As an integral part of its decision
making process, the Food and Drug Administration (FDA) is obligated
under the National Environmental Policy Act of 1969 (NEPA) to
consider the environmental impact of its actions, including
allowing notifications for food contact substances to become
effective and approving food additive petitions, color additive
petitions, GRAS affirmation petitions, requests for exemption from
regulation as a food additive, and actions on certain food labeling
citizen petitions, nutrient content claims petitions, and health
claims petitions. In 1997, FDA amended its regulations in part 25
(21 CFR part 25) to provide for categorical exclusions for
additional classes of actions that do not individually or
cumulatively have a significant effect on the human environment (62
FR 40570, July 29, 1997). As a result of that rulemaking, FDA no
longer routinely requires submission of information about the
manufacturing and production of FDA-regulated articles. FDA also
has eliminated the previously required Environmental Assessment
(EA) and abbreviated EA formats from the amended regulations.
Instead, FDA has provided guidance that contains sample formats to
help industry submit a claim of categorical exclusion or an EA to
the Center for Food Safety and Applied Nutrition (CFSAN). The
guidance document entitled, Preparing a Claim of Categorical
Exclusion or an Environmental Assessment for Submission to the
Center for Food Safety and Applied Nutrition identifies,
interprets, and clarifies existing requirements imposed by statute
and regulation, consistent with the Council on Environmental
Quality regulations (40 CFR 1507.3). It consists of recommendations
that do not themselves create requirements; rather, they are
explanatory guidance for FDAs own procedures in order to ensure
full compliance with the purposes and provisions of NEPA.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
0541_Guidance_for_industry.doc
Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition