ENV Pesticide Compliance

ENV Pesticide Compliance › Laws, Policies & Guidance

Laws, Policies & Guidance

 

The focus of this page is the laws, regulations, policies, and guidance that regulatory authorities have issued as final or proposed for the purpose of addressing compliance and enforcement issues. This section contains country specific information on Compliance and Enforcement approaches and frameworks from the various countries:

  • National legislation and regulations relevant to government pesticide programs
  • Compliance risk assessment and performance measurement frameworks
  • Compliance and enforcement policies
  • Guidance documents
  • Legal sampling procedures

The following links were provided by the regulatory authorities of countries listed below:

Australia  • Belgium • Canada • Germany • Ireland • Japan •The Netherlands • Switzerland • United States

 

Australia

Australian Pesticides and Veterinary Medicines Authority (APVMA)

  • Laws, Policies & Guidance

The APVMA assesses applications relating to agricultural chemicals and veterinary medicines submitted by companies and individuals seeking registration so they can supply their product to the marketplace.

The APVMA’s role is that of an industry regulator. Part of the APVMA's role and responsibility is to monitor and enforce compliance with the Agvet (Agricultural and Veterinary) Code up to and including the point of retail sale.

The APVMA also works closely with State and Territory departments to ensure there is effective coordination and communication of compliance efforts.

While the APVMA regulates a broad range of products the information provided below is focused on Plant Protection Products reflecting the mandate of the WGP. 

  • Laws/regulations
Title and Link Description
Agricultural and Veterinary Chemicals (Administration) Act 1992 (external site) This Act establishes the APVMA as an independent statutory authority of the Commonwealth responsible for the regulation and control of agvet chemicals in Australia up to the point of retail sale. This Act also contains all the internal details of the establishment of and the functions and powers of the APVMA. It also contains provisions controlling the import and export of chemicals, investigative powers and enforcement provisions (civil penalty orders and criminal proceedings).
Agricultural and Veterinary Chemicals Act 1994 (external site) This Act is the mechanism that sets up a uniform system with the states and territories to regulate agricultural and veterinary chemicals.  The legislative framework sets up a single Agricultural and Veterinary Chemicals Code that operates thoughout Australia.
Agricultural and Veterinary Chemicals Code Act 1994 (external site) This Act contains the Agvet Code as a schedule. The Agvet Code contains the detailed provisions allowing the APVMA to evaluate, approve or register and review active constituents and agricultural and veterinary chemical products and their labels; to issue permits and to licence the manufacture of chemical products; provides for controls to regulate the supply of chemical products; and includes provisions for ensuring compliance with, and for the enforcement of, the Code.
Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994 (external site) This Act contains measures that allow for the assessment and collection of levies in regard to agricultural and veterinary products registered for use in Australia.
Agricultural and Veterinary Chemicals (Administration) Regulations 1995 (external site) These regulations prescribe requirements regarding the APVMA’s annual operational plan and annual report, the provision of information regarding active constituents and chemical products, a prohibition of the import and manufacture of certain active constituents and chemical products and provides for infringement notices.
Agricultural and Veterinary Chemicals Code Regulations 1995 (external site) These regulations prescribe requirements regarding a range of matters set down in the Agricultural and Veterinary Chemicals Code, such as provisions about notices, variation of relevant particulars and conditions and how timeframes and fees are calculated for applications for approval or registration of active constituents and chemical products.
Agricultural and Veterinary Chemical Products (Collection of Levy) Regulation (external site) These regulations specify the rate of levy applicable.

There are a number of legislative instruments enacted under the Agricultural and Veterinary Chemicals Code that provide detail on rules in the Code and associated regulations. These include, for instance, the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 and the Agricultural and Veterinary Chemicals Code (Notifiable Variations) Instrument 2016.

  • Guidance 

Current APVMA compliance and enforcement guidelines

 

Belgium

In Belgium, the information on the authorisation of plant protection products and fertilisers is available via Phytoweb.

 

Canada
  • Laws:

The Pest Control Products Act (PCPA) - The PCPA received Royal Assent on December 12, 2002, and came into force on June 28, 2006.

Health Canada’s Pest Management Regulatory Agency (PMRA) also administers the Pesticide Residue Compensation Act and must consider other Acts that impact on pest management, such as the Food and Drugs Act (FDA).

In addition, the PMRA uses the Agriculture and Agri-Food Administrative Monetary Penalties Act as an enforcement tool for the PCPA.

