Summary

• FCNs are required to have an environmental assessment (EA) or a claim of categorical exclusion.

• The categorical exclusions which have been applied most frequently are 21 CFR 25.32(i) and 21 CFR 25.32(j).

• An EA may be needed for an action meeting categorical exclusion criteria if there are extraordinary circumstances.

• When you are not sure about the environmental requirements for your FCN, contact OFAS for guidance.

• OFAS will provide you with recommendations for preparing an environmental assessment for your FCN.