• Introduction
• Australia
• Canada
• China
• EU
• USA
• Can the legislative criteria be applied in other countries?

• Legislation
• Groundwater risks
  
• Surface water risks
  
• Risks for bees
• Risks for soil organisms

Terminology reference

Applicable legislation

• Agricultural and Veterinary Chemicals Code Act 1994
• Agricultural and Veterinary Chemicals Code Regulations 1995
• Agriculture and Veterinary Chemicals (Administration) Act 1992
• Agricultural and Veterinary Chemicals (Administration) Regulations 1995

Legislative criteria - protection goal

The protection goal for the environment (the safety criteria) is:

• that the use of the active ingredient or formulated product in accordance with label instructions is not likely to have an unintended effect that is harmful to animals, plants or things or to the environment.

Legislative criteria - matters to be taken into account in making a decision

In determining whether the protection goals (safety criteria) are met the decision-maker must have regard to a number of technical matters.

For the active ingredient these include:

• the toxicity of the active ingredient and its residues, including metabolites and degradation products
• the method of manufacture
• the chemical composition of the active ingredient
• the methods of analysis of the chemical composition of the active ingredient
• whether the constituent conforms to the relevant standard

For the formulated product these include:

• the toxicity of the product and its residues, including metabolites and degradation products
• how the product is formulated and the composition and form of the constituents
• method of analysis for the chemical compositor and form of the constituents of the chemical product
• whether the product conforms to a relevant standard

As relevant, the decision-maker will have regard to the following:

• the stability of the product
• the specifications for containers of the product

The Agricultural and Veterinary Chemicals (Administration) Act 1992 and associated The Agricultural and Veterinary Chemicals (Administration) Regulations 1995 prohibit the import or export, manufacture and use of pesticides that are subject to international agreements (Stockholm convention) and therefore such pesticides cannot be authorised.

Legislative criteria -decision-making principles

The decision-maker must register the pesticide if the legislative criteria are met. Otherwise the application is refused.

Applicable legislation

• Pest Control Products Act
• Pest Control Products Regulations

Legislative criteria - protection goal

The protection goal for the environment is:

• minimize environmental risks posed by pest control products and encourage the development and implementation of innovative, sustainable pest management strategies by facilitating access to pest control products that pose lower risks and by other appropriate measures.
• prevent unacceptable environmental risks

• provide reasonable certainty that no harm to the environment, including its biological diversity, will result from exposure to, or use of the pesticide, taking into account conditions of registration

Legislative criteria - matters to be taken into account in making a decision

In respect of environmental risks these include the Toxic Substances Management Policy and international agreements on Persistent Organic Pollutants and the Montreal Protocol on ozone depleting substances.

Further details about TPMS can be found at
https://www.canada.ca/en/environment-climate-change/services/management-toxic-substances/policy.html

Legislative criteria -decision-making principles

The decision-maker must register the pesticide if the legislative criteria are met. Otherwise the application is denied.

Applicable legislation

Regulation on Pesticide Administration 2017 (in Chinese)

Legislative criteria - protection goal

The protection goal is specified in environmental risk assessment guidelines.

Legislative criteria - matters to be taken into account in making a decision

n.a.

Legislative criteria -decision-making principles

n.a.

Applicable legislation

• Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
• Commission Regulation (EU) No 546/2011 implementing Regulation Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products
• Regulation (EC) No 1272/2008 of the European Parliament and Council on classification, labelling and packaging of substances and mixtures
• Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration
• Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 a framework for Community action in the field of water policy

Legislative criteria - protection goal

The protection goal for the environment is that the pesticide:

• has no immediate or delayed harmful effect on animal health, directly or through drinking water, food, feed or air, taking into account known cumulative and synergistic effect (where there are scientific methods to assess such effects are available)
• has no unacceptable effects on plants or plant products
• has no have unacceptable effects on the environment taking into account:
  • fate and distribution in the environment Including contamination of surface waters, ground water, air and soil
  • impact on non-target species
  • impact on biodiversity and the ecosystem.

