______
2012/CTI2/CD/FOR/015
Afternoon Session III
Chemical Dialogue Regulators Forum, 28 Feb- 1 Mar 2011 - Meeting Summary
Purpose: Information
Submitted by: United States
/ APEC Chemical Regulators' ForumSingapore
30 March 2012
APEC Chemical Dialogue Regulator’s Forum,
"Seminar on the Chemicals Sector – Regulations and Economic Development"
February 28 and March 1, 2011
Washington, DC, U.S.A.
Meeting Summary
During the seminar, participants discussed the link between good regulatory practices on the chemicals sector and economic development. In addition, participants had in-depth discussions on chemical inventories, a specific regulatory tool for the sound management of chemicals. Finally, participants brainstormed ideas on needs and priorities for future regulators’ forum meetings, seminars and possible project proposals.
February 28, 2011
Chemical legislation & regulations and their links to economic development
Description of Presentations: Chemicals management regimes among the APEC economies are at various levels of development, with multiple economies recently enacting chemical legislation, regulatory actions and efforts to align with international commitments. The sessions focused on how the chemical sector and regulatory efforts support economic development and also relate to current APEC and international interests with green growth and a green economy.
Following the Mid-Morning Presentations on the existing and new regulatory efforts, a question was posed about the ideal balance between flexibility and simplicity of regulations- wherein it was suggested that a more flexible regulatory regime is inherently more complex. The response was that complex regulations may not always benefit the consumer. The supporting example was of a US industry program that provided consumers with ingredient lists of some chemical products, purported to be more effective than the diverse and complex assortment of proposed state regulations that the voluntary program averted. Industry recognized the importance of consumer confidence in chemical products in the marketplace.
A second question related to how APEC might promote sharing of chemical hazard assessment based on the OECD model that saves $153 million Euros per year.[1] Response was positive but cautious, recognizing that the process occurs over time. Some economies in the region have bilateral agreements to further explore or facilitate such activities. It was proposed that a voluntary sharing of hazard assessment may precede regulations, and that industry recognized the benefit of participating in and supporting these processes.
Tools for chemicals management: Scope of Chemical Inventories and confidential business information
Description: A chemical inventory is a list of industrial chemicals manufactured in, or imported by, a economy. An inventory is a database created from information submitted to government authorities, and the content can range from only names of chemicals to the amount produced, location, and uses. These sessions focused on the scope of chemical inventories in the region, including: the overall scope of the inventor, definition of chemical for reporting purposes, and exclusions. Depending on the chemical and its uses, manufacturers may request that data they submit to government authorities as part of an inventory submission be confidential business information (CBI). At the same time, there is a need for regulators and the general public to know about chemicals in commerce and the risks that they may pose. The session focused on the scope of chemical inventories in the region and how the economies’ approach and handling of confidential business information claims differ in the context of chemical inventories.
The US has the largest CBI inventory wherein ca. 20% of chemicals on the inventory are CBI and still more are exempt from listing on the inventory at all. Some economies in the Asia Pacific region weigh public health against the company’s desire for trade secrets. Those economies rely more on intellectual property law and patent law to protect companies’ Research and Development investments. Only 4% of the inventory is CBI in Chinese Taipei and only a quarter of one percent of chemicals listed on the Australian inventory are granted CBI protection.
There was further discussion about sun-setting provisions for CBI. In the US, companies may ask for their chemicals to be placed on the confidential inventory until a specified date, at which time the chemical would be moved to the public inventory in what is described as a “self-sunset” provision. In Australia, chemicals are only listed on the inventory after 5 years; however, this is to offer companies the chance to recuperate regulatory costs rather than R&D investments.
A question was asked about whether a cost benefit was performed prior to the electronic publication of the inventory in New Zealand. The response was that the data published was already in the possession of that economy and therefore did not impose a reporting cost on industry in that economy; the only costs were the technology costs of making a database available on the internet.
Another question was about the threshold for reporting in two economies, and what CBI would be allowed in those economies. New Zealand replied that recent regulator activity changed neither the reporting thresholds nor the reported data in that economy. Another economy replied that the threshold is the combination of three factors, the most important of which is volume (mass). The regulations on the requirements for CBI justifications for that economy are based on Canada’s.
The next question was a request for a characterization of the reporting format in Canada. Canada was not represented at the meeting, but another economy answered that Canada required the name of the Company, Name of the Product, and the Chemical Formulation were all included on a 1 pager.
Another question directed at the US CBI review and declassification program, asked about collaboration with industry and challenges in the implantation of that program. It was replied that the primary challenge has been in the sheer volume of historical documents that must be reviewed in a short time frame. Companies have been helpful and flexible to adapt to this new review process.
