ILMA Compoundings - May 2019 - 16

INDUSTRY RUNDOWN

International Insight
The Industrial Chemicals Act 2019
and Australia
By James Eggenschwiler
After several years of public consultations, the Industrial
Chemicals Act 2019 officially became law on April 3,
2019, with an implementation/enforcement date of July
1, 2020. This long-awaited legislation makes significant
changes to the regulatory landscape and process
for chemical substances (and ultimately products),
beginning with the replacement of the National Industrial Chemical Notification and Assessment Scheme
(NICNAS) with the Australian Industrial Chemical Introduction Scheme (AICIS).
NEW PHILOSOPHICAL APPROACH
The differences begin with the philosophies that underpin
the two approaches. NICNAS, as its name implies, was
operationally hinged on the two elements of "notification"
and "assessment." Nearly every aspect of the scheme required
some form of submittal to the agency, and a formal response
authorizing activity to a varying degree depending on the situation. AICIS begins by fundamentally dividing its regulatory
approach into two distinct categories: chemicals of low risk
to human health and the environment, potentially without
the requirement of assessment; and chemicals of medium or
high risk to human health or the environment, that require
assessment. It is at this point that the new regulatory philosophy impacts the approach by dividing the types of controls.
With the designation "low risk," the governing philosophy
presumes that less regulation and action by the agency is warranted. In contrast, the categories of "medium risk" and "high
risk" carry with them the presumption that greater regulatory
involvement is warranted and necessary to not only ensure
public safety, but enhance public confidence as well. In recent
years, NICNAS came under fire for its use of staff resources
toscrutinize "low hazard" categories, such as low-concern polymers, by employing very detailed evaluations of notifications
and "self-assessment" that could last as long as four months.
PROCESS IMPROVEMENTS
Exemptions and reported introductions
By establishing these separate fundamental pathways, AICIS
is expected to improve speed to market for new chemicals

16

MAY 2019

| COMPOUNDINGS | ILMA.ORG

and conserve valuable resources for better (and possibly
faster) evaluation of medium-hazard or high-hazard new
chemicals, as well as "existing" inventory (now the AIIC)
listed chemicals discussed below.
One of the most obvious improvements that will likely
produce this gain is the expansion of potential exemptions
available, and the offer for use of reported introductions
concerning new chemicals that enjoy a nonhazardous or low
hazard profile. These exemptions and reported introductions
will still require submittal of a dossier in order to qualify,
but the data necessary to be submitted will be abbreviated
compared to that currently required under NICNAS. In the
case of reported introductions, the dossier will accompany
a pre-introduction report, and a follow-up report following
the introduction. More details concerning exemptions and
reported introductions will be provided once AICIS has
issued detailed regulations, in the coming months.
It seems natural that an expanded list of exemptions,
and an added process that replaces formal registration and
assessment with a new chemical introduction method that
is monitored through reporting, will be much faster and less
resource-intensive than the previous requirement of formal
assessment. Legislative proponents of these two options cited
substantially reduced resource utilization and attendant costs
without increasing risk to end users or the public.
Assessed introductions
AICIS creates a point at which more complex or data-heavy
reviews that require more scrutiny and supplemental data
can be segregated from easier and faster assessments. At
the front end, the act requires that these assessments be
completed within a maximum of 70 working days. It also
requires that the executive director be involved in the consideration of the application submitted. That functions as a
mandate governing the process unless the executive director
determines that: (i) additional information is needed on the
applicant (registrant), or (ii) that information is required
through consultation with other prescribed bodies. This
offers meaningful efficiency against current processes.
This reference to "other prescribed bodies" opens a door
that also could be praiseworthy from an efficiency and best
practices standpoint, and also ominous in its potential
Continued on page 19
http://www.ILMA.ORG
ILMA Compoundings - May 2019

Table of Contents for the Digital Edition of ILMA Compoundings - May 2019