Legislative criteria - matters to be taken into account in making a decision

In determining whether the protection goals are met the decision-maker must have regard to a number of technical matters.

For the active ingredient these include:

• the active ingredient is not considered to be a persistent organic pollutant or a persistent, bioaccumulative and toxic substance or a very persistent and very bioaccumulative substance
• is not considered to have endocrine disrupting properties that may cause adverse effects on non-target organisms less exposure under realistic conditions of use is negligible
• under realistic conditions of use will result in negligible exposure of honeybees or has not unacceptable acute or chronic effect on colony survival and development
• that the predicted concentration of the active ingredient, metabolites, degradation or reaction products in groundwater complies with the criteria of uniform principles for evaluation and authorisation of pesticides as provided for in Commission Regulation (EU) 546/2011.

The thresholds that define a persistent organic pollutant are:

• persistence - the DT50 in water is greater than 2 months or the DT50 in soil or sediment is greater than 6 months
• bioaccumulation - the bio-concentration factor or bioaccumulation factor in aquatic species is greater than 5000 or that the partition coefficient n-octanol/water (logKo/w) is greater than 5, or other evidence such as bioaccumulation in other non-target species, high toxicity or ecotoxicity.
• long-range transport - levels of the active ingredient in locations distant from the source of its release are of potential concern; monitoring data or environmental fate properties and/or model results show long-range transport with the potential for transfer to the receiving environment, have occurred via air, water or migratory species; an active substance that migrates significantly through air has a DT50 greater than 2 days

The thresholds that defines a persistent, bioaccumulative and toxic substance are:

• Persistence - the half-life in marine water is higher than 60 days; the half-life in fresh and estuarine water is higher than 40 days; the half-life in marine sediment is higher than 180 days; the half-life in fresh or estuarine sediment is higher than 120 days; or the half-life in soil is higher than 120 days
• Bioaccumulation - the bio-concentration factor is higher than 2000
• Toxicity - the long-term no-observed effect concentration for non-target marine or freshwater organisms is less than 0.01mg/l;
• a mutagen based positive evidence from human epidemiological studies or positive results from certain in vivo tests
• known to have carcinogenic potential for humans or presumed to have carcinogenic potential for humans
• a known, presumed or suspected  human reproductive toxicant
• other evidence of chronic toxicity as identified by specific target organ toxicity through repeated exposure

Further detail on the classification of mutagens, carcinogens,  reproductive toxins and chronic toxicity is provided in
Regulation (EC) No 1272/2008

The thresholds that define the ‘very persistent’ criterion are:

• persistence - the half-life in marine, fresh-or estuarine water is higher than 60 days; the half-life in marine, fresh- or estuarine water sediment is higher than 180 days; or the half-life in soil is higher than 180 days
• bioaccumulation - the bioaccumulation factor is greater than 5000

All of the above requirements that apply to the active ingredient also apply to safeners and synergists.

Requirements for the authorisation of formulated products include:

• the active ingredient, safener and synergists have been approved and in accordance with specifications
• the formulated product does not contain certain prohibited co-formulants (specified in Annex III of Commission Regulation (EU) 1107/2009)
• the formulation is designed to limit user exposure and other risks
• the nature and quantity of all ingredients (including toxicologically relevant impurities) can be determined by appropriate methods
• residues resulting from authorised use can be determined by appropriate methods
• the physical and chemical properties are acceptable for the use and storage of the product
• recognised tests and analyses should be used and carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product in questions and representative of the conditions prevailing the the zone where the product is intended to be used
• interaction between the active ingredient, safeness, synergists and co-formulants shall be taken into account in the evaluation

Further detail on the evaluation principles  are provided in Commission Regulation (EU) No 546/2011

Legislative criteria -decision-making principles

The decision-maker must register the pesticide if administrative requirements and human health and environmental criteria are met.

