U.S. EPA, Instruction Manual for Reporting Under the TSCA §5 New Chemicals Program (2003)

• Author: Carolyne R. Hathaway/William K. Rawson/Ann Claassen/Julia A. Hatcher
• Pages: 335-385

Instruction Manual for Reporting Under the TSCA §5 New Chemicals Program Page 335

INSTRUCTION MANUAL FOR REPORTING UNDER THE

TSCA §5 NEW CHEMICALS PROGRAM

How this Manual is organized:

I. GENERAL INSTRUCTIONS FOR REPORTING UNDER THE TOXIC SUBSTANCES

CONTROL ACT §5 NEW CHEMICALS PROGRAM - PREMANUFACTURE NOTICE

FORM

A. Substances Which Must Be Reported ("New" Chemicals)

B. Who Must Submit A Premanufacture Notice

C. Substances Excluded from Notification

D. When to Submit a Notice

E. Filling Out and Submitting the Form

F. Binding Boxes

G. Test Data and Other Data

H. Confidentiality

I. Consolidated Notices

J. Submission of Information by Others

K. Consultation with EPA Concerning the Premanufacture Notice

L. Notice of Commencement (NOC) of Manufacture (or Import) (40 CFR §720.102)

M. Recordkeeping

N. Recognition of Pollution Prevention and Recycling Benefits

Page 336 TSCA Deskbook

II. PAGE-BY-PAGE INSTRUCTIONS FOR COMPLETING THE TSCA §5 NEW CHEMICALS

PROGRAM PREMANUFACTURE NOTICE FORM

1. Type of Notice (Page 1 )

2. Certification (Page 2)

Part I -- GENERAL INFORMATION

Section A - Submitter Identification (Page 3)

Section B - Chemical Identity Information (Pages 4-6)

1. Class 1 or Class 2 chemica l substances (Page 4)

2. Polymers (Page 5)

3. Impurities (Page 6)

4. Synonyms

5. Trade Identification

6. Generic chemical name

7. Byproducts -

Section C - Production, Import, & Use Information (Page 7)

1. Production volume

2. Use information

3. Hazard information

Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE (Pages 8-10)

Section A - Industrial Sites Controlled by the Submitter (Pages 8-9)

Section B - Industrial Sites Controlled by Others (Page 10)

(OPTIONAL) POLLUTION PREVENTION AND RECYCLING INFORMATION (Page 11) -

Technical Information

a. Process Chemistry

b. Product Substitution/ Source Reduction

c. Process Modifications

d. Operating Practices

h. Alternative Waste Disposal Methods

i. Toxicity Information

Part III - LIST OF ATTACHMENTS (Page 12)

Physical and Chemical Properties Worksheet (Optional - page 13)

Appendix A: Types of test data for submission

Appendix B: Contact Persons

Instruction Manual for Reporting Under the TSCA §5 New Chemicals Program Page 337

I. GENERAL INSTRUCTIONS FOR REPORTING UNDER THE

TSCA §5 NEW CHEMICALS PROGRAM -

PREMANUFACTURE NOTICE FORM

A. Substances Which must Be Reported ("New" Chemicals)

1. General - You are responsible for determining whether a substance you intend to

manufacture or import is a "new" chemical substance as defined by the Toxic Substances Control

Act (TSCA, the Act) and 40 Code of Federal Regulations (CFR) §720.3. You must submit a

premanufacture notice (PMN) if you intend to manufacture (import is considered manufacture)

any new chemical substance which is not on the TSCA Inventory or otherwise excluded from

notification, as discussed below. To submit a PMN, you must use Form EPA 7710-25. Part II of

this Manual is a step-by-step guide to form 7710-25 (rev 5-95).

2. Bona fide request for a TSCA Inventory search- The specific identities of some

chemical substances on the Inventory are confidential and therefore do not appear on the

Inventory available to the public. Such substances are described by generic names in the

Appendix to the Inventory. If a substance you intend to manufacture or import is not on the

published Inventory but falls within one of the generic categories in the Appendix, you may

request that EPA search the Inventory's confidential file. EPA will search the confidential file

only if you can demonstrate a bona fide intent to manufacture or import the substance. This

policy is to ensure that this search procedure cannot be used for, essentially, industrial espionage.

The procedure for demonstrating such a bona fide intent is codified at 40 CFR §720.25.

Certain information must be submitted with a bona fide request: an infrared spectrum must be

supplied unless this analysis is not suitable for the particular substance, in which case a spectrum

or instrument readout from a more appropriate method must be submitted; a currently correct

Chemical Abstracts (CA) Index name or CA preferred name, whichever is appropriate; a

currently correct Chemical Abstracts Service (CAS) register number (CASRN) (if the substance

already has a CASRN assigned to it); molecular formula and a complete or partial chemical

structure diagram if known or reasonably ascertainable; and a description of R&D activities that

have already been conducted (include, for example, years research conducted, end use

application, toxicity data, etc.). Three additional information requirements established in the

PMN Rule Amendments, published March 29, 1995 (60 Federal Register (FR) 60 pp.

16298-16351) for a TSCA Inventory search include: the most probable manufacturing site,

"major intended application or use" of the substance, and the approximate date when the

submitter would be likely to submit a §5 notice for the substance if it is not found in the

Inventory. If the substance is being imported, a statement should include: a) how long the

substance has been used outside of the U.S., b) name of the country(ies) in which the substance is

being used, and c) whether the substance has been used outside the U.S. for the same use as that

intended after proposed importation. No specific form is required to be used.

The address to which to send bonafide submissions (by US mail) is: