Current ecotoxicity testing needs among selected U.S. federal agencies

Patricia Ceger¹, Natalia Garcia-Reyero Vinas², David Allen³, Elyssa Arnold⁴, Raanan Bloom⁵, Jennifer C Brennan⁶, Carol Clarke⁷, Karen Eisenreich⁸, Kellie Fay⁹, Jonathan Hamm¹⁰, Paula F P Henry¹¹, Katherine Horak¹², Wesley Hunter¹³, Donna Judkins¹⁴, Patrice Klein¹⁵, Nicole Kleinstreuer¹⁶, Kara Koehrn¹⁷, Carlie A LaLone¹⁸, James P Laurenson¹⁹, Jessica K Leet²⁰, Anna Lowit²¹, Scott G Lynn²², Teresa Norberg-King²³, Edward J Perkins²⁴, Elijah J Petersen²⁵, Barnett A Rattner²⁶, Catherine S Sprankle²⁷, Thomas Steeger²⁸, Jim E Warren²⁹, Sarah Winfield³⁰, Edward Odenkirchen³¹

Affiliations

¹ Integrated Laboratory Systems, LLC, P.O. Box 13501, Research Triangle Park, NC, 27709, USA. Electronic address: pceger1@ils-inc.com.
² U.S. Army Engineer Research and Development Center, 3909 Halls Ferry Rd., Vicksburg, MS, 39180, USA. Electronic address: natalia.g.vinas@erdc.dren.mil.
³ Integrated Laboratory Systems, LLC, P.O. Box 13501, Research Triangle Park, NC, 27709, USA. Electronic address: dallen@ils-inc.com.
⁴ U.S. Environmental Protection Agency, Office of Pesticide Programs, MC7507P, 1200 Pennsylvania Avenue NW, Washington, DC, 20460, USA. Electronic address: Arnold.Elyssa@epa.gov.
⁵ U.S. Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. Electronic address: raanan.bloom@fda.hhs.gov.
⁶ U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics, 7401M, 1200 Pennsylvania Avenue NW, Washington, DC, 20460, USA. Electronic address: Brennan.Jennifer@epa.gov.
⁷ U.S. Department of Agriculture, Animal Care, 4700 River Rd., Riverdale, MD 20737, USA. Electronic address: Carol.L.Clarke@usda.gov.
⁸ U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics, 7401M, 1200 Pennsylvania Avenue NW, Washington, DC, 20460, USA. Electronic address: Eisenreich.Karen@epa.gov.
⁹ U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics, 7401M, 1200 Pennsylvania Avenue NW, Washington, DC, 20460, USA. Electronic address: Fay.Kellie@epa.gov.
¹⁰ Integrated Laboratory Systems, LLC, P.O. Box 13501, Research Triangle Park, NC, 27709, USA. Electronic address: jhamm@ils-inc.com.
¹¹ U.S. Geological Survey, Eastern Ecological Science Center, 12100 Beech Forest Rd, Laurel, MD, 20708, USA. Electronic address: phenry@usgs.gov.
¹² U.S. Department of Agriculture, Wildlife Services National Wildlife Research Center, 4101 LaPorte Ave. Fort Collins, CO, 80521, USA. Electronic address: Katherine.e.horak@usda.gov.
¹³ U.S. Food and Drug Administration, Center for Veterinary Medicine, HFV-161, 7500 Standish Place, Rockville, MD, 20855, USA. Electronic address: Wesley.Hunter@fda.hhs.gov.
¹⁴ U.S. Environmental Protection Agency, Office of Pesticide Programs, MC7507P, 1200 Pennsylvania Avenue NW, Washington, DC, 20460, USA. Electronic address: Judkins.Donna@epa.gov.
¹⁵ U.S. Department of Agriculture, Forest Service, 1400 Independence Ave. SW, Washington, DC, 20250, USA. Electronic address: Patrice.n.klein@usda.gov.
¹⁶ National Institute of Environmental Health Sciences, National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, P.O. Box 12233, Research Triangle Park, NC, 27709, USA. Electronic address: nicole.kleinstreuer@niehs.nih.gov.
¹⁷ U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics, 7401M, 1200 Pennsylvania Avenue NW, Washington, DC, 20460, USA. Electronic address: Koehrn.kara@epa.gov.
¹⁸ U.S. Environmental Protection Agency, Office of Research and Development, 8101R, 6201 Congdon Blvd., Duluth, MN, 55804, USA. Electronic address: lalone.carlie@epa.gov.
¹⁹ U.S. Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. Electronic address: james.laurenson@fda.hhs.gov.
²⁰ U.S. Geological Survey, Columbia Environmental Research Center (CERC), Columbia, MO, 65201, USA. Electronic address: jleet@usgs.gov.
²¹ U.S. Environmental Protection Agency, Office of Pesticide Programs, MC7507P, 1200 Pennsylvania Avenue NW, Washington, DC, 20460, USA. Electronic address: Lowit.Anna@epa.gov.
²² U.S. Environmental Protection Agency, Office of Pesticide Programs, MC7507P, 1200 Pennsylvania Avenue NW, Washington, DC, 20460, USA. Electronic address: Lynn.Scott@epa.gov.
²³ U.S. Environmental Protection Agency, Office of Research and Development, 8101R, 6201 Congdon Blvd., Duluth, MN, 55804, USA. Electronic address: norberg-king.teresa@epa.gov.
²⁴ U.S. Army Engineer Research and Development Center, 3909 Halls Ferry Rd., Vicksburg, MS, 39180, USA. Electronic address: Edward.J.Perkins@erdc.den.mil.
²⁵ U.S. Department of Commerce, National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD, 2089, USA. Electronic address: elijah.petersen@nist.gov.
²⁶ U.S. Geological Survey, Eastern Ecological Science Center, 10300 Baltimore Ave, BARC-EAST Bldg. 308, Beltsville, MD, 20705, USA. Electronic address: brattner@usgs.gov.
²⁷ Integrated Laboratory Systems, LLC, P.O. Box 13501, Research Triangle Park, NC, 27709, USA. Electronic address: csprankle@ils-inc.com.
²⁸ U.S. Environmental Protection Agency, Office of Pesticide Programs, MC7507P, 1200 Pennsylvania Avenue NW, Washington, DC, 20460, USA. Electronic address: Steeger.Thomas@epa.gov.
²⁹ U.S. Department of Agriculture, Forest Service, 1400 Independence Ave. SW, Washington, DC, 20250, USA. Electronic address: Jim.E.Warren@usda.gov.
³⁰ U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, HFS-009, College Park, MD, 20740, USA. Electronic address: Sarah.Winfield@fda.hhs.gov.
³¹ U.S. Environmental Protection Agency, Office of Pesticide Programs, MC7507P, 1200 Pennsylvania Avenue NW, Washington, DC, 20460, USA. Electronic address: Odenkirchen.Edward@epa.gov.

PMID: 35660046
PMCID: PMC9623878
DOI: 10.1016/j.yrtph.2022.105195

Review

Current ecotoxicity testing needs among selected U.S. federal agencies

Patricia Ceger et al. Regul Toxicol Pharmacol. 2022 Aug.

. 2022 Aug:133:105195.

doi: 10.1016/j.yrtph.2022.105195. Epub 2022 Jun 2.

