11 research outputs found
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U.S. EPA reregistration eligibility decision (RED) for the rodenticide cluster: overview of the regulatory process, response of registrants and stakeholders, and implications for agricultural and urban rodent control
After several years of reviewing study data and conducting risk assessments, in September of 1998 the U.S. Environmental Protection Agency (U.S. EPA) issued for comment a Reregistration Eligibility Decision (RED) document for pesticide products in the Rodenticide Cluster. The RED document covered 243 rodenticide products containing the following active ingredients: brodifacoum, bromadiolone, bromethalin, chlorophacinone, diphacinone and its sodium salt, and pival and its sodium salt. The U.S. EPA’s human health risk assessment in the RED document concluded that it was concerned about the risk to children due to accidental exposures to these chemicals through use in and around residences. With regard to ecological effects, the Agency concluded that there is a high risk of secondary poisoning, especially to mammals, from the use of these rodenticides outdoors in rural and suburban areas. In order to address the potential risks to children, the U.S. EPA initially required several mitigation measures designed to minimize exposure (e.g., addition of dye and bittering agent to formulations, labeling changes). The Agency also initiated implementation of a Rodenticide Stakeholder Process through which these and other risk mitigation measures would be discussed and required as needed. To help mitigate potential risks to non-target wildlife, the Agency initially determined that all uses of field-bait rodenticides containing more than 0.005% of chlorophacinone or diphacinone were ineligible for reregistration. The U.S. EPA also decided that all rodenticide products labeled for field use (except those limited to manual underground baiting) should be reclassified as Restricted Use pesticides. This paper reviews the regulatory process for the Rodenticide Cluster RED and discusses the response of the California Department of Food and Agriculture (CDFA) and other registrants to the requirements proposed in the RED document including formation of the Rodenticide Registrants Task Force (RRTF). It also outlines how an on-going dialogue with the Agency, both through the Rodenticide Stakeholder Process and in separate discussions, has diminished the RED requirements from those originally proposed. In addition, the paper discusses the implications and potential impacts of the current RED reregistration requirements for those applicators involved in agricultural and urban rodent control
Recommended from our members
U.S. EPA reregistration eligibility decision (RED) for the rodenticide cluster: overview of the regulatory process, response of registrants and stakeholders, and implications for agricultural and urban rodent control
After several years of reviewing study data and conducting risk assessments, in September of 1998 the U.S. Environmental Protection Agency (U.S. EPA) issued for comment a Reregistration Eligibility Decision (RED) document for pesticide products in the Rodenticide Cluster. The RED document covered 243 rodenticide products containing the following active ingredients: brodifacoum, bromadiolone, bromethalin, chlorophacinone, diphacinone and its sodium salt, and pival and its sodium salt. The U.S. EPA’s human health risk assessment in the RED document concluded that it was concerned about the risk to children due to accidental exposures to these chemicals through use in and around residences. With regard to ecological effects, the Agency concluded that there is a high risk of secondary poisoning, especially to mammals, from the use of these rodenticides outdoors in rural and suburban areas. In order to address the potential risks to children, the U.S. EPA initially required several mitigation measures designed to minimize exposure (e.g., addition of dye and bittering agent to formulations, labeling changes). The Agency also initiated implementation of a Rodenticide Stakeholder Process through which these and other risk mitigation measures would be discussed and required as needed. To help mitigate potential risks to non-target wildlife, the Agency initially determined that all uses of field-bait rodenticides containing more than 0.005% of chlorophacinone or diphacinone were ineligible for reregistration. The U.S. EPA also decided that all rodenticide products labeled for field use (except those limited to manual underground baiting) should be reclassified as Restricted Use pesticides. This paper reviews the regulatory process for the Rodenticide Cluster RED and discusses the response of the California Department of Food and Agriculture (CDFA) and other registrants to the requirements proposed in the RED document including formation of the Rodenticide Registrants Task Force (RRTF). It also outlines how an on-going dialogue with the Agency, both through the Rodenticide Stakeholder Process and in separate discussions, has diminished the RED requirements from those originally proposed. In addition, the paper discusses the implications and potential impacts of the current RED reregistration requirements for those applicators involved in agricultural and urban rodent control
Low-field 0.55 T MRI for assessment of pulmonary groundglass and fibrosis-like opacities: Inter-reader and inter-modality concordance
Purpose: To evaluate detection and characterization of groundglass and fibrosis-like opacities imaged by non -contrast 0.55 Tesla MRI, and versus clinically-acquired chest CT images, in a cohort of post-Covid patients.Materials and methods: 64 individuals (26 women, mean age 53 +/- 14 years, range 19-85) with history of Covid-19 pneumonia were recruited through a survivorship registry, with 106 non-contrast low-field 0.55 T cardio-pulmonary MRI exams acquired from 9/8/2020-9/28/2021. MRI exams were obtained at an average interval of 9.5 +/- 4.5 months from initial symptom report (range 1-18 months). Of these, 20 participants with 22 MRI exams had corresponding clinically-acquired CT chest imaging obtained within 30 days of MRI (average interval 18 +/- 9 days, range 0-30). MR and CT images were reviewed and scored by two thoracic radiologists, for presence and extent of lung opacity by quadrant, opacity distribution, and presence versus absence of fibrosis-like subpleural reticulation and subpleural lines. Scoring was performed for each of four lung quadrants: right upper and middle lobe, right lower lobe, left upper lobe and lingula, and left lower lobe. Agreement between readers and mo-dalities was assessed with simple and linear weighted Cohen's kappa (k) coefficients.Results: Inter-reader concordance on CT for opacity presence, opacity extent, opacity distribution, and presence of subpleural lines and reticulation was 99%, 78%, 97%, 99%, and 94% (k 0.96, 0.86, 0.94, 0.97, 0.89), respectively. Inter-reader concordance on MR, among all 106 exams, for opacity presence, opacity extent, opacity distribution, and presence of subpleural lines and reticulation was 85%, 48%, 70%, 86%, and 76% (k 0.57, 0.32, 0.46, 0.47, 0.37), respectively. Inter-modality agreement between CT and MRI for opacity presence, opacity extent, opacity distribution, and presence subpleural lines and reticulation was 86%, 52%, 79%, 93%, and 76% (k 0.43, 0.63, 0.65, 0.80, 0.52).Conclusion: Low-field 0.55 T non-contrast MRI demonstrates fair to moderate inter-reader concordance, and moderate to substantial inter-modality agreement with CT, for detection and characterization of groundglass and fibrosis-like opacities