Review of agricultural and veterinary chemicals

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has a Chemical Review Program which can reconsider the approval of existing agricultural and veterinary chemicals (active constituents), the registration of chemical products, or the approval of product labels.

A review may be initiated when new research or evidence raises concerns about the safety of a particular chemical or product.

Reviews may be based on one or more areas of concern including environmental safety, worker safety, public health, residues or trade, or less commonly, may consider the issue of product efficacy. Depending on the degree of urgency, the APVMA may initiate a review immediately (within 28 days) or it may give notice for up to three years in advance.

Chemical Review Program History
Legislative Basis
People Involved in Reviewing Chemicals
Steps in Review Process
Public Consultation
Outcomes of Reviews
Results of Reviews
Contacting the Chemical Review Program
Finalising chemical reviews

Chemical Review Program History

When the National Registration Scheme (NRS) was introduced in March 1995, the APVMA assumed responsibility for over 5000 chemical product registrations. These were granted in Australia’s States and Territories under earlier arrangements. Some of these registrations were issued as far back as the 1950s.

Considerable new data has been generated, both here and overseas, for chemicals which have been on the market for a number of years. Sometimes information becomes available which indicate that certain older chemicals need to be reassessed using the current regulatory standards.

Existing Chemical Review Program

The former Existing Chemical Review Program (ERCP) was one of two major chemical review programs run by the APVMA from 1995 to 2000. It was a systematic and comprehensive review of older chemicals to ensure that they met contemporary standards of safety and performance, taking into account any new information and scientific data generated since their registration. In cooperation with its advisory agencies in the Commonwealth Government health and environment departments, the APVMA considered all the approved active constituents on the Australian market and ranked them for review on the basis of:

extent of likely or possible human health risk (acute and chronic)
completeness of the toxicological database for each chemical
likely exposure—use patterns and amounts used in Australia
ecotoxicity concerns—level of hazard, extent of use and use patterns
overseas reports—published literature and information from other regulatory agencies
regulatory actions by other national or international agencies
nominations of chemicals for review by the public, industry, government and academic institutions
input from State/Territory agencies

Consultation with the community, industry and farmers was a major feature of this program. Taking into account input from these groups, the APVMA formed a 'priority list' of about 80 chemicals. From this list between five and seven chemicals were selected to make up ‘review cycles’ within the program.

Steps in the ECRP process

companies that had registered products containing chemicals chosen for review were notified and required to submit any data they had about the use of the chemicals
through advertising, the APVMA sought public submissions which addressed the benefits of, or problems with, the chemicals under review
scientific data submitted was reviewed by the APVMA and three external advisory Commonwealth agencies (which were the then Environment Australia, the National Occupational Health and Safety Commission and the Department of Health and Aged Care)
an evaluation of the chemical was released for public comment
decisions on the future use of chemicals under review were made by the APVMA Board (formerly the NRA Board) as reviews were completed
all participants in the review were notified of the Board's decision and regulatory actions were implemented. Outcomes of reviews were published in the APVMA's Agricultural and Veterinary Chemicals Gazette

Special Review Program

The Special Review Program was the second major chemical review program run by the APVMA from 1995 to 2000. It allowed the APVMA to immediately review a chemical if issues of significant concern arose that warranted prompt regulatory action with respect to human health, the environment, trade or efficacy.

Special reviews could be triggered by, for example, the findings of new research, the availability of new scientific data, or concerns about the use or safety of the chemicals.

Special reviews, while thorough, were undertaken for specific reasons and took less time to complete than a scheduled ECRP review, depending on the complexity of the issue and amount of data reviewed.

Steps in the Special Review process

the APVMA became aware of significant concerns about a particular chemical, product or label and determined if a prompt regulatory action was necessary
if a review was to be conducted, the APVMA consulted all parties affected by the nominations (applicants, commodity groups, state regulatory agencies) and gave them the opportunity to respond to the concerns raised and to take part in the review
all data and submissions were evaluated, including any evaluation reports from external Australian Government agencies and other APVMA assessment areas
based on this information, appropriate regulatory action was recommended, and the APVMA Board (NRA Board) decided on the appropriate action to take
all participants in the review were notified of the Board's decision and regulatory actions were implemented. Outcomes of special reviews were published in the APVMA's Agricultural and Veterinary Chemicals Gazette

Chemical Review Program

In 2000, following an internal review of the APVMA’s two chemical review programs, the ECRP (a systematic review of chemicals scored according to perceived risks to human health or the environment) and the Special Review Program (a program specifically targeting issues as they arose) were rolled together into the Chemical Review Program.

