ENVI Committee Report
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10. RE-EVALUATION OF PESTICIDES AND SPECIAL REVIEWS
10.1 Pesticides, once registered, and therefore deemed to be safe and of value, do not presently undergo systematic re-evaluation unless there is evidence or strong indication that they pose unacceptable risks to human health or the environment.
10.2 In his 1999 report, the Commissioner of the Environment and Sustainable Development criticized the PMRA for not re-evaluating "old pesticides,"175 pointing out that of the 500 active ingredients in registered pesticides, over 300 were approved before 1981 and over 150 before 1960. The Commissioner expressed frustration over the lack of progress that the Canadian government has made towards the re-evaluation of pesticides.
| The need to re-evaluate pesticides has been formally recognized by the federal government for over 13 years, and we expected that it would have developed a program to do so. We found Canada's track record to be one of inaction and unfulfilled commitments.176 |
As new information becomes available on the fate and effects of toxic chemicals, new testing schemes are introduced into the risk assessment framework. The re-evaluation of old pesticides is necessary because pesticides that were registered 15 years ago did not receive the same scrutiny as those that are currently being registered.
10.3 Although the PMRA is conducting re-evaluations of some old pesticides, progress has been slow and it is unclear if these reviews have incorporated parameters such as cumulative and aggregate risk. The Committee discovered that some re-evaluations have been under way for up to 20 years (e.g. review on pentachlorophenol).177 In the view of the Commissioner of the Environment and Sustainable Development, the World Wildlife Fund (WWF), the Canadian Environmental Defence Fund (CEDF) and the Canadian Manufacturers of Chemical Specialities Association (CMCS), the re-evaluation of pesticides is not as effective, or progressing as quickly, as it should be in Canada. They propose, therefore, that a rigorous, clear, timely and well-funded re-evaluation program be established immediately.
10.4 The CMCS indicated that its members currently have difficulty understanding the way evaluations will be addressed, including the amount of information that will be accepted from other countries, the cost to the registrants, and the timelines. The CMCS, the CEDF, the WWF and the Crop Protection Institute (CPI) feel that the re-evaluation program should set precise triggers for what will be evaluated, when and why, and establish a mechanism for communication and for public appeals.178 The PMRA responded, in part, to these concerns by publishing a regulatory proposal entitled 'A New Approach to Re-evaluation' in December of 1999.
10.5 This new approach to the re-evaluation of pesticides was presented by the PMRA to the Pest Management Advisory Council, to the Economic Management Advisory Committee and to other government departments for comments. As recommended in 1990 by the Pesticide Registration Review Team and accepted by cabinet, the re-evaluations will utilize reviews from other countries if they are up to Canadian standards.179 The PMRA told the Committee that the assessments will incorporate considerations of US practices, as outlined in the US Food Quality Protection Act, and will address aggregate risk from all sources of exposure as well as cumulative risk for pesticides with similar modes of action when assessment methodologies become available. The PMRA will also be applying an increased safety factor for infants and children. It is expected that by 2005-06, all pesticides that were registered prior to 1995 will have been re-evaluated. The target for completion of the re-evaluations of organophosphate pesticides is December 2000.180
10.6 Given the unknown, and therefore potential, risks posed by pesticides, the Committee would ideally like to see the re-evaluations completed in as short a timeframe as possible. However, we respect that the evaluation process that is carried out in Canada will benefit from the evaluations conducted in the United States and other countries and we also do not wish to see the re-evaluation process hinder the registration of new and potentially safer alternatives. Given these two considerations, it is our position that completion of re-evaluations no later than 2006 is acceptable.
| The Committee recommends that the re-evaluation program be adequately funded so that all pesticides registered prior to 1995 be re-evaluated no later than 2006. |
10.7 The PMRA's directive on re-evaluation proposes a four-program approach. These four programs, in some ways, dictate the priority and/or speed with which reviews will be completed. For example, two of the programs will be tied to US priorities, progress and success. The PMRA directive also requests public involvement in setting priorities. The Committee is in agreement with most of the witnesses who have stated that children should be the primary focus of risk assessment and risk management activities. Priority for re-evaluation should be given to substances that are suspected of affecting fetal development and the health of children, especially neurotoxicants and endocrine disrupting substances.
