[Federal Register Volume 68, Number 211 (Friday, October 31, 2003)]
[Notices]
[Pages 62086-62088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-27391]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2000D-1598]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Suggested 
Documentation for Substantiating Whether Foods Have or Have Not Been 
Developed Using Bioengineering

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by 
December 1, 2003.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Suggested Documentation for Substantiating Whether Foods Have or Have 
Not Been Developed Using Bioengineering

    On May 29, 1992 (57 FR 22984), FDA (we) published a statement of 
policy entitled ``Statement of Policy: Foods Derived From New Plant 
Varieties`` (the 1992 policy). The 1992 policy stated that the method 
of development of a new plant variety, including plants developed using 
bioengineering, is not information that is material under section 
201(n) of the act (21 U.S.C. 321(n)) and, therefore, would not be 
required in the labeling of food. This conclusion is consistent with 
our historic interpretation of section 201(n) of the act, in that the 
method of plant breeding is not required to be disclosed in labeling. 
In the Federal Register of April 28, 1993 (58 FR 25837) (the 1993 
information request), we requested additional information on labeling 
issues that had risen from our 1992 policy. Subsequently, in 1999, we 
held three public meetings to get public input on our existing policy 
with regard to its premarket review of foods produced through 
biotechnology and the labeling of such products. In response to 
comments that we received on our 1992 policy, the 1993 information 
request, and the public meetings, we decided to develop guidance for 
voluntary labeling indicating whether foods have or have not been 
developed using bioengineering. This guidance will assist manufacturers 
in labeling foods that have or have not been developed using 
bioengineering so that the labeling statement is truthful, not 
misleading, and scientifically valid. The information that the 
manufacturers will collect is documentation of handling practices so 
that they can truthfully label their products to indicate, if they so 
choose, whether the food has or has not been developed using 
bioengineering.
    In general, FDA anticipates that manufacturers claiming that a 
product is not developed using bioengineered material would 
substantiate the claim. If validated testing is not available to ensure 
the absence of bioengineered material for a specific food, we suggest 
that manufacturers document handling practices to substantiate a claim 
that a food was not developed using bioengineering, rather than using a 
``free''claim. Thus, to substantiate handling practices, the 
manufacturers

[[Page 62087]]

would have to document the source of such foods. Examples of 
documentation that we anticipate will demonstrate handling practices 
and procedures about how the food was processed are recordkeeping, 
certifications or affidavits from farmers, processors, and others in 
the food production and distribution chain. We are neither suggesting 
that firms maintain a certain set list of documents nor are we 
suggesting that anything less or different would likely be considered 
unacceptable. Rather, we are leaving it to each firm's discretion to 
maintain appropriate documentation to demonstrate that the food was 
produced using traditional methods.
    Description of Respondents: Manufacturers of foods that were and 
were not produced using bioengineering.
    In the 1993 information request, we requested information on 
labeling of foods that have or have not been developed using 
bioengineering. Additionally, in 1999, we held three public meetings to 
get public input on our existing policy on the labeling of foods 
produced through biotechnology and the premarket review of such 
products. In response to comments that we received, we decided to 
develop guidance for the voluntary labeling of foods indicating if they 
have or have not been developed using bioengineering. In the Federal 
Register of January 18, 2001 (66 FR 4839) FDA published a 60-day notice 
requesting public comment on the information collection provisions. The 
following is a discussion of the comments received and FDA's response 
to those comments.
    Most of the comments agreed that labeling food products as 
bioengineered or nonbioengineered would result in costs due to 
segregation, testing, or third-party validation, in addition to label 
changes. However, some comments said the producers that choose to label 
their products as nonbioengineered and the consumers that choose to 
purchase these products should incur these costs. Other comments said 
that these costs should be borne by the growers, manufacturers, 
processors, and marketers of bioengineered foods. Who should bear the 
paperwork burden is not within the scope of the guidance.
    One comment stated that FDA underestimated the number of small 
firms that will choose to label their product as not bioengineered, but 
will not attempt to make an organic claim. The comment did not offer 
any evidence to substantiate this claim or give an estimate of how many 
small firms will choose to make a nonbioengineered claim. FDA's 
estimate of the number of products that would label their products with 
a bioengineered claim is based on the number of products making an 
organic claim and the number of products that are not currently making 
an organic claim on their label, but are making a statement about 
bioengineering on their Web site, through a press release, or other 
venue. The PRA analysis estimates the burden for the expected number of 
firms making bioengineered claims, however, if more firms choose to 
make bioengineered claims then the paperwork burden would be higher.
    Numerous comments pointed out that mandatory labeling would have 
high costs for additional activities such as segregation, testing, 
labeling, quality control, and certification. One comment estimated 
that these costs could be as high as 6-17 percent of the farmgate 
price. The paperwork reduction analysis only estimates the paperwork 
burden associated with voluntary labeling, and so does not dispute 
these estimates, but does not include them in the analysis.
    FDA estimates the burden for this collection of information as 
follows:

