Threshold of Regulation Policy for Food-Contact Articles
SUPPORTING STATEMENT
1. Circumstances
Making the Collection of Information Necessary
Under
section 409(a) of the Federal Food, Drug, and Cosmetic Act (the 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 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 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
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
The
agency is not equipped to receive these submissions electronically at
this time. Therefore, this information collection will not involve
the use of automated, electronic, mechanical, or other technological
collection techniques or other forms of information technology. FDA
is working diligently to develop the necessary technology
infrastructure to enable it to accept these submissions
electronically in the future. The agency has made progress toward
completion of a Public Key Infrastructure (PKI) capable system that
we expect to enable us to accept these submissions electronically.
Accordingly, FDA has carefully evaluated the nature and regulatory
significance of the submission, in particular the significant legal
consequences attendant to the signing and submitting of the request
for exemption, and
request that the agency be authorized to continue this information
collection activity in non-electronic format.
The request for exemption must be signed by a responsible person, and in signing the request, that person is certifying that the information in it is accurate. The request for exemption carries legal implications for the firm and the signatory. Therefore, these documents carry significant risk of repudiation. For this reason, FDA believes that the significant legal consequences attendant to the signature warrant a level of authentication and signer non-repudiation that only digital signatures in a PKI model can currently provide. Because CFSAN lacks that model, but is working with other FDA units toward putting it in place, the agency believes that other forms of electronic submission that the agency might be able to accept present unacceptable risks that provide a basis to not accept these submissions electronically until an acceptable infrastructure is in place. FDA estimates that none of the respondents (0%) 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.cfsan.fda.gov.
A list of exempted substances can also be obtained by contacting
FDA's Office of Food Additive Safety (HFS-200), 5100 Paint Branch
Parkway, 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 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), in the Federal Register of April 9,
2010 (75 FR 18209), FDA published a 60-day notice requesting public
comment on the information collection provisions. FDA received no
comments.
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 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
12
a. Annualized Hour Burden Estimate
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.
FDA estimates the burden of this collection of information as follows:
Table 1: Estimated Annual Reporting Burden1 |
|||||
21 CFR Section |
No. of Respondents |
Annual Frequency per Response |
Total Annual Responses |
Hours per Response |
Total Hours |
170.39 |
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 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 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.cfsan.fda.gov. 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.
12 b. 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 25 hours to review.
FDA estimates the hourly cost for review to be $46.93 per hour, the GS-13/Step-4 rate for the Washington-Baltimore locality pay area for the year 2010. To account for overhead, this cost is increased by 100 percent, making the total cost $93.86 per hour. FDA estimates the cost to the Federal Government for the review of records to be $2,346.50 per review ($93.86/hour x 25 hours). Thus, FDA estimates that the annual cost to the Federal Government would be $16,425.50 ($2,346.50 x 7 requests).
15. Explanation
for Program Changes or Adjustments
The
decrease in burden is due to the decrease in the estimated number of
respondents.
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.cfsan.fda.gov.
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 | DPresley |
| File Modified | 2010-06-28 |
| File Created | 2010-06-28 |