An Overview of Chlorpyrifos Legislation

1. CHLORPYRIFOS (CPF):

CPF is classified as a post-emergent, non-selective, broad-spectrum organophosphate pesticide that was introduced by Dow Chemical in 1965 under the protection of U.S. Patent 3,244,586 (National Center for Biotechnology Information, 2022).

2. FEDERAL FOOD, DRUG, AND COSMETIC ACT (FFDCA)

In 1938, FFDCA was passed, ultimately giving the Food and Drug Administration (FDA) authority to oversee the safety of food, drugs, medical devices, and cosmetics (Congressional Research Service, 2012). Under Section 408 and 409 of the FFDCA, EPA has regulatory authority to set a tolerance (a maximum legally allowable pesticide residue limit) for expected pesticide residues remaining in or on raw agricultural commodities and processed food in order for a pesticide to be registered for use on food crops (Congressional Research Service, 2012). EPA must find that the tolerance is safe through the consideration of the pesticide’s toxicity and its breakdown products, cumulative exposure in foods and other exposure sources, and special risks posed to infants and children (Congressional Research Service, 2012). In this case, safe is defined as a “reasonable certainty that no harm will result from aggregate exposure to the pesticide residue, including all anticipated dietary exposures and all other exposures for which there is reliable information” (FFDCA, 1934). Tolerance-setting proceedings begin when a pesticide manufacturer submits a petition to EPA requesting the creation of a tolerance. The petition must include scientific data complying with EPA data requirements and statutory standards. Opponents of a tolerance are permitted to object, request an evidentiary hearing, and challenge EPA's final decision in court as long as the objection is filed within 60 days of EPA’s initial ruling (Congressional Research Service, 2012). EPA’s final order on the objection is subject to judicial review. If a commodity’s pesticide residues levels are found to be above EPA tolerance levels, it is subject to enforcement actions (Congressional Research Service, 2012). Section 408 governs tolerances for pesticide residues on raw agricultural commodities and mandates EPA to revoke or change a tolerance that is determined to be unsafe (Congressional Research Service, 2012). Section 409 regulates tolerances for pesticide residues that concentrate in processed foods using a strictly risk based safety standard to prioritize negative health risks over economic benefits (Congressional Research Service, 2012).

Before August 2021 and under FFDCA (40 CFR 180.342.), EPA established CPF tolerances for residues in or on the following food commodities: alfalfa forage (3.0 ppm), alfalfa hay (13 ppm), almond (0.2 ppm), almond hulls (12 ppm), apple (0.01 ppm), apple pomace (0.02 ppm) , banana (0.1 ppm), dried pulp of sugar beet (5.0 ppm), molasses of sugar beet (15 ppm), roots of sugar beet (1.0 ppm), tops of sugar beet (8.0 ppm), cattle fat (0.3 ppm), cattle meat (0.05 ppm), cattle meat byproducts (0.05 ppm), sweet cherry (1.0 ppm), cherry tart (1.0 ppm), dried citrus pulp (5.0 ppm), citrus oil (20 ppm), corn field forage (8.0 ppm), corn field grain (0.05 ppm), refined corn field oil (0.25 ppm) corn field stover (8.0 ppm), sweet corn forage (8.0 ppm), sweet corn kernel plus cob with husk removed (0.05 ppm), sweet corn stover (8.0 ppm), undelinted seed cotton (0.2 ppm), cranberry (1.0 ppm), cucumber (0.05 ppm), egg (0.01 ppm), fig (0.01 ppm), citrus fruit group 10 (1.0 ppm), goat fat (0.2 ppm), goat meat (0.05 ppm), goat meat byproducts (0.05 ppm), hazelnut (0.2 ppm), hog fat (0.2 ppm), hog meat (0.05 ppm), hog meat byproducts (0.05 ppm), horse fat (0.25 ppm), horse meat (0.25 ppm), horse meat byproducts (0.25 ppm), kiwifruit (2.0 ppm), milk fat (0.25 ppm), nectarine (0.05 ppm), onion bulb (0.5 ppm), peach (0.05 ppm), peanut (0.2 ppm), refined peanut oil (0.2 ppm), pear (0.05 ppm), pecan (0.2 ppm), pepper (1.0 ppm), peppermint tops (0.8 ppm), peppermint oil (8.0 ppm) fresh prune plums (0.05 ppm), poultry fat (0.1 ppm), poultry meat (0.1 ppm), poultry meat byproducts (0.1 ppm), pumpkin (0.05 ppm), radish (2.0 ppm), rutabaga (0.5 ppm), sheep fat (0.2 ppm), sheep meat (0.05 ppm), sheep meat byproducts (0.05 ppm), spearmint tops (0.8 ppm), spearmint oil (8.0 ppm), sorghum grain forage (0.5 ppm), sorghum grain (0.5 ppm), sorghum grain stover (2.0 ppm), soybean seed (0.3 ppm), strawberry (0.2 ppm), sunflower seed (0.1 ppm), sweet potato roots (0.05 ppm), turnip roots (1.0 ppm), turnip tops (0.3 ppm), leafy brassica vegetable group 5 (1.0 ppm), legume vegetable group 6 except soybean (0.05 ppm), walnut (0.2 ppm), wheat forage (3.0 ppm), wheat grain (0.5 ppm), and wheat straw (6.0 ppm). EPA also established CPF pesticide tolerances with regional registrations in or on asparagus (5.0 ppm) and grape (.01 ppm). A tolerance of 0.1 ppm is established for residues of CPF in or on all other food commodities in food service establishments where food and food products are prepared and served (Chlorpyrifos Tolerances for Residues, 2011).