             Table 1.--Estimated Annual Reporting Burden\1\
------------------------------------------------------------------------
               Annual
   No. of     Frequency     Total     Hours per  Operating &     Total
Respondents      per       Annual     Response   Maintenance     Hours
              Response    Responses                 Costs
------------------------------------------------------------------------
893          21          18,753      1           1,781,400    18,753
------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs
  associated with this collection of information.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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                      Annual Frequency     Total Annual                         Operating &
No. of Respondents    per Recordkeeper        Records      Hours per Record  Maintenance Costs     Total Hours
----------------------------------------------------------------------------------------------------------------
68                  26                   1,768             1                 53,040             1,768
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates that almost all of the organic producers and 
manufacturers who have issued statements that they will not use 
bioengineered ingredients will choose to label, and therefore, will 
incur the reporting burden. We determined the estimates for the annual 
reporting burden by using the approximately 18,753 products (16,985 
organic products and 1,768 nonorganic products) from producers who may 
not use bioengineered ingredients in their products. These 
manufacturers include producers who market to a niche of consumers who 
choose not to use products with bioengeered ingredients and 
manufacturers who have stated that they do not use bioengineered 
ingredients in their products. We estimated that the numbers of firms 
that will choose to label is 893 (825 firms for organic products and 68 
for nonorganic products). We estimated that the manufacturers of these 
products would choose to state on their label and in their labeling 
that those products were not developed using bioengineering. Such 
labeling would increase their paperwork burden. The estimates on the 
annual reporting burden (table 1 of this document) are based on agency 
knowledge of, and experience with, food labeling. The 18,753 product 
estimate may be too low if FDA has been unable to identify all 
producers that could use nonbioengineering labels or if FDA's labeling 
guidance encourages producers who have not issued bioengineering 
statements to now use such statements on the label. On the other hand, 
this may be an overestimate if some producers, who have been making 
statements indicating that they will try to use foods that were not 
developed using bioengineering, choose not to label their products.
    We believe that the burden associated with the voluntary labeling 
of foods that have not been developed using bioengineering would be a 
one-time burden for the small number of firms that would decide, 
voluntarily, to add

[[Page 62088]]

this additional information to the labels for their products, separate 
from any other label changes for their products. We estimate that at 
least 90 percent of firms would coordinate the addition of the 
statement on the label that their products were not developed using 
bioengineering with other changes in their labels, in which case the 
voluntary cost of transmitting the information to consumers in labeling 
would be included almost entirely in the cost of other voluntary or 
required labeling changes. The incremental cost for these 803 firms 
(893 x 90 percent) would be approximately $50 per label for 16,878 
labels, or $843,900 total. For the remaining 90 firms that would not 
coordinate changes with other labeling changes, we estimate that the 
cost would be approximately $500 per label for 1,875 labels, or 
$937,500 total. The estimated total operating and maintenance costs in 
table 1 of this document are, therefore, $1,781,400.
    When determining the annual recordkeeping burden (table 2 of this 
document), we estimated that the number of firms that would maintain 
records to substantiate labeling that their products were not developed 
using bioengineering is the same as the number of respondents with the 
reporting burden minus the number of firms marketing organic products 
(i.e., 68). We did not include products that are labeled ``organic'' in 
the estimated annual recordkeeeping burden because according to a 
proposal in the Federal Register of March 13, 2000 (65 FR 13512), 
issued by the Agriculture Marketing Service of the U.S. Department of 
Agriculture, a food labeled as ``organic'' would not be permitted to 
contain bioengineered materials. Therefore, the 16,985 organic products 
available today would be able to bear a voluntary labeling statement 
that the food was not developed using bioengineering. Thus, there is no 
additional paperwork burden to substantiate a claim that a product is 
not developed using bioengineering for these products. Because most of 
the nonorganic products whose producers have stated they will not use 
bioengineered ingredients are made by large firms for whom the 
verification process is not likely to impose a significant burden 
relative to the size of their operation, we assume that the paperwork 
processing time associated with testing or source verification for 
these products is approximately 1 hour for a total of 1,768 hours per 
year. Therefore, FDA estimated that the total recordkeeping burden 
would be 1,768 hours per year. Based on our experience, we have 
estimated that the overhead and maintenance cost are $30 per hour. The 
estimated total operating and maintenance cost in table 2 of this 
document are, therefore, $53,040 total.

    Dated: October 24, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-27391 Filed 10-30-03; 8:45 am]
BILLING CODE 4160-01-S