Purpose and scope

The primary purpose is to set forth procedures for handling retaliation complaints brought under section 402 of the Food Safety Modernization Act (FSMA), which added section 1012 to the Federal Food, Drug, and Cosmetic Act (FD&C). This part explains the procedures and interpretations related to employee protections for reporting or opposing violations of the FD&C as described in 1987.100(a).

• See the overall part for context at 1987.

The protection covers an employee who has engaged in protected activity related to a violation or alleged violation of the FD&C or any order, rule, regulation, standard, or ban under the FD&C. That protection is described in 1987.100(a).

• "Protected activity" in this provision relates specifically to actions concerning the FD&C and related orders, rules, regulations, standards, or bans.

This part establishes procedures for the expeditious handling of retaliation complaints under section 1012 of the FD&C, including submission of complaints, investigations, issuance of findings and preliminary orders, objections, litigation before administrative law judges, post-hearing administrative review, and withdrawals and settlements, as described in 1987.100(b).

• The rules in this part work together with procedures in 29 CFR part 18 (as noted in the same paragraph) to handle adjudicative steps.

Yes; the rules allow retaliation complaints to be filed by employees or by persons acting on their behalf, as stated in 1987.100(b).

• "Persons acting on their behalf" can include authorized representatives or advocates who submit complaints for the employee.

The procedures are based on section 402 of the Food Safety Modernization Act (FSMA), which added section 1012 to the Federal Food, Drug, and Cosmetic Act (FD&C), i.e., 21 U.S.C. 399d, and the relevant FD&C provisions, as explained in 1987.100(a).

• The citation also references the FD&C generally as 21 U.S.C. 301 et seq.

Yes; this part provides the Secretary's interpretations on certain statutory issues related to section 1012 of the FD&C, as stated in 1987.100(b).

• Those interpretations are incorporated into the rules to clarify application of the statute and procedures.

This part is intended to work together with the procedures codified at [29 CFR part 18] (administrative hearing procedures) to set forth the full process for complaints, hearings, and review under section 1012 of the FD&C, as described in 1987.100(b).

• Use the rules in this part for FSMA retaliation specifics and [29 CFR part 18] for general adjudicative procedures.

The protection covers retaliation by an employer because the employee engaged in protected activity concerning a violation or alleged violation of the FD&C or any order, rule, regulation, standard, or ban under the FD&C, as stated in 1987.100(a).

• The provision focuses on retaliation tied to FD&C-related reporting or oppositional activities.

Yes; withdrawals and settlements are explicitly included among the procedures covered by this part for handling retaliation complaints under section 1012 of the FD&C, as listed in 1987.100(b).

• This means the part provides for resolution options short of a full hearing, as well as formal adjudication processes.

The FSMA provision referenced (section 402) was signed into law on January 4, 2011, as noted in 1987.100(a).

• That statute amended the FD&C by adding section 1012 (21 U.S.C. 399d).

The procedures cover filing of complaints, investigations, issuance of findings and preliminary orders, objections to findings and orders, litigation before administrative law judges (ALJs), post-hearing administrative review, and related withdrawals and settlements, as specified in 1987.100(b).

• For hearing procedures and ALJ rules, these work in concert with [29 CFR part 18].

Section 1012 of the FD&C (codified at 21 U.S.C. 399d) was added by section 402 of the FSMA and provides the specific employee protection against retaliation, as referenced in 1987.100(a).

• That statutory addition is the legal foundation for the procedures in this part.

Yes; this part specifically includes procedures for issuance of findings and preliminary orders as part of the expeditious handling of retaliation complaints under section 1012 of the FD&C, according to 1987.100(b).

• Findings and preliminary orders are steps before final adjudication or settlement.

Part 1987 is titled "Procedures for Handling Retaliation Complaints Under Section 402 of the FDA Food Safety Modernization Act," and it covers complaints, investigations, findings, and preliminary orders related to FSMA whistleblower protections, as shown on the part's page 1987 and in 1987.100.

Yes; objections to findings and orders are explicitly part of the procedures established under this part for handling retaliation complaints under section 1012, as stated in 1987.100(b).

• That means parties have a process to dispute findings or preliminary orders before further adjudication.

The official source for the regulatory text is the e-CFR (Electronic Code of Federal Regulations), which is referenced on the part's page and in the section header for 1987.100.