Tools for Chemicals Management: Reporting Data, Maintaining & Updating Chemical Inventories & Links to Other Chemical Management Tools
There are many issues associated with the definition of a chemical. Some chemicals have well defined, discrete structures; however, there are many less well –defined materials, such as chemicals mined and used in an unaltered state, chemicals without discrete structures, geological materials, polymers, etc. The session also discussed on the type of data required by a chemicals inventory, and the reporting forms used by the economies in the region, including use codes and chemical nomenclature. They also touched upon the experiences economies have maintaining and updating inventories along with how inventories may be used for priority setting, defining new and existing chemicals, and other chemical management activities.
A regulator asked what have been the most useful features of inventories for industries. It was replied that a useful inventory should be searchable to determine if the chemical is on the inventory. There also needs to be a process for determining if a chemical is on the confidential portion of an inventory.
Tuesday March 1, 2011
Tools for Chemicals Management: Economy & Stakeholder Updates Including Efforts on Chemical Inventories & Links to Other Chemical Management Tools & Review of Priorities and the APEC Project Proposal Application Process
By providing basic information on the chemicals imported, used, and manufactured in a economy, an inventory can serve as an important basis for informed chemical management. The first morning session heard additional updates from economies and stakeholders on the development and use of inventories in addition to other chemical management activities. Subsequently, a review of previous priorities identified for possible project proposals was presented with an overview of the application process.
In Indonesia, the new Chemicals Regulationsmay be approved by the House of Representatives by 2012. Thailand, Philippines and Indonesia, have support from UNITAR for GHS. TheIndonesian Ministry of Industry will take primary responsibility for enacting the new law. If there is a conflict between the framework in the new law and the old laws, the new law will supersede those old laws.
In Malaysia,For EHS notification, of the 1116 companies identified, 242 are already registered. By April or May EHS registration will no longer be voluntary.
In Australia, progress continues toward GHS coordination in a steering committee that was formed in 2009. Regulators for Transport, Worker Safety, Environmental, Health, and the Attorney General (for chemical security) coordinate the portfolios. The Australian government wants to improve regulation,coordination, and consensus building in the direction of this major challenge.
As of January 1st, 20010 NICNAS must review industrial materials as part of the new chemicals program. This is an administrative change.
A US industry group put forth guidance for GHS on petroleum substances, mostly classes of UVCBs [Unknown or Variable compositions, Complex reaction products and Biological materials] to the UN GHS subcommittee. They submit that a grouping and category concept forglobal harmonization of hazard assessment obviates the need for testing of all substances and will reduce costs to industry and governments.
Regulators Forum Future Seminars and/or Project Proposals
With the “Case Study Workshop on the Chemicals Sector – From Principles to Practice” last March, there was a survey of participants on priority interests for future train-the-trainer seminars and/or project proposals. Having just reviewed some of these topics, and participated in this regulators’ forum seminar with a focus on chemical inventories, this session was devoted to brainstorming regulatory topics of future interest for meetings, seminars (including webinars) and possible project proposals.
It was noted that many of the economies that participated in the survey were not present for the current meetings and that some economies that were present did not participate in the survey.
It was proposed that to create a good training workshop required an original concept; a decision about the breadth versus the depth of training; and selection of the delivery method, date, and location of the meeting.
There was an open question about whether the training should be for trainers or for regulators.
It was proposed that there is a potential to link the existing work to industry Global Products Strategy (GPS), which includes stewardship for full life cycle, makes safety information available as an ICCA GHS profile, wherein the consumer can search for chemical safety information by product name. “High Priority” chemicals as defined by participating companies will be available by 2018. The Global Product Strategy (GPS) currently contains 1400 substances in its database.
There are three possible target economies:
- Those looking into developing a regulatory framework
- Those developing frameworks
- Those reforming frameworks (most of those present at the meeting)
We should look into how to combine this group’s priorities with another group’s, maybe from the energy group? It may be possible to put together something on the 2011 goals as they related to new technologies, think about ties into the “green economy” and UN framework with theCouncil on Sustainable Development.
In 2003 Taipei held a 2 day in dept training for 273 attendees, mostly regulators.
The Russian Federation was recognized. This session is their first attendance the regulator’s forum. Russia will host APEC next year. The Russian Federation invited APEC member economies to the CD in 2012 and welcomed advice on hosting the meeting. Russia has implemented chemical management activities for 12 years on the basis of national standards, but there is no federal law on chemical safety although one may be approved in a year. APEC meetings will boost the regulators’ profile.
Delivery and location of potential Workshop/Training
Asia Pacific region or Latin America region to host training workshop in a developing economy.
Also discussed was the possibility of using electronic means such as webinars and teleconferences as an additional option.
Finally, there is interest in CD based training for users to view on their own computers.
Another idea put forward was to pair with other organizations for expertise.
It was recognized that the priorities of those in the room seem to be the same as on the survey.
Specific foci may attract certain subgroups.
Australia, New Zealand, and Chinese Taipei would co-sponsor again.
End
1
[1] See “Cutting Costs in Chemicals Management: How OECD Helps Governments and Industry” available at