PRB 98-1E
SITUATION WITH RESPECT TO rbST IN CANADA
Prepared by:
Frédéric Forge
Science and Technology Division
October 1998
Provel, a division of Eli Lilly
Canada Inc., submitted an application for approval of its product based on recombinant
bovine somatotropin (rbST) in March 1988. At Provel’s request, the application was
put on hold in May 1996.
In 1990, Monsanto Canada made
an application for approval of its rbST-based product (sometribove, marketed under the
name "Nutrilac").
In April 1994, the Standing
Committee on Agriculture and Agri-Food published a report entitled rbST in Canada.
The Committee made seven recommendations including the imposition of a one-year moratorium
for conducting a detailed review of the impact of rbST and creation of a task force to
carry out that review.
A one-year moratorium on the
sale of rbST was put in place in July 1994. This moratorium is still in effect.
In September 1994, the Minister
of Agriculture and Agri-Food created an rbST Task Force; this task force includes a
representative from each of the following organizations: Agriculture and Agri-Food Canada,
Consumers Association of Canada, Dairy Farmers of Canada, Industry Canada, Monsanto Canada
inc., the Council for the Dairy Industry of Canada and Provel ( a division of Eli Lilly
Canada Inc.).
In May 1995, the rbST Task
Force published its report entitled Review of the Potential Impact of Recombinant
Bovine Somatotropin (rbST) in Canada. (See Section on Impact of rbST on the Dairy
Industry.)
In May 1997, an article in the Globe
and Mail reported that some Health Canada scientists had questioned the process for
assessing the impact of rbST on human health.
In July 1997, the
Dairy Farmers of Canada asked that the Auditor General review the rbST approval process,
that the Codex alimentarius Commission(1)
express an opinion on whether the hormone is harmless, and that Health Canada inform the
public of the process for assessing the approach used in deciding whether to grant
approval.
In July 1997, the
Netherlands proposed a motion to the Codex alimentarius requesting that
establishment of a maximum limit for residues be delayed while data relating to human
health were reassessed by the Joint FAO-WHO Expert Committee(2) on Food Additives and the application of
"legitimate factors other than the scientific analysis" was reviewed. Canada
voted against the motion.
The
assessment of rbST is still on-going. Health Canada has asked Monsanto for further
information on the impact of rbST on the animals treated. There have also been two major
developments:
- An internal Health Canada team made up of renowned
scientists has examined the process for assessing rbST following the questioning of this
process by scientists from the department (some criticisms had appeared in the press). The
study has revealed certain flaws in the evaluation process and its scientific findings.
- An evaluation by a third party, which will be included in
the decision-making process, is under way. Two groups of experts -- under the direction of
the Canadian Association of Veterinarians for the animal health aspect and the Royal
College of Physicians and Surgeons of Canada for the human health aspect -- are currently
evaluating the product. The report is scheduled to appear in the fall of 1998.
As long as rbST has not
received a notice of compliance, it cannot be sold legally in Canada.
(1) The Codex
alimentarius (the Latin term for food code) Commission is part of the World Health
Organization (WHO) and the United Nations Food and Agriculture Organization (FAO) and has
146 member countries. Since it was established in 1962, one of its goals has been to
define food standards and codes governing hygiene and technology in light of the safety of
food additives and contaminants (it has evaluated more than 700 additives and determined
more than 3,200 maximum levels of pesticide residues).
(2) United Nations Food and Agriculture
Organization (FAO) and the World Health Organization (WHO). |