U.S. Federal Agency interests and key considerations for new approach methodologies for nanomaterials

doi:10.14573/altex.2105041

. 2022;39(2):183–206.

doi: 10.14573/altex.2105041. Epub 2021 Dec 3.

U.S. Federal Agency interests and key considerations for new approach methodologies for nanomaterials

Elijah J Petersen¹, Patricia Ceger², David G Allen², Jayme Coyle^{3

4}, Raymond Derk³, Natalia Garcia-Reyero⁵, John Gordon⁶, Nicole C Kleinstreuer⁷, Joanna Matheson⁶, Danielle McShan⁸, Bryant C Nelson¹, Anil K Patri⁹, Penelope Rice¹⁰, Liying Rojanasakul³, Abhilash Sasidharan¹¹, Louis Scarano¹¹, Xiaoqing Chang²

Affiliations

¹ U.S. Department of Commerce, National Institute of Standards and Technology, Gaithersburg, MD, USA.
² Integrated Laboratory Systems, LLC, P.O. Box 13501, Research Triangle Park, NC 27709, USA.
³ National Institute for Occupational Safety and Health, Health Effects Laboratory Division, Morgantown, WV, USA.
⁴ Current affiliation: UES, Inc., Dayton, OH, USA.
⁵ U.S. Army Engineer Research and Development Center, Vicksburg, MS, USA.
⁶ U.S. Consumer Product Safety Commission, Bethesda, MD, USA.
⁷ National Institute of Environmental Health Sciences, National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, Research Triangle Park, NC, USA.
⁸ U.S. Environmental Protection Agency, Office of Pesticide Programs, Washington, DC, USA.
⁹ U.S. Food and Drug Administration, National Center for Toxicological Research, Jefferson, AR, USA.
¹⁰ U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park, MD, USA.
¹¹ U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics, Washington, DC, USA.

PMID: 34874455
PMCID: PMC9115850
DOI: 10.14573/altex.2105041

U.S. Federal Agency interests and key considerations for new approach methodologies for nanomaterials

Elijah J Petersen et al. ALTEX. 2022.

. 2022;39(2):183–206.

doi: 10.14573/altex.2105041. Epub 2021 Dec 3.

Authors

Affiliations

¹ U.S. Department of Commerce, National Institute of Standards and Technology, Gaithersburg, MD, USA.
² Integrated Laboratory Systems, LLC, P.O. Box 13501, Research Triangle Park, NC 27709, USA.
³ National Institute for Occupational Safety and Health, Health Effects Laboratory Division, Morgantown, WV, USA.
⁴ Current affiliation: UES, Inc., Dayton, OH, USA.
⁵ U.S. Army Engineer Research and Development Center, Vicksburg, MS, USA.
⁶ U.S. Consumer Product Safety Commission, Bethesda, MD, USA.
⁷ National Institute of Environmental Health Sciences, National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, Research Triangle Park, NC, USA.
⁸ U.S. Environmental Protection Agency, Office of Pesticide Programs, Washington, DC, USA.
⁹ U.S. Food and Drug Administration, National Center for Toxicological Research, Jefferson, AR, USA.
¹⁰ U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park, MD, USA.
¹¹ U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics, Washington, DC, USA.

PMID: 34874455
PMCID: PMC9115850
DOI: 10.14573/altex.2105041

Abstract

Engineered nanomaterials (ENMs) come in a wide array of shapes, sizes, surface coatings, and compositions, and often possess novel or enhanced properties compared to larger sized particles of the same elemental composition. To ensure the safe commercialization of products containing ENMs, it is important to thoroughly understand their potential risks. Given that ENMs can be created in an almost infinite number of variations, it is not feasible to conduct in vivo testing on each type of ENM. Instead, new approach methodologies (NAMs) such as in vitro or in chemico test methods may be needed, given their capacity for higher throughput testing, lower cost, and ability to provide information on toxicological mechanisms. However, the different behaviors of ENMs compared to dissolved chemicals may challenge safety testing of ENMs using NAMs. In this study, member agencies within the Interagency Coordinating Committee on the Validation of Alternative Methods were queried about what types of ENMs are of agency interest and whether there is agency-specific guidance for ENM toxicity testing. To support the ability of NAMs to provide robust results in ENM testing, two key issues in the usage of NAMs, namely dosimetry and interference/bias controls, are thoroughly discussed.

