Anthraquinone
Anthraquinone is an avian repellant registered for use on commercial and industrial grounds and for treated seed. It has been registered as a pesticide in the U.S. since 1998.
On this page:
Basic Information
Anthraquinone is used in both agricultural and non-agricultural settings. Agricultural uses consist of seed treatments for corn and rice, with the latter predominately in the Arkansas Grand Prairie, the Mississippi Delta, and the Gulf Coast. Non-agricultural uses include foliar applications to turf at airports, athletic fields, and other non-agricultural sites.
EPA Actions
Registration Review
Anthraquinone was first registered as a biopesticide in 1998. In August 2015, EPA reclassified anthraquinone as a conventional pesticide and initiated registration review for the pesticide in 2017. Registration review ensures pesticides continue to meet the standard for registration, in other words, that the pesticide, among other things, will not cause unreasonable adverse effects when used according to label directions and precautions, including that there is a reasonable certainty of no harm from combined dietary and residential exposure. All documents related to the registration review can be located in the registration review docket EPA-HQ-OPP-2017-0326 at www.regulations.gov.
In April 2022, EPA released the final work plan and draft risk assessments and issued a data call-in to address data gaps identified in registration review. The draft human health risk assessment and draft ecological risk assessment were released for public comment until June 6, 2022. After reviewing and considering the public comments received on these draft risk assessments, EPA will proceed with the next step in the registration review process and issue a proposed interim decision (PID). The PID will propose mitigation measures to address potential occupational and ecological risks of concern. EPA expects to issue the PID for public comment in early 2023.
In May 2022, EPA stamped new anthraquinone labels that do not allow application on residential turf, which will fully mitigate aggregate risks of concern that were identified based on the calculations completed in the draft human health risk assessment. This early mitigation is discussed further in the next section.
Treated Rice-Seed Data
In 2021, EPA, as part of its registration review process for anthraquinone, reviewed rice field trial data submitted by the anthraquinone registrant. The data indicated that use of anthraquinone as a rice seed treatment is expected to result in detectable residues in or on food or feed. At this time, however, there is no established tolerance (i.e., maximum amount of a pesticide allowed to remain in or on a food) to cover those residues in or on rice commodities; thus, any harvested rice commodities containing such residues will be adulterated. It is unlawful to ship adulterated commodities through interstate commerce. EPA previously considered the rice seed treatment a non-food use thus not needing a tolerance.
In information EPA provided to the Food and Drug Administration (FDA), EPA states there are no dietary (rice and water) risks of concern from the use of anthraquinone on treated rice for any population subgroups, including infants and children. EPA’s dietary assessment is conservative and protective of potential dietary exposures.
EPA has concluded there are no resulting risks of concern from the consumption of rice commodities that could enter or are already available from the channels of trade. However, based on the calculations completed in the draft human health risk assessment, EPA identified potential cancer risk concerns from residential exposures to treated turf and occupational exposures for pesticide handlers for each use. Because there are risk concerns from residential exposures alone, the aggregate exposures also result in risk concerns.
EPA has worked with the registrant to address these concerns by removing residential turf use sites from the label. An updated label was stamped on May 9, 2022, with the use sites of concern removed. Once these label changes are implemented (no later than January 9, 2023), there will be no aggregate risks of concern (i.e., combined dietary and residential exposures). EPA has also required the registrants address all data gaps in this registration review case through the issuance of the April 2022 data call-in. This includes requiring that the registrant develop the data needed to establish tolerances for the rice seed treatment use by 2024.
Frequent Questions about Anthraquinone Use on Rice Seed:
- When will EPA establish tolerances for residues resulting from the use of anthraquinone to treat rice seed?
- Why is this an issue now? I have used this AV-1011® Liquid Rice Seed Treatment for several years.
- What should I do with harvested rice grown from seed treated with anthraquinone?
- Will this affect the availability of anthraquinone in 2023?
- Is rice grown from anthraquinone-treated seed (and associated rice commodities) safe to eat? What about baby food made with rice?
- Is corn grown from anthraquinone-treated seed safe to eat?
1. When will EPA establish tolerances for residues resulting from the use of anthraquinone to treat rice seed?
EPA anticipates establishing tolerances no sooner than 2024 for anthraquinone. This is because the Agency needs several studies to support the establishment of tolerances.
The needed studies include nature of the residue in plants and livestock, a residue analytical method, multiresidue methods, processed food/feed for rice, a confined accumulation in rotational crop study, and storage stability data, as needed, to support these studies.
EPA issued a data call-in that requires the registrant to fulfill these, and other data gaps identified in registration review. Some studies take up to two years for development and must then be reviewed by EPA. After these studies are submitted, EPA can review them to determine whether tolerances for residues of anthraquinone of rice are safe and can be established.
2. Why is this an issue now? I have used this AV-1011® Liquid Rice Seed Treatment for several years.
In 2021, EPA, as part of its registration review process for anthraquinone, reviewed rice field trial data submitted by the registrant for anthraquinone. That data indicated that use of anthraquinone as a rice seed treatment is expected to result in detectable residues of anthraquinone in or on rice and is, therefore, considered a use that may result in pesticide residues on food or feed. Thus, tolerances are needed to cover residues resulting from the rice seed use. For reasons discussed above, tolerances cannot be established at this time.
3. What should I do with harvested rice grown from seed treated with anthraquinone?
Currently, there is no tolerance for residues of anthraquinone in or on rice. Without a tolerance or exemption from the requirement of a tolerance, food containing a pesticide chemical residue is adulterated under section 402(a)(2)(B) of the Federal Food, Drug and Cosmetic Act (FFDCA).
Distribution of adulterated food is a violation of FFDCA, and FDA may take regulatory action if it finds violative anthraquinone residues in rice. However, FDA has not routinely monitored anthraquinone in rice because EPA previously considered anthraquinone treatment of rice seed a non-food use. FDA is planning to incorporate anthraquinone as an analyte in the quantitative multi-residue method used by the Pesticide Residue Monitoring Program in future years.
Recently, EPA informed FDA, based on its human health risk assessment, that dietary exposure to anthraquinone residues in or on rice commodities does not pose a health concern. As a result, FDA does not intend to start routine testing on rice from this year's harvest or past harvests.
For general information about how FDA enforces tolerances, visit FDA's Center for Food Safety and Applied Nutrition web page. If you have more specific questions for FDA, please contact FDA's Food and Cosmetics Information Center.
4. Will this affect the availability of anthraquinone in 2023?
EPA is not requiring anthraquinone products to be removed from the channels of sale and distribution at this time. Since there are no dietary risks of concern from the use of anthraquinone on treated rice, as noted in EPA’s April 2022 memo to the FDA, EPA is requiring the registrant to develop the data needed to establish tolerances for the rice seed treatment use. However, growers should be aware that because there are no tolerances at this time, rice commodities containing anthraquinone residues are adulterated and therefore, illegal to sell in interstate commerce.
5. Is rice grown from anthraquinone-treated seed (and associated rice commodities) safe to eat? What about baby food made with rice?
EPA has assessed the risks from dietary exposure from residues of anthraquinone on rice and rice commodities that may result from use of anthraquinone as a seed treatment on rice. EPA's dietary assessments incorporated several assumptions regarding eating rice and various food forms of rice (including rice baby food), as well as from drinking water. EPA's dietary assessments are therefore protective of potential dietary exposures for all population subgroups, including those comprised of infants and children. Based on the conclusions in the risk assessment, EPA has determined that exposures to anthraquinone will not result in dietary risks of concern from consuming rice, rice commodities, and drinking water for all population subgroups, including those comprised of infants and children.
Because there are risk of concerns from residential exposures alone, the aggregate exposures also result in risk concerns. EPA addressed these concerns by removing residential turf use sites from the label. Once these label changes are implemented (no later than January 9, 2023), there will be no aggregate risk of concern.
6. Is corn grown from anthraquinone-treated seed safe to eat?
In March 2021, the EPA confirmed (based on a corn radiotracer study the registrant submitted) that residues of anthraquinone are not expected in or on corn commodities. As a result, EPA does not expect any risks of concern to corn grown from anthraquinone-treated seed.