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Response to the DAFF enquiry into: A National Scheme for Assessment, Registration and Control of Use of Agricultural and Veterinary Chemicals – Discussion Paper
9 February 2010
Community Consultative Community
Dear Sir/Madam,
Re: A National Scheme for Assessment, Registration and Control of Use of Agricultural and Veterinary Chemicals
The Community Consultative Committee (CCC) of the Australian Pesticides and Veterinary Medicines Authority (APVMA) provides a vehicle for effective two-way communication between the national chemical regulator and community representatives concerned about pesticides and veterinary medicines.
http://www.apvma.gov.au/about/committees/consultative/index.php
The CCC supports a National Approach Assessment, Registration and Control of Use of Agricultural and Veterinary Chemicals and is pleased to have the opportunity to submit this response.
However we are not for change for change sake.
“The underlying rationale for regulating agvet chemicals rests on two things. First is the likelihood that their uncontrolled use could have negative consequences for public health, occupational health and safety, crop/animal safety, the environment and trade. In economic terms some of those consequences take the form of external costs. Second is the existence of information failures or asymmetries. For example, while the producer knows what chemicals have been applied to a food crop consumers are unlikely to be able to tell (Discussion paper p. 11).”
The CCC supports this underlying rationale and urges COAG to use this as a basis for determining what model/s will be used and the progressing of this important issue.
It is important in our view to ensure all stakeholders have confidence in the regulation of new and existing agvet chemicals and the issues surrounding the safe use of agvet chemicals through to food safety.
Q1 In either the current state and territory control of use or APVMA responsibilities for agvet chemicals are there any gaps, overlaps or unnecessary inclusions and, if so, what are they?
- Different jurisdictions monitor compliance in different ways, approaches to minor use, control of use, enforcement, control of use, intensity of approach, monitoring of residue levels/contamination, enforcement
- No state has a single entity or agency to control of use activities
- No standard for all users to have accredited training
We support the need for a standard approach for elements of agvet chemicals, compliance, control of use, intensity of approach, monitoring of residue levels/contamination, enforcement, regulation, responsible use, education of users and consumers to name but a few.
This would allow a consistent standard/approach across all jurisdictions, which would allow all stakeholders of the agvet sector (e.g. manufactures right down to the buyers of food) to have confidence that no matter where they are in the agvet chain or jurisdiction there is a consistent approach to the regulation, manufacturing and use of agvet chemicals in Australia.
The CCC draws attention to the role of risk communication as an area of a gap in what is currently happening. The United States of America Food and Drug and Administration (FDA) in its 2009 Strategic Plan for Risk Communication suggest the following regarding Risk Communication:
- “interactively sharing risk and benefit information to enable people to make informed judgements about use of FDA-regulated products and
- providing guidance to relevant industries about how they can most effectively communicate the risks and benefits of regulated products.”
(FDA 2009, p. 8)
Further the FDA nominates the underlying principles that guide its planning and commitment to how the agency conveys the risk and benefits of regulated products.
- Risk communication is science based
- Risk benefit information provides context and is adapted to audience needs
- Risk communication is results oriented
(FDA, 2009, pp. 10-12)
The World Health Organisation states “Risk communication is an interactive process of exchange of information and opinion on risk among risk assessors, risk managers, and other interested parties” and “is an integral and ongoing part of the risk analysis exercise, and ideally all stakeholder groups should be involved from the start.” (WHO, 2010)
“Good risk communication and consultation results in an outcome where there is a high level of agreement between the affected parties. It also entails knowing how to respond to public concern and is a genuine process conducted with the community’s interest in mind. Good risk communication and community involvement will enable government and industry to better understand public perceptions and to more readily anticipate community responses. It will increase the effectiveness of risk management decisions and reduce unwarranted tension. It will explain risks more effectively and constructively inform communities.”
(Dept. Health and Ageing, 2004)
The CCC asks that the four consultative committees representing the community, government, rural industries and the chemical industry continue into the new framework to ensure all stakeholders views and concerns are known before major decisions are made. At present only the APVMA has a process of regular engagement with its stakeholders.