In response to a U.S. Court of Appeals order to issue a final rule on CPF tolerances by August 20, 2021, EPA determined that it is unable to conclude with certainty that risks from total CPF exposure (such as exposures from food, water, and residential use) from current registered CPF uses meet FFDCA safety standards (Chlorpyrifos Tolerance Revocation, 2021). This ruling becomes effective on Ocotber 29, 2021 and will result in the expiration of all tolerances for CPF residues listed in 40 CFR 180.342. on February 28, 2022 (Chlorpyrifos Tolerance Revocation, 2021).

3. CPF REGULATORY AUTHORITY UNDER FFDCA

EPA’s regulatory authority on this issue is granted in FFDCA sections 408(b)(1)(A), 408(b)(2)(A), and 408(d)(4)(A)(i) (FFDCA, 1938). EPA’s mission to protect the health of humans and the environment coincides with FFDCA because it allows EPA to prevent pesticide exposure at levels that result in adverse health outcomes as exemplified in the act’s definition of “safe” and EPA’s recent effort to revoke CPF tolerances due to the agency’s inability to determine that CPF is safe.

4. STATE AND LOCAL AGENCY INVOLVEMENT

States and other political subdivisions may not set or enforce a regulatory limit on a pesticide chemical residue in or on a food if a federal standard applies unless the state’s regulatory standard is identical to the federal limit and there is a clear intention to prohibit or penalize production, processing, shipping, and handling of food with pesticide residue levels above the limit (FFDCA, 1938). However, any state has the right to petition for the authority to set a regulatory limit on a pesticide chemical residue in or on food non-identical to the federal limit as long as it is supported by scientific data regarding pesticide chemical residue, consumption data within the relevant state, and human exposure data (FFDCA, 1938). If there is evidence to suggest that significant public health risks will result from acute exposure to the pesticide residue in question then the petition will be considered as urgent (FFDCA, 1938). If a decision regarding the urgent petition is not made within 30 days, then the state will be able to establish a temporary pesticide residue limit until a final decision is reached (FFDCA, 1934). The state may be granted regulatory authority over the pesticide residue limit of choice if the proposal is supported by compelling local conditions and would not cause food to be in violation of the federal rule (FFDCA, 1934).

5. PERSONAL IMPLICATIONS

Between 2009 and 2013, 6 million pounds of CPF pesticides were used on 10 million acres of agricultural land (Vogel, 2016). Between 2006 and 2012, CPF was applied to more than 50% of the nation's apple and broccoli crops, 45% of onion crops, 46% of walnut crops, and 41% of cauliflower crops (Vogel, 2016). Corn, soybeans, alfalfa, oranges, and almonds receive the highest CPF doses, which is notable considering the quantity of domestic agricultural land devoted to corn and soybean production (Vogel, 2016).

