[Federal Register Volume 66, Number 12 (Thursday, January 18, 2001)]
[Notices]
[Pages 4839-4842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1047]
[[Page 4839]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00D-1598]
Draft Guidance for Industry: Voluntary Labeling Indicating
Whether Foods Have or Have Not Been Developed Using Bioengineering;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA (we)) is announcing the
availability of a draft guidance for industry entitled ``Voluntary
Labeling Indicating Whether Foods Have or Have Not Been Developed Using
Bioengineering.'' FDA developed this draft guidance to assist
manufacturers, who wish to voluntarily label their foods (human and
animal) as being made with or without bioengineering or the use of
bioengineered ingredients, to ensure that labeling is truthful and not
misleading. FDA is taking this action in response to requests from food
manufacturers and as part of the Clinton administration's initiatives
to strengthen science-based regulation of bioengineered foods and
consumer access to information.
DATES: Submit written comments concerning the draft guidance to ensure
adequate consideration in the preparation of a revised guidance, if
warranted, by March 19, 2001. However, you may submit written comments
at any time. Submit written comments concerning the collection of
information by March 19, 2001.
ADDRESSES: Submit written comments on the draft guidance and the
collection of information to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Identify the comments with the docket number found in
brackets in the heading of this document. Submit written requests for
single copies of the draft guidance entitled ``Draft Guidance for
Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not
Been Developed Using Bioengineering'' to the Office of Nutritional
Products, Labeling, and Dietary Supplements (HFS-800), Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 200 C St.
SW., Washington, DC 20204. Send one self-addressed adhesive label to
assist that office in processing your request, or include a fax number
to which the draft guidance may be sent. Alternatively, you may request
a copy of the draft guidance by calling 202-205-4561, or you may fax
your request to 202-205-4594. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
Regarding human food issues: Catalina Ferre-Hockensmith, Center for
Food Safety and Applied Nutrition (HFS-822), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, 202-205-4168.
Regarding animal feed issues: William D. Price, Center for
Veterinary Medicine (HFV-200), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6652.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 29, 1992 (57 FR 22984), FDA
published its ``Statement of Policy: Foods Derived from New Plant
Varieties'' (the 1992 policy). The 1992 policy applies to foods (human
and animal) developed from new plant varieties, including varieties
that are developed using recombinant deoxyribonucleic acid (rDNA)
technology, which is often referred to as ``genetic engineering,''
``biotechnology,'' or ``bioengineering.'' The 1992 policy provides
guidance to industry on scientific and regulatory issues related to
bioengineered foods and solicited written comments from interested
persons. It includes guidance on questions to be answered by developers
of foods from new plant varieties to ensure that the new products are
safe and comply with applicable legal requirements.
In the 1992 policy, we also address the labeling of foods derived
from new plant varieties, including plants developed by bioengineering.
The 1992 policy does not establish special labeling requirements for
bioengineered foods as a class of foods. The 1992 policy states that we
have no basis for concluding that bioengeered foods differ from other
foods in any meaningful or uniform way, or that, as a class, foods
developed by the new techniques present any different or greater safety
concern than foods developed by traditional plant breeding.
Although we do not require special labeling for bioengineered
foods, as a class of foods, in the 1992 policy we advised that labeling
requirements that apply to foods in general also apply to foods
produced using biotechnology. Section 403(i) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C. 343(i)) requires that each food
bear a common or usual name or, in the absence of such a name, an
appropriately descriptive term. In addition, under section 201(n) of
the act (21 U.S.C. 321(n)), the labeling of food must reveal all facts
that are material in light of representations made in the labeling or
in light of consequences that may result from the use of the foods.
Thus:
If a bioengineered food is significantly different from
its traditional counterpart, such that the common or usual name no
longer adequately describes the new food, the name must be changed to
describe the difference.
If an issue exists for the food or a constituent of the
food regarding how the food is used or consequences of its use, a
statement must be made on the labeling to describe the issue.
If a bioengineered food has a significantly different
nutritional property, its labeling must reflect the difference.
If a new food includes an allergen that consumers would
not expect to be present based on the name of the food, the presence of
that allergen must be disclosed in the labeling.
In the Federal Register of April 28, 1993 (58 FR 25837), we
requested data and information (the 1993 information request) on
certain labeling issues that had arisen from the labeling guidance in
the 1992 policy. In 1999, we held three public meetings (64 FR 57470,
October 25, 1999). The purpose of those meetings was for us to share
our current approach and experience over the previous 5 years regarding
bioengineered foods, to solicit views on whether our policies should be
modified, and to gather information to be used to assess the most
appropriate means of providing information to the public about
bioengineered products in the food supply. We received more than 50,000
written comments about our policy regarding safety and labeling of
bioengineered foods. The theme related to labeling in those comments
and the testimony at the meetings was that there are very strongly held
but divergent views as to whether bioengineered foods should be
required to bear special labeling. However, there was general agreement
that providing more information to consumers about bioengineered foods
would be useful. A number of comments supported the need for guidance
from FDA regarding appropriate ways that industry could voluntarily
provide information on a food label about bioengineering.
[[Page 4840]]
We have reviewed information in the comments received in response
to the 1992 policy and the 1993 information request as well as the
comments from the meetings held in 1999. Most of the comments that
addressed labeling requested mandatory disclosure of the fact that the
food or its ingredients was bioengineered or was produced from
bioengineered food. However, these comments did not provide data or
other information regarding consequences to consumers from eating the
foods or any other basis for us to find under section 201(n) of the act
that such a disclosure was a material fact. Many of the comments
expressed concern about possible long-term consequences from consuming
bioengineered foods, but they did not contend that any of the
bioengineered foods already on the market have adverse health effects.
The comments were mainly expressions of concern about the unknown. We
are still not aware of any data or other information that would form a
basis for concluding that the fact that a food or its ingredients was
produced using bioengineering is a material fact that must be disclosed
under sections 403(a) and 201(n) of the act. We are, therefore,
reaffirming our decision to not require special labeling of all
bioengineered foods.
We are providing guidance to assist manufacturers who wish to label
their foods voluntarily as being made with or without the use of
bioengineered ingredients. While the use of bioengineering is not a
material fact, many consumers are interested in the information, and
some manufacturers may want to respond to this consumer desire. We
developed this guidance using information from the comments and from
focus groups, as well as other resources. The guidance is intended to
help manufacturers ensure that their labeling is truthful and not
misleading. In addition, because the act defines food as articles used
for food or drink for man or other animals, this guidance applies to
animal feeds as well as to human foods.
The guidance addresses the use of statements in the labeling of
foods that are bioengineered or contain bioengineered ingredients. It
is intended to provide guidance on how a manufacturer may make
statements in the labeling about bioengineered foods and ingredients,
without such statements being false or misleading.
The guidance also addresses the use of statements in the labeling
that indicate that the food, or its ingredients, was not bioengineered.
The agency is soliciting comments on the entire guidance document, but
it is particularly interested in comments on how the draft guidance
deals with statements like ``GMO free,'' ``GM free,'' ``biotech free,''
and ``no genetically engineered materials.'' For example, we are
seeking comment on whether, and how, statements like ``GM free'' or
``no genetically engineered material'' can be made without being false
or misleading. In the guidance document, FDA advises that the term
``free'' may be difficult to use without being false or misleading. If
it implies ``zero,'' it may be very difficult to substantiate. The
adventitious presence of bioengineered material may make a ``zero''
claim inaccurate. Further, these terms would be misleading if they
imply that the food is superior because the food is not bioengineered.
We have concluded that the use, or absence of use, of bioengineering in
the production of a food is not a fact that is material either with
respect to consequences resulting from the use of the food or due to
representations on the labeling.
We suggest in the guidance that terms like ``GM free'' and
``biotech free'' either not be used in bioengineering labeling
statements or be in a context that makes clear that a zero level of
bioengineered material is not implied. We recognize that the terms are
popular among those manufacturers who have already made label
statements that a food was not bioengineered. FDA requests comments on
whether statements like ``GM free,'' ``biotech free,'' and ``no
genetically engineered materials'' can be made without being false or
misleading, and, if so, how. Does such a statement imply zero content
of bioengineered material? If so, would a clarifying statement help the
consumer to understand that there may be some low level of
bioengineered material present? Should substantiation of no detectable
bioengineered material be required in the absence of a clarifying
statement? Does ``biotech free'' or another similar term imply that the
labeled food is superior to foods that are not so labeled? If so, would
a clarifying statement, for example, a statement that the absence of
the use of bioengineering does not make the food superior to food not
so labeled or to a bioengineered food or ingredient, clarify the term
adequately? Would such a clarifying statement be needed in all
instances or are there some uses of ``GM free'' and similar terms that
would not imply that the labeled food is superior, and why? We
specifically request comment on these as well as any other aspects of
how to avoid false or misleading statements in the labeling about the
absence of use of bioengineering in the production of a food or its
ingredients.
This Level 1 draft guidance represents our current thinking on the
voluntary labeling indicating whether foods have or have not been
developed using bioengineering. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such an approach satisfies the
requirements of applicable statutes, and regulations. The draft
guidance is being distributed for comment purposes in accordance with
FDA's good guidance practices (65 FR 56468, September 19, 2000).
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on: (1) Whether the proposed collection of information
is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Title: Suggested Documentation for Substantiating Whether Foods
Have or Have Not Been Developed Using Bioengineering
Description: 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 and, therefore, would not be required in the labeling
of
[[Page 4841]]
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 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 that claim 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 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.
FDA estimates the burden of this collection of information as
follows:
Table 1.-Estimated Annual Reporting Burden \1\
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Annual
No. of Respondents Frequency per Total Annual Hours per Operating and Total Hours
Response Responses Response Maintenance 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 associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden \1\
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Annual Operating and
No. of Recordkeepers Frequency per Total Annual Hours per Maintenance Total Hours
Recordkeeper Records Recordkeeper Costs
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68 26 1,768 1 $53,040 1,768
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\1\There are no capital 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 non-organic 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 non-organic 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 non-bioengineering 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 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
[[Page 4842]]
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 non-organic 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.
III. Comments
Interested persons may submit to the Dockets Management Branch
(address above) written comments on the draft guidance by March 19,
2001, to ensure adequate consideration in the preparation of a revised
guidance, if warranted. However, interested persons may submit written
comments at any time. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Submit to the Dockets Management Branch written comments
concerning this collection of information by March 19, 2001. The
guidance and received comments are available for public examination in
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
IV. Electronic Access
An electronic version of the draft guidance also is available on
the Internet at http://www.cfsan.fda.gov/dms/.
Dated: November 15, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-1047 Filed 1-17-01; 8:45 am]
BILLING CODE 4160-01-F