U.S. EPA, Premanufacture Notice Questions and Answers (1983) (ELR Order No. AD-508)

• Author: Carolyne R. Hathaway/William K. Rawson/Ann Claassen/Julia A. Hatcher
• Pages: 389-392

Premanufacture Notice Questions and Answers Page 389

Premanufacture Notice Questions and

Answers

EPA

6/22/83

PMN Questions and An swers

is document will b e supplemented with additional

questions and answer s as they become available

June 22, 1983

General

1. Q. How many premanufac ture notices (PMNs)

has the Envi ronmental Protection Agenc y (EPA)

received?

A. From commencement of the notice review progra m

on July 1, 1979 to March 31, 1983, EPA received 2,201

valid PMNs. Of the total numb er, the review period

had expired on 1,878 and 777 had entered commercia l

production.

2. Q. How many TME’s?

A. During the s ame period, EPA reviewed 196 test-

marketing exemption applicat ions (TME As) under

§5(h)(1) of the Act and granted 173 such exemptions.

3. Q. What act ions has EPA taken under §5(e) of

the Toxic Substances C ontrol Act (TSCA)?

A. During th is period, EPA issued seven §5(e) orders

regulating t he production of 18 new chemical sub-

stances pendin g the development of additional data ,

and entered into voluntary control agree ments with the

submitters of 49 notices. In addition, submitters wit h-

drew nine §5 notices in the fac e of likely regulation.

4. Q. What act ions must I perform to be in compli-

ance by the ee ctive date of the nal ru le?

A.

(a) If you submit a PMN on or after the eect ive

date, you must use EPA form 7710-25 (4-26-

83) and provide all information requested on

the form (including full re ports of all test data

to the extent that such inform ation is known

to or reasonably ascert ainable by you). If you

claim any of the inf ormation as Condentia l

Business Information (CBI), you must also

submit a second copy of the form, including

attachments, which doe s not contain CBI.

(b) You must submit a notice of commencement

of manufacture or impor t in accordance with

§720.102 for any new chemical s ubstance

whose review period ha s expired, and which

has been manufa ctured or imported for a com-

mercial purpose. ( is requirement also applies

retroactively to any submitter who ha s not pro-

vided a notice of commencement for any new

chemical substa nce that has gone through the

review period and ha s been manufactured or

imported for a commercial pur pose.) Submit-

ters must substantiate cla ims of condentiality

for chemical identity at the t ime a notice of

commencement is submitted.

(c) In addition, you must maintai n the records

specied in §720.78. Such records must be

retained for ve years f rom the date of com-

mencement of manufacture or import .

Q. When does the PMN not ice period begin?

A. e notice period begi ns on the date of receipts by

the Agency of a PMN. If the notice i s not complete,

the notice period will not be gin to run until the notice

is complete. Section 720.65 species admi nistrative

procedures applicable to incomplete notices.

6. Q. Is there a product ion volume limit for PMNs ?

What about R&D volu me limits?

A. No. ere is no production volume limit for PMNs

or R&D chemicals. However, R&D chemic als can

only be manufactu red in amounts required to conduct

the R&D activit y.

7. Q. Are there any substant ive changes under the

nal PMN repor ting rule that ae ct PMN review

procedures or requ irements?

A.

(a) EPA has developed a procedure for con-

solidated PMN notices in order to reduce the

administr ative burden on a submitter who

intends to manufactu re two or more structur-

ally related new chemic al substances which

have similar use , exposure, environmental

release, and test d ata. e submitter must con-

tact the Pre-notice Communic ations Coordina-

tor, prior to submittal of a consolidated PMN

to determine if the criteria for consol idation are

met.

(b) Any person who manufactures a new chem i-

cal substanc e under a R&D exemption must

evaluate any inform ation or test data in his or

her possession or control to determine whether

there is any risk to healt h associated with the

new chemical subst ance, and provide notica-