2020 MRL Harmonization
US human health risk assessment of pesticides used in organic products:
a different approach with the same goal
Global Minor Use Summit 2024
Jane Stewart, BASF
Toxicology and Consumer Safety
SAFE USE – SAFE FOOD
2
What is organic?
Organic Food
Organic Farmers
Organic Market
Organic Livestock
Organic Production
Organic Pesticide Products
Organic Processing
Toxicology and Consumer Safety
SAFE USE – SAFE FOOD
3
The National Organic Program Rule
7 CFR Part 205 – also knowns as the Organic Foods Production Act
The National List of Allowed Synthetic and Prohibited Non-synthetic substances
Synthetic substances allowed for use
Nonsynthetic substances prohibited for use
Man-made
Natural source
Toxicology and Consumer Safety
SAFE USE – SAFE FOOD
4
The National Organic Program Rule Philosophy #1
60
CROPS
48
LIVESTOCK
43
PROCESSING
Number of synthetic substances permitted on the National List
In general, synthetic substances are prohibited for crop and livestock production unless specifically allowed.
Toxicology and Consumer Safety
SAFE USE – SAFE FOOD
5
The National Organic Program Rule Philosophy #2
Number of nonsynthetic substances prohibited on the National List
9
CROPS
1
LIVESTOCK
In general, nonsynthetic substances are allowed for crop and livestock production unless specifically prohibited.
Toxicology and Consumer Safety
SAFE USE – SAFE FOOD
6
Pesticides used in organic production can be divided into 3 categories:
Biochemicals
Synthetic Substances
Microbials
Synthetic substances are man-made. They are not produced from a natural source.
Synthetic substances and their breakdown products must have no adverse effect on human health and must not contribute to contamination of crops, soil, or water.
Biochemicals are naturally occuring or structurally similar to naturally occuring substances.
Biochemicals must have non-toxic mode of action and a demonstrated history of exposure to humans and the environment with minimal toxcity.
Microbials are microorganism such as bacteria, fungus, algae, virus or protozoan.
Microbials are Intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant.
Pyrethrin
Non-synthetic Substances
Toxicology and Consumer Safety
SAFE USE – SAFE FOOD
7
28.01.2024
7
Toxicity and residue testing required for synthetic pesticides
This Photo by Unknown Author is licensed under CC BY-NC
Toxicology and Consumer Safety
SAFE USE – SAFE FOOD
Tier I
Tier II
Tier III
8
Testing tiers required for biochemical pesticides
§158.2050 Toxicology Requirements
§158.2040 Residue Requirements
Residue chemistry data requirements apply to biochemical pesticide products when Tier II or Tier III toxicology data are required.
Toxicology and Consumer Safety
SAFE USE – SAFE FOOD
Tier I
Tier II
Tier III
9
Testing tiers required for microbial pesticides
§158.2140 Toxicology Requirements
§158.2130 Residue Requirements
Residue chemistry data requirements apply to microbial pesticide products when results of toxicology testing indicate the potential to cause adverse human health effects, or that the microbial product may produce a mammalian toxin with residues in food or feed crops.
Toxicology and Consumer Safety
SAFE USE – SAFE FOOD
Toxicity Tier I
Toxicity Tier II
Toxicity Tier III
Residue work triggered
Adverse Effects
No Adverse Effects
10
Adverse Effects
Applicants should consider the unique characteristics of their pesticide when addressing specific data requirements and protocols, and are encouraged to consult with the agencies before testing begins. Waivers for certain data requirements will be considered when accompanied by a sound scientific rationale.
Nonsynthetic Pesticide: Product Testing Pathway
Toxicology and Consumer Safety
SAFE USE – SAFE FOOD
11
Nonsynthetic vs. Synthetic Pesticide Human Safety Testing
Tiered approach vs. upfront approach
Toxicology
Residue
Toxicology
Residue
Toxicology
Residue
Toxicology
Non-synthetic Pesticides
Biiochemicals - Microbials
Synthetic Pesticides
Toxicology and Consumer Safety
SAFE USE – SAFE FOOD
Thank You!
12
Toxicology and Consumer Safety
SAFE USE – SAFE FOOD