0704 supporting statement 2015

Guidance on Consultation Procedures:
Foods Derived From New Plant Varieties
OMB Control No. 0910-0704
SUPPORTING STATEMENT, Part A
Terms of Clearance: None.
A.

Justification

1. Circumstances Making the Collection of Information Necessary
Since 1992, when FDA issued its Statement of Policy: Foods Derived From New Plant
Varieties (the 1992 policy) (57 FR 22984, May 29, 1992), FDA has encouraged
developers of new plant varieties, including those varieties that are developed through
biotechnology, to consult with FDA during the plant development process to discuss
possible scientific and regulatory issues that might arise. In the 1992 policy, FDA
explained that, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act),
developers of new foods (in this document food refers to both human food and
animal feed) have a responsibility to ensure that the foods they offer to consumers are
safe and are in compliance with all requirements of the FD&C Act (57 FR 22984 at
22985). FDA recommends that producers who use biotechnology in the manufacture or
development of foods and food ingredients work cooperatively with FDA to ensure that
products derived through biotechnology are safe and comply with all applicable legal
requirements. FDA has instituted a voluntary consultation process with industry. To
facilitate this process the Agency has issued a guidance entitled, “Guidance on
Consultation Procedures: Foods From New Plant Varieties,” which is available on
FDA’s website at http://www.fda.gov/FoodGuidances) fosters communication by
encouraging developers to submit to FDA their evaluation of the food safety of their new
plant variety. Such communication will help to ensure that any potential food safety
issues regarding a new plant variety are resolved during development, and will help to
ensure that all market entry decisions by the industry are made consistently and in full
compliance with the standards of the FD&C Act.
FDA issued its 1992 policy statement and its guidance on consultation procedures under
the broad statutory authority of the FDA to protect the public health by ensuring that
foods are safe, wholesome, sanitary, and properly labeled found in section 903 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 393), as well as the authority
found in the food additive provisions in sections 201(s) and 409 of the act (21 U.S.C.
Sections 321(s) and 348) and in the adulterated food provisions in section 402(a)(1) of
the act (21 U.S.C. Section 342(a)(1)).

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We request OMB approval of the information collection provisions associated with
consultations described in the 1992 policy statement and detailed in “Guidance on
Consultation Procedures: Foods Derived from New Plant Varieties” (1996 and revised
1997; the consultation procedures); and, Form FDA 3665.
2. Purpose and Use of the Information Collection
Under the consultation procedures, any person who is responsible for the development,
distribution, importation, or sale of a food derived from a bioengineered plant variety
may voluntarily consult with FDA and eventually submit summary safety and nutritional
analysis which would form the basis of a biotechnology notification file (BNF). Based
on the agency's experience, FDA expects that it ordinarily will be the seed developers and
purveyors who notify the agency about such a bioengineered food.
Under the consultation procedures as described in the 1992 policy statement and the 1996
(1997) guidance that are the subject of this information collection request, a notifier
submits a request for consultation to FDA through FDA’s Center for Food Safety and
Applied Nutrition (CFSAN). CFSAN receives the requests for final consultation and
shares all BNF submissions with CVM. The two centers jointly review all notifications
as a single review team. Thus, FDA has a single point of contact for industry.
Depending on the plant and how it will be used as food for humans or animals, either
CFSAN or the Center for Veterinary Medicine (CVM) may take a leadership role in the
consultation. CVM reviews all notifications with animal feed uses. CFSAN reviews all
notifications with human food uses. The majority of notifications have both food and
feed uses. Files are established and records are maintained by CFSAN. At some stage
after a consultation has been initiated, the developer submits a summary of its safety and
nutritional assessment in support of its product (final consultation). After reviewing this
submission, FDA may, as needed, request information to clarify particular points. When
FDA has no further questions about the safety or regulatory status of the new plant
variety, FDA sends a letter to that effect to the developer and the consultation is
completed.
In FDA’s experience, there has been a considerable interest, from a broad segment of the
public, including members of the regulated industry, other federal, state, and local
government agencies, international government agencies, and public interest groups, in
BNFs evaluated under the policy. FDA has prepared a list of completed consultations
(BNFs) and has made the text of the letter issued by the agency in response to each BNF
and the text of the agency memo summarizing the completed evaluation of each BNF
easily accessible to the public on FDA’s Internet site
(http://www.fda.gov/Food/Biotechnology/Submissions/default.htm).
Description of Respondents: Respondents to this collection of information include
developers of new plant varieties intended for food use. Respondents are from the
private sector (for-profit businesses, as well as not-for-profit institutions such as

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university and other U.S. government-supported researchers) and from the Federal
Government.
3. Use of Improved Information Technology and Burden Reduction
Consultation submissions contain summaries of data and narrative text. FDA currently
accepts this information electronically via the Electronic Submission Gateway (ESG) or
electronic media (such as: CD ROM, DVD). The agency estimates that about fifty
percent (50%) of the notifications will be submitted electronically in the next three years.
4. Efforts to Identify Duplication and Use of Similar Information
Many plants developed using rDNA technology are considered "regulated articles" under
regulations of USDA’s Animal and Plant Health Inspection Service (APHIS) (7 CFR Part
340), which regulates the introduction of certain "genetically engineered" plants into the
environment. A developer must obtain authorization from APHIS to field test such crops
and, depending on the nature of the crop, a developer files either a permit application or a
notification. A developer’s submission to APHIS includes information on the plant from
which the food is derived, and details of the genetic changes to the plant. APHIS
considers issues of agricultural and environmental safety during field trials, such as
whether the crop could cause harm to plants or plant products, non-target organisms, or
threatened and endangered species. After a period of research and development to gather
safety data, a developer may request that APHIS grant “non-regulated” status to the
genetically engineered plant, meaning that the agency has determined that the plant is as
safe as similar conventionally bred varieties and as such will no longer be subject to
APHIS oversight. In contrast, FDA’s consultation procedure requests the submission only
of data and information about food derived from the plant. FDA considers issues of food
and feed safety, as well as any other food regulatory issues including labeling. Therefore,
although a submission to APHIS would include some information that would be included
under FDA’s voluntary consultation procedures (e.g., the identity of the parent plant), the
submission is not duplicative.
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 et
seq.), the U.S. Environmental Protection Agency (EPA) has authority to regulate all
pesticides, regardless of how they are made or their mode of action. Thus, a plant
bioengineered to contain a pesticide will also be reviewed by EPA. No person may sell or
distribute a pesticide in the United States that is not registered, except under certain
circumstances; EPA also has the authority to regulate unregistered pesticides, e.g., in
field testing. EPA can establish conditions for use as part of the registration and for uses
of unregistered pesticides. The EPA also sets tolerance limits for residues of pesticides on
and in food and animal feed, or establishes an exemption from the requirement for a
tolerance, under the Federal Food, Drug and Cosmetic Act (FFDCA; the act). Under the
FFDCA, FDA has authority to regulate a non-pesticidal substance that may be introduced
into a new plant variety and that is expected to become a component of food. Any food

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safety questions beyond those associated with the pesticide, such as those raised by
unintended compositional changes, are under FDA's jurisdiction (57 FR 22984 at 23005).
As such, FDA’s consultation procedures apply to those non-pesticidal aspects of
bioengineered foods derived from a new plant variety modified to contain a pesticidal
substance.
5. Impact on Small Businesses or Other Small Entities
FDA estimates that five percent (5 %) of respondents are small businesses. The policy
statement has been in place since 1992 and the food biotechnology industry has actively
consulted with FDA since 1994. In 1996, FDA provided guidance to industry on
procedures for these consultations. At least 25 companies and universities have
completed over 80 biotechnology consultations with FDA. Most of these companies are
multinationals with hundreds of millions of dollars in annual sales and do not meet the
criteria for a small business. However, at least one of the companies that have consulted
with FDA would meet the small entity definitions.
The consultation procedure minimizes the reporting burden on all businesses, including
small businesses, by providing that the notifier submit a summary of data and
information, rather than the data and information itself. There is no burden to the notifier
for developing the data and information that underlie the BNF because they would have
already generated such data and information to ensure that the bioengineered food is as
safe as comparable food and is otherwise in compliance with all applicable requirements
of the act. FDA aids small businesses in complying with its requirements through the
agency’s Regional Small Business Representatives and through the scientific and
administrative staffs within the agency. FDA has provided a Small Business Guide on
the agency’s website at http://www.fda.gov/oc/industry/.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally. The current voluntary consultation policy has been
functioning since the 1992 policy statement. As discussed, over 80 consultations have
been completed. If the information collection being considered here was not conducted,
businesses would not have the opportunity to consult with FDA. It has been the
experience of FDA that industry welcomes the opportunity to consult with FDA,
especially if the process is transparent to public scrutiny, because the outcome of the
consultation process will support their business interests by improving public and
customer confidence in their product.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information.

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8. Comments in Response to the Federal Register Notice and Efforts to Consult
Outside the Agency
In the Federal Register of December 11, 2014 (79 FR 73590), FDA published a 60-day
notice requesting public comment on the proposed collection of information. One
comment was received however it was not responsive to the information collection topics
solicited in the notice and is therefore not addressed in this document.
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
FDA believes that, in most cases, neither the existence of a BNF, nor most or all of its
content, would satisfy the criteria for exemption from disclosure. At this time, we do not
proactively disclose evidence of a developer’s submission until after subject completes
the consultation procedure. After the consultation is complete, we place on the FDA
Internet site an electronic version of the agency response to the company and a
memorandum summarizing the submission
(http://www.fda.gov/Food/Biotechnology/Submissions/default.htm). Information
submitted to FDA in a BNF may contain trade secret and commercial confidential
information. As a result, all files are maintained in a secured area. Form FDA 3665, its
instructions, and related guidance, provide instructions for assisting FDA with protecting
confidential information. A submitter may choose to provide a redacted copy of the
submission, identifying that information that the submitter views as trade secret or as
confidential commercial or financial information. Only information that is releasable
under the agency’s regulations in 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
This information collection does not involve any questions that are of a personally
sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
Description of Respondents: Respondents to this collection of information include
developers of new plant varieties intended for food use. As noted above, in this
document food refers to both human food and animal feed.

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FDA estimates the burden of this collection of information as follows:
Table 1.--Estimated Annual Reporting Burden1
Total
No. of
No. of Responses Annual
Respondents
per Respondent
Responses

Average
Burden per
Response

Activity
FDA Form No.
Initial
consultation None
20
2
40
Final
consultation FDA 3665
12
1
12
Total
1
There are no capital costs or operating and maintenance costs associated with this collection of
information.

Total
Hours
4

160

150

1,800
1,960

Initial Consultations
Initial consultations are generally a one-time burden, although a developer might return
more than once to discuss additional issues before submitting a final consultation. As
noted in its guidance to industry, FDA encourages developers to consult early in the
development phase of their products, and as often as necessary. Historically, firms
developing a new bioengineered plant variety intended for food use have generally
initiated consultation with FDA early in the process of developing such a variety, even
though there is no legal obligation for such consultation. These consultations have served
to make FDA aware of foods and food ingredients before these products are distributed
commercially, and have provided FDA with the information necessary to address any
potential questions regarding the safety, labeling, or regulatory status of the food or food
ingredient. As such, these consultations have provided assistance to both industry and the
Agency in exercising their mutual responsibilities under the FD&C Act.
Generally, for an initial consultation, a developer requests a meeting by sending FDA a
letter with an agenda. A mutually convenient time is arranged and the developer comes to
discuss their product. In preparation for a meeting, a developer might prepare written
materials or a slide presentation to discuss their product under development. A meeting
between the developer and FDA typically lasts between 1 and 2 hours. As a result of such
a meeting, FDA establishes a file called a biotechnology notification file, or BNF, to
collect all documentation and communication regarding the bioengineered plant. For
example, FDA typically places information such as the developer's letter, agenda, and
any written materials (such as copies of a slide presentation) in a BNF, as well as any
memorandum FDA prepares as a record of the meeting. FDA has not issued any
recommendations as to the format for these types of materials (e.g., there is no form
associated with requesting a meeting).
Depending on the introduced trait, the experience the developer has had with the kind of
modification being considered, and their familiarity with the consultation procedures, a
developer might choose to do a final consultation without an initial consultation.

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FDA estimates that CVM and CFSAN jointly received, on average, 40 initial
consultations per year in the last three years via telephone, e-mail or written letter.
Based on this information, we expect to receive no more than 40 annually in the next
three years, as shown in Table 1.
Final Consultations
Final consultations are a one-time burden. At some stage in the process of research and
development, a developer will have accumulated the information that the developer
believes is adequate to ensure that food derived from the new plant variety is safe and
that it demonstrates compliance with the relevant provisions of the FD&C Act. The
developer will then be in a position to conclude any ongoing consultation with FDA. The
developer submits to FDA a summary of the safety and nutritional assessment that has
been conducted about the bioengineered food that is intended to be introduced into
commercial distribution. FDA evaluates the submission to ensure that all potential safety
and regulatory questions have been addressed. FDA has developed a form that prompts