Keywords: dosimetry; engineered nanomaterials; experimental bias; in vitro; risk assessment.

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Conflict of interest statement

Conflict of interest

The authors declare that they have no conflicts of interest.

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References

1. 7 U.S.C. § 136 et seq. (1947). Federal Insecticide, Fungicide, and Rodenticide Act. http://www.gpo.gov/fdsys/pkg/USCODE-1996-title7/html/USCODE-1996-title7-...
1. 7 U.S.C. § 136 et seq. (1972). Federal Insecticide, Fungicide, and Rodenticide Act (as amended), http://www.gpo.gov/fdsys/pkg/USCODE-1996-title7/html/USCODE-1996-title7-...
1. 7 U.S.C. § 136 (1996). Food Quality Protection Act of 1996. govinfo.gov/content/pkg/PLAW-104publ170/pdf/PLAW-104publ170.pdf (accessed 17.10.2019).
1. 15 U.S.C. § 2601 et seq. (1976). Toxic Substances Control Act. https://www.govinfo.gov/content/pkg/STATUTE-90/pdf/STATUTE-90-Pg2003.pdf...
1. 15 U.S.C. § 1261 et seq. (2008). Federal Hazardous Substances Act. https://www.govinfo.gov/content/pkg/COMPS-387/pdf/COMPS-387.pdf

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[1] 7 U.S.C. § 136 et seq. (1947). Federal Insecticide, Fungicide, and Rodenticide Act. http://www.gpo.gov/fdsys/pkg/USCODE-1996-title7/html/USCODE-1996-title7-...

[2] 7 U.S.C. § 136 et seq. (1947). Federal Insecticide, Fungicide, and Rodenticide Act. http://www.gpo.gov/fdsys/pkg/USCODE-1996-title7/html/USCODE-1996-title7-...

[3] 7 U.S.C. § 136 et seq. (1972). Federal Insecticide, Fungicide, and Rodenticide Act (as amended), http://www.gpo.gov/fdsys/pkg/USCODE-1996-title7/html/USCODE-1996-title7-...

[4] 7 U.S.C. § 136 et seq. (1972). Federal Insecticide, Fungicide, and Rodenticide Act (as amended), http://www.gpo.gov/fdsys/pkg/USCODE-1996-title7/html/USCODE-1996-title7-...

[5] 7 U.S.C. § 136 (1996). Food Quality Protection Act of 1996. govinfo.gov/content/pkg/PLAW-104publ170/pdf/PLAW-104publ170.pdf (accessed 17.10.2019).

[6] 7 U.S.C. § 136 (1996). Food Quality Protection Act of 1996. govinfo.gov/content/pkg/PLAW-104publ170/pdf/PLAW-104publ170.pdf (accessed 17.10.2019).

[7] 15 U.S.C. § 2601 et seq. (1976). Toxic Substances Control Act. https://www.govinfo.gov/content/pkg/STATUTE-90/pdf/STATUTE-90-Pg2003.pdf...

[8] 15 U.S.C. § 2601 et seq. (1976). Toxic Substances Control Act. https://www.govinfo.gov/content/pkg/STATUTE-90/pdf/STATUTE-90-Pg2003.pdf...

[9] 15 U.S.C. § 1261 et seq. (2008). Federal Hazardous Substances Act. https://www.govinfo.gov/content/pkg/COMPS-387/pdf/COMPS-387.pdf

[10] 15 U.S.C. § 1261 et seq. (2008). Federal Hazardous Substances Act. https://www.govinfo.gov/content/pkg/COMPS-387/pdf/COMPS-387.pdf

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U.S. Federal Agency interests and key considerations for new approach methodologies for nanomaterials

Affiliations

U.S. Federal Agency interests and key considerations for new approach methodologies for nanomaterials

Authors

Affiliations

Abstract

Conflict of interest statement

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MeSH terms

Grants and funding

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