Specific decision-making principles apply:

In relation to absence of unacceptable effects on plants or land products there must be:

• no relevant phytotoxic effects on treated plants or plant products
• no reduction of yield at harvest due to phytotoxic effects unless the reduction is compensated for by other advantages (eg enhancement of the quality of the treated plants or plant products)
• no unacceptable adverse effects on the quality of treated plants or plant products
• no unacceptable adverse effects on treated plants or plant products used for propagation or reproduction
• no unacceptable impact on succeeding crops
• no unacceptable impact on adjacent crops, and
• the instructions for cleaning the application equipment must be practical and effective

In relation to fate and distribution in the environment (unless it can be demonstrated otherwise under field conditions) no authorisation can be granted:

• if the active substance and significant metabolites and breakdown or reaction products
  • persist in soil in field tests for more than 1 year (DT90> 1 year and DT50> 3 months) or
  • in laboratory tests form non-extractable residues in amounts >70% of the initial dose after 100 days with a mineralisation rate of <5% in 100 days
• if the active substance and significant metabolites and breakdown or reaction products in groundwater exceed
  • the limits set out in Directive 2006/118/EC or
  • the limit determined during the evaluation process or, where no such limit has been set, the concentration corresponding to one tenth of the ADI
• if the active substance and significant metabolites and breakdown or reaction products in surface water
  • exceed limits for drinking water quality set out in Directive 2000/60/EC (if the surface water is intended for the abstraction of drinking water), or
  • has an unacceptable impact on non-target species, including animals
• if the airborne concentration of the active substance exceeds the AOEL or the limit values for operators, by-standers or workers

In relation to impact on non-target species no authorisation can be granted:

• where there is a possibility of birds and other non-target terrestrial vertebrates being exposed
  • the acute and short-term toxicity/exposure ratio for birds and non-target terrestrial vertebrates is less than 10 on the basis of LD50 or the long-term toxicity/exposure ratio is less than 5
  • the bioconcentration factor (related to fat tissue) is greater than 1
• where there is a possibility of aquatic organisms being exposed
  • the toxicity/exposure ratio for fish and Daphnia is less than 100 for acute exposure and less than 10 for long-term exposure or
  • the algae grown inhibition/exposure ratio is less than 10, or
  • the maximum bioconcentration factor is greater than 1000 for pesticides containing active substances that are readily biodegradable or greater than 100 for those that are not readily biodegradable
• where there is a possibility of honey-bees being exposed and the hazard quotient for oral or contact exposure of honeybees are greater than 50
• where there is a possibility of beneficial arthropods other than honeybees being exposed, if more than 30% of the test organisms are affected in lethal or sublethal laboratory tests conducted at the maximum proposed application rate
• where there is the possibility of earthworms being expose, if the nature toxicity/exposure ratio for earthworks is less than 10 or the long-term toxicity/exposure ration is less than 5
• where there is a possibility of non-target soil micro-organisms being exposed if the nitrogen or carbon mineralisation processes in laboratory studies are affected by more than 25% after 100 days

Applicable legislation

• Federal Insecticide, Fungicide and Rodenticide Act

7 U.S.C. §136 et seq (1996), Chapter 6, Section 136, Title 7 - Agriculture

• Endangered Species Act

16 U.S.C. §1531 et seq. (1973)

Legislative criteria - protection goal

The protection goal for the environment is:

• that the pesticide will perform is intended function without unreasonable adverse effects* on the environment and when used in accordance with wide-spread and commonly recognised practice will not generally cause unreasonable adverse effects on the environment.
• the pesticide will not jeopardise the existence of a federally listed species or endangered species or destroy or adversely modify any designated critical habitat for that species.

* Unreasonable adverse effects on the environment is defined as ‘any unreasonable risk to man or the environment, taking into account the economic, social and environmental costs and benefits of the use of the pesticide’.

Legislative criteria - matters to be taken into account in making a decision

n.a.

Legislative criteria -decision-making principles

The decision-maker must register the pesticide if the legislative criteria are met. Otherwise the application is denied.