CPF exposure occurs through residues on food, contaminated drinking water, absorption through the skin, pregnancy, and the inhalation of atmospheric CPF, which is of concern due to CPF’s ability to be carried long distances in the air and toxic spray drift from nearby pesticide applications. Furthermore, EPA determined that low CPF exposure in pregnant mothers could result in long-term, quantifiable, and potentially irreversible neurobehavioral deficiencies in prenatally exposed children (Rauh, 2012). In this determination, EPA relied on evidence presented in a Columbia Center for Children’s Environmental Health (CCCEH) study testing the association between CPF exposure (based on sampling of blood in the mother’s umbilical cord) to differences in fetal brain development and morphology using magnetic resonance imaging (MRI) in 40 children (5.9 - 11.2 y, selected from a nonclinical, representative community-based cohort) (Rauh, 2012). The authors found disturbances in brain structure including abnormal tissue enlargement and tissue thinning to be consistent with the IQ deficits previously reported in children with high CPF exposure levels, suggesting a significant correlation between prenatal CPF exposure and IQ deficits, working memory at age seven, and long-term neurobehavioral deficit (Rauh, 2012). Notably, brain abnormalities occurred at exposure levels below EPA toxicity threshold, which is based on exposures high enough to cause cholinesterase inhibition.

The implications of CPF’s widespread usage and its many mechanisms of exposure directly affect me, consumers of CPF tainted food, water, and air, farm workers, agricultural communities, pregnant women, and children. Specifically, CPF exposure in utero has more than likely affected the development of myself and my three siblings. Not only did my mother grow up in Texas, Iowa, and Indiana (states that all depend on high levels of CPFs for agricultural production), but while pregnant with my siblings and I, my mother also consumed a hefty diet of inorganic fruits and vegetables that happen to have high tolerance residues under FFDCA, some of which include beets (tolerance of 15 ppm) and dried citrus pulp (5 ppm) (because she is a vegetarian and didn’t realize the implications of inorganic produce). While CPF tolerances will be revoked by the time I have children, thus lowering my potential rates of CPF exposure, it is likely that I will still be exposed to CPF through groundwater pollution and pesticide drift given that I’d like to eventually move to a rural area that could still be employing CPF pesticides in order to increase agricultural yields as much as possible.

6. OTHER POLICY TOOLS USED TO REGULATE CHLORPYRIFOS

1947: The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was enacted, which governs the registration, distribution, sale, and utilization of pesticides through the U.S. Department of Agriculture (FIFRA, 1996).

1970: With the creation of the EPA, regulatory authority of FIFRA transferred to EPA from USDA. Under this act, EPA must register all pesticides sold or distributed domestically based on a cost-benefit analysis of a product's use according to valid and reliable scientific data (FIFRA, 1996). Required data includes evidence of the product's usefulness, its chemical and toxicological properties, its likely environmental distribution, and its possible adverse effects on wildlife, plants, and other environmental elements (FIFRA, 1996). The pesticide manufacturer is responsible for providing the data necessary to support that it will not cause unreasonable adverse environmental effects (FIFRA, 1996). Any unreasonable risk to man or the environment accounts for the economic, social, and environmental costs and benefits of the pesticide’s use, and human dietary risk resultant from pesticide residues in or on any food inconsistent with the standard under section 408 of the FFDCA (FIFRA, 1996). If the applicant's data fails to suggest that the product's use poses no unreasonable adverse effects on the environment, registration is denied (FIFRA, 1996). After a pesticide’s registration, the registrant continues to bear this responsibility and may be required to prove its case again if scientific data challenges the EPA's original assessment of risk and benefits (FIFRA, 1996). A successful registration process ends with a product’s label’s approval, which designates legally binding instructions for the pesticide’s use on certain crops, including any limitations or conditions on how or when the pesticide must be applied or not applied in order to avoid adverse impacts on the environment or on adjacent or future crops in order to ensure efficacy and minimize applicator exposure (FIFRA, 1996). In order to cancel or suspend a pesticides’ registration, EPA considers the impact of the proposed action on production, the agricultural economy, and prices of agricultural commodities and retail food prices (FIFRA, 1996). With this being said, FIFRA is known as a balancing statute in which EPA must conclude that the food production benefits of a pesticide outweigh any risks to be granted registration (FIFRA, 1996).

