Major Developments in Global Pesticide Regulations in 2018

Release Date:

2019-01-22

China ❂ Release of Risk Assessment Guidelines and Models Under China’s New Regulations on Pesticide Management To help enterprises better meet the product risk‑assessment requirements under the new Regulations, a series of risk‑assessment guidelines (or draft documents for public comment) and models have been successively published. In the area of human health risk assessment, the following have been released: “Guideline for Health Risk Assessment of Public‑Health Insecticides—Part 4: Mosquito Nets (Draft for Public Comment),” “Instructions for Use of the Unit Exposure Estimate for Backpack Spraying Operators (Version 1),” and the pesticide applicator risk‑assessment model COPrisk. Under environmental risk assessment, the “Guideline for Environmental Risk Assessment in Pesticide Registration—Part 8: Soil…” has been issued.

China

❂ Release of Risk Assessment Guidelines and Models under China’s New Pesticide Management Regulations

To help enterprises better meet the product risk‑assessment requirements under the new Regulations on the Administration of Pesticides, a series of risk‑assessment guidelines (or draft documents for public comment) and models have been successively released. In the area of human health risk assessment, the following have been issued: “Guidance on Health Risk Assessment of Public‑Health Insecticides—Part 4: Mosquito Nets (Draft for Public Comment),” “Instructions for Use of the Unit Exposure Estimate for Operators of Backpack Sprayers (Version 1),” and the pesticide‑application‑worker risk‑assessment model COPrisk. Under environmental risk assessment, the “Guidance on Environmental Risk Assessment for Pesticide Registration—Part 8: Soil Organisms” has entered into force, while the “Guidance on Environmental Risk Assessment for Pesticide Registration—Part 9: Tank‑Mix Formulations (Draft for Public Comment)” has also been published.

❂ The first batch of pesticide registration test units approved under China’s new Regulations on the Administration of Pesticides has been announced.

In September 2018, in accordance with the Administrative Licensing Law and the Regulations on the Administration of Pesticides, the Ministry of Agriculture and Rural Affairs publicly announced 26 pesticide registration‑testing institutions that had been accredited, including eight laboratories accredited for multiple types of tests. Specifically, eight laboratories were accredited for chemical‑property testing, seven for toxicological testing, six for efficacy testing, five for residue testing, and nine for environmental‑impact testing.

❂ China’s Ministry of Environmental Protection has released the “Comprehensive Catalogue of Environmental Protection (2017 Edition).”

In February 2018, the Ministry of Environmental Protection issued the “Comprehensive Catalogue of Environmental Protection (2017 Edition),” which comprises two parts: a list of “high-pollution, high-environmental-risk” products—referred to as “dual‑high” products—and a list of key environmental protection equipment. Among these, 65 chemical pesticides were included in the “dual‑high” product list. To date, this comprehensive catalogue has played a positive role in areas such as taxation, trade, and finance; numerous batches of “dual‑high” products have successively had their export tax rebates revoked and been subject to bans on processing trade.

European Union

❂ The European Union has published its criteria for identifying endocrine-disrupting pesticides, along with the accompanying guidance documents.

The criteria for identifying endocrine disruptors, along with the accompanying guidance document, jointly drafted by ECHA and EFSA, were officially published on June 7, 2018. This guidance aims to establish a set of scientific criteria for the identification of endocrine disruptors. Prior to this, on May 10, 2018, the European Union’s pesticide regulation (Regulation (EC) No 1107/2009) was amended to introduce corresponding criteria for the screening of endocrine disruptors (Commission Regulation (EU) 2018/605), which subsequently entered into force. Effective November 10, 2018, all ongoing reviews and new applications for EU pesticide registration must apply these criteria and, in conjunction with the guidance document, conduct an endocrine‑disrupting‑property assessment of the products.

❂ The 27 EU member states have approved the draft Brexit agreement.

