Source: https://www.federalregister.gov/documents/2019/02/20/2019-02806/agency-information-collection-activities-proposed-collection-comment-request-accreditation-of
Timestamp: 2020-08-09 08:43:19
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Federal Register :: Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and Issue Certifications
Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and Issue Certifications
A Notice by the Food and Drug Administration on 02/20/2019
Submit either electronic or written comments on the collection of information by April 22, 2019.
Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications—21 CFR Part 1; Subpart M
https://www.federalregister.gov/d/2019-02806
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for the accreditation of third-party certification bodies to conduct food safety audits and issue certifications.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 22, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 22, 2019. Comments Start Printed Page 5085received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
Instructions: All submissions received must include the Docket No. FDA-2019-N-0721 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and Issue Certifications.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
FDA provides for accreditation of third-party certification bodies (CBs) to conduct food safety audits of eligible foreign food facilities, and issue food and facility certifications, pursuant to the FDA Food Safety Modernization Act. In accordance with 21 CFR part 1.600, Subpart M, FDA uses certifications issued by accredited third-party auditors/CBs in deciding whether to admit certain imported food into the United States that FDA has determined poses a food safety risk and in deciding whether an importer is eligible to participate in a program for expedited review and entry of food imports. Except for limited circumstances in which we may directly accredit CBs to participate in the accredited third-party audits and certification program, we will recognize accreditation bodies (ABs) to accredit third-party auditors/CBs. Use of accredited third-party CBs and food and facility certifications has helped us prevent potentially harmful food from reaching U.S. consumers and thereby improve the safety of the U.S. food supply. This collection of Start Printed Page 5086information increases efficiency by reducing the number of redundant audits to assess compliance with applicable food safety requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations.
We estimate that there are about 200,000 foreign food and feed exporters that offer their food and feed for import into the United States. These foreign food and feed exporters include approximately 130,000 food and feed production facilities and approximately 71,000 farms. A proportion of these foreign food and feed exporters may offer food subject to mandatory certification requirements under section 801(q) of the FD&C Act (21 U.S.C. 381(q)(3)). In that case, the eligible entities must either comply with this collection of information to obtain certification from a CB accredited under the third-party program to continue exporting their food products into the United States, or a foreign government designated by FDA, or lose their access to U.S. markets. We assume that in any given year, 75 foreign food and feed exporters will be subject to section 801(q) of the FD&C Act.
Avg. burden per recordkeeping (in hours)
§ 1.625 25 426 10,600 0.25 (15 minutes) 2,663
Total Annual Recordkeeping Burden 6,253
1 There are no operations and maintenance costs associated with annual recordkeeping burden.
§ 1.673 1 1 1 10 10
§ 1.623(a) 25 8.79 220 0.25 (15 minutes) 55
§ 1.656(a) 2 207 48.5 10,040 0.25 (15 minutes) 2,510
§ 1.656(a) 4 1 55.4 55 0.25 (15 minutes) 14
§ 1.656(b) 5 207 1 207 0.25 (15 minutes) 52
§ 1.656(b) 6 1 1 1 0.25 (15 minutes) 1
§ 1.656(e) 7 208 0.25 52 0.25 (15 minutes) 13
§ 1.656(e) 8 207 0.25 52 0.25 (15 minutes) 13
Total Annual Reporting Burden 7,919
1 There are no operating or maintenance costs associated with annual reporting.
2 Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to their accrediting ABs.
3 Annual reporting of regulatory audit reports by CBs accredited by recognized ABs to the FDA.
4 Annual reporting of regulatory audit reports by directly accredited CBs to the FDA.
5 Annual reporting of self-assessment by accredited CBs to their recognized ABs.
6 Annual reporting of self-assessment by directly-accredited CBs to the FDA.
7 Annual reporting of serious risk to public health by CBs accredited under the third-party program to eligible entities.
8 Annual reporting of serious risk to public health by accredited CBs to their recognized ABs.
The total annual recordkeeping burden by 25 recognized ABs and 208 CBs accredited under the third-party program is estimated at 6,253 hours (see table 1). We assume that all ABs that apply for recognition in the program become recognized and all CBs that apply for accreditation are accredited. The total annual reporting burden by 25 recognized ABs and 208 CBs accredited under the program is estimated at 7,919 hours (see table 2).
We have adjusted our burden estimate since last OMB approval of the information collection to reflect the removal of burden associated with one-time recordkeeping activities resulting from the implementation of new provisions. This results in an overall decrease of 60,650 annual burden hours.
[FR Doc. 2019-02806 Filed 2-19-19; 8:45 am]