In summary the CCC asks that Risk Communication become an objective and principle of the new framework to ensure all stakeholders have input and that the regulator knows the views of its stakeholders.
Q2 How effective are the current registration arrangements for facilitating adequate chemical access for minor uses?
- At present there is no consistency
Q3 What particular costs or benefits would arise from greater integration of assessment, authorisation and control of use of agvet chemicals?
- Consistent approach to data collection
- Consistent information flow as information collected would be based on same format/criteria/terminology
- Reliable actual use figures
- Consistent/standard use of AERP
- Consistent/standard use of agvet chemicals
With a national framework for the regulation of agvet chemicals we urge COAG to ensure whatever model/s used to ensure all data collection would be based on the same terminology, definitions, format, approach; this would allow the data that is collected to enhance evidenced based policy and decision making.
Q4 What do you take the precautionary principle to mean? What are the potential costs or benefits that could arise from adoption of a more precautionary approach in circumstances where lack of full scientific certainty exists in agvet chemical assessment, registration or control of use?
In a situation of lack of full scientific certainty, communities would expect their regulatory agencies to err on the side of caution – that is, not to permit use of chemicals unless data were available for a full scientific review of its uses for the designated range of conditions. Failure to act in such a manner would lead to lack of trust in the agency and of its processes, affecting not only communities’ responses to the chemical subject to the review but also to the entire functioning of the system. Doubt in the integrity of the system then has much wider ramifications, as witnessed in the downfall of governments, agencies and ministers in the aftermath of the BSE experiences in the UK and Europe.
Q12 What would be the advantages and disadvantages of introducing a requirement for reregistration of agvet chemicals after a set time?
One immediate advantage of requiring reregistration would be the regular review of the evidence for safety of the chemical and its efficacy in relation to newer chemicals introduced onto the market since its original registration.
Q15 What role, if any, could off label access to chemicals for minor use play in an integrated national system?
- Actual use of chemicals would be better identified and the outcomes more openly recorded and reported.
- Prohibition of off-label use is really only a legally sanctioned position for the manufacturer – who may be well aware of other uses in practice but does not want to accept responsibility for such uses.
- One standard approach is preferred for all chemical usage.
Q22 Should there be a required level of training for access to agvet chemicals and, if so, what should be the basis for establishing that requirement (eg level of training and scope of operation, such as commercial operator or private landholder)?
The CCC supports a national standard approach of training of resellers and users of agvet chemicals. As part of its deliberations we ask COAG to ensure accreditation is appropriate and assessable to these stakeholders to build on and enhance what is currently happening.
Other comment:
The APVMA currently charges $320 for a permit application. Resource costs of servicing permits average around $2,000. So there is a cross subsidy of around $1,680 per application. (In its draft cost recovery impact statement the APVMA (2008) proposed a fee increase to $700.) page 35. This situation is not tenable if the agency remains on a ‘fully cost recovered’ financial basis.
Yours sincerely
Heather Yeatman, DPH
Chair, Community Consultative Committee
APVMA
References:
Rose, R. & Shepherd, N. (2009). A National Scheme for Assessment, Registration and Control of Use of Agricultural and Veterinary Chemicals:Discussion Paper.
U.S. Department of Health and Human Services Food and Drug Administration. (2009). FDA’S Strategic Plan for Risk Communication.
World Health Organisation. Risk Communication.
http://www.who.int/foodsafety/micro/riskcommunication/en/ accessed 23rd January 2010
Australian Government, Department of Health and Ageing. (2004).
Environmental Health Risk Assessment Guidelines for assessing human health risks from environmental hazards:2.3 Risk Perception and Risk Communication.
http://www.health.gov.au/internet/main/publishing.nsf/Content/ohp-ehra-2004.htm~ohp-ehra-2004-framework.htm~ohp-ehra-2004-framework-3.htm accessed 23rd January 2010