1996: The Clinton administration signed the Food Quality Protection Act in order to amend FIFRA and the FFDC. Regarding tolerances, FQPA requires EPA to make a safety finding when determining tolerances, use the safety standard to reevaluate all pesticide tolerances already established when FQPA was signed over a 10-year period, assess cumulative risk from pesticide exposure from multiple sources when evaluating tolerances, consider aggregate pesticide exposure that have common toxicity mechanisms, and consider children’s susceptibility to pesticides by using a tenfold safety factor when establishing and reevaluating tolerances (FQPA, 1996). Using newly-developed risk-assessment methodologies (including the 10X safety factor, drinking water and residential exposure, cumulative exposure and risk assessment, and risk assessment for pesticides with a common toxicity mechanisms), EPA reassessed the required 9,721 pesticide tolerances during the 10-year timeframe which resulted in the revocation or modification of about 4,000 tolerances (FQPA, 1996). Furthermore, FQPA required EPA to fast-track the approval of pesticide tolerances of reduced risk and antimicrobial pesticide products, analyze pesticides for a relationship to the degradation of the endocrine system, and conduct a periodic review of pesticide registrations every fifteen years through the Registration Review Program to due the development of new scientific information (FQPA, 1996).

2000: EPA prohibited residential CPF use and established no-spray buffer zones of 10 to 100 feet around certain structures including daycares and hospitals due to unsafe exposures to children.

2006: EPA revised CPF tolerance residues (Environmental and Energy Law Program, 2017).

2007: The Pesticide Action Network of North America (PANNA) and the Natural Resources Defense (NRDC) filed a joint petition to EPA to revoke all tolerances and cancel all registrations for the pesticide CPF because despite the fact that CPF was just banned for nearly all residential and indoor uses, EPA still determined that CPF was safe for industrial and agricultural use (Environmental and Energy Law Program, 2017).

July 22, 2010: NRDC and PANNA challenge EPA’s failure to respond by filing a lawsuit in federal court (Environmental and Energy Law Program, 2017).

July 2012 and July 2014: EPA provides interim responses, denying the following objections raised by the PANNA and NRDC petition: EPA ignored genetic evidence of vulnerable populations and data regarding cancer risks, EPA unnecessarily delayed a decision regarding endocrine disrupting effects, EPA's 2006 cumulative risk assessment (CRA) misrepresented risks and failed to apply FQPA 10X safety factor, EPA over-relied on registrant data (Environmental and Energy Law Program, 2017). In response, EPA planned to expedite a CPF review, but they do not adhere to the negotiated schedules, so in April 2012 and September 2014, PANNA filed writs of mandamus with the Ninth Circuit (Environmental and Energy Law Program, 2017).

August 10, 2015: The Ninth Circuit issued a mandamus order directing EPA to fully respond to the administrative petition by October 31, 2015 (Environmental and Energy Law Program, 2017).

November 6, 2015: EPA issued a proposed rule to revoke all CPF tolerances based on its unfinished registration risk assessment and insufficient time to complete its drinking water assessment and its review of data addressing the potential for neurodevelopmental effects (Chlorpyrifos Tolerance Revocations, 2015).

November 10, 2016: EPA published the revised human health hazard assessment (RHHRA) and drinking water exposure assessment for CPF under FIFRA in which it analyzed national watershed data and characterized dietary exposure risk from drinking water residues (Britton et. al, 2016). EPA found that expected CPF residues on food crops and the majority of estimated drinking water exposures from allowed CPF uses exceeded safety standards (Britton et. al, 2016). Furthermore, RHHRA demonstrated that there are no acceptable CPF uses due to all food uses exceeding acceptable levels, with children under two years of age experiencing CPF exposure levels 140 times what the EPA considers acceptable standards (Britton et. al, 2016). EPA determined that the [CCCEH] study, with supporting results from the other two U.S. cohort studies and seven epidemiological studies reviewed in 2015 provides sufficient evidence that neurodevelopmental effects occur at CPF exposure levels below that required for AChE inhibition (Britton et. al, 2016).

April 05, 2017: EPA Administrator Pruitt denied the NRDC/PANNA petition against the EPA’s own scientific consensus (that CPF exposure is connected to severe health problems among children, farm workers, and users of rural drinking water) and indicated that it will delay action until the statutory deadline for CPF reassessment on Oct. 1, 2022 against the negotiated rulemaking schedule (Environmental and Energy Law Program, 2017).

June 5, 2017: Earth justice, PANNA, NRDC, United Farm Workers, California Rural Legal Assistance Foundation, Farmworker Association of Florida, Farmworker Justice, Green Latinos, Labor Council for Latin American Advancement, League of United Latin American Citizens, Learning Disabilities Association of America, National Hispanic Medical Association and Pineros y Campesinos Unidos del Noroeste jointly filed an administrative appeal regarding the Denial Order which challenged EPA’s failure to finalize the CPF ban (Environmental and Energy Law Program, 2017). The objectors assert that EPA is required to meet the FFDCA safety standard in reviewing any petition to revoke tolerances and that EPA’s proposed rule failed to apply that standard. The objectors also find that the record demonstrated that CPF results in unsafe drinking water exposures and adverse neurodevelopmental effects, therefore, EPA must issue a final rule revoking all CPF tolerances (Environmental and Energy Law Program, 2017).

