Threshold of Regulation for Substances Used in Food-Contact Articles
SUPPORTING STATEMENT
Terms of Clearance: None.
1. Circumstances
Making the Collection of Information Necessary
Under
section 409(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 348(a)), the use of a food additive is deemed unsafe
unless one of the following is applicable: (1) it conforms to an
exemption for investigational use under section 409(j) of the FD&C
Act; (2) it conforms to the terms of a regulation prescribing its
use; or (3) in the case of a food additive which meets the definition
of a food-contact substance in section 409(h)(6) of the FD&C Act,
there is either a regulation authorizing its use in accordance with
section 409(a)(3)(A) or an effective notification in accordance with
section 409(a)(3)(B).
The regulations in § 170.39 (21 CFR 170.39) established a process that provides the manufacturer with an opportunity to demonstrate that the likelihood or extent of migration to food of a substance used in a food-contact article is so trivial that the use need not be the subject of a food additive listing regulation or an effective notification. The agency has established two thresholds for the regulation of substances used in food-contact articles. The first exempts those substances used in food-contact articles where the resulting dietary concentration would be at or below 0.5 part per billion (ppb). The second exempts regulated direct food additives for use in food-contact articles where the resulting dietary exposure is 1 percent or less of the acceptable daily intake for these substances.
In order to determine whether the intended use of a substance in a food-contact article meets the threshold criteria, certain information specified in § 170.39(c) must be submitted to FDA. This information includes the following components: (1) the chemical composition of the substance for which the request is made; (2) detailed information on the conditions of use of the substance; (3) a clear statement of the basis for the request for exemption from regulation as a food additive; (4) data that will enable FDA to estimate the daily dietary concentration resulting from the proposed use of the substance; (5) results of a literature search for toxicological data on the substance and its impurities; and (6) information on the environmental impact that would result from the proposed use.
FDA requests the extension of OMB approval of the information collection requirements in the following citation:
21 CFR 170.39 - Reporting
This section specifies criteria that must be met to obtain an exemption from the food additive petition process for food-contact articles.
2. Purpose
and Use of the Information Collection
FDA
uses this information to determine whether the food-contact article
meets the threshold criteria. Requests for exemptions from the food
additive listing regulation requirement are letter-type submissions
from manufacturers of food packaging and food processing equipment.
These submissions are reviewed by FDA personnel to ascertain if the
substance(s) is adequately identified and if the proposed use meets
the criteria specified in 21 CFR 170.39 for an exemption. If the
data are sufficient to support an exemption under 21 CFR 170.39, the
agency informs the requestor by letter that the intended use of the
substance in a food-contact article is not required to be the subject
of a food additive listing regulation or a food contact notification.
Description
of Respondents: Respondents
to this information collection are individual manufacturers and
suppliers of substances used in food-contact articles (i.e., food
packaging and food processing equipment) or of the articles
themselves. Respondents are from the private sector (for-profit
businesses).
3. Use
of Improved Information Technology and Burden Reduction
FDA
has developed an option for electronic submission via the Electronic
Submission Gateway (ESG) for this information collection. The ESG is
an electronic system that currently accepts information for other
information collections. FDA estimates that, once the ESG is
available for this collection, fifty percent (50%) of the respondents
will use electronic means to submit the required information.
4. Efforts
to Identify Duplication and Use of Similar Information
A
critical element in FDA’s Threshold of Regulation Policy is
that the use of a substance exempted by the agency is not limited to
only the manufacturer who submitted the request for an exemption.
Other manufacturers may use exempted substances in food-contact
articles as long as the conditions of use (e.g., use levels,
temperature, type of food contacted, etc.) are those for which the
exemption was issued. Manufacturers and other interested persons can
easily access an up-to-date list of exempted substances which is on
display at FDA’s Division of Dockets Management and is also
available on the Internet at
http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/default.htm.
A list of exempted substances can also be obtained by contacting
FDA’s Office of Food Additive Safety (HFS-200), 5001 Campus
Drive, College Park, MD 20740. This list includes the name of the
company that made the request, the chemical name of the exempted
substance, and the specific use for which it has been exempted, as
well as any appropriate limitations. Having the list of exempted
substances publicly available also decreases the likelihood that a
company would submit a food additive petition or a food contact
substance notification for the use of a substance for which the
agency has previously granted an exemption from the food additive
listing regulation requirement.
