Regulatory Update – The Green Deal

In this bi-annual regulatory update, we focus on important pesticide updates, MOAH, sulfur dioxide, FDA reorganizational proposal, and the future of natural gas in California. The two most important changes for California agriculture are the European Green Deal and the California Sustainable Pest Management Initiative.

The European Green Deal

Understanding The European Union

The European union takes pesticide use very seriously and as a result, MRLs tend to be more restrictive compared to United States (hazard based). Not only is the Default limit for MRLs 0.01 ppm, but they also require a high amount of testing before a product can be exported to the EU and violations can be heavily publicized. This risk coupled with retail standard hurdles are two areas any company exporting their product should be hyper aware of.

“Cut-Off” criteria can cause sudden loss of MRLs

If a pesticide is found to be inherently dangerous, based on the criteria below, EU Reg. 1107/2019 requires it be “cut-off” from the marketplace. With the loss of an EU registration, the MRL will often revert to the default.

  • Health Effects
    • Carcinogenic
    • Genotoxic
    • Toxic for reproduction
    • Endocrine disruptor
  • Environmental Effects
    • Persistent organic pollutant
    • Persistent, bioaccumulative, and toxic
    • Very persistent and very bioaccumulative
    • Ecotoxicology (i.e. risk to bees)

A change in MRL due to the cut-off criteria becomes effective in 20 days, there’s an additional 6 month “grace period” for commodity where the cut-off product was used legally.

The EU Green Deal

Announced in 2019, the goal of the European Green Deal is to make the EU carbon-neutral by 2050. This legislation focuses on cutting pollution and embracing clean products and technologies. Importantly for food producers, the Green Deal includes a target of 50% reduction in the use and risk of chemical pesticides and a 50% reduction in the use of the most hazardous pesticides by 2030.

Key Pesticide Measures

  1. Legally binding targets reducing the use and risk of chemical pesticides by 50% by the year 2023.
  2. A ban on all pesticide use in sensitive areas, including all urban green areas by the general public.
  3. Environmentally friendly pest control ensuring all farmers practice integrated pest management in which chemical pesticides are used only as a last resort.
  4. Promoting low-risk alternatives with national targets to increase non-chemical methods of pest control and sales of non-chemical plant protection products.
  5. Helping farms access required advice and guidance for more sustainable farming with less chemical pesticides.
  6. Enabling the use of new technologies such as precision farming, which contributes to further reducing the use of chemical pesticides.
  7. Common agricultural policy funding for investments and advice in sustainable practices
  8. Accelerating approvals of biological alternatives for farmers and other pesticide users.
  9. Global solidarity by supporting sustainable agriculture in countries exporting food to the EU and introducing a new, more environmental approach on maximum residues level.

Pesticide Measures: What’s the Latest?!

  • Concerns over inflation, Ukraine situation impacting food prices.
    • 2030 target for 50% reductions has been extended to 2035.
  • Divisions within the EU Parliament developing on the issue.
    • DG SANTE vs DG AGRI.
    • Parliamentary elections in 2 months.
  • Many of agricultural member states like France are pushing for a “mirror clause”:
    • EU trading partners like the US would need to meet the same sanitary, phytosanitary, welfare and environmental standards as EU producers.
  • The Green Deal will be an issue of debate for some years to come!

U.S. Statements to the WTO – July 2023

  • Import tolerances –Specific Trade Concern 534.
  • MRLs are limits for food safety and trade, not developed for environmental indicators.
  • Pollinator health is impacted by multiple variables (pathogens, habitat loss, etc.) and not just pesticides.
  • EU MRL process-Specific Trade Concern 448.
  • Obligations under WTO to base controls on science and risk with least trade restrictive manner possible.
  • EU should conduct full risk assessments before MRLs are reduced or withdrawn.

CA Sustainable Pest Management Program

Launched by the DPR, CalEPA and CDFA, Sustainable Pest Management (SPM) is a “holistic, whole-system approach applicable in agricultural and other managed ecosystems and urban and rural communities that builds on the concept of integrated pest management (IPM) to include the wider context of the three sustainable pills”.

Sustainable Management Working Group

  • A diverse group of thirty three members representing agriculture, environmental, regulatory and research interests.
  • Created to accelerate the transition away from high risk pesticides
  • Goal to reduce use of toxic pesticides, move “toward safe, sustainable pest management practices”

By 2050, two key goals are:

  • Eliminate the use of “Priority Pesticides” by transitioning to sustainable pest management practices”.
  • Adoption of sustainable pest management as the de facto pest management system in California.

Priority Pesticides Evaluation Criteria

  • Active ingredients that pose health/environmental hazards.
    • Human hazards include carcinogens, endocrine disruptors, reproductive/developmental toxicants.
    • Environmental hazards include groundwater/toxic air contaminants, toxins to non-target pollinators, mammals, birds and fish.
  • Availability of viable alternatives.
    • Viability includes efficacy, affordability, availability.“
  • Special considerations of pest management situations that potentially cause severe or widespread adverse impacts”.

Sustainable Pest Management Next Steps

By 2025: SPM Work Group call on state to develop a plan and funding mechanism to implement the plan.

  • Prioritize and expedite review of alternative new products to high-risk pesticides.
  • Develop an evaluation process for products with existing registrations.
  • Develop purchasing criteria to identify and validate agricultural products grown with SPM.

By 2030:

  • Prioritize state and regional collaboration to strengthen biosecurity measures against invasive pests, while protecting CA natural resources.
  • Ensure that growers understand their role in invasive pest detection and reporting.
  • Expand research and development, state extension to support SPM.
  • Train all PCAs in SPM.
  • Achieve the same goals for urban SPM.           

Other Issues to Watch

MOAH (mineral oil aromatic hydrocarbons)

In May 2022, the European Commission set recommended limits for MOAH, considered a possible genotoxin. Previously there were only limits for infant formula but after studies conducted, high levels were found. MOAH can be found in the environment, food processing (additives, lubricants, release agents), and as migration from packing materials.

EU Draft Opinion on food limits:

  • Dry foods/low fat content (≤ 4% fat/oil): 0.5 ppm.
  • Higher fat content (> 4% fat/oil, ≤ 50 % fat/oil): 1 ppm.
  • Fats/oils, foods with > 50 % fat/oil: 2 ppm.

Sulfur dioxide (SO2)

In November 2022 the EU published a toxicological evaluation on sulfites.

  • Have proposed lower consumption rate for sulfites (38 mg SO2/kg body weight/day).
    • Lack of toxicity data/increased safety margin.
    • Some uses may be cancelled.
  • EU requesting additional data from industry by (07/14/23).

FDA Reorganization Proposal

Released on June 27, 2023, an FDA restructuring has been proposed. In this proposal, the Deputy Commissioner for Human Foods would report directly to FDA Commissioner and have full authority over all components of the Human Foods Program (HFP). This proposal also includes the food component of the Office of Regulatory Affairs (ORA).

Why is this happening, you might ask? The short answer is the infant formula recall. During the recall, the department realized a gap in communication and transparency, leading events to play out in the manner which they did. This new restructuring is an attempt to overcome the lack of communication and transparency uncovered in the infant formula recall.

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