July 25, 2017: Senator Udall (D-NM) introduced the Protect Children, Farmers, and Farmworkers from Nerve Agent Pesticides Act of 2017 bill in the US. Senate in order to amend the FFDCA to prohibit CPF use on food and FIFRA to prohibit the registration of CPF pesticides (Environmental and Energy Law Program, 2017).

Dec. 29, 2017: Under the Endangered Species Act (ESA), the National Marine Fisheries Service (NMFS) issued a Biological Opinion on CPF, stating that “EPA’s proposed registration of CPF pesticides is likely to jeopardize the existence of 38 of the 77 listed species and adversely modify 37 of the 50 designated critical habitats” and recommending reasonable alternatives to minimize impacts on threatened and endangered species for EPA to follow (Environmental and Energy Law Program, 2017).

Aug. 9, 2018: The Court of Appeals vacated the Denial order, ordered EPA to revoke all CPF tolerances and cancel all CPF registrations within 60 days, and found that there was no justification for EPA’s 2017 decision to maintain a tolerance for CPF despite scientific evidence that its CPF residue on food causes neurodevelopmental damage to children (Environmental and Energy Law Program, 2017). EPA requested a rehearing of that decision before an en banc panel of the 9th Circuit, which was granted, effectively vacating the August 9, 2018 panel decision (Environmental and Energy Law Program, 2017).

January 3, 2019: The Ban Toxic Pesticides Act of 2019, proposed by Representative Velazquez, was intended to cancel the registration of all uses of CPF, revoke any tolerance or exemption that allows the presence of CPF residue in or on food or resultant from its use (in accordance with section 408 of FFDCA), prohibit the sale and use of existing CPF stocks, and deem CPF to cause unreasonable adverse effects on the environment due in part to dietary risks to humans posed by residues of that pesticide chemical on food (Ban Toxic Pesticides Act of 2019, 2020).

April 11, 2019: Senator Gillibrand (D-NY) introduces the Safe School Meals for Kids Act of 2019 bill in order to keep CPF treated food out of school meal programs nationwide (Environmental and Energy Law Program, 2017).

July 18, 2019: As required by the Ninth Circuit, EPA Assistant Administrator Dunn issued CPF; Final Order Denying Objections to March 2017 Petition Denial Order under Section 408 of the FFDCA as a final act in response to a 2007 petition from the PANNA and NRDC to revoke all tolerances and cancel all registrations for the insecticide CPF (Environmental and Energy Law Program, 2017). By claiming that identified health risks were not supported by valid, complete, and reliable evidence, EPA denied previous objections raised by the PANNA and NRDC petition (Environmental and Energy Law Program, 2017).

Aug. 7, 2019: The District of Columbia, New York, Washington, Maryland, Vermont, California, and Massachusetts filed a petition for the Ninth Circuit to review EPA’s Objection Denial Order (Environmental and Energy Law Program, 2017).

Aug. 7, 2019: PANNA, NRDC, League of United Latin American Citizens, California Rural Legal Assistance Foundation, Farmworker Association of Florida, Farmworker Justice, Labor Council for Latin American Advancement, Learning Disabilities Association of America, National Hispanic Medical Association, Pineros y Campesinos Unidos del Noroeste, and United Farm Workers filed a petition for the Ninth Circuit to review EPA’s Objection Denial Order (July 2019) and Petition Denial Order (Environmental and Energy Law Program, 2017).

Dec. 6, 2019: The European Union voted to ban the sale of CPF after Jan. 31, 2020 (Environmental and Energy Law Program, 2017).

Feb. 6, 2020: Pesticide manufacturer Corteva announces that it will stop making CPF (Environmental and Energy Law Program, 2017).

August 30, 2021: In response to a U.S. Court of Appeals order to issue a final rule on CPF tolerances by August 20, 2021, EPA determined that it is unable to conclude that risks from total CPF exposure (such as exposures from food, water, and residential use) from current registered CPF uses meet FFDCA safety standard (Chlorpyrifos Tolerance Revocation, 2021).

February 28, 2022: Under FFDCA, all CPF tolerances will expire (Chlorpyrifos Tolerance Revocation, 2021).

Bibliography:

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