0817 Gluten SSA Final Rule August 2020

UNITED STATES FOOD AND DRUG ADMINISTRATION
Recordkeeping Requirements for Gluten-Free Labeling
of Fermented or Hydrolyzed Foods
OMB Control No. 0910-0817
RIN 0910-AH00
SUPPORTING STATEMENT
Part A – Justification:
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, the agency, us or
we) rulemaking to establish requirements for “gluten-free” labeling for foods that are fermented
or hydrolyzed or that contain fermented or hydrolyzed ingredients. These requirements are
intended to help ensure that individuals with celiac disease receive truthful and accurate
information with respect to fermented or hydrolyzed foods labeled as “gluten-free.” Celiac
disease, a hereditary, chronic inflammatory disorder of the small intestine, has no cure, but
individuals who have this disease are advised to avoid all sources of gluten in their diet to
protect against adverse health effects associated with the disease. Section 21 CFR 101.91
defines the term “gluten-free” and establishes requirements for the voluntary use of that term in
food labeling. Section 101.91 is intended to ensure that individuals with celiac disease are not
misled and are provided with truthful and accurate information with foods so labeled. The
regulation provides that “[w]hen compliance with [the regulation] is based on an analysis of
the food, FDA will use a scientifically valid method that can reliably detect the presence of 20
parts per million (ppm) gluten in a variety of food matrices, including both raw and cooked or
baked products.” See § 101.91(c). We established this 20-ppm limit for intact gluten
considering multiple factors, including currently available analytical methods and the needs of
individuals with celiac disease, as well as factors such as ease of compliance and enforcement,
stakeholder concerns, economics, trade issues, and legal authorities. Although test methods for
the detection of gluten fragments in fermented and hydrolyzed foods have advanced, there is
still uncertainty in interpreting the results of these test methods on a quantitative basis that
equates the test results to an equivalent amount of intact gluten. Thus, alternative means are
necessary to verify compliance with the provisions of the regulation for fermented and
hydrolyzed foods, such as cheese, yogurt, vinegar, sauerkraut, pickles, green olives, beers, and
wine, or hydrolyzed plant proteins used to improve flavor or texture in processed foods such as
soups, sauces, and seasonings.
Consistent with section 206 of the Food Allergen Labeling and Consumer Protection Act
(FALCPA) and sections 403(a)(1), 201(n), and 701(a) of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 343(a)(1), 321(n), and 371(a)), we are implementing
requirements to permit the voluntary use of the term gluten free in the labeling of foods that are
fermented, hydrolyzed, or distilled, or that contain fermented, hydrolyzed, or distilled
ingredients. While the regulations at 21 CFR 101.91 define the term “gluten-free” and set forth
requirements for the voluntary use of the term in food labeling, they do not require

manufacturers who label their foods as gluten free to test those foods for its presence. The
rulemaking would amend our regulations to provide alternative means for us to verify
compliance based on records that are maintained by the manufacturer of the food bearing the
gluten free claim and made available to us for inspection and copying.
We therefore request OMB approval of recordkeeping associated with requirements in 21 CFR
101.91 regarding the gluten free labeling of food, and as discussed in this supporting statement.
2. Purpose and Use of the Information Collection
The rulemaking amends § 101.91 to require that manufacturers of fermented or hydrolyzed
foods bearing the “gluten-free” claim create and maintain records regarding the food
demonstrating adequate assurances that the food is “gluten- free” before fermentation or
hydrolysis and that gluten has not been introduced during the manufacturing process.
Likewise, for foods containing one or more fermented or hydrolyzed ingredient and bearing the
“gluten-free” claim, manufacturers would be required to create and maintain records
demonstrating adequate assurance that the fermented or hydrolyzed ingredients are “glutenfree” under the regulations. Such adequate assurance can include test results, certificates of
analysis (CoAs), or other appropriate verification documentation for each of the ingredients
used in the food. Alternatively, adequate assurance can include test results of the food before
fermentation or hydrolysis of the food. Finally, the rulemaking would require manufacturers to
document that any potential for gluten cross-contact has been adequately assessed, and where
such a potential has been identified, that measures have been implemented to prevent the
introduction of gluten into the food during the manufacturing process.
We believe these information collection requirements will help ensure that the subject foods are
adequately labeled and that consumers may rely on the product labeling.
Description of Respondents: Respondents are manufacturers of foods that are fermented,
hydrolyzed, or contain fermented or hydrolyzed ingredients and bear the claim “gluten-free,”
“no gluten,” “free of gluten,” or “without gluten.” Respondents are from the private sector (forprofit businesses).
3. Use of Improved Information Technology and Burden Reduction
While the rulemaking does not require the use of specific information technology, we believe
that respondents will utilize electronic means to create and maintain the proposed
recordkeeping. The records required would need to be reasonably accessible by FDA during an
inspection at each manufacturing facility to determine whether the food has been manufactured
and labeled in compliance with the regulations. Records that can be immediately retrieved
from another location by electronic means are considered reasonably accessible.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. Upon implementation of the regulation
we will review our food labeling regulations, currently approved under OMB control no. 09100381, to determine whether consolidating burden attendant to activities related to this request is
appropriate.