Authors

Affiliations

¹ Integrated Laboratory Systems, LLC, P.O. Box 13501, Research Triangle Park, NC, 27709, USA. Electronic address: pceger1@ils-inc.com.
² U.S. Army Engineer Research and Development Center, 3909 Halls Ferry Rd., Vicksburg, MS, 39180, USA. Electronic address: natalia.g.vinas@erdc.dren.mil.
³ Integrated Laboratory Systems, LLC, P.O. Box 13501, Research Triangle Park, NC, 27709, USA. Electronic address: dallen@ils-inc.com.
⁴ U.S. Environmental Protection Agency, Office of Pesticide Programs, MC7507P, 1200 Pennsylvania Avenue NW, Washington, DC, 20460, USA. Electronic address: Arnold.Elyssa@epa.gov.
⁵ U.S. Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. Electronic address: raanan.bloom@fda.hhs.gov.
⁶ U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics, 7401M, 1200 Pennsylvania Avenue NW, Washington, DC, 20460, USA. Electronic address: Brennan.Jennifer@epa.gov.
⁷ U.S. Department of Agriculture, Animal Care, 4700 River Rd., Riverdale, MD 20737, USA. Electronic address: Carol.L.Clarke@usda.gov.
⁸ U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics, 7401M, 1200 Pennsylvania Avenue NW, Washington, DC, 20460, USA. Electronic address: Eisenreich.Karen@epa.gov.
⁹ U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics, 7401M, 1200 Pennsylvania Avenue NW, Washington, DC, 20460, USA. Electronic address: Fay.Kellie@epa.gov.
¹⁰ Integrated Laboratory Systems, LLC, P.O. Box 13501, Research Triangle Park, NC, 27709, USA. Electronic address: jhamm@ils-inc.com.
¹¹ U.S. Geological Survey, Eastern Ecological Science Center, 12100 Beech Forest Rd, Laurel, MD, 20708, USA. Electronic address: phenry@usgs.gov.
¹² U.S. Department of Agriculture, Wildlife Services National Wildlife Research Center, 4101 LaPorte Ave. Fort Collins, CO, 80521, USA. Electronic address: Katherine.e.horak@usda.gov.
¹³ U.S. Food and Drug Administration, Center for Veterinary Medicine, HFV-161, 7500 Standish Place, Rockville, MD, 20855, USA. Electronic address: Wesley.Hunter@fda.hhs.gov.
¹⁴ U.S. Environmental Protection Agency, Office of Pesticide Programs, MC7507P, 1200 Pennsylvania Avenue NW, Washington, DC, 20460, USA. Electronic address: Judkins.Donna@epa.gov.
¹⁵ U.S. Department of Agriculture, Forest Service, 1400 Independence Ave. SW, Washington, DC, 20250, USA. Electronic address: Patrice.n.klein@usda.gov.
¹⁶ National Institute of Environmental Health Sciences, National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, P.O. Box 12233, Research Triangle Park, NC, 27709, USA. Electronic address: nicole.kleinstreuer@niehs.nih.gov.
¹⁷ U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics, 7401M, 1200 Pennsylvania Avenue NW, Washington, DC, 20460, USA. Electronic address: Koehrn.kara@epa.gov.
¹⁸ U.S. Environmental Protection Agency, Office of Research and Development, 8101R, 6201 Congdon Blvd., Duluth, MN, 55804, USA. Electronic address: lalone.carlie@epa.gov.
¹⁹ U.S. Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. Electronic address: james.laurenson@fda.hhs.gov.
²⁰ U.S. Geological Survey, Columbia Environmental Research Center (CERC), Columbia, MO, 65201, USA. Electronic address: jleet@usgs.gov.
²¹ U.S. Environmental Protection Agency, Office of Pesticide Programs, MC7507P, 1200 Pennsylvania Avenue NW, Washington, DC, 20460, USA. Electronic address: Lowit.Anna@epa.gov.
²² U.S. Environmental Protection Agency, Office of Pesticide Programs, MC7507P, 1200 Pennsylvania Avenue NW, Washington, DC, 20460, USA. Electronic address: Lynn.Scott@epa.gov.
²³ U.S. Environmental Protection Agency, Office of Research and Development, 8101R, 6201 Congdon Blvd., Duluth, MN, 55804, USA. Electronic address: norberg-king.teresa@epa.gov.
²⁴ U.S. Army Engineer Research and Development Center, 3909 Halls Ferry Rd., Vicksburg, MS, 39180, USA. Electronic address: Edward.J.Perkins@erdc.den.mil.
²⁵ U.S. Department of Commerce, National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD, 2089, USA. Electronic address: elijah.petersen@nist.gov.
²⁶ U.S. Geological Survey, Eastern Ecological Science Center, 10300 Baltimore Ave, BARC-EAST Bldg. 308, Beltsville, MD, 20705, USA. Electronic address: brattner@usgs.gov.
²⁷ Integrated Laboratory Systems, LLC, P.O. Box 13501, Research Triangle Park, NC, 27709, USA. Electronic address: csprankle@ils-inc.com.
²⁸ U.S. Environmental Protection Agency, Office of Pesticide Programs, MC7507P, 1200 Pennsylvania Avenue NW, Washington, DC, 20460, USA. Electronic address: Steeger.Thomas@epa.gov.
²⁹ U.S. Department of Agriculture, Forest Service, 1400 Independence Ave. SW, Washington, DC, 20250, USA. Electronic address: Jim.E.Warren@usda.gov.
³⁰ U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, HFS-009, College Park, MD, 20740, USA. Electronic address: Sarah.Winfield@fda.hhs.gov.
³¹ U.S. Environmental Protection Agency, Office of Pesticide Programs, MC7507P, 1200 Pennsylvania Avenue NW, Washington, DC, 20460, USA. Electronic address: Odenkirchen.Edward@epa.gov.

