Section B - INDUSTRIAL SITES CONTROLLED BY OTHERS
Complete section B for typical processing or use operations involving the new chemical substance at sites you do not control. Complete a separate,
section B for each type of processing, or use operation involving the new chemical substance. If the same operation is performed at more than one
site describe the typical operation common to these sites and enter the number of sites . Identify additional sites on a continuation sheet.
1. Operation Description - To claim information in this section as confidential, circle or bracket the specific information that you claim as confidential.
(1) Diagram the major unit operation steps and chemical conversions. On the diagram, identify by letter and briefly describe each worker activity.
(2) Provide the identity, the approximate weight (by kg/day or kg/batch), and entry point of all feedstocks (including reactants, solvents,
and catalysts, etc). (3) Identify by number the points of release to the environment of the new chemical substance.
I I Mark (X) this box if you attach a continuation sheet.
2. Worker Exposure/Environmental Release
(1) - From the diagram above, provide the letter for each worker activity. Complete 2-8 for each worker activity described.
(2) Estimate the number of workers exposed.
(4) Estimate the typical duration of exposure per worker in (a) hours per day and (b) days per year.
(6) Describe any protective equipment and engineering controls, if any, used to protect workers.
(7) - Estimate the percent of the new substance as formulated when packaged or used as a final product.
(9) - From the process diagram above, enter the number of each release point. Complete 9-13 for each release point identified.
(10) Estimate the amount of the new substance released (a) directly to the environment or (b) into control technology to the environment
(in kg/day or kg/batch).
(12) - Describe control technology, if any, that will be used to limit the release of the new substance to the environment.
(14) - Identify byproducts which may result from the operation.
(3), (5), (8), (11), (13) and (15) - Mark (X) this column if any of the proceeding entries are confidential business information (CBI).
Letter
of
Act-
ivity
(1)
# of
Workers
Exposed
(2)
CBI
(3L
Duration
of
Exposure'
(4a)
CBI
Protective
Equip./
Engineering
Controls
(6)
Form-
ulation
GO
CBI
(8)
Release
Number
(9)
Amount of
New
Substance
Released
(10a)
HOb)
CBI
(11)
Control
Technology
(12)
CBI
(13)
(14) - Byproducts:
(15)
n
Mark (X) this box if you attach a continuation sheet.
FORM EPA 7710-25 (Rev. 1-91)
Page 10
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OPTIONAL POLLUTION PREVENTION INFORMATION
To claim information in this section as confidential circle or bracket the specific information that you claim as confidential.
In this section you may provide information not reported elsewhere in this form regarding your
efforts to reduce or minimize potential risks associated with activities surrounding
manufacturing, processing, use and disposal of the PMN substance. Please include new
information pertinent to pollution prevention, including source reduction, recycling activities
and safer processes or products available due to the new chemical substance. Source reduction
includes the reduction in the amount or toxitity of chemical wastes by technological
modification, process and procedure modification, product reformulation, raw materials
substitution, and/or inventory control. Recycling refers to the reclamation of useful chemical
components from wastes that would otherwise be treated or released as air emissions or water
discharges, or land disposal. Descriptions of pollution prevention, source reduction and
recycling should emphasize potential risk reduction subsequent to compliance with existing
regulatory requirements and can be either quantitative or qualitative. The EPA is interested in
this information to assess overall net reductions in toxicity or environmental releases and
exposures, not the shifting of risks to other environmental media or non-environmental areas
(e.g., occupational or consumer exposure). In addition, information on the relative cost or
performance characteristics of the PMN substance to potential alternatives may be provided.
All information provided in this section will be taken into consideration during the review
of this substance.
Describe the expected net benefits, such as (1) an overall reduction in risk to human health or the environment; (2) a reduction in
the volume manufactured; (3) a reduction in the generation of waste materials through recycling, source reduction or other
means; (4) a reduction in potential toxicity or human exposure and/or environmental release; (5) an increase in product
L performance, a decrease in the cost of production and/or improved operation efficiency of the new chemical substance in
^comparison to existing chemical substances used in similar applications; or (6) the extent to which the new chemical substance
may be a substitute for an existing substance that poses a greater overall risk to human health or the environment.
| | Mark (X) this box if you attach a continuation sheet.
FORM EPA 7710-25 (Rev. 1-91) page j j
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Part HI - LIST OF ATTACHMENTS
Attach continuation sheets for sections of the form and test data and other data (including physical/chemical properties and
structure/activity information), and optional information after this page. Clearly identify the attachment and the section of the form to
which it relates, if appropriate. Number consecutively the pages of the attachments. In the column below, enter the inclusive page
numbers of each attachment.
Mark (X) the "Confidential" box next to any attachment name you claim as confidential. Read the Instructions Manual for
guidance on how to claim any information in an attachment as confidential You must include with the sanitized copy of the notice
form a sanitized version of any attachment in which you claim information as confidential.
Attachment name
Attachment
page number(s)
Confi-
dential
1 1 Mark (X) this box if you attach a continuation sheet. Enter the attachment name and number.
FORM EPA 7710-25 (Rev. 1-91)
Page 12
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PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET
To assist EPA's review of physical and chemical properties data, please complete the following worksheet for data you provide
and include it in the notice. Identify the property measured, the page of the notice on which the property appears, the value
of the property, the units in which the property is measured (as necessary), and whether or not the property is claimed as
confidential. You are not required to submit this worksheet; however, EPA strongly recommends that you do so, as it will simplify
review and ensure that confidential information is properly protected. You should submit this worksheet as a supplement to
your submission of test data. This worksheet is not a substitute for submission of test data.
Property
(a)
Vapor pressure of-
Density/relative density
Solubility o^-
Solvent .
°C
Solubility in water a Temperarnrp
Melting temperature
Boiling/sublimation temperature
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Glossary
Bona fide
CBI
CCD
CDB/IMD
CDSCS/IMD
CEB/ETD
Chemical Substance
CIB/IMD
CIS/IMD
Consent Order
CREB/HERD
DAPSS
Document submitted by a chemical manufacturer or importer that
states intent to introduce a chemical substance into U.S. com-
merce (see page 1-1).
Confidential Business Information (see Appendix E).
Chemical Control Division.
Confidential Data Branch of the Information Management
Division.
Confidential Document and Systems Control Section of the Infor-
mation Management Division.
Chemical Engineering Branch of the Economics and Technology
Division.
Any organic or inorganic substance of a particular molecular
identity including (1) any combination of such substances occur-
ring in whole or in part as a result of a chemical reaction occur-
ring in nature and (2) any element or uncombined radical. The
term does not include (1) mixtures; (2) pesticides defined under
the Federal Insecticide, Fungicide, and Rodenticide Act that are
regulated by the Office of Pesticide Programs, USEPA;
(3) tobacco, alcohol, and firearms; (4) foods, food additives,
drugs, cosmetics or devices defined under the Federal Food,
Drug, and Cosmetic Act that are regulated by the Food and Drug
Administration; and (5) source materials, special nuclear
materials, or byproducts that are defined under the Atomic
Energy Act of 1954.
Chemical Information Branch of the Information Management
Division.
Chemical Inventory Section of the Information Management
Division.
A binding agreement between EPA and the manufacturer or im-
porter of a new chemical substance whereby the manufacturer or
importer is allowed to produce the substance in compliance with
EPA-imposed controls while developing sufficient data on health
and/or environmental effects (see page IV-1).
Chemical Review and Evaluation Branch of the Health and En-
vironmental Review Division.
Document and Personnel Security System. A confidential system
that tracks the receipt, circulation, and archival of confidential
and non-confidential documents at the Office of Toxic
Substances (OTS), as well as tracking information on CBI-cleared
government and contractor personnel. Typical submissions in-
clude Premanufacture Notices (PMNs), exemption applications,
bona fides, Notices to Export, Follow-up documents, and other
communcations related to the Toxic Substances Control Act.
DAPSS serves several functions including: automatically assign-
ing document control numbers to various types of documents;
tracking the life cycle of documents, including number of copies
made, distributed, returned and shredded; analyzing document
workload patterns, CBI claims, 12(b) program accomplishments,
and other document profiles; flagging overdue documents; flag-
ging the CBI status of document borrowers; and flagging the CBI
clearance end-dates for personnel. The system interfaces with a
bar code numbering system that expedites document circulation
and tracking.
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Glossary (continued)
DDB/EED
DMB/IMD
Document Control Number
EAB/EED
EED
EEB/HERD
ETD
Follow-up Review
HERD
ICB/ETD
IMD
ISS/IMD
Low Volume Exemption
MITS
PENTA
PMN
Polymer Exemption
New Chemical Substance
Design and Development Branch of the Exposure Evaluation Divi-
sion.
Data Management Branch of the Information Management
Division.
Unique number assigned to any information that contains TSCA
CBI.
Exposure Assessment Branch of the Exposure Evaluation
Division.
Exposure Evaluation Division.
Environmental Effects Branch of the Health and Environmental
Review Division.
Economics and Technology Division.