  • Regulations:

Under the PCPA:

Under the Pesticide Residue Compensation Act:

Under the Agriculture and Agri-Food Administrative Monetary Penalties Act:

  • Policies:

 

Germany

In Germany the Federal Office for Consumer Protection and Food Safety (BVL) is the competent national authority for the authorisation of PPPs. Before BVL takes a decision about the authorisation the PPP is tested and evaluated in regard to its efficacy and its effects on the environment. This is partly the task of the BVL, but also of other authorities, as the Federal Institute for Risk Assessment (BfR), the Federal Research Centre for Cultivated Plants (JKI) and the Federal Authority for Environmental protection (UBA).

Germany is a Federal Republic with 16 Federal States. According to the German Plant Protection Act, the control of the placing on the market and practical use of PPPs is task of the plant protection services of the Federal States. The Federal States are also responsible for punishment is the case of violation against the German Plant Protection law or related laws. To increase the efficiency of controls the BVL and the Federal States have created standards for the co-ordination of the control-program. They are compiled in the German plant protection control-manual, which meets the requirements for co-ordinated and comprehensive controls and monitoring in respect of the placing on the market and use of plant protection products within the meaning of Article 68 of regulation 1107/2009 EC. The BVL laboratory acts as the Competence Centre for analysis of pesticide formulations, and analyses PPP-samples taken within the control-program.

  • Laws/Regulations (available in Germany only; original titles included for information):
  • Policies:
  • Directive 2009/128/EC of the European Parliament and of the Council establishing a framework for Community action to achieve the sustainable use of pesticides

  • Guidance:

The Plant Protection control manual

Ireland

The Pesticide Controls Division (PCD) is a Division of the Department of Agriculture, Food and Marine (DAFM), and is the Competent Authority for pesticides (Plant Protection Products and Biocides) in Ireland.  PCD is charged with developing and implementing an effective and efficient regulatory regime for pesticide products, such that a very high level of protection is achieved for humans, animals and the environment, and to police the levels of pesticide residues in and on food.
PCD achieves its objectives by i) implementing an annual inspection program of wholesale and retail outlets of pesticides; ii) reviewing the pesticide application records of approx. 1300 end-users of plant protection products (farmers); iii) on-farm follow-up investigations of all Irish produce found to breach MRL legislation; iv) implementing additional controls at Border Inspection Points on certain commodities from 3rd countries considered to be high risk with respect to pesticide residues in accordance with legislation (EC) No 669/2009.

 

Title
[Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market
Directive 2009/128/EC establishing a framework for Community action to achieve the sustainable use of pesticides
Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products
The Poisons Act 1961 as amended by the Misuse of Drugs Act 1977
Chemicals Act, 2008
Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin
Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in foodstuffs
Regulation (EC) No. 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules
Regulation (EC) No 850/2004 on persistent organic pollutants
Directive 1999/45/EC concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations
Directive 2002/32/EC on undesirable substances in animal feed
Regulation (EU) No 649/2012 concerning the export and import of hazardous chemicals
Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures [=CLP Regulations]
Regulation (EC) No 1902/2006 concerning the registration, evaluation, authorisation and restriction of chemicals (REACH)

 

Japan

 Japanese law on pesticide registration and control (unofficial English translation)

Note: Only the original Japanese text of the law is legally applicable.  The unofficial English translation is solely for reference to facilitate understanding of the content of the law and shall not be used as a legal basis or for judgment.

 

The Netherlands

The Netherlands Food and Consumer Product Safety Authority

The task of the Netherlands Food and Consumer Product Safety Authority (NVWA) is to protect human and animal health. It monitors food and consumer products to safeguard public health and animal health and welfare. The Authority controls the whole production chain, from raw materials and processing aids to end products and consumption.

NVWA is for example responsible for inspections related to pesticides that are manufactured, imported into, sold or used in the Netherlands and for ensuring that pesticides can be used safely and have no negative effects on human health, food, nature or the environment.

The Pesticides & Biocides Law and pesticides regulation (PBL; roughly translated) is the main law that enables the NVWA to supervise the trade and use of pesticides. NVWA enforces compliance with the PBL by developing and implementing a (multi) annual Pesticide Compliance Program.

NVWA accomplishes this role, in collaboration with a network of other federal departments and agencies such as the Customs Office, The Human Environment and Transport Inspectorate, the Inspectorate of Social Affairs and Employment, Dutch Water Boards and the police. Also, we cooperate with provincial and territorial governments. For analyses product, water or soil samples we cooperate with Rikilt laboratory that provides analytical support services to compliance monitoring and investigation activities.

