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 C&E 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 CanadaGermanyIreland • The NetherlandsUnited 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.
Agricultural and Veterinary Chemicals Act 1994 (external site) This Act contains the constitutional and other legal provisions that enable the Agvet Code to have effect. The Commonwealth's administrative law package applies that allows exclusive rights of review of APVMA decisions taken under the Agvet Codes as though the decisions were made under Commonwealth laws.
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 provisions 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 functions in relation to the Director of Public Prosecutions of the Commonwealth which enable the Director to bring prosecutions and proceedings for offences against the Agvet Codes or the Agvet Regulations.
Agricultural and Veterinary Chemicals Code Regulations 1995 (external site) These regulations prescribe detailed provisions of the Agvet Code.
Agricultural and Veterinary Chemical Products (Collection of Levy) Regulation (external site) These Regulations prescribe the State laws under which an agricultural or veterinary chemical product is registered under the Collection of Levy Act and specifies the rate of levy applicable.
Agricultural & Veterinary Chemicals Code Instrument No.1 (Application Fees) 2010 (external site) and Agricultural & Veterinary Chemicals Code Instrument No.2 (Modular Assessment Fees) 2010 (external site) These legislative instruments set out more fully the criteria for the fee charging regimes provided under the Agricultural & Veterinary Chemicals Code Regulations 1995 in relation to applications made to register agricultural and veterinary chemical products.
Agricultural and Veterinary Chemicals Code Instrument No. 3 (Assessment Periods for Applications where Additional Information is Submitted Voluntarily) 2008 (ComLaw) (external site) This instrument sets out criteria for working out which particular periods specified in the Agricultural and Veterinary Chemicals Code Regulations 1995 and within which the APVMA must determine an application are to apply to those applications where information is voluntarily submitted to the APVMA.

A consolidated list of offences and penalties under the administered legislation is available through the APVMA website – at http://www.apvma.gov.au/compliance/penalties/index.php

 

Guidance

NOTE: These guideline documents are currently under review as part of implementing the agvet reforms, with legislative change to take effect from 01 July 2014. New and updated procedures will be made available during the first half of 2014.

Information published for the purpose of sections 8(2)(b) and 8(2)(d) of the Freedom of Information Act as part of the Information Publication Scheme (for the whole agency), and specific Operational Information for Compliance 

Reports of Non-Compliance Screening and Process 

Importer Records – Checking & Record Keeping 

Preparing and Authorising Evidence Certificates 

APVMA Inspectors Procedural Manual 

Initiating and Reporting Progress of an Investigation 

Guidelines for the Recall of Agricultural and Veterinary Chemicals  (February 2009 edition – requires review)

Generic list of Guidelines for whole of APVMA (non-compliance specific)

 

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.

The PMRA must also consider other Acts which have impacts on pest management, such as:

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

 

Regulations:

Pest Control Products Regulations
Pest Control Products Incident Reporting Regulations
Pest Control Products Sales Information Reporting Regulations
Agriculture and Agri-Food Administrative Monetary Penalties Regulations
Pesticide Residue Compensation Regulations

 

Policies:

Regulatory Directive: Compliance Policy – 2007
Administrative Monetary Penalties (AMPs) Booklet

 

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):

Plant Protection Act (Gesetz zum Schutz der Kulturpflanzen) 

Regulation on the assessment of plant protection equipment (Verordnung über die Prüfung von Pflanzenschutzgeräten)

Regulation on the application of pesticides by aircraft (Verordnung über die Anwendung von Pflanzenschutzmitteln mit Luftfahrzeugen)

Regulation on bans for the use of plant protection products (Verordnung über Anwendungsverbote für Pflanzenschutzmittel)

Phytosanitary expertise Regulation (Pflanzenschutz-Sachkundeverordnung)

Regulation on maximum amounts of Residues of pesticides and Pesticides, fertilizers and other residues in or on foods (Verordnung über Höchstmengen an Rückständen von Pflanzenschutz- und Schädlingsbekämpfungsmitteln, Düngemitteln und sonstigen Mitteln in oder auf Lebensmitteln)

Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market

 

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

PCD is a Division of the Department of Agriculture, Food and Marine, 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)

 

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

 

http://www.government.nl/issues/agriculture-and-livestock/agriculture-and-horticulture

 

United States

The United States' Environmental Protection Agency (EPA) enforces requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that govern the 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 pesticide 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 pesticides enforcement.


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 U.S. Customs and Border Protection (CBP) procedures codified at 19 CFR §§12.110 - 12117. Once EPA Regional Office staff approve the NOA, it is returned to the importer. The importer must present the EPA approved NOA form to CBP at the port of entry. EPA's Office of Enforcement and Compliance Assurance (OECA) has the primary enforcement responsibility for pesticide importation requirements, with the support of EPA's Regional Offices.

Required Notice of Arrival Form provided here: Form 3540-1 (PDF) (2 pp, 90K, 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