Evidence map›Paper›PMID 36119357›Full record

ReviewFrontiers in toxicology2022

Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health.

Andreas O Stucki, Tara S Barton-Maclaren, Yadvinder Bhuller, Joseph E Henriquez, Tala R Henry, Carole Hirn, Jacqueline Miller-Holt, Edith G Nagy, Monique M Perron, Deborah E Ratzlaff and 2 more

Abstract readReview
In one paragraph

Review in Frontiers in toxicology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 78 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

78 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. Readiness of theFrontiers in toxicology · 2026
    Article
  11. Application ofFrontiers in toxicology · 2026
    Review
  12. Review
  13. Article
  14. Review
  15. Article
  16. Advances in Cytotoxicity Testing: From In Vitro Assays to In Silico Models.International journal of molecular sciences · 2025
    Review
  17. Transferability and Reproducibility of the HepaRG CometChip Assay.Environmental and molecular mutagenesis · 2025
    Article
  18. Are New Approach Methodologies (NAMs) the Holy Grail of toxicology?Toxicological sciences : an official journal of the Society of Toxicology · 2025
    Review
  19. Review
  20. Comparative review of human health reference values of the United States.Toxicological sciences : an official journal of the Society of Toxicology · 2025
    Review

18 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Andreas O StuckiPETA Science Consortium International e.V., Stuttgart, Germany.
Tara S Barton-MaclarenSafe Environments Directorate, Healthy Environments and Consumer Safety Branch, Health Canada, Ottawa, ON, Canada.
Yadvinder BhullerPest Management Regulatory Agency, Health Canada, Ottawa, ON, Canada.
Joseph E HenriquezCorteva Agriscience, Indianapolis, IN, United States.
Tala R HenryOffice of Pollution Prevention and Toxics, US Environmental Protection Agency, Washington, DC, United States.
Carole HirnScientific and Regulatory Affairs, JT International SA, Geneva, Switzerland.
Jacqueline Miller-HoltScientific and Regulatory Affairs, JT International SA, Geneva, Switzerland.
Edith G NagyBergeson & Campbell PC, Washington, DC, United States.
Monique M PerronOffice of Pesticide Programs, US Environmental Protection Agency, Washington, DC, United States.
Deborah E RatzlaffSafe Environments Directorate, Healthy Environments and Consumer Safety Branch, Health Canada, Ottawa, ON, Canada.
Todd J StedefordBergeson & Campbell PC, Washington, DC, United States.
Amy J ClippingerPETA Science Consortium International e.V., Stuttgart, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

New approach methodologies (NAMs) are increasingly being used for regulatory decision making by agencies worldwide because of their potential to reliably and efficiently produce information that is fit for purpose while reducing animal use. This article summarizes the ability to use NAMs for the assessment of human health effects of industrial chemicals and pesticides within the United States, Canada, and European Union regulatory frameworks. While all regulations include some flexibility to allow for the use of NAMs, the implementation of this flexibility varies across product type and regulatory scheme. This article provides an overview of various agencies' guidelines and strategic plans on the use of NAMs, and specific examples of the successful application of NAMs to meet regulatory requirements. It also summarizes intra- and inter-agency collaborations that strengthen scientific, regulatory, and public confidence in NAMs, thereby fostering their global use as reliable and relevant tools for toxicological evaluations. Ultimately, understanding the current regulatory landscape helps inform the scientific community on the steps needed to further advance timely uptake of approaches that best protect human health and the environment.

Indexed as

industrial chemicalsin silicoin vitronew approach methodologies (NAMs)pesticidesrisk assesmenttoxicity testing

Identifiers

PMID36119357
PMCPMC9475191

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.