10.8 The Committee recognizes that the re-evaluation of all pesticides that were registered prior to 1995 will require both human and capital resources. It remains unclear, however, how the PMRA is going to fund these re-evaluations. The Canadian Association of Physicians for the Environment indicated that funding sources must be made clear to ensure that funding is not an obstacle to the process.181 The Canadian Manufacturers of Chemical Specialties Association and the Crop Protection Institute felt that the PMRA should avoid funding re-evaluations by shifting resources away from new product registration.182 The former witnesses stated instead there should be an additional allocation of resources from the Treasury Board.183
10.9 An additional mechanism for the re-evaluation of previously registered products is through special review. Special reviews on specific pesticides or groups of pesticides can be initiated in response to new information. For example, a special review of carbofuran was initiated in 1990 as a result of requests from Environment Canada scientists. This review resulted in the discontinuation of the granular form of this pesticide. Unfortunately no other special reviews have been initiated by PMRA since that time.184
10.10 Special reviews could be an invaluable tool for responding to concerns arising from post-registration monitoring or from the mandatory reporting of adverse effects that the PMRA is proposing. The PMRA is currently proposing that triggers and processes for re-evaluation and special reviews be articulated in the new Pest Control Act. They are proposing that the Act would state, among other things, that the Minister 'must initiate a special review if there is reason to believe that risks or value may not be acceptable' and 'must respond with a rational to a request from the public to initiate a special review.'185 Scientific advancement or a request from the public could also trigger a special review. In addition to requirements for re-evaluation and special review, the new Pest Control Act should authorize the Minister to impose requirements regarding the disposal of pesticide stocks. This requirement would help avoid the long-term storage or dumping of de-registered pesticides.
10.11 Although the PMRA's proposals for special reviews are welcome, the new legislation should state that a special review must be initiated if there is reason to believe that the risks may not be acceptable, without specifying when or how this would be determined.
| The Committee recommends that the new Pest Control Act contain provisions for special review of pesticide registrations, and that when a member country of the Organization for Economic Co-operation and Development (OECD) bans a pesticide for safety reasons such a review be mandatory. |
10.12 The re-evaluation of all pesticides registered prior to 1995 is a monumental task. The re-evaluation of pesticides must not only be as thorough as the assessments that are currently conducted by the PMRA but must also take into account all relevant recommendations made in this report.
10.13 In order to avoid having backlogs of re-evaluations, the Committee believes that a systematic re-evaluation process is required. The US has a process for mandatory re-evaluation every 15 years.186 With this is mind the Committee recommends that the longest time a pesticide should be registered for use without evaluation be 15 years. For example, if a product were registered in 2000, provided there were no special reviews conducted on that pesticide, it would automatically be reviewed again in 2015. If, however, a special review was conducted in 2005 then the pesticide could remain registered until 2020 before a mandatory re-evaluation would triggered.
| The Committee recommends that the new Pest Control Act specify that, in the event that a pesticide has gone 15 years without being assessed, either through registration or special review, a re-evaluation by the Pest Management Regulatory Agency be required within one year. |
10.14 The re-evaluation of pesticides is of top priority for the witnesses and for the PMRA alike. The combination of a rigorous and well-funded re-evaluation program and a system for special review will enable the PMRA to keep pesticides that are on the market up to date.
175 Old pesticides are loosely described as pesticides that were registered prior to 1995.
176 Report of the Commissioner of the Environment and Sustainable Development, Chapter 3, 1999.
177 Canadian Environmental Law Association and the Ontario College of Family Physicians, Brief to the Committee.
178 Evidence, Meeting No. 5, November 17, 1999; Evidence, Meeting No. 129, June 10, 1999; Evidence, Meeting No. 9, November 25, 1999.
179 Pest Management Regulatory Agency, Proposed Amendments to the Pest Control Products Act, January 1999.
180 Evidence, Meeting No. 126, June 1, 1999.
181 Evidence, Meeting No. 11, December 1, 1999.
182 Evidence, Canadian Manufacturers of Chemical Specialities Association, Meeting No. 8, November 24, 1999; Evidence, The Crop Protection Institute, Meeting No. 9, November 25, 1999.
183 Evidence, Meeting No. 8, November 24, 1999.
184 Report of the Commissioner of Environment and Sustainable Development, Chapter 3, 1999.
185 Pest Management Regulatory Agency, Proposed Amendments to the Pest Control Products Act, January 1999.
186 United States Code, Title 7, Chapter 6, section 136a(g)(1).