SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. ( printed page 27132)

Focused Mitigation Strategies To Protect Food Against Intentional Adulteration—21 CFR Part 121

OMB Control Number 0910-0812—Extension

This information collection supports FDA regulations. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act, certain provisions have been established to protect against the intentional adulteration of food. Section 418 of the FD&C Act (21 U.S.C. 350g) addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food and are required to register under section 415 of the FD&C Act (21 U.S.C. 350d). Section 419 of the FD&C Act (21 U.S.C. 350h) addresses intentional adulteration in the context of fruits and vegetables that are raw agricultural commodities. Section 420 of the FD&C Act (21 U.S.C. 350i) addresses intentional adulteration in the context of high-risk foods and exempts farms except for farms that produce milk. These provisions are codified at part 121 (21 CFR part 121), and include requirements that an owner, operator, or agent in charge of a facility must:

• Prepare and implement a written food defense plan that includes a vulnerability assessment to identify significant vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions, and verification (§ 121.126);
• identify any significant vulnerabilities and actionable process steps by conducting a vulnerability assessment for each type of food manufactured, processed, packed, or held at the facility using appropriate methods to evaluate each point, step, or procedure in a food operation (§ 121.130);
• identify and implement mitigation strategies at each actionable process step to provide assurances that the significant vulnerability at each step will be significantly minimized or prevented and the food manufactured, processed, packed, or held by the facility will not be adulterated. For each mitigation strategy implemented at each actionable process step, include a written explanation of how the mitigation strategy sufficiently minimizes or prevents the significant vulnerability associated with the actionable process step (§ 121.135);
• establish and implement mitigation strategies management components, as appropriate to ensure the proper implementation of each such mitigation strategy, taking into account the nature of the mitigation strategy and its role in the facility's food defense system (§ 121.138);
• establish and implement food defense monitoring procedures, for monitoring the mitigation strategies, as appropriate to the nature of the mitigation strategy and its role in the facility's food defense system (§ 121.140);
• establish and implement food defense corrective action procedures that must be taken if mitigation strategies are not properly implemented, as appropriate to the nature of the actionable process step and the nature of the mitigation strategy (§ 121.145);
• establish and implement specified food defense verification activities, as appropriate to the nature of the mitigation strategy and its role in the facility's food defense system (§ 121.150);
• conduct a reanalysis of the food defense plan (§ 121.157);
• ensure that all individuals who perform required food defense activities are qualified to perform their assigned duties (§ 121.4); and
• establish and maintain certain records, including the written food defense plan (vulnerability assessment, mitigation strategies and procedures for food defense monitoring, corrective actions, and verification) and documentation related to training of personnel. All records are subject to certain general recordkeeping and record retention requirements (§§ 121.301 to 121.330).

Description of Respondents: The respondents to this information collection are manufacturers of retail food products marketed in the United States.

In the Federal Register of February 25, 2019 (84 FR 6009), we published a 60-day notice soliciting public comment of the proposed collections of information. Several comments were received in response to the notice and are summarized here. Minor comments included general support for efforts at protecting food against intentional adulteration. Other comments, however, questioned the estimates we ascribed to meeting the requirements found in subpart C of the applicable regulations: Food defense measures (§§ 121.126 through 121.157 (21 CFR 121.126 through 121.157)). The comments offered alternative estimates ranging from few to several hours, and most correlated this time to aspects of developing plans, conducting vulnerability assessments, and documenting procedures, activities which we attribute to the initial review and implementation of new regulations. We also note that alternative compliance dates were established for the covered entities and have yet to be realized. In addition, to assist respondents in complying with the regulation, including the information collection requirements, we offer both Agency guidance as well as an FDA Food Defense Plan Builder, a user-friendly tool designed to help owners and operators of food facilities develop a personalized food defense plan, which is currently under development with stakeholder input. These and other resources are available from our website at https://www.fda.gov. Finally, none of the comments appeared to question the applicability of the recordkeeping or the associated retention requirements found in part 121, subpart D.

While we continue to invite comment regarding our burden estimates, we note that they reflect what we believe is representative of the industry average. This information collection covers numerous respondents with varying facility sizes and with differing product inventories. As compliance with the regulatory requirements continues to take effect, we will continue to evaluate the associated information collection burden accordingly. Although we always appreciate feedback regarding ways to improve efficiencies associated with our information collection activities, we decline to adopt alternative burden estimates for the information collection at this time. Rather, we retain the current estimates, which are as follows: ( printed page 27133)

Certain facilities may qualify for an exemption under the regulations. Because these facilities must provide documentation upon request to verify their exempt status, we have characterized this as a reporting burden. We estimate 18,080 respondents will prepare and update relevant files an average of 30 minutes annually, for a total annual burden of 9,040 hours (30 minutes × 18,080 firms).

Under the regulations, an owner, operator, or agent in charge of a facility must prepare, or have prepared, and implement a written food defense plan, including written identification of actionable process steps, written mitigation strategies, written procedures for defense monitoring, written food defense corrective actions, and written food defense verification procedures. The estimated recordkeeping burden associated with these activities totals 2,516,482 annual recordkeeping burden hours and 409,486 annual recordkeeping responses.

We estimate an average of 3,247 firms will continue to need to create a food defense plan under § 121.126, that a one-time burden of 60 hours will be needed to create a plan, and that a burden of 10 hours will be required to update the plan. We annualize this estimate by dividing the total number of burden hours (70) over a 3-year period as reflected in table 2, row 1.

Under § 121.130, each of the estimated 9,759 food production facilities will identify and specify actionable process steps for its food defense plan. We estimate that an individual at the level of an operations manager incurs a burden of 20 hours for this activity, as reflected in table 2, row 2.

Under § 121.135(b), each of the estimated 9,759 food production facilities must identify and implement mitigation strategies to provide assurances that any significant vulnerability at each step is significantly minimized or prevented, ensuring that the food manufactured, processed, packed, or held by the facility will not be adulterated. We do not specify a specific number or set of mitigation strategies to be implemented. Some of the covered facilities are already implementing mitigation strategies. We estimate that it requires an average of 20 hours per facility to satisfy the recordkeeping burden associated with these activities for a total of 195,180 hours, as reflected in table 2, row 3.

We estimate that the recordkeeping activities associated with monitoring, documenting mitigation strategies, and implementing necessary corrective actions require first-line supervisors or others responsible for quality control an average of 175 hours for each recordkeeping, and that these provisions apply to each of the 9,759 facilities. This results in a total of 1,707,825 annual burden hours, as reflected in table 2, row 4.

We estimate that recordkeeping activities associated with training under § 121.4 total 244,802 annual burden hours, as reflected in table 2, row 5. We estimate that there are 1.2 million employees working at the regulated facilities and that 30 percent of them (367,203) require training. We estimate that the average burden for the associated recordkeeping activity is approximately 40 minutes (or 0.67 hours) per record.

Finally, we estimate the 9,759 food production facilities will fulfill the recordkeeping requirements under §§ 121.305 and 121.310, and that it will require an average of 10 hours per record, as reflected in table 2, row 6.