10a PRMA Flashcards
what is PRMA?
pest management regulatory agency
-the federal agency responsible for regulation of pest control product (“pesticides”) in canada
-PRMA=federal authority under the pest control products act (PCPA)
in addition to regulating pesticides, the PRMA also:
-develop pest management policies and guidelines
-promote sustainable pest management
-continuously improve the regulatory process to increase efficiency
-enforce compliance with the PCPA
-distribute pest management information to the public and stakeholders
what is the primary PRMA mandate?
prevent unacceptable risks to people and the environment from the use of pest control products
what are the secondary mandates of PMRA?
- support sustainable development in agriculture (balance environmental and economic needs)
- encourage development and implementation of lower risk products and sustainable pest management strategies
- minimize health and environmental risks posed by pest control products
- increase public awareness of and interaction in the regulatory process
what is the pesticide registration process?
before a pesticide can be registered, it has to be tested to determine:
-risks to humans
-risks to environment
-the pesticides value (efficacy)
-these tests are completed by the manufacturer (e.g., Bayer, Syngenta, Monsanto, etc.) and must follow the principles of Good Lab Practices
the PRMA reviews the submitted data to determine if the product is acceptable for use in canada
-the PRMA also compares results with regulatory counterparts in the EU (EFSA) and USA (EPA) to ensure that they have reached similar conclusions
what is the table of the pesticide evaluation process?
what is the graph of pesticide registrations in canada?
how much does the product chemistry, biology/efficacy, toxicology, and environmental chemistry cost in the pesticide registration process?
-product chemistry: from synthesis to production=110-120 million USD
-biology/efficacy: lab and greenhouse experiments->pilot trials->field trials->optimization=140 million USD
-toxicology (mammalian and environmental): toxicity testing (various sp.)
-environmental chemistry: fate, metabolism and residues= 90-100 million USD (combined)
how much does the pesticide registration cost?
-from start to finish of registration process, companies typically go from 100,000 to 1 active ingredient, with an end cost of 350M USD
-canada-specific registration costs=10M (mostly persistence and efficacy)
-newly registered products are on ‘probation’ for 3-5 years (thus can easily be removed from market if unexpected problems occur)
what is the typical time for the pesticide registration process?
typical timeframes
-screening (product chemistry, efficacy): 4-5 years
-research (toxicology, chemistry): 3-4 years
-regulatory evaluation (e.g. PMRA): 1-2 years
(re-evaluation and special review: at least every 15 years)
what is the PCPA?
pest control products act
-original PCPA introduced in 1969
-most recent PCPA bill introduced in 2002, and came into full effect in 2005
-the PCPA is the federal law that controls the import, sale, manufacture and use of pesticides in canada
-focus: manage risks to humans and the environment posed by pesticides
-all pesticides proposed for registration must go through a pre-market assessment to ensure only products that pose acceptable risks and have value are registered
what are the primary objectives of PCPA 2002?
- strengthen the environmental and human health protection provided by the PCPA
- make the registration system more transparent
- strengthen post-registration controls
what are the pesticide residues in food (PCPA 2002)?
-maximum residue limits (MRL) are specified by the PRMA to ensure food is safe to eat
-MRLs are established as regulations under the food and drug act (FDA)
-the canadian food inspection agency (CIFA) is responsible for monitoring the food supply to ensure compliance with the FDA
-there were approx. 24,000 MRLs in canada in 2020
what are the PCPA 2002 vs. 1969 main improvements?
- strengthened human health and environmental protection
- make registration system more transparent
- strengthen post-registration control of pesticides
main improvements: strengthened human health and environmental protection by:
-requiring special protection for infants, children and other vulnerable groups (using safety factors)
-taking account of pesticide exposures from all sources, including food and water (aggregate exposure) and considering cumulative effects of pesticides that act in the same way
-supporting pesticide risk reduction. For example, ensuring that only pesticides that make a useful contribution to pest management are registered (value); encouraging the registration of lower-risk products; setting use rates and use frequencies as low as possible
-requiring that Material Safety Data Sheets (MSDSs) are provided in all places where pesticides are sold and use
-ensuring environmental evaluations and take into account effects on animals, plants and biological diversity
main improvements: make registration system more transparent by:
-allowing public consultation on all major pesticide registration decisions
-allowing the public to view test data on which pesticide evaluations are based (confidential test data)
-allowing PMRA to share scientific studies with provincial, territorial and international regulators (incl. international Joint Reviews)
-legislating that companies must provide pesticide sales data to the PRMA
main improvements: strengthen post-registration control of pesticides by:
-require incident reporting from pesticide companies (adverse effects on human and environmental health from normal use must be reported)
-requiring re-evaluations of older pesticides every 15 years after they are registered. Also, provides the minister with the authority to remove pesticides from the market if required data are not supplied
-providing increased power of inspection with higher maximum penalties (up to $1M) when pesticides are not marketed or used in accordance with the law
-using the precautionary principle during re-evaluations and special reviews (i.e. do not wait for full scientific certainty before taking mitigative action)
what is incident reporting in canada?
policy introduced in 2008: serves as a way to collect information about potential risks of registered pesticides already in use
-year 1 (2008): 934 incident reports filed
-by 2020 (year 13): >25,000 incident reports filed (2,400 in 2017-2018; 5,650 between 2018 and 2020)
what is the different in incident reporting between the us and canada?
must report on major effects to human health and domestic animals from use in both canada and the usa. in 2008:
-61% of incidents occurred in canada, 39% in US (canadian reports include all incidents; US reports only major incidents)
-50% of canadian incidents in ON; SK-highest incident filling per population size
for US incidents, registrants are only required to report human death, human major incidents and domestic animal death
-in canada, all six categories
what are the 6 types of incident in canada?
rankings in 2008
1. domestic animal=539 (58%)
2. human=266
3. environment=85
4. packaging failure =36
5. scientific study=12
6. food residue=1
what are the majority of incidence reporting?
-the number of human and domestic animal incidents is higher than other categories because they include both canadian and US data
-the majority of environmental incidents were lawn damage
-most incident reports do not contain enough information to determine if a pesticide has been used according to label instructions (reporting of a particular effect does not necessarily mean that it was caused by the suspected pesticide)
-the information from a single report is generally not sufficient to evaluate the level of risk or recommend regulatory actions
-potential risk will be identified by searching for trends or patterns in data
-incident reporting helps inform the big picture
what is the case study of flea products?
2008 trend: a high number of incidents reported for flea products
-14 major effects and 15 deaths (domestic animal): incidents primarily occurring with cats and young dogs
-most cases involved “spot-on” products, most pyrethroid based
what was the action and result of the flea products case study?
-the trend was spotted due to the pattern of incident reporting on pest control products
-action: better labelling, better use directions, clearer precautionary statements on products
-result: domestic animal deaths and adverse effects decreased
-however: ‘use as directed’ is still allowed on the label of flea products-so problem is not 100% solved. Products still misused by people who do not properly read the product labels and use instructions