To
avoid unnecessary duplication, existing data are used whenever
possible by FDA in evaluating requests for exemption of components of
food-contact articles under 21 CFR 170.39. This includes data in FDA
files as well as data available in the scientific literature. For
example, existing data in FDA files on the migration of components of
food-contact articles into food or food simulating solvents can often
be used to predict the level of migration resulting from similar uses
of other components of food-contact articles. However, because the
extent of migration of a component of a food-contact article into
food depends on a number of factors (e.g., the chemical nature of the
substance, the temperature of use, the type of food contacted, the
length of time in contact with food, the amount of food contacted
over the lifetime of a repeat-use article), and because substances
used in the manufacture of food-contact articles possess a wide range
of chemical and physical properties and are used under a variety of
conditions, additional information is often needed to determine
whether a particular use of a specific substance results in a dietary
concentration that is below the “threshold of regulation.”
5. Impact
on Small Businesses or Other Small Entities
FDA
estimates that approximately ten percent (10%) of the respondents are
small businesses. FDA’s
threshold of regulation process minimizes the burden on all
businesses by providing a procedure that is less burdensome than the
current food additive petition process. Because agency reviews made
under this process require significantly less resources than petition
reviews, decisions authorizing the marketing of a product are issued
relatively quickly (i.e., within 4- 5 months as opposed to the 1-4
years required for the review of a petition and the issuance of a
regulation). As a result, components of food-contact articles that
are found to be exempt from the food additive listing regulation
requirement can be marketed sooner than those authorized by the
petition process. Because the types of information needed for
approval under the premarket notification process for those uses of
food-contact articles involving dietary concentrations of 0.5 ppb or
less is identical to that required under 21 CFR 170.39, the burden on
industry for the preparation of a premarket notification would be
similar to the burden for the preparation of a request submitted
under the existing threshold of regulation process.
The agency has established the types of data necessary to demonstrate that the use of a component of a food-contact article meets the criteria for an exemption under 21 CFR 170.39. However, the agency does not have the resources to generate the data needed to support a request for an exemption under this policy. Whenever possible, assistance will be given to requestors to minimize the likelihood that unnecessary work is performed. FDA aids small businesses in dealing with the requirements through the Division of Education and Communication in the Center for Food Safety and Applied Nutrition (CFSAN) and through the scientific and administrative staffs of the agency.
Whenever
possible, to reduce the burden on all businesses, FDA will provide
assistance to requestors to minimize the likelihood that unnecessary
work is performed. CFSAN’s Division of Education and
Communication will also aid small businesses in dealing with the
submission requirements specified in 21 CFR 170.39. It should be
emphasized that the Threshold of Regulation Policy itself is, in
part, a response to representatives of the food packaging and
processing industries who have proposed, both informally and formally
(Petition submitted by the Society of Plastics Industries; Docket No.
77-0122) that FDA establish a Threshold of Regulation Policy for
food-contact articles.
6. Consequences
of Collecting the Information Less Frequently
Respondents
will submit the required information on an occasional basis, as
required by 21 CFR
170.39. Any
restriction of the right to require certain types of data for
requests submitted under this policy would significantly decrease the
number of food contact substances exempted from the requirement that
they be the subject of food additive petitions or food contact
substance notifications. Exemptions would be restricted to those
situations which involve substances which are generally recognized as
safe (GRAS) substances whose use was sanctioned prior to January 1,
1958, and substances approved for investigational use under section
409(j) of the FD&C Act. All other components of food-contact
articles whose use results in or which may reasonably be expected to
result in migration into food, even in trivial amounts, would require
premarket approval via the food additive petition process or the
notification process.
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), FDA published a 60 day notice for
public comment in the FEDERAL REISTER of May 11, 2016 (81 FR 29271).
No comments were received.
9. Explanation
of Any Payment or Gift to Respondents
FDA
does not provide any payment or gift to respondents.
10. Assurance
of Confidentiality Provided to Respondents
Requests
for exemptions of components of food-contact articles from the food
additive listing regulation requirement often contain trade secret
and commercial confidential information. Only information that is
releasable under the agency’s regulations (21 CFR part 20)
would be released to the public. This information is also
safeguarded by Section 301(j) of the FD&C Act and would be
protected from disclosure under the Freedom of Information Act (FOIA)
under sections 552(a) and (b) (5 U.S.C. 552(a) and (b)).
11. Justification
for
Sensitive
Questions
There
are no questions of a personally sensitive nature in the data
requirements for requests for exemptions under the FDA’s
Threshold of Regulation Policy.