After more than a year of negotiations, on November 25, 2018, the leaders of the 27 EU member states unanimously adopted the draft Brexit agreement, marking a consensus within the EU on the UK’s withdrawal. The draft was originally scheduled for a vote in the UK Parliament in December; however, due to domestic opposition in the UK, the vote was postponed until mid-January 2019. If the UK proceeds with an orderly exit under the agreement, the regulatory framework for pesticide products will remain aligned with EU rules during the transition period, and existing approvals for active substances, PPP authorizations, and maximum residue levels (MRLs) will continue to be valid in both the UK and the EU. Moving forward, the UK will introduce its own national-level regulatory requirements for pesticide products.

❂ The European Union has published a list of low-risk active substances.

In July 2018, the European Commission published a list of low-risk pesticide active substances, which comprises 55 substances, 30 of which are microbial strains. Once approved, low-risk substances are granted a 15-year approval period, longer than the 10-year validity period for conventional active substances. Furthermore, compared with standard formulation products, formulation products containing low-risk active substances also enjoy an extended data protection period.

❂ Annex III of the EU PPP Regulation—List of Prohibited Additives—is expected to be published by the end of this year or early next year.

The European Union will publish, by the end of this year or early next year, Annex III to Regulation (EC) No 1107/2009—the list of prohibited adjuvants in plant protection products. According to reports, the decision on whether a substance is included on this list will be based on an assessment of its hazards and risks. With regard to hazards, substances that meet the criteria for carcinogenicity, mutagenicity, or reproductive toxicity (CMR categories 1A or 1B), persistence, bioaccumulation, and toxicity (PBT, vPvB), persistent organic pollutants (POPs), endocrine disruptors (EDs), or those subject to restrictions under Annexes XVII and XIV of the EU REACH Regulation are highly likely to be added to the list. In addition, Member States will evaluate whether the use of such adjuvants would give rise to unacceptable risks.

United States

❂ The U.S. EPA’s Pesticide Registration Improvement Act, PRIA 3, has lapsed.

After multiple extensions of its validity in 2017, the EPA’s Pesticide Registration Improvement Act (PRIA) III was last extended until December 21, 2018; the enactment date for PRIA IV remains uncertain. However, recently, due to the failure to sign the U.S. appropriations bill and the subsequent federal government shutdown, PRIA III could not be extended again. Under the relevant provisions of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), once PRIA III expired, new registration applications filed after December 21, 2018, would receive a 70% reduction in review fees compared to the original registration fee; however, these applications would no longer be reviewed according to the fixed review timelines established under PRIA III. Furthermore, owing to the federal government shutdown, the EPA ceased accepting any applications submitted after December 28, 2018, pending the resumption of normal government operations.

❂ The U.S. EPA is intensifying enforcement against unregistered pesticides.

On February 15, 2018, the U.S. Environmental Protection Agency announced that Amazon would pay a $1.2 million fine as punishment for illegally selling and distributing unapproved imported pesticide and insecticide products in the United States. Amazon agreed to closely monitor and remove illegal pesticide products from its website going forward, with the aim of “significantly reducing the number of illegal pesticides available through its online marketplace.”

Similarly, Medline Industries was also fined nearly $5 million by the EPA in September this year for selling unregistered pesticides.

In addition, the U.S. company KX Technologies LLC and its Singaporean affiliate, KX Technologies Pte. Limited, were imposed an administrative fine of USD 76,362 for failing to comply with regulatory obligations regarding the submission of annual reports and import/export clearance notifications.

❂ EPA Updates the “Pesticide Label Manual”

To help relevant pesticide companies better prepare pesticide labels, the EPA has updated Chapters 3, 7, and 17 of the Pesticide Label Manual. The key content covers basic labeling requirements, precautionary statements, and labeling requirements for net quantity. Under the EPA, pesticide labels are considered part of federal law, and any use that violates label provisions is deemed unlawful.

Source: Pesticide Registration Abroad

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