Oral Comments

of the

American Petroleum Institute

on

U.S. Government Positions for the 20th Session of the 

United Nations Subcommittee of Experts on the Globally Harmonized System
of Classification and Labelling of Chemicals 

(UNSCEGHS)

75 FR 69472 – 69473, November 12, 2010

November 30, 2010

By

Derek D. Swick

Policy Advisor

  HYPERLINK "mailto:swickd@api.org"  swickd@api.org 

202.682.8341

American Petroleum Institute

1220 L Street, Northwest

Washington, DC  20005

202-682-8000

Oral Comments of the American Petroleum Institute

Proposals in Preparation for the 20th Session of the 

United Nations Subcommittee of Experts on the Globally Harmonized System
of Classification and Labelling of Chemicals (UNSCEGHS)

Introduction 

My name is Derek Swick, and I am a Policy Advisor with the American
Petroleum Institute (API).  API is a nationwide, not-for-profit trade
association whose members include over 400 companies engaged in all
aspects of the oil and natural gas industry, including exploration,
production, transportation, refining, and marketing.  

API is pleased to make these comments to the U.S. Interagency GHS
Coordinating Group for consideration in developing U.S. government
positions for the 20th Session of the United Nations Subcommittee of
Experts on the Globally Harmonized System of Classification and
Labelling of Chemicals (UNSCEGHS).

API member companies comply with many OSHA standards including the HCS
and support OSHA’s efforts to ensure that workers are provided with
information about hazards of chemicals they may be exposed to in the
workplace.  Through HCS compliance programs and broader safety and
product stewardship programs, API’s members evaluate the hazards of
the chemicals they produce or import and provide information about them
through container labels and detailed chemical information sheets (i.e.,
the Material Safety Data Sheet (MSDS or SDS)).  Each member company
prepares and implements a written hazard communication program, ensures
that chemical containers are labeled, provides employees with access to
SDSs, and conducts training for potentially exposed employees.  API
members are regulated under the existing HCS, and any change to it will
directly affect them.

Our following comments are organized by UNSCEGHS paper and topic.  

ST/SG/AC.10/C.4/2010/20 

Proposals from the informal working group on GHS implementation issues:
Global list of GHS classified chemicals 

API supports the UNSCEGHS discussion on a global list of GHS classified
chemicals.  API would like to summarize and emphasize positions
presented in comments on OSHA’s GHS NPRM and in the submission by the
International Petroleum Industry Environmental Conservation Association
(IPIECA) in response to the UNSCEGHS survey on classification lists.

A global list of GHS classified chemicals has maximized value when it is
accepted by all countries implementing the GHS.  The proliferation of
national/regional lists is contrary to harmonization.

The benefits of a global list of GHS classified chemicals include
supporting cost-effective implementation, avoiding duplication of
effort, and promoting harmonization/consistency in classification. These
benefits apply to everyone:

A global list of GHS classified chemicals is useful to governments to
avoid duplication of effort in creating national systems, facilitate
international trade in chemicals, promote harmonization/consistency, and
reduce the costs of enforcement.  Also an international list of
chemicals classified in terms of the GHS will improve safety for workers
and others through consistent and harmonized communications on chemical
hazards and practices to follow for safe handling and use.

A global list of GHS classified chemicals is useful to manufacturers to
promote cost-effective implementation, to facilitate international trade
in chemicals; in applying expert systems resulting in maximizing expert
resources and minimizing labor and costs, to facilitate electronic
transmission systems with international scope, to promote
harmonization/consistency, to expand the use of training programs on
health and safety, to improve the credibility of communication, and to
reduce laboratory testing on animals.

A global list of GHS classified chemicals will greatly benefit countries
without national GHS implementing legislation and regulation and
countries lacking the capacity to implement the GHS.   

A global list of GHS classified chemicals will focus attention on
divergent chemical classifications on multiple regional lists and
regional classifications that stray from the GHS criteria.  

In order to promote the overarching GHS goals of global harmonization
and facilitation of trade, it is essential that any global list of GHS
classified chemicals:

be based on a rigorous, evidence-based scientific process to be defined
in advance and applied globally;

contain the data to support the classifications or a section explaining
the rationale behind the classifications;

ensure accuracy by including impurities and CAS numbers for the
chemicals;

include mechanisms for updating as new evidence-based science becomes
available; 

have defined criteria for source data;

provide a conflict resolution mechanism; and

have provisions for stakeholder input/data.

Furthermore, the fundamental premise in the GHS of self-classification
should be maintained in efforts to develop any list of GHS
classifications.  According to the GHS Purple Book

“One objective of the GHS is for it to be simple and transparent with
a clear distinction between classes and categories in order to allow for
“self classification” as far as possible.”

Thus, future discussions on this topic must consider the benefits of a
global list of GHS classified chemicals along with the need to maintain
GHS’s self-classification premise and criteria-based approach.

 

Developing and maintaining a global list of GHS classified chemicals
will be very resource intensive.  It will be important to prioritize
resources to develop a list that has maximum impact and value for the
resources expended.  A first step would be to review existing
national/regional classification lists to establish priority setting,
since those lists already represent priorities for those countries. The
first step in development of any classification list is the development
and agreement on the criteria for inclusion of chemicals on the list.

It would be logical to start with common hazardous high volume chemicals
with multiple suppliers that are involved in international trade.  To
facilitate acceptance and a propitious beginning, it would also be
logical to start with the chemicals where there is already agreement
among the existing regional classification lists.

