Manufacturing Today - July 2017 - 10

COLUMN BY | LYNN L. BERGESON

	 Information	under	the	rule	may	be	
claimed	 as	 confidential	 at	 the	 time	 it	
is	 submitted.	 Submitters	 must	 provide	 upfront	 substantiation	 of	 confidentiality	 claims	 for	 processing	 and	
use	information,	and	for	confidentiality	claims	for	site	or	chemical	identity.

B UY AMERICAN

While	 the	 publication	 of	 the	 draft	
guidance	within	four	months	of	issuance	 of	 the	 final	 rule	 is	 laudable,	 the	
draft	 guidance	 does	 not	 significantly	
expand	 upon	 that	 which	 is	 already	
known,	 nor	 does	 it	 make	 the	 rule	
clearer	or	easier	with	which	to	comply	
in	all	respects.	
	 Companies	subject	to	the	reporting	
requirements	of	the	final	rule	can	expect	to	continue	to	struggle	in	sorting	
out	what	discrete	forms	are	required	
to	be	reported.

A LFAB INC.

E CONOMY

Discussion

the draft guidance
reiterates that
under tsca, the
definition of
"manufacture"
includes import.

	 The	draft	guidance	is	helpful	in	responding	to	questions	regarding	what	
the	final	rule	means	by	"coating"	and	
why	 coated	 nanomaterials	 are	 defined	separately	from	mixtures,	given	
that	there	is	no	discussion	of	what	is	
meant	 by	 coating	 in	 the	 proposed	 or	
final	 rule.	 The	 draft	 guidance	 is	 also	
helpful	 in	 more	 clearly	 articulating	
the	scope	of	the	135-day	reporting	period	 in	 connection	 with	 forming	 an	
intent	to	manufacture	or	process	a	reportable	material.	
	 EPA	 notes	 that	 the	 135-day	 period	 is	 not	 a	 formal	 review	 period	
that	 prohibits	 manufacture	 before	
the	 end	 of	 the	 135-day	 period.	 Rath10			manufacturing-today.com		JULY 2017

er,	 based	 on	 EPA's	 experience	 with	
premanufacture	 notice	 reviews	 in	
the	new	chemicals	program,	EPA	believes	 that	 in	 most	 cases	 companies	
have	the	requisite	intent	to	manufacture	 or	 process	 a	 reportable	 chemical	substance	at	least	135	days	before	
manufacturing	or	processing	will	begin,	 and	 the	 rule	 requires	 reporting	
based	 upon	 this	 presumed	 intent.	 If	
a	 company	 does	 not	 form	 the	 requisite	intent	135	days	ahead	of	time,	the	
guidance	 clarifies	 that	 the	 company	
must	 report	 within	 30	 days	 of	 the	
formation	of	such	an	intent.	If	a	company	 desires	 to	 begin	 manufacture	
or	processing	less	than	135	days	after	
the	 submission	 is	 made,	 EPA	 notes	
that	 the	 company	 is	 free	 to	 do	 so.	
There	is	no	obligation	upon	the	company	to	wait	135	days	after	reporting	
to	manufacture	or	process.
	 The	 draft	 guidance	 also	 clarifies	
that	 for	 each	 reportable	 chemical	
substance,	 each	 processor	 of	 that	

substance	 is	 required	 to	 report.	 EPA	
is	casting	a	wide	net	to	ensure	that	all	
methods	and	instances	of	processing	
are	 covered,	 even	 though	 EPA	 may	
receive	a	substantial	amount	of	duplicative	 information	 from	 processors	
that	 use	 standard	 industry	 practices.	
EPA	does	not	reconcile	this	fact	with	
the	requirement	in	Section	8(a)(5)(A)	
to	avoid	requiring	"reporting	which	is	
unnecessary	or	duplicative."
	 On	 the	 whole,	 EPA's	 significant	 efforts	 to	 prepare	 and	 issue	 guidance	
quickly	are	appreciated.	Questions	undoubtedly	will	remain,	however.	Comments	were	due	by	June	15,	2017.	mt
Lynn L. Bergeson is Managing Partner of Bergeson
& Campbell, P.C. (B&C®), a Washington, D.C., law firm
focusing on conventional, nanoscale and biobased
industrial, agricultural and specialty chemical product
regulation and approval matters, environmental health
and safety law, chemical product litigation and associated business counseling and litigation issues. She is
President of The Acta Group, with offices in Washington,
D.C., Manchester, UK, and Beijing, China, and President of
B&C® Consortia Management LLC (BCCM), with offices
in Washington, D.C.


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Table of Contents for the Digital Edition of Manufacturing Today - July 2017

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