[Federal Register Volume 85, Number 207 (Monday, October 26, 2020)]
[Notices]
[Pages 67744-67746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23398]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1869]


Alignment of Third-Party Food Safety Standards With Food Safety 
Regulations: Notice of Pilot Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
seeking requests for participation from members of the public, 
including owners of third-party human food safety standards, interested 
in participating in a voluntary pilot program to evaluate third-party 
food safety standards. On July 13, 2020, FDA announced the New Era of 
Smarter Food Safety Blueprint and the desire to explore the increased 
use of reliable third-party audits to help ensure safer food, including 
exploring the use of reliable audit data in risk-prioritization for FDA 
regulatory activities, for example, with respect to inspections of both 
imported and domestically produced foods. Under the pilot program, FDA 
will assess third-party food safety standards for alignment with 
certain FDA food safety regulations. Knowing that these third-party 
standards align with certain FDA food safety regulations would give 
those relying on audits conducted to those standards confidence that 
they are meeting certain FDA requirements for supplier verification 
audits. The pilot will enable FDA to gain information and experience 
that will allow the Agency to evaluate the resources and tools required 
to conduct alignment reviews.

DATES: The pilot will conclude October 26, 2021.

ADDRESSES: Submit written or electronic submissions for the pilot 
program to [email protected].

FOR FURTHER INFORMATION CONTACT: Franciel Ikeji, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-4971.

SUPPLEMENTARY INFORMATION:

I. Background

    Ensuring the safety of food for human and animal use is a shared 
responsibility between the public and private sectors. FDA has 
established regulatory standards, inspects facilities, and may take 
action if there are violations. But it is primarily the responsibility 
of industry to ensure that food products intended for human and animal 
consumption in the United States are safe and meet applicable food 
safety requirements. The FDA Food Safety Modernization Act (FSMA) (Pub. 
L. 111-353) modified the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 301, et seq..) to establish a framework that focuses on 
prevention and recognizes the important part we all play in protecting 
consumers from unsafe food.
    FSMA and the implementing regulations place new obligations on 
certain entities in the food industry to verify that their suppliers 
are meeting FDA safety standards. More specifically, three regulations 
that FDA issued under FSMA have supplier verification requirements. 
Those regulations are the Current Good Manufacturing Practice, Hazard 
Analysis, and Risk-Based Preventive Controls for Human Food (PCHF) 
regulation (part 117 (21 CFR part 117)); the Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food 
for Animals (PCAF) regulation (part 507 (21 CFR part 507)); and Foreign 
Supplier Verification Programs for Food Importers (FSVP) regulation (21 
CFR part 1, subpart L). Subparts A, C, D, E, F, and G of part 117 in 
the PCHF regulation include requirements for domestic and foreign 
facilities that are required to register under section 415 of the FD&C 
Act (21 U.S.C. 350d) to conduct a hazard analysis and implement risk-
based preventive controls for human food (the human food preventive 
controls requirements). Subpart G of part 117 requires the receiving 
facility to establish and implement a written supply-chain program (21 
CFR 117.405(a) and (b)) and conduct appropriate supplier verification 
activities for those raw materials and other ingredients for which the 
receiving facility has identified a hazard requiring a supply-chain-
applied control (21 CFR 117.425 and 117.415(a)(3)(iii)). Generally, 
when a hazard in a raw material or other ingredient will be controlled 
by the supplier and is one for which there is a reasonable probability 
that exposure to the hazard will result in serious adverse health 
consequences or death, the

[[Page 67745]]