Dutch Law: The Pesticides & Biocides Law and pesticides regulation

EU-Regulations, Directives
Regulation 1107/2009 Bringing pesticides on the market
Directive 128/2009 Sustainable use of pesticides
Regulation 1198/2009 Pesticide Statistics 
Directive 42/2006 Machine use of pesticides
Regulation (EG) 396/2005  Pesticide Residues

 

Switzerland

 Swiss Federal Plant Protection Service

 

United States

The United States Environmental Protection Agency (EPA) enforces requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that govern the registration, distribution, sale, and use of pesticides. The Act applies to all types of pesticides, including insecticides, herbicides, fungicides, rodenticides, and antimicrobials. EPA takes enforcement actions to address the distribution or sale of unregistered pesticides, registered pesticides whose composition differs from that submitted at registration, and registered pesticides that are misbranded or adulterated. EPA may also stop the sale or seize pesticides products which do not meet FIFRA requirements. One aspect of EPA’s FIFRA enforcement program is to ensure pesticides entering the United States meet FIFRA requirements.

EPA and the states verify and ensure FIFRA compliance through a comprehensive FIFRA compliance monitoring program which includes inspecting facilities, reviewing records and taking enforcement action where necessary. The FIFRA compliance assistance program provides businesses, federal facilities, local governments and tribes with tools to help meet environmental regulatory requirements. Individuals applying pesticides must do so in a manner not only consistent with federal laws, but also consistent with state laws and regulations which differ from state to state. In general, states have primary authority for compliance monitoring and enforcing against use of pesticides in violation of the labeling requirements. Additionally, the agency with primary responsibility for pesticides differs from state to state. Usually it is a state's department of agriculture, but may be a state's environmental agency or other agency.

Please see the following website for additional information about enforceable pesticide-related requirements.

 

  • Laws/Regulations

EPA regulates pesticides under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).   In addition, the Pesticide Registration Improvement Act (PRIA) of 2003 establishes pesticide registration service fees for registration actions taken by EPA’s Office of Pesticide Programs. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and accompanying regulations at Title 40 of the Code of Federal Regulations, provides the basis for regulation, sale, distribution and use of pesticides in the U.S. FIFRA authorizes EPA to review and register pesticides for specified uses. EPA also has the authority to suspend or cancel the registration of a pesticide if subsequent information shows that continued use would pose unreasonable risks. Some key elements of FIFRA include: 

  • FIFRA is a product licensing statute; pesticide products must obtain an EPA registration before manufacture, transport, and sale;Pesticide registration is based on a risk/benefit standard;
  • FIFRA provides strong authority to require data--authority to issue Data Call-ins;
  • Pesticide use is regulated through labeling, packaging, composition, and disposal;
  • FIFRA provides emergency exemption authority--permits approval of unregistered uses of registered products on a time limited basis; and
  • FIFRA provides ability to suspend or cancel a product's registration and establishes an appeals process and adjudicatory functions, etc. to implement those actions.

 

Import Notifications of Pesticides and Devices (FIFRA Section 17(c))

The importation of pesticides and devices is governed by FIFRA Section 17(c). All imported pesticides intended for use in the United States must be registered as required by Section 3 of FIFRA before being permitted entry into the US. Devices that are imported to be used in conjunction with pesticides, although not required to be registered, must not bear any statement, design, or graphic representation that is false or misleading in any particular. Pesticides and devices must be properly labeled in accordance with FIFRA and Title 40 of the Code of Federal Regulations, Section 156.

When importing pesticides or devices to the U.S., the importer must submit to the appropriate EPA Regional Offices an EPA Form 3540-1 "Notice of Arrival (NOA) of Pesticides and Devices" in accordance with the procedures codified at 19 CFR §§12.110 - 12117. Once EPA Regional Office staff have approved the shipment, they return the NOA form to the importer. Upon arrival of a shipment of pesticides or devices, the importer must present the approved NOA form to the district director of Customs at the port of entry. In the alternative, the importer or the importer's agent may file an electronic alternative to the Notice of Arrival, with the filing of the entry documentation, via any CBP-authorized electronic data interchange system. 

Required EPA Form 3540-1-Notice of Arrival of Pesticides and Devices (2 pp, 970K, about PDF) 

 

  • Policies:

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Enforcement Response Policies

 

Pesticide Registration (PR) Notices

PR Notices are issued by the Office of Pesticide Programs to inform pesticide registrants and other interested persons about important policies, procedures and regulatory decisions regarding pesticides and devices. 

 

  • Guidance:

Inspections are the core of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) compliance monitoring program. FIFRA inspections are conducted by federal, state, and tribal inspectors. Inspections are conducted under sections 5, 7, 8, 9, 13, 24, and 26 of the Act and 40 CFR parts 150-189. 

FIFRA inspectors:

  • conduct inspections and investigations to detect violations and collect evidence necessary to successfully prosecute FIFRA violators;
  • collect physical samples and documentary evidence; and
  • remove potential violative pesticides from the channels of trade. 

EPA negotiates cooperative agreements with each state and tribe for compliance monitoring and enforcement of pesticide registration and labeling requirements.

FIFRA Inspection Manual (October 2013)

 

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