Análisis de un protocolo basado en la norma USEPA 1.213 para la evaluación regulatoria de la eficacia de las cebaderas en el control seguro de roedores pequeños / Analysis of a protocol based on the USEPA 1.213 standard for the regulatory evaluation of the efficacy of the bait station system in the safe control of small rodents

Varios rodenticidas modernos son formulados con compuestos anticoagulantes superwarfarínicos. Debido a su alta toxicidad en humanos, los cebos suelen ser formulados con otros ingredientes destinados a generar respuestas de rechazo en el caso de ingestión accidental o intento de suicidio; aun así, las unidades hospitalarias reportan anualmente numerosos casos de intoxicaciones con rodenticidas. Se han desarrollado cebaderas con el propósito de brindar al usuario alta eficacia y seguridad extendida. Dado que en muchos países existe experiencia limitada para la evaluación regulatoria de cebos combinados con cebaderas, en este trabajo se presenta un protocolo adaptado a partir de la guía USEPA- 1.213/1990, el cual se propone para verificar la aptitud de las cebaderas para controlar roedores en ambientes hogareños, ocupacionales y otros espacios urbanos. Se incluye una discusión de aspectos técnicos que se espera que sean de ayuda para los asesores de las agencias regulatorias intervinientes al interpretar los resultados en términos de eficacia y seguridad. El sistema cebadera-cebo examinado mostró alta letalidad en ratas adultas jóvenes. La inspección, carga y recarga de producto fresco se realizó en forma simple, rápida y segura; sólo excepcionalmente se observó dispersión del cebo fuera de la cebadera. Sin embargo, debe tenerse en cuenta que el sistema que solicita un registro ante la autoridad regulatoria debe ser adecuado a la especie que se busca controlar, considerando las diferencias de peso corporal entre ratas y ratones, entre machos y hembras, y entre animales jóvenes y adultos, lo cual determina la facilidad de ingreso al interior del dispositivo (cebadera) donde se coloca el cebo contenido en su embalaje unitario original. (AU)

Several modern rodenticides are formulated with anticoagulant superwarfarin compounds. Due to their high toxicity in humans, these baits are usually formulated with other ingredients intended to generate rejection responses in the case of accidental ingestion or suicide attempt. However, hospital units report numerous cases of poisoning with rodenticides every year. Box-like bait stations have been developed to provide the user with high efficacy and extended safety. Given that in many countries there is limited experience for the regulatory consideration of bait stations, this work presents a protocol adapted from the USEPA-1.213/1990 guideline, proposed to verify the aptitude of these devices to control wild rodents in home, work, and other urban spaces. The work includes a discussion of technical issues that are expected to be helpful to advisors of the regulatory agencies involved in interpreting the results in terms of efficacy and safety. The bait-station system examined showed high efficacy in young adult rats. The inspection, loading and reloading of fresh product were carried out in a simple, fast and safe way; bait dispersal outside the station was only rarely observed. However, it must be taken into account that the system that require a registration by the regulatory authority must be appropriate to the species sought to be controlled. This is important due to differences in body weight between rats and mice, between males and females, and between young and aged animals, which determines the ease of entry into the station where the bait contained in its original unitary packaging is placed. (AU)

The EPA's Commitment to Children's Environmental Health: History and Current Challenges.

Children's environmental health (CEH) has a 25-year history at the US Environmental Protection Agency (EPA), during which the agency has advanced CEH through research, policy, and programs that address children's special vulnerability to environmental harm. However, the Trump administration took many actions that weakened efforts to improve CEH. The actions included downgrading or ignoring CEH concerns in decision-making, defunding research, sidelining the Children's Health Protection Advisory Committee, and rescinding regulations that were written in part to protect children. To improve CEH, federal environmental statutes should be reviewed to ensure they are sufficiently protective. The administrator should ensure the EPA's children's health agenda encompasses the most important current challenges and that there is accountability for improvement. Guidance documents should be reviewed and updated to be protective of CEH and the federal lead strategy refocused on primary prevention. The Office of Children's Health Protection's historically low funding and staffing should be remedied. Finally, the EPA should update CEH data systems, reinvigorate the role of the Children's Health Protection Advisory Committee, and restore funding for CEH research that is aligned with environmental justice and regulatory decision-making needs. (Am J Public Health. 2022;112(1):124-134. https://doi.org/10.2105/AJPH.2021.306537).