PMID: 35660046
PMCID: PMC9623878
DOI: 10.1016/j.yrtph.2022.105195

Abstract

U.S. regulatory and research agencies use ecotoxicity test data to assess the hazards associated with substances that may be released into the environment, including but not limited to industrial chemicals, pharmaceuticals, pesticides, food additives, and color additives. These data are used to conduct hazard assessments and evaluate potential risks to aquatic life (e.g., invertebrates, fish), birds, wildlife species, or the environment. To identify opportunities for regulatory uses of non-animal replacements for ecotoxicity tests, the needs and uses for data from tests utilizing animals must first be clarified. Accordingly, the objective of this review was to identify the ecotoxicity test data relied upon by U.S. federal agencies. The standards, test guidelines, guidance documents, and/or endpoints that are used to address each of the agencies' regulatory and research needs regarding ecotoxicity testing are described in the context of their application to decision-making. Testing and information use, needs, and/or requirements relevant to the regulatory or programmatic mandates of the agencies taking part in the Interagency Coordinating Committee on the Validation of Alternative Methods Ecotoxicology Workgroup are captured. This information will be useful for coordinating efforts to develop and implement alternative test methods to reduce, refine, or replace animal use in chemical safety evaluations.

Keywords: Animal testing; Aquatic toxicology; Ecotoxicity testing; Ecotoxicology; New approach methodologies; Non-animal methods; Regulatory requirements; U.S. federal agencies.

PubMed Disclaimer

References

1. 7 U.S.C. § 136, 1996. Food Quality Protection Act of 1996.
1. 7 U.S.C. § 136 et seq., 1996. Federal Insecticide, Fungicide, and Rodenticide Act (as amended).
1. 7 U.S.C. § 2131 et seq., 2012. The Animal Welfare Act.
1. 9 CFR § 2.31 (d)(1)(ii), 2004. Institutional Animal Care and Use Committee (IACUC).
1. 15 U.S.C. § 2601 et seq., 2016. The Frank R. Lautenberg Chemical Safety for the 21st Century Act.

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions

Substances

Actions

Grants and funding

HHSN273201500010C/ES/NIEHS NIH HHS/United States

LinkOut - more resources

Full Text Sources
Medical
- MedlinePlus Health Information

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Current ecotoxicity testing needs among selected U.S. federal agencies

Affiliations

Current ecotoxicity testing needs among selected U.S. federal agencies

Authors

Affiliations

Abstract

References

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Medical