[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Draft Guidance for Industry: Voluntary Labeling Indicating 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availability of a draft guidance for industry entitled ``Voluntary 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 FDA developed this draft guidance to assist 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DATES: Submit written comments concerning the draft guidance to ensure 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ADDRESSES: Submit written comments on the draft guidance and the 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single copies of the draft guidance entitled ``Draft Guidance for 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> If a bioengineered food has a significantly different 
nutritional property, its labeling must reflect the difference.
    <bullet> 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

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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