[Federal Register: October 31, 2003 (Volume 68, Number 211)]
[Notices]
[Page 62086-62088]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31oc03-67]
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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\
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Annual
No. of Frequency Total Hours per Operating & Total
Respondents per Annual Response Maintenance Hours
Response Responses Costs
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893 21 18,753 1 1,781,400 18,753
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\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
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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