A regulatory relic: After 60 years of research on cancer risk, the Delaney Clause continues to keep us in the past.

The Delaney Clause of the Federal Food, Drug, and Cosmetic Act became law in 1958 because of concerns that potentially harmful chemicals were finding their way into foods and causing cancer. It states, "[n]o additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal." The United States Food and Drug Administration (US FDA) and United States Environmental Protection Agency (US EPA, prior to implementation of the Food Quality Protection Act) were charged with implementing this clause. Over 60 years, advances in cancer research have elucidated how chemicals induce cancer. Significant advancements in analytical methodologies have allowed for accurate and progressively lower detection limits, resulting in detection of trace amounts. Based on current scientific knowledge, there is a need to revisit the Delaney Clause's utility. The lack of scientific merit to the Delaney Clause was very apparent when recently the US FDA had to revoke the food additive approvals of 6 synthetic flavoring substances because high dose testing in animals demonstrated a carcinogenic response. However, US FDA determined that these 6 synthetic flavoring substances do not pose a risk to public health under the conditions of intended use. The 7th substance, styrene, was de-listed because it is no longer used by industry. The scientific community is committed to improving public health by promoting relevant science in risk assessment and regulatory decision making, and this was discussed in scientific sessions at the American Association for the Advancement of Science (AAAS) 2020 Annual Meeting and the Society of Toxicology (SOT) 2019 Annual Meeting. Expert presentations included advances in cancer research since the 1950s; the role of the Delaney Clause in the current regulatory paradigm with a focus on synthetic food additives; and the impact of the clause on scientific advances and regulatory decision making. The sessions concluded with panel discussions on making the clause more relevant based on 21st-century science.

US EPA's regulatory pesticide evaluations need clearer guidelines for considering mammary gland tumors and other mammary gland effects.

Breast cancer risk from pesticides may be missed if effects on mammary gland are not assessed in toxicology studies required for registration. Using US EPA's registration documents, we identified pesticides that cause mammary tumors or alter development, and evaluated how those findings were considered in risk assessment. Of 28 pesticides that produced mammary tumors, EPA's risk assessment acknowledges those tumors for nine and dismisses the remaining cases. For five pesticides that alter mammary gland development, the implications for lactation and cancer risk are not assessed. Many of the mammary-active pesticides activate pathways related to endocrine disruption: altering steroid synthesis in H295R cells, activating nuclear receptors, or affecting xenobiotic metabolizing enzymes. Clearer guidelines based on breast cancer biology would strengthen assessment of mammary gland effects, including sensitive histology and hormone measures. Potential cancer risks from several common pesticides should be re-evaluated, including: malathion, triclopyr, atrazine, propylene oxide, and 3-iodo-2-propynyl butylcarbamate (IPBC).

Application of the Food Quality Protection Act children's health safety factor in the U.S. EPA pesticide risk assessments.

BACKGROUND: The Food Quality Protection Act of 1996, or FQPA, required the Environmental Protection Agency to set allowable levels for pesticides in a way that would "ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue." The act stipulated that an additional tenfold margin of safety for pesticide risk assessments shall be applied to account for pre- and postnatal toxicity and for any data gaps regarding pesticide exposure and toxicity, unless there are reliable data to demonstrate that a different margin would be safe for infants and children. DISCUSSION: To examine the implementation of the FQPA-mandated additional margin of safety, this analysis reviews 59 pesticide risk assessments published by the EPA between 2011 and 2019. The list includes 12 pesticides used in the largest amount in the U.S.; a group of 35 pesticides detected on fruits and vegetables; and 12 organophosphate pesticides. For the non-organophosphate pesticides reviewed here, the EPA applied an additional children's health safety factor in 13% of acute dietary exposure scenarios and 12% of chronic dietary exposure scenarios. For incidental oral, dermal and inhalation exposures, additional FQPA factors were applied for 15, 31, and 41%, respectively, of the non-organophosphate pesticides, primarily due to data uncertainties. For the organophosphate pesticides as a group, a tenfold children's health safety factor was proposed in 2015. Notably, in 2017 that decision was reversed for chlorpyrifos. CONCLUSIONS: For the majority of pesticides reviewed in this study, the EPA did not apply an additional FQPA safety factor, missing an opportunity to fully use the FQPA authority for protecting children's health.