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5. Impact on Small Businesses or Other Small Entities
The labeling applies to all products labeled gluten free and we do not believe this poses undue
burden on small entities. We estimate that ten percent (10%) of respondents are small
businesses. We aid small businesses in complying with its requirements through the agency’s
Regional Small Business Representatives and through the scientific and administrative staffs
within the agency. We also provide assistance via our Small Business Assistance webpage on
the agency’s website at https://www.fda.gov/industry/small-business-assistance.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with statutory and regulatory requirements.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), we published a 60-day notice requesting public comment
in the Federal Register of November 18, 2015 (80 FR 71990). Because of an inadvertent error
that resulted in conflicting dates by which comments would be received, we extended the
comment period to April 25, 2016 (see 81 FR 8869). Comments received in response to the
proposed rule are discussed in our final rule published on August 12, 2020 (85 FR 49240).
We received over 500 comments on the proposed rule from consumers; consumer groups; trade
organizations; industry; public health organizations; public advocacy groups; and other
organizations. In our final rule, we numbered each comment to help distinguish among
different topics. We grouped similar comments together under the same number, and, in some
cases, we separated different issues discussed in the same comment letter and designated them
as distinct comments for purposes of our responses. The number assigned to each comment
topic is for organizational purposes only and does not signify the comment’s value, importance,
or the order in which it was received. At comment 13, we address potential concerns pertaining
to electronic records. At the same time, none of the comments suggested a revision or
alternative to burden estimates proffered in our proposed rule.
9. Explanation of Any Payment or Gift to Respondents
There are no incentives, payments, or gifts associated with this information collection.
10. Assurance of Confidentiality Provided to Respondents
Records that may be reviewed during FDA inspections are subject to FDA regulations in 21
CFR part 20. Confidential commercial information is protected from disclosure under the
Freedom of Information Act in accordance with section 552(a) and (b) (5 U.S.C. 552(a) and
(b)) and by part 20. To the extent that § 20.64 applies, we will honor the confidentiality of any
data in investigation records compiled for law enforcement purposes.

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Privacy Act
This ICR does not request any personally identifiable information and does not include a form
that requires a Privacy Act Statement.
11. Justification for Sensitive Questions
The collection of information does not involve sensitive questions.
12. Estimates of Annualized Burden Hours and Cost
12a. Annualized Hour Burden Estimate
Activity under 21
CFR 101.91
Developing SOP for
gluten control and
associated documentation

21 CFR 101.91
Documentation necessary to
verify compliance with
gluten free labeling

Table 1.--Estimated One-Time Recordkeeping Burden
No. of
Records per
Total
Burden per
Respondents
Respondent
Annual
Recordkeeping
Records
5000
17.75
88,750
.51

Table 2.--Estimated Annual Recordkeeping Burden
No. of
Records per
Annual
Burden per
Respondents
Respondent
Records
Recordkeeping
5000
56.25
281,250
.43

Total
Hours
45,203

Total
Hours
120,458

In our Regulatory Impact Analysis (RIA), available under docket no. FDA-2014-N-1021, for
the final rule, we provide a breakdown of specific calculations regarding potential burden we
expect manufacturers of affected products will incur along with the associated recordkeeping
activities and contributing considerations. These figures are based on an upper-bound
estimated 5,000 product manufacturers. Here we provide a cumulative estimate of the average
recordkeeping burden we believe attributable to the information collection tasks,
acknowledging a one time assimilation period to establish procedures necessary to comply with
the gluten free labeling requirement, including the establishment of standard operating
procedures, sample testing, and documentation and retention of results.
12b. Annualized Cost Burden Estimate
We assume records will be retained by an employee whose position is commensurate to a
production manager in the food manufacturing industry. The mean wage for Standard
Occupations Classification (SOC) 11-9013 Farmers, Ranchers, and Other Agricultural
Managers in the North American Industry Classification System (NAICS) code 311000 Food
Manufacturing in 2018 was $38.43. (Bureau of Labor Statistics, Occupational Employment
Statistics, May 2018, National Industry-Specific Occupational Employment and Wage
Estimates for NAICS 31100 - Food Manufacturing, (first,

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https://www.bls.gov/oes/current/oes_nat.htm, then choose 11-0000, Management Occupations
at https://www.bls.gov/oes/current/oes_nat.htm#11-0000.)) We increased this wage by 50
percent to $57.65 to account for overhead. The overall estimated cost incurred by the
respondents is $3,279,939.10 (56,894 burden hours x $57.65/hour), which we have rounded to
$3,279,939.
Activity
Recordkeeping

Total Burden Hours

Hourly Wage Rate

56,894

Total Respondent Costs

$57.65

$3,279,939

13. Estimates of Other Total Annual Costs to Respondents/Recordkeepers or Capital Costs
We estimate no other cost burden to respondents.
14. Annualized Cost to the Federal Government
Assuming we allocate 14 full-time employees (FTEs) per year to inspect firms and review
records to determine compliance with 21 CFR 101.91, and a salary rate equal to an inspector at
the GS-13, step 5 level in the locality pay area of Washington-Baltimore ($116,353/year) in
2020, double it to account for overhead; we calculate a cost of $232,706 per FTE. Using this
figure, we estimate a cost to the Federal government of approximately $3,257,884 per year for
inspecting and reviewing records for compliance with § 101.91 ($232,706/FTE x 14 FTEs).
15. Explanation for Program Changes or Adjustments
This is a new information collection. We have not adjusted estimates from our proposed rule.
16. Plans for Tabulation and Publication and Project Time Schedule
This information collected will not be published or tabulated.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
The information collection establishes recordkeeping requirements; display of the OMB control
number is not applicable.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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