12. Estimates
of Annualized Burden Hours and Costs
12a.
Annualized Hour Burden Estimate
FDA estimates the burden of this collection of information as follows:
Table 1.--Estimated Annual Reporting Burden1
21 CFR Section |
No. of Respondents |
No. of Responses per Respondent |
Total Annual Responses |
Average Burden per Response |
Total Hours |
170.39; threshold of regulation for substances used in food-contact articles. |
7 |
1 |
7 |
48 |
336 |
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
In compiling these estimates, FDA consulted its records of the number of regulation exemption requests received in the past 3 years. The annual hours per response reporting estimate of 48 hours is based on information received from representatives of the food packaging and processing industries and agency records.
FDA estimates that approximately 7 requests per year will be submitted under the threshold of regulation exemption process of § 170.39, for a total of 336 hours. The threshold of regulation process offers one advantage over the premarket notification process for food-contact substances established by section 409(h) of the FD&C Act (OMB control number 0910-0495) in that the use of a substance exempted by the agency is not limited to only the manufacturer or supplier who submitted the request for an exemption. Other manufacturers or suppliers may use exempted substances in food-contact articles as long as the conditions of use (e.g., use levels, temperature, type of food contacted, etc.) are those for which the exemption was issued. As a result, the overall burden on both the agency and the regulated industry would be significantly less in that other manufacturers and suppliers would not have to prepare, and FDA would not have to review, similar submissions for identical components of food-contact articles used under identical conditions. Manufacturers and other interested persons can easily access an up-to-date list of exempted substances which is on display at FDA's Division of Dockets Management and on the Internet at http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/default.htm. Having the list of exempted substances publicly available decreases the likelihood that a company would submit a food additive petition or a notification for the same type of food-contact application of a substance for which the agency has previously granted an exemption from the food additive listing regulation requirement.
12b. Annualized Cost Burden Estimate
Based on information provided to FDA, the annualized cost for the collection of information and preparation of a simple request for review under the proposed Threshold of Regulation Policy would range from $5,000-$25,000 depending on the complexity of the project. If analytical studies are required to show that the dietary exposure resulting from the proposed use is below the threshold of regulation, FDA estimates that the additional cost would vary from $10,000 to $75,000 depending on the complexity of the project (i.e., the number of substances and food simulating solvents involved, the method of analysis). Based on these estimates, the total cost to the respondent to submit requests under FDA’s Threshold of Regulation Policy would vary from $5,000-$100,000.
13. Estimates
of Other Total Annual Costs to Respondents and/or
Recordkeepers/Capital Costs
There
are no capital,
start-up, operating, or maintenance costs associated
with this collection.
14. Annualized
Cost to
the Federal Government
FDA
estimates that it will receive an average of 7 requests per year
for review under the Threshold of Regulation Policy. An abbreviated
review of the chemistry, toxicology and environmental impact
information requires an average of 25 hours to review.
FDA estimates the hourly cost for review to be $48.57 per hour, the GS-13/Step-4 rate for the Washington-Baltimore locality pay area for the year 2016. To account for overhead, this cost is increased by 100 percent, making the total cost $97.14 per hour. FDA estimates the cost to the Federal Government for the review of records to be $2,428.50 per review ($97.14/hour x 25 hours). Thus, FDA estimates that the annual cost to the Federal Government would be $16,999.50 ($2,428.50 x 7 requests).
15. Explanation
for Program Changes or Adjustments
The
estimated burden for this collection is unchanged.
16. Plans for Tabulation and Publication and Project Time Schedule
The
agency does not publish information from this information collection
other than, as noted above, by making available a list of substances
exempted under 21 CFR 170.39 at the Division of Dockets Management
and on the Internet at
http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/default.htm.
This list includes the name of the company that made the request,
the chemical name of the exempted substance and the specific use for
which it has been exempted, as well as any appropriate limitations.
It does not include any trade names or other confidential
information. The agency’s finding of no significant
environmental impact and the evidence supporting that finding,
contained in an environmental assessment, are also available for
public inspection at the Division of Dockets Management.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
There
are no reasons why display of the expiration date for OMB approval of
the information collection would be inappropriate.
18. Exceptions
to Certification for Paperwork Reduction Act Submissions
There
are no exceptions to the certification.
| File Type | application/msword |
| File Title | Supporting Statement for |
| Author | Joanna Capezzuto |
| Last Modified By | Mizrachi, Ila |
| File Modified | 2016-10-31 |
| File Created | 2016-10-12 |