ST/SG/AC.10/C.4/2010/15 

Proposals to address issues from the programme of work for the practical
classification issues correspondence group 

This paper proposes recommended editorial changes to the GHS text which
would be incorporated into the next revised edition of the GHS.  The
changes include adding to GHS Chapter 1.3 that CMR classification is
usually based on the ingredients and testing out is only on a
case-by-case basis.  This proposed change would de-emphasize the role of
data on the mixture as a whole for use in classification of CMRs.    

API supports the text in the individual germ cell mutagenicity,
carcinogenicity, and reproductive toxicity chapters that allows
classification based on test data for the mixture as a whole on a
case-by case basis. Testing out should be allowed if data are
sufficient.  

Currently the GHS germ cell mutagenicity, carcinogenicity, and
reproductive toxicity chapters state that

“… classification may be modified on a case-by case basis based on
the available test data for the mixture as a whole. In such cases, the
test results for the mixture as a whole must be shown to be conclusive
taking into account dose and other factors such as duration,
observations and analysis (e.g. statistical analysis, test sensitivity)
of germ cell mutagenicity, carcinogenicity, and reproduction test
systems. Adequate documentation supporting the classification should be
retained and made available for review upon request.”

It is important that the GHS maintain for CMRs this principle that
allows consideration of test data for the mixture as a whole on a
case-by-case basis taking into account certain factors.  In the
formative GHS discussions this concept was a deal breaker for USA
stakeholders.  There was much discussion and the text currently in the
germ cell mutagenicity, carcinogenicity, and reproductive toxicity
chapters was agreed to.  The U.S. should oppose this editorial amendment
to GHS Chapter 1.3 at the upcoming UNSCEGHS meeting.  

ST/SG/AC.10/C.4/2010/17 

Draft terms of reference for the work on corrosivity criteria 

Can the U.S. Interagency GHS Coordinating Group explain the tasks and
work that will be done under the Terms of Reference for the work on
corrosivity criteria?  It is not clear from this paper exactly what work
is to be done.  

Several points in the paper are broad, general, and vague and there
appears to be at least one typographical error.

Point (b) is not clear.

(b) Identify the discrepancies between assignment to sub-categories 1A,
1B and 1C, based on testing and the one based on theoretical approaches
(bridging principles, mixtures calculations, pH…);

What are the assignments to sub-categories 1A, 1B, and 1C based on
theoretical approaches (bridging principles, mixtures calculations, pH)
that are to be considered?  Where are these assignments to
sub-categories 1A, 1B, and 1C based on theoretical approaches (bridging
principles, mixtures calculations, pH) to be found?  Are there reference
documents?

Point (c) is not clear.

(c) Identify differences in assignment to categories in lists provided
by different regulations and guidance documents for the most common
substances. Analyse the reasons for these differences and use these
results for the work under paragraphs 1, 2 and 4.

What are the regulations and guidance documents that are to be
considered?  What are the most common substances? Should the text
actually read “paragraphs a, b and d”?

Point (d) is not clear.

(d) Check the way OECD guidelines are referenced to and their relevance.

What does this mean?

The U.S. should request clarification on the terms of reference for the
work on corrosivity criteria at the upcoming UNSCEGHS meeting.  

Programme of Work of the Practical Classification Issues (PCI)
Correspondence Group in the Next Biennium (2011 – 2012)  

API thanks the U.S. delegation to UNSCEGHS in agreeing to lead future
work on the harmonization of IMO and GHS SDS formats and requirements.  

At the 19th Session of the UNSCEGHS, the Sub-Committee agreed (1) to
include an item on the development of guidance to address the needs of
IMO for MARPOL Annex I cargoes and marine fuel oils in the GHS in the
Sub-Committee’s program of work for the next biennium and (2) that the
proposals made by IPIECA in UN/SCEGHS/19/INF.18 be taken as the basis
for the work.  The U.S. agreed to lead this work in the next biennium
and suggested that the future work be addressed by the correspondence
group on practical classification issues (i.e., PCI Correspondence
Group).  The Sub-Committee agreed with this proposal.  API, through
IPIECA, looks forward to working with the PCI Correspondence Group in
framing its programme of work for the next biennium and the timely and
successful completion of that work.

As the UNSCEGHS begins its work on the harmonization of the divergent
IMO and GHS SDS formats and requirements, API believes it is critical
for the U.S. Coast Guard to become involved in U.S. representation at
the UNSCEGHS.  The U.S. Coast Guard should begin to play an active role
in the U.S. Interagency GHS Coordinating Group as the Coast Guard is
currently grappling with implementation of the GHS as evidenced by Coast
Guard SDS requirements for MARPOL Annex 1 cargoes and marine fuel oils
which will be proposed in the near future.  See the June 26, 2009 U.S.
Coast Guard Federal Register Notice on U.S. implementation of SOLAS
regulation VI/5-1.  Further, we encourage a representative of the U.S.
Coast Guard to sit on the U.S. delegation for upcoming UNSCEGHS meetings
and to actively participate in PCI Correspondence Group discussions on
this issue.   

Conclusion and Continued Need for U.S. Stakeholder Input before UNSCEGHS
Meetings 

API thanks the U.S. Interagency GHS Coordinating Group for organizing
this public meeting in preparation for the upcoming session of UNSCEGHS.
 Such open meetings should take place before every UNSCEGHS session and
not only for meetings at the conclusion of the UNSCEGHS biennium.  

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