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Bibliography Tag: epa regulation

Benbrook et al., 2023

Benbrook C, Mesnage R, Sawyer W. “Genotoxicity Assays Published since 2016 Shed New Light on the Oncogenic Potential of Glyphosate-Based Herbicides.” Agrochemicals. 2023; 2(1):47-68. https://doi.org/10.3390/agrochemicals2010005

ABSTRACT:

Controversy over the oncogenicity of glyphosate-based herbicides (GBHs) persists seven years after a 2015 IARC Monograph classified glyphosate/GBHs as “probably carcinogenic” to humans. Most regulatory authorities have concluded that technical glyphosate poses little or no oncogenic risk via dietary exposure. The US EPA classified glyphosate as “not likely” to pose cancer risk in 1991, a decision reaffirmed in reports issued in 2017 and 2020. A Federal Circuit Court of Appeals in the US vacated EPA’s assessment of glyphosate human-health risks in 2022 and required EPA to revisit old and take into account new data in its forthcoming, possibly final glyphosate/GBH reregistration decision. Divergent assessments of GBH genotoxicity are the primary reason for differing conclusions regarding GBH oncogenic potential. We assessed whether assays published since completion of the EPA and IARC reviews shed new light on glyphosate/GBH genotoxicity. We found 94 such assays, 33 testing technical glyphosate (73% positive) and 61 on GBHs (95% positive). Seven of 7 in vivo human studies report positive results. In light of genotoxicity results published since 2015, the conclusion that GBHs pose no risk of cancer via a genotoxic mechanism is untenable. FULL TEXT

EPA, 2015b

Environmental Protection Agency, “Evaluation of the Carcinogenic Potential of Glyphosate Case No. 1071-83-6 .” Office of Chemical Safety and Pollution Prevention, October 1, 2015.

ABSTRACT:

On September 16, 2015, the Cancer Assessment Review Committee (CARC) of the Health
Effects Division, of the Office of Pesticide Programs evaluated the carcinogenic potential of
Glyphosate in accordance with the EPA ‘s Final Guidelines for Carcinogen Risk Assessment
(March, 2005). Attached please find the final Cancer Assessment Document.

FULL TEXT

Benbrook, 2022a

Benbrook, Charles; “Tracking pesticide residues and risk levels in individual samples—insights and applications;” Environmental Sciences Europe, 2022, 34(1); DOI: 10.1186/s12302-022-00636-w.

ABSTRACT:

BACKGROUND: A method is now available to quantify the number of pesticide residues and relative pesticide dietary risks in individual servings of food. The Dietary Risk Index (DRI) system combines the results of United States and United Kingdom pesticide residue testing programs with data on food serving sizes and each pesticide’s chronic Reference Dose or Acceptable Daily Intake. Chronic DRI values are a ratio: the amount of residue in a serving of food relative to the maximum amount allowed by regulators.

RESULTS: The DRI system generates individual sample tables reporting the number of residues detected and individual pesticide and aggregate-pesticide DRI values in specific, individual samples of food. It is the first such system to do so worldwide. Output tables produce accurate estimates of real-world dietary risks based on current toxicology data and exposure benchmarks set by regulators. System outputs allow assessment of the distribution of pesticide dietary risks across foods and pesticides and demonstrate that dietary risk levels are highly skewed. A large number of samples pose moderate, low, or very-low risks, and relatively few samples pose high or very-high risks.

CONCLUSIONS: The DRI system provides the food industry, regulators and analysts with a simple, accessible online tool to assess pesticide dietary-risk levels by food, by pesticide, as a function of country of origin, and on food grown on conventional versus organic farms. DRI system output tables show that the number of residues in a sample of food is a consistently poor indicator of dietary risk levels. By identifying the relatively small number of high-risk samples, efforts to mitigate pesticide dietary risks can be targeted where the most worrisome risks are.

FULL TEXT

 

Henderson et al., 1993

Henderson, P. T., Brouwer, D. H., Opdam, J. J., Stevenson, H., & Stouten, J. T.; “Risk assessment for worker exposure to agricultural pesticides: review of a workshop;” Annals of Occupational Hygeine, 1993, 37(5), 499-507; DOI: 10.1093/annhyg/37.5.499.

INTRODUCTION:

Pesticides are unusual among occupational chemical hazards, because they are designed to injure or to kill living organisms and are intrinsically toxic. Ideally they would be non-injurious to non-target organisms including man, but most are not highly selective. Therefore, their use should be regulated so that the health and safety of agricultural workers are assured. The key question is: “Are actual exposures safe?” The confidence with which this question can be answered depends on the knowledge of the toxicological properties of the pesticide followed by an assessment of the exposure that may be considered safe. Toxicological evaluation derives the ‘no observed-adverse-effect-levels’ (NOAEL) from experimental studies. The actual exposure must also be known. Comparing this with the NOAEL gives an insight to the risks experienced by the workers. There are several ways to estimate or assess exposure of the field worker. For the levels of exposure many factors are important, including physico-chemical properties of the pesticide, agricultural conditions, working procedure and environmental conditions. The central theme of the present Workshop was to achieve consensus about the optimum approach to:
—measurement of exposure of the agricultural worker, in which both ‘external’ and ‘internal’ exposure, in particular the role of biological monitoring, is considered;

—predictive exposure modelling;

—risk assessment and risk management of occupational exposure to pesticides.
Therefore four papers which follow this review were prepared. During the workshop, which was attended by 28 invited experts (see the List of Participants at the end of this review), the manuscripts were presented and each was critically reviewed by two or three invited respondents. This was followed by in-depth discussions. The present review summarizes the workshop discussions on the different subjects. The various recommendations and proposals that were presented, will be considered as starting points for deriving a harmonized approach to exposure and risk assessment.

 

Messina and Goodis, 2020

Messina, Edward & Goodis, Mike; “Overview of EPA’s Pesticide Program”; Presented at the Farm, Ranch, and Rural Communities Committee Meeting; November 13, 2020. Environmental Protection Agency, 2020.

PRESENTATION OUTLINE

  • Background
  • Office of Pesticide Programs Structure and Responsibilities
  • Pesticide Legislation
  • Pesticide Registration and Registration Review Process
  • Risk Assessment, Risk Characterization, and Risk Management
  • Public Involvement
  • Collaboration with Domestic & International Partners
  • Updates on EPA Issues

 FULL PRESENTATION

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