Manufacturing Today - November/December 2017 - 9

LYNN L. BERGESON | COLUMN BY

	 On	Jan.	12,	2017,	EPA	issued	a	final	
rule.	The	rule	imposes	a	one-time	reporting	 obligation	 and	 recordkeeping	requirements	for	certain	discrete	
forms	 of	 chemical	 substances	 that	
are	manufactured	or	processed	at	the	
nanoscale.	 Manufacturers	 (including	
importers)	 and	 processors,	 or	 persons	 who	 intend	 to	 manufacture	 or	
process	new	discrete	forms	of	certain	
chemical	nanoscale	materials	not	previously	reported	to	EPA,	must	also	report	certain	information	to	EPA	prior	
to	manufacture	or	processing.

What Must Be Reported

Chemical Substances that
would be Reportable
The	final	rule	applies	to	chemical	substances,	 as	 defined	 in	 TSCA	 Section	
3,	 that	 are	 solids	 at	 25	 ºC,	 and	 that	
are	 manufactured	 or	 processed	 in	 a	
form	 where	 any	 particles,	 including	

Reportable Information

L EGAL

Discussion

EPA	is	to	be	commended	for	crafting	a	
final	rule	that	is	clearer	than	the	proposal	 and	 more	 likely	 to	 elicit	 useful	
information.	 Complying	 will	 remain	
challenging,	 and	 the	 guidance	 notes	
that	 it	 "will	 not	 provide	 answers	 to	
all	of	the	potential	questions	that	will	
arise	 as	 manufacturers	 and	 processors	 seek	 to	 comply	 with	 the	 rule."	
EPA	 states	 that	 it	 will	 answer	 questions	 on	 a	 case-by-case	 basis,	 and	
fortunately	 intends	 to	 add	 further	
questions/answers	 and	 revisions	 to	
the	guidance	based	on	questions	identified	by	persons	who	may	be	subject	
to	the	rule.	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.

NOVEMBER/DECEMBER 2017		 manufacturing-today.com			9

K AYS ENGINEERING

aggregates	 and	 agglomerates,	 are	 in	
the	 size	 range	 of	 1-100	 nanometers	
(nm)	 in	 at	 least	 one	 dimension;	 and	
that	 are	 manufactured	 or	 processed	
intentionally	 to	 exhibit	 one	 or	 more	
"unique	and	novel"	properties.	
	 The	 final	 rule	 does	 not	 apply	 to	
chemical	 substances	 manufactured	
or	 processed	 in	 forms	 that	 contain	
less	 than	 one	 percent	 by	 weight	 of	
any	 particles,	 including	 aggregates	
and	agglomerates,	in	the	size	range	of	
1-100	nm.	"Unique	and	novel"	properties	means	"any	size-dependent	properties	that	vary	from	those	associated	
with	other	forms	or	sizes	of	the	same	
chemical	substance,	and	such	properties	are	a	reason	that	the	chemical	substance	 is	 manufactured	 or	 processed	
in	 that	 form	 or	 size."	 Reportable	
chemical	 substances	 do	 not	 include	
chemical	 substances	 manufactured	
or	 processed	 at	 the	 nanoscale	 that	
contain	 incidental	 amounts	 of	 parti-

A LFAB INC.

The	 rule	 requires	 reporting	 of	 information	 including	 chemical	 identity,	
actual	 or	 anticipated	 production	 volume,	 methods	 of	 manufacture,	 use,	
exposure	 and	 release	 information,	
and	available	health	and	safety	information.	 Any	 person	 required	 to	 report	 under	 the	 rule	 must	 supply	 the	
information	 identified	 in	 the	 form	
developed	 by	 EPA	 to	 the	 extent	 it	 is	
known	to	or	reasonably	ascertainable.	
EPA	issued	guidance	on	Aug.	14,	2017,	
on	 the	 reporting	 rule	 which	 stakeholders	are	urged	to	review.

S U P P LY C H A I N

epa has stated that
it needs information
on these existing nanoscale materials
to ensure the products that contain
them are safe.

cles	in	the	size	range	of	1-100	nm,	certain	 biological	 materials,	 chemicals	
that	dissociate	completely	in	water	to	
form	ions	of	less	than	1	nm	in	size,	and	
chemicals	formed	at	the	nanoscale	as	
part	of	a	film	on	a	surface.

B UY AMERICAN

The	 information	 to	 be	 reported	 includes,	 insofar	 as	 "known	 to	 or	 reasonably	 ascertainable"	 by	 the	 person	 reporting,	 the	 specific	 chemical	
identity,	 production	 volume,	 methods	 of	 manufacture	 and	 processing,	
exposure	 and	 release	 information,	
and	 existing	 information	 concerning	
environmental	 and	 health	 effects.	
Persons	who	manufacture	or	process	
a	discrete	form	of	a	reportable	chemical	substance	at	any	time	during	the	
three	years	prior	to	the	effective	date	
of	 the	 final	 rule	 must	 report	 to	 EPA	
one	year	after	the	effective	date	of	the	
final	rule.	This	means	that	for	companies	that	have	manufactured,	imported,	or	processed	reportable	nanoscale	
materials	at	any	time	between	Aug.	14,	
2014,	 and	 Aug.	 14,	 2017,	 must	 submit	
reports	 for	 these	 substances	 to	 EPA	
no	later	than	Aug.	14,	2018.
	 There	 is	 also	 a	 standing	 one-time	
reporting	 requirement	 for	 persons	
who	intend	to	manufacture	or	process	
a	 new	 discrete	 form	 of	 a	 reportable	
existing	 chemical	 substance	 on	 or	
after	the	Aug.	14,	2017,	effective	date.	
These	persons	are	required	to	report	
to	EPA	either	at	least	135	days	before	
commencing	 manufacture,	 import,	
or	 processing	 reportable	 nanoscale	

materials	 or,	 if	 they	 have	 formed	 an	
intent	 less	 than	 135	 days	 before	 such	
manufacture,	 import,	 or	 processing,	
then	 within	 30	 days	 after	 forming	
such	an	intent.


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Table of Contents for the Digital Edition of Manufacturing Today - November/December 2017

Table of Contents
Manufacturing Today - November/December 2017 - Cover1
Manufacturing Today - November/December 2017 - Cover2
Manufacturing Today - November/December 2017 - 1
Manufacturing Today - November/December 2017 - Table of Contents
Manufacturing Today - November/December 2017 - 3
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Manufacturing Today - November/December 2017 - Cover3
Manufacturing Today - November/December 2017 - Cover4
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