Process by which substances referred from the new chemical
process and existing chemicals are monitored for potential
unreasonable risks under circumstances where changes in
manufacturing, processing, distribution in commerce, use, and
disposal take place.
Health and Environmental Review Division.
Industrial Chemistry Branch of the Economics and Technology
Division.
Information Management Division.
Information Services Section of the Information Management
Division.
See page V-1
The Management Information Tracking System. A non-confiden-
tial tracking and scheduling system for PMNs and exemption ap-
plications and notices reviewed under the new chemicals review
and follow-up review process. MITS serves several functions in-
cluding: tracking and interim status of applications during the
review process; recording and analyzing information on the final
disposition and other characteristics of all applications received;
and supporting Program Managers and other reviewers in their
daily work with status update reports, workload reports, and up-
coming calendars.
A confidential §5 data base that contains scientific and regulatory
information on all PMNs and exemption applications and notices
reviewed under the new chemicals and Follow-up review pro-
cess. The data base is designed so that cases can be quickly
isolated and referenced by their pertinent properties. The objec-
tive of PENTA is to automate descriptive information for each
case and to provide to reviewers information on how similar
cases were handled in the past.
Premanufacture Notice. Required of manufacturers and importers
of chemical substances under TSCA, this submission activates
new chemical review by EPA. The submission reports data on
health and environmental effects related to the manufacture, use,
and disposal of the new chemical substances.
See page V-1.
Any chemical substance that is not included on the TSCA
Chemical Substance Inventory.
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Glossary (continued)
OB/HERD Oncology Branch of the Health and Environmental Review
Division.
PNMB/CCD Premanufacture Notice Management Branch of the Chemical
Control Division.
RIB/ETD Regulatory Impacts Branch of the Economics and Technology
Division.
RPDB/CCD Regulatory Program Development Branch of the Chemical Control
Division.
Standard Review The process by which specific concerns raised at the Focus
meeting are examined in detail by a case review team. Concerns
for health and environmental effects are addressed in a series
of meetings and resultant reports.
TEB/HERD Toxic Effects Branch of the Health and Environmental Review
Division.
Test Market Exemption See page V-1.
TSCA Inventory Computerized inventory of all chemical substances that are cur-
rently manufactured, imported, or processed in the United States
(see page 11-1).
Unilateral Order Action by EPA that bans the manufacture or importation of a
new chemical substance where the manufacturer does not enter
into an agreement with EPA on the conditions of the Order.
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Bibliography
The following citations provide background materials regarding legal authority and regulatory
development of new chemical review. Reprints of regulatory background materials, Premanufacture
Notices, Instructions, and other materials on new chemical review may be obtained by contacting
the TSCA Assistance Office at 554-1404 or (800) 424-9065.
Legal Authority for New Chemical Review
Public Law 94-469. 1976 (October 11). Toxic Substances Control Act.
Final Rules Published in the Federal Register
USEPA. 1977. U.S. Environmental Protection Agency. Office of Toxic Substances. Inventory
Reporting Regulations. (42 FR 64572).
USEPA. 1982. U.S. Environmental Protection Agency. Premanufacture Notification; Exemption for
Chemicals Used In or for the Manufacture or Processing of Instant Photographic and Peel-Apart
Film Articles. (47 FR 24308).
USEPA. 1983. U.S. Environmental Protection Agency. Office of Toxic Substances. Premanufacture
Notification; Premanufacture Notice Requirements and Review Procedures. (48 FR 21722).
USEPA. 1983. U.S. Environmental Protection Agency. Office of Toxic Substances. Premanufacture
Notification; Revision of Regulation and Partial Stay of Effective Date. (48 FR 41132).
USEPA. 1984. U.S. Environmental Protection Agency. Office of Toxic Substances. Premanufacture
Notification Exemptions; Exemptions for Polymers. (49 FR 46066).
USEPA. 1984. U.S. Environmental Protection Agency. Significant New Uses of Chemical
Substances; Certain Chemicals. (49 FR 35011).
USEPA. 1985. U.S. Environmental Protection Agency. Premanufacture Notification Exemption; Ex-
emption for Chemical Substances Manufactured in Quantities of 1,000 kg or less per year. (50 FR
16477).
PMN Forms and Instructional Manual
USEPA. 1983. U.S. Environmental Protection Agency. Instructions Manual for Premanufacture
Notification of New Chemical Substances. Washington, DC: Office of Toxic Substances, USEPA.
EPA-7710-25II) (5-23-83).
USEPA. 1984. U.S. Environmental Protection Agency. Premanufacture Notice for New Chemical
Substances. EPA Form 7710-25 (12-18-84).
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