The focus of the Chemical Review Program is to act on concerns as they arise rather than on a more systematic reconsideration of those chemicals on the list of active constituent approvals. The single program can accommodate both comprehensive and targeted reviews.

As a result of the two review programs being combined, the two review lists have been combined into a single list, the Priority Candidate Review List (PCRL). The PCRL identifies and prioritises those chemicals nominated for review by the APVMA. To be listed, chemicals are scored against the agreed selection criteria for public health, occupational health and safety, environment, efficacy and quality and trade issues.

Legislative Basis

The APVMA has powers under the Agricultural and Veterinary Chemicals Code Act 1994 to review currently approved chemicals and registered products.

These powers allow the APVMA to reconsider the registration of chemical products, the approvals of active ingredients and labels, and to require relevant information to be provided by sponsor companies. Relevant trial work can be requested by the APVMA to generate results needed for the review, and additional information can be requested for delivery within specific time frames.

Outcomes of a review can include the suspension or cancellation of the approval of an active constituent, the registration of a product, or the approval of a product’s label.

People Involved in Reviewing Chemicals

The APVMA draws on the specialist expertise of its own staff and other Australian Government advisory agencies to review agricultural and veterinary chemicals. It may also seek advice from state and territory primary industry departments on matters relating to product efficacy.

Work teams conducting reviews comprise:

APVMA review managers, responsible for project management of individual chemical reviews
specialist staff in the APVMA who review details of product efficacy, chemistry, residues, and implications for trade
evaluators in the Chemical Assessment Section of the Australian Government Department of the Environment and Heritage (DEH) who review the environmental aspects of the selected chemicals
evaluators in the Office of Chemical Safety (OCS) of the Therapeutic Goods Administration in the Department of Health and Ageing who conduct human health risk assessments (public health and occupational health and safety)

The APVMA may also call on other expert agencies for advice if required.

Steps in Review Process

The time taken to conduct reviews will be influenced by the number of different stakeholders that need to be consulted, the amount of data submitted, the number of products and uses currently registered, the complexity of the issues, and the extent of review outcomes that require implementation.

The process for reviewing chemicals can be summarised as:

The APVMA becomes aware of concerns about a chemical, product or label and determines if a review is warranted
The review is prioritised, scoped, and scheduled based on the urgency and nature of the concern
Chemical companies that have registered products and active constituent approvals for the review chemical are notified and are required to submit specific data relevant to the review
The APVMA calls for public submissions that address the benefits of, or problems with, the continued registration of the chemical under review
All submissions and scientific data are evaluated by the APVMA and external advisory agencies (OCS and DEH) as appropriate
Based on these evaluations, a draft regulatory approach is developed. The Preliminary Review Findings Report is generally released for public comment (for a period of 6–12 weeks), prior to any final regulatory decisions
A regulatory approach is recommended to the APVMA Board which makes the final decision on the future use of the chemical. Evaluation of additional data may be required for chemicals for which an interim regulatory approach has been approved
Participants in the review are notified of the Board’s decision and the regulatory actions are implemented
Outcomes of the reviews are published in the APVMA’s Agricultural and Veterinary Chemicals Gazette and on it’s website.

Public Consultation

The review process involves extensive consultation with the public and industry.

Submissions from farmers, householders, local government authorities, pest controllers and other chemical users help the APVMA to construct a picture of chemical use, identify problems or concerns, and determine implications for agriculture if a chemical is to be withdrawn or its use continued.

Accurate information about a chemical and its use is important in the development of realistic regulatory recommendations. Any feedback on the Preliminary Review Findings should be made during the advertised public comment period and before the APVMA Board makes its final decision about future use of the chemical.

Individuals who make submissions to the review are asked to provide evidence (where appropriate) of whether a chemical would or would not:

adversely affect human beings
be harmful to workers
be hazardous to the environment
pose a threat to trade
be effective when used according to the label directions

Outcomes of Reviews

The APVMA must be satisfied that continued registration and approval of the chemical:

would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues
would not be likely to have an effect that is harmful to human beings
would not be likely to have an unintended effect that is harmful to animals, plants, or to the environment
would not unduly prejudice trade or commerce between Australia and other countries

The APVMA must be satisfied that Agvet products, if used according to instructions for use, are effective for their intended use.

The APVMA’s Chemical Review Program makes objective, scientifically based recommendations about the future registration of chemicals under review. Depending on a review’s findings, chemicals (and the products containing them) might be:

confirmed as safe and appropriate for registered use
restricted in use
required to be reformulated
required to have a change in labelling to limit the situations in which product/s may be used
suspended, cancelled, or withdrawn from the market

Chemicals reviewed or under review