Environment Committee on Nov. 20th, 2006

[The Acting Chair, Liberal, John Godfrey]

I was thinking Dr. Khatter might. Which one of you two wanted to respond?

[Dr. Kapil Khatter]

I think we'd be very happy to have the idea that the burden of proof is on industry established in CEPA. I think the reality right now for existing substances is that it's not. And it really is a reasonable person test. I think if the Canadian public, when they bought a product, could ask the manufacturer whether the product, including all the substances and chemicals in it, was safe enough for them if they used it as directed, they would expect the answer to be yes. When it comes to existing substances, for which there is no data and for which no data has been submitted to the government, the answer is simply, “We don't know“. I don't think the Canadian public expects the government to be chasing after each and every product and chemical and policing this while those that are putting these substances and chemicals on the market aren't taking the responsibility for ensuring that what they are putting into the market is safe enough for use.

[The Acting Chair, Liberal, John Godfrey]

Thank you, Dr. Khatter.

Mr. Vellacott.

[Maurice Vellacott, Conservative, Saskatoon—Wanuskewin, SK]

There already were a couple of questions on the issue of confidentiality. I guess maybe our department people can respond on this as well. But apparently mask names may be used to hide some of that confidential information regarding a substance, “Where the publication...of the explicit chemical or biological name of a substance would result in the release of confidential business information”. So I'm curious. I don't know what the sense of the industry members is in terms of that particular possibility, and whether they get faced with this sometimes. In particular, how often have those mask-name regulations been used, and for what types of compounds?

Shannon, do you want to start?

[John Arseneau]

She has asked me to provide a little bit of background information on the use of mask names in the context of the new substances program.

Very often when a notifier brings forward a chemical for assessment, review, and entry into the market, there is a commercial context to that entry, and therefore they request a masking of the name on the DSL.

We assess and control the chemical exactly the same as we would with any others. We have received about 3,000 of those requests over the life of the program. We've refused requests just under 500 times. For the purposes of notifying the public and consumers of that chemical of any requirement we have imposed for notification for more data if there is a change in use or if there were conditions imposed, we reveal the name of that chemical. But generally, like other OECD countries with similar programs, we allow for the commercial confidentiality if there is no adverse public interest effect.

[Maurice Vellacott, Conservative, Saskatoon—Wanuskewin, SK]

I don't know if any others want to respond to that.

[Shannon Coombs]

That was a very good answer.

[Maurice Vellacott, Conservative, Saskatoon—Wanuskewin, SK]

Jessica.

[Jessica Ginsburg]

I would just make one additional point. I was involved in the new substances notification regulations on organisms that are essentially biotechnology products. In the context of that process I tried very hard, as a concerned member of the public, to find out what the protocols were on claiming confidentiality for biotechnology products, which, as you are probably aware, are a huge concern of the public. How biotech products are dealt with is a very hot topic right now in politics.

The response I was given was that despite the fact that there are guidelines around how the department and notifiers shall deal with confidential information, the de facto operating policy of the department was to treat all of the information as confidential unless they received written consent.

I asked three different people and received three different answers. That seemed to be the consensus in the end, but from my perspective there's obviously some confusion, which is part of the reason why we feel the test to be met in order to claim confidentiality should be part of the legislative language and not just part of the guidance.

[Maurice Vellacott, Conservative, Saskatoon—Wanuskewin, SK]

It's pretty widely accepted that the sharing of information obtained in other jurisdictions can help us speed up risk assessment. How is the issue of confidentiality handled with respect to the international sharing of information? Do confidentiality issues hinder the transfer of information, and how can that problem be addressed?

[John Arseneau]

I suppose I should try to respond to that as well. Thank you very much for the question.

Commercial confidentiality concerns do indeed have a huge impact on the useful exchange of information internationally among regulatory agencies. We try to overcome that problem by entering into confidential information exchange agreements with other jurisdictions.

For example, when REACH is finally adopted it will contain a clause that mirrors a clause in CEPA that allows for the confidential exchange of information. We also have a useful arrangement with Australia already in place. There are some difficulties with the United States because of the way the confidentiality arrangements are written into TOSC. There are some impediments there, but we've tried to overcome them through something called the four corners arrangement. It includes the chemical companies themselves waiving confidentiality requirements so they can share data with both agencies at the same time.

So we're constantly trying to do that, but there are some legal impediments there.

[The Acting Chair, Liberal, John Godfrey]

Thank you, Mr. Arseneau.

Monsieur Lussier.

[Marcel Lussier, Bloc, Brossard—La Prairie, QC]

In terms of confidentiality, I have some questions about the refusal to keep certain documents. What recourse do applicants have in this regard? Do they have a right to appeal if their confidentiality request is refused?

[The Acting Chair, Liberal, John Godfrey]

Mr. Arseneau.

[John Arseneau]

Thank you very much for the question.

The acceptance or refusal of a confidentiality request is a reviewable decision on the part of the minister and the exercise of the minister's discretion. There is communication between the government and the company claiming confidentiality--an exploration of what can be released that is not necessarily commercially confidential within the guidelines we use. Then the ministers make a decision. The companies involved have a period within which they can choose to appeal that decision through the judicial system.

[The Acting Chair, Liberal, John Godfrey]

Ms. Ginsburg.

[Jessica Ginsburg]

I want to reiterate what Mr. Arseneau said and highlight the fact that there is an appeal provision for companies that feel their information should have been kept confidential, but there's no comparable provision allowing appeals for the public or other interested parties who feel that information should be disclosed--at least not in the text of the act.

[Marcel Lussier, Bloc, Brossard—La Prairie, QC]

I would go even further. The documents are submitted to Environment Canada and Health Canada. As a result, departments have technical information on each product. If a product is ingested, it is written somewhere that a physician may consult Environment Canada or Health Canada for information about how to treat the patient who consumed this product.

How should we proceed in these cases? Is it a rapid procedure or a procedure that takes two weeks?

[Paul Glover]

I am not sure of the timeframe for this part of the act. However, under this act, either department can provide the information necessary to assist an individual, such as a physician. In fact, the possibility to provide information held by either department is included in the act.

[Marcel Lussier, Bloc, Brossard—La Prairie, QC]

How do you know that it is a physician calling and not a competitor?

[Paul Glover]

For this application of the act, physicians or groups must identify the reason why they are requesting the information. They should not request it only because thy want this information; they must be asking it for it for a patient.

[Marcel Lussier, Bloc, Brossard—La Prairie, QC]

Like in an emergency?

[Paul Glover]

Yes.

[Marcel Lussier, Bloc, Brossard—La Prairie, QC]

All right.

The Senate is currently studying a bill on the Workplace Hazardous Materials Information System (WHMIS). All confidentiality matters are being reviewed.

Are you aware of this bill?

[Paul Glover]

No, I am not aware of this bill.