appropriate supplier verification activity is an onsite audit of the 
supplier, and it must be conducted before using the food and at least 
annually thereafter (Sec.  117.430(b)(1) (21 CFR 117.430(b)(1))).
    For animal food facilities that are required to register, subparts 
A, C, D, E, and F of part 507 in PCAF include requirements to conduct a 
hazard analysis and implement risk-based preventive controls for animal 
food (the animal food preventive controls requirements). Subpart E of 
part 507 establishes requirements, similar to those in PCHF, for a 
supply-chain program for those raw materials and other ingredients for 
which a receiving facility has identified a hazard requiring a supply-
chain-applied control.
    Under the FSVP regulation, FSVP importers are required to develop, 
maintain, and follow a foreign supplier verification program that 
provides adequate assurances that imported food meets applicable U.S. 
food safety standards. The FSVP regulation requires importers to 
conduct a hazard analysis to determine whether there are any hazards 
that require a control (21 CFR 1.504) and, based on the hazard 
analysis, determine the appropriate type of verification activity as 
well as the frequency of conducting the activity. When a hazard in a 
food is controlled by the foreign supplier and is one for which there 
is a reasonable probability that exposure to the hazard will cause 
serious adverse health consequences or death to humans or animals, the 
default verification activity is to conduct an annual onsite audit 
before initially importing the food from the supplier and at least 
annually thereafter (Sec.  1.506(d)(2) (21 CFR 1.506(d)(2))).
    In all three regulations, audits are not required if the receiving 
facility or importer has made a written determination that other 
verification activities and/or less frequent onsite auditing of the 
supplier provide adequate verification. See Sec. Sec.  1.506(d)(2), 
117.430(b)(2), and 507.130(b)(2).
    The FSMA supply-chain programs do not require these annual onsite 
audits to be conducted by auditors accredited under FDA's Accredited 
Third-Party Certification Programs (21 CFR part 1, subpart M), which 
established a voluntary program for the accreditation of third-party 
certification bodies to conduct food safety audits and issue 
certifications for foreign facilities. The PCHF, PCAF, and FSVP 
regulations do, however, require the onsite audits under these 
regulations to be conducted by ``qualified auditors. '' (A qualified 
auditor means a person who has the technical expertise obtained through 
education, training, or experience (or a combination thereof) necessary 
to perform the auditing function). See 21 CFR 1.500, 117.3, and 507.3. 
Importantly, too, the audits must consider applicable FDA regulations. 
See 21 CFR 1.506(e)(1)(i), 117.435, and 507.135.
    FDA is aware that there are a variety of third-party food safety 
standards used by industry to assess a supplier's performance and that 
importers and receiving facilities may voluntarily rely on audits that 
use those private standards. Because the supply-chain verification 
provisions of PCHF, PCAF, and FSVP require that audits consider 
applicable FDA food safety regulations, importers and receiving 
facilities may seek assurances regarding how these standards align with 
FDA food safety standards. Having such assurances may provide importers 
and receiving facilities with confidence that they can use audits 
conducted under the standards to fulfill the PCHF, PCAF, and FSVP 
requirements for supplier verification. This pilot will assess whether 
some of these third-party food safety standards are aligned with food 
safety requirements in two specific FDA human food safety regulations: 
The PCHF regulation and the Standards for the Growing, Harvesting, 
Packing, and Holding of Produce for Human Consumption (Produce Safety) 
regulation (21 CFR part 112). The pilot will not assess alignment with 
FDA animal food safety regulations.
    FDA has published templates that may be used to help receiving 
facilities, importers, and other stakeholders compare the third-party 
food safety standards used in an audit to the food safety requirements 
in applicable FDA regulations (FDA Audit Comparison Templates) https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm602286.htm. The templates 
are arranged in a table format for easy comparison of the third-party 
food safety standards to the food safety requirements of FDA 
regulations.
    While these templates are useful, the pilot will allow us to assess 
how the third-party food safety standards used in audits align with 
human food safety requirements in the PCHF and the Produce Safety 
regulations. We expect that FDA alignment determinations would create 
efficiencies for industry, so that importers and receiving facilities 
know whether the third-party food safety standards used to audit their 
suppliers adequately consider food safety requirements in two of FDA's 
regulations. Similarly, we expect that it would be more efficient for 
FDA investigators to know if the standards against which a supplier was 
audited align with FDA regulations, so that the investigators can more 
efficiently determine whether importers and receiving facilities are in 
compliance with the FSMA supply-chain verification requirements for 
audits. The pilot will assist FDA in gathering information to determine 
whether these expectations are accurate.
    The pilot will also evaluate the process for determining alignment, 
including the resources required for FDA to review and assess third-
party standards for alignment with relevant FDA regulations. While the 
pilot will be focused on human food safety requirements in the PCHF and 
Produce Safety regulations, any program that FDA puts in place as a 
result of the Agency's experience with the pilot would likely also 
include a review of standards for food for animal consumption to assess 
and determine alignment of third-party animal food safety standards to 
the food safety requirements in the PCAF regulation.
    We also note that the goals of this pilot align with the ``FDA 
Strategy for the Safety of Imported Food,'' which includes an objective 
that FDA take into account the public health assurances of reliable 
audits such as those issued under FDA's Accredited Third-Party 
Certification Program or pursuant to other assurance programs aligned 
with FDA food safety requirements. FDA recognizes that audits can 
provide valuable public health assurances if they are reliable and if 
the standards under which audits are conducted are aligned with 
relevant FDA food safety regulations. The goals of the program also 
align with the New Era of Smarter Food Safety Blueprint. As explained 
in the Blueprint, FDA is considering the benefits of using reliable 
audit information in resource allocation decision making and risk 
prioritization of regulatory activities such as import screening to 
ensure that food offered for import meets U.S. food safety 
requirements. Because this pilot is only focused on assessing third-
party food safety standards, and not the overall quality of audit 
programs or the qualifications of auditors, we believe that the pilot 
will help evaluate the requirements for making alignment determinations 
as an important step in determining the reliability of third-party 
audits.

[[Page 67746]]

II. FDA Determination of Alignment of Third-Party Food Safety Standards 
Voluntary Pilot Program

A. Scope and Selection Attributes

    FDA is seeking requests for participation from members of the 
public, including owners of third-party human food safety standards, 
who are interested in participating in a voluntary pilot program to 
determine whether third-party food safety standards align with food 
safety requirements in the PCHF and the Produce Safety regulations. 
Upon being selected to participate in the program, participants will 
submit their standards for assessment. FDA plans to select and assess 
up to five private third-party human food safety standards for 
alignment with food safety requirements in the PCHF or the Produce 
Safety regulation. Participants in the pilot program will be asked to 
provide FDA with technical feedback on the pilot. The Agency will use 
its discretion in choosing participants for assessment based on (in no 
particular order):
    (1) The order the requests for participation are received;
    (2) the desired diversity of third-party human food safety 
standards for assessment in the pilot (e.g., PCHF, Produce Safety); and
    (3) the Agency's determination of available resources to conduct 
the assessment given the level of effort and other priorities.
    FDA reserves the right to request additional information or 
clarification from participants in the pilot and to rescind 
participation if the additional information or clarification is not 
promptly and accurately provided.

B. Duration

    The pilot will run for 1 year from the date of publication of this 
notice and will conclude on October 26, 2021. FDA reserves the right to 
extend the pilot for more time as needed. To assure we have adequate 
time to assess the standards during the pilot period, we are asking 
members of the public, including owners of third-party human food 
safety standards, to submit their request to participate in the pilot 
program by November 25, 2020.

C. Submission of Requests To Participate

    Members of the public, including owners of third-party human food 
safety standards, that are interested in participating should submit a 
written request to participate to Franciel Ikeji (see FOR FURTHER 
INFORMATION CONTACT). Electronic requests should be submitted to 
[email protected]. We strongly encourage interested 
persons to electronically submit their requests to participate. Written 
and electronic requests to participate in the pilot program should be 
submitted by November 25, 2020.
    The request to participate should include the following 
information: Company and contact name; contact phone number; and 
contact email address. Additionally, although not required for 
consideration, FDA is particularly interested in whether you are the 
owner of a third-party food safety standard, and the type of food 
safety standard you have developed (e.g., produce safety, human 
processed food). For a limited number of applicants that FDA identifies 
as possible candidates for participation in the pilot, FDA may ask you 
to submit a completed FDA Food Safety Audit Comparison Template https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm602286.htm. If the pilot 
participant chooses to submit an alternative comparison tool, the 
format should enable FDA to easily compare the third-party food safety 
standard to the relevant FDA regulations (i.e., placing the relevant 
requirements of FDA's regulations in numerical order to the left of any 
third-party food safety standards). FDA may also ask pilot participants 
for additional information on submitted food safety standards.

D. Assessment and Alignment of Program Standards

    The pilot program will be conducted from October 26, 2020 to 
October 26, 2021 and may be extended as needed. Each person that 
submits a request to participate will be notified that FDA has received 
the request. This notification only acknowledges that FDA has received 
the request and does not guarantee that FDA will accept you for 
participation in the pilot. By the conclusion of the pilot, 
participants will be notified as to whether FDA determined the food 
safety standard to be in alignment or not in alignment with the 
relevant FDA regulation.
    FDA will publish information on its website regarding the third-
party standards that FDA determines to be in alignment with FDA 
regulations.

E. Evaluation of Pilot Program

    FDA intends to evaluate the pilot program on several factors, 
including, but not limited to, the resources required to review and 
assess third-party standards for alignment with relevant FDA 
regulations, the ability of pilot participants to provide adequate 
information to enable FDA to make a determination of alignment, and 
whether FDA Audit Comparison Templates are a helpful tool in making 
alignment determinations. After FDA evaluates the pilot program, the 
Agency will utilize the information to evaluate the resources and tools 
required to conduct alignment reviews.

    Dated: October 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23398 Filed 10-23-20; 8:45 am]
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