U.S. EPA, Supplementary Premanufacture Questions and Answers (1983) (ELR Order No. AD-509)

• Author: Carolyne R. Hathaway/William K. Rawson/Ann Claassen/Julia A. Hatcher
• Pages: 395-398

Supplementary Premanufacture Questions and Answers Page 395

Supplementary Premanufacture

Questions and Answers

EPA

9/83

SUPPLEMEN TARY PREMAN UFACTURE

QUESTIONS A ND ANSWER S September 1983

General

Q: 1. In situations when PM N Submissions are

judged to be incomplete , well into the 90 day

review period, w ill the 90-day clock be s topped

and resta rted when the additional i nformation is

received, or wi ll it be started over upon receipt of

the informat ion.

A: If the notice is decla red incomplete, the review

period has not begun no mat ter when in the initial

review period the notice is d eclared incomplete. ere-

fore, the review period beg ins again at day one when a

complete notice is received. However, EPA may, within

its discretion, restar t the clock upon the day the notice

was declared inc omplete if it is determined that the

review can be c ompleted within the remai ning period.

SEE 40 CFR 720.65(c).

Q: 2. When a submit ter is notied of an Incomplete

Notice, is thi s done by Registered Mail?

A: Generally, notication is  rst done informally w ith

a telephone call. e noticat ion is followed by a for-

mal notice by Registere d Mail.

Q: 3. If a submitter objec ts to a nding that his

PMN is incomplete, how ma ny days will the OTS

Director ta ke to decide on the appeal?

A: EPA will notify the submitter in writing within 10

days of receiving the objections. SEE 40 CFR 720.65 (c).

Q: 4. Does the ten d ay time limit for objections to

an “incomplete ” notice determination begi n when

EPA calls the subm itter or when the submitter

receives writ ten notication?

A: e ten day time limit be gins when the submitter

receives written notic ation.

Q: 5. Please dene i ndustrial use and com mercial

use and the d ierence between these t wo uses.

A: As described i n the Instructions Manual for PMN,

a use would be considered industri al if the new chemi-

cal substanc e or products containing it wi ll be used

at the site of other manufactu rers or processors, e.g.,

textile dyeing or pai nt formulation. e use would

be considered commercial if t he chemical substance

or products containing it wi ll be used by a commer-

cial enterprise providing a c onsumer service, e .g., use

by painting contractors or com mercial dry cle aning

establishments.

Q: 6. Will t he replacement generic name that is to

be entered by EPA for the Inventory b e made avail-

able to the manuf acturer for his/her revie w or com-

ment prior to publication?

A: If the generic name submitte d is too general as

determined by the Agenc y, the submitter is contacted

and works with the Ag ency to develop a generic name

acceptable to both. If ag reement is not reached, EPA

proposes a name, noties t he submitter, and allows the

submitter an opportunit y to give the Agency a writ-

ten rebuttal within 3 0 days. If the submitter does not

respond within 30 days, t he name is entered on the

Inventory. If a response is received, proposing another

acceptable name, th at name will be entered. If the

name is not acceptable, EPA will noti fy the submitter

of the nal choice for a name a nd after 30 days will

enter that name on the Inventory.

Q: 7. If a compound was led for the orig inal

Inventory and a pos tcard acknowledged re ceipt of

the form, but no subsequent corre spondence has

been received, h as the compound been accepted for

the Inventory?

A: If you have a postcard rec eipt from the Agency, your

Inventory report was led, a nd your chemical sub -

stance is considered to be on the Inventory.

Q: 8. Should I list a pilot pla n operation as an

industria l site on Page 7 of the PMN Form?

A: Yes, if the pilot plant will conti nue to produce the

chemical af ter R&D is complete.

Q: 9. On the process desc ription, does the product

containi ng the PMN material constit ute an envi-

ronmental relea se? Does it have to be numbered on

the diagr am and listed on Page 8 of the form?

A: No, a product which contains t he PMN material

does not constitute an environmenta l release. It does

not have to be numbered on the diagra m on Page 8 of

the PMN Form. However, you must clearly identify

the steps in which the new c hemical substa nce is made

into a product in the process description.

Q: 10. What is your de nition of an “authorized

ocial?” Must it be a c ompany ocer?

A: An “authorized ocia l” is one who is responsible for

the truth and acc uracy of each statement in the notice.

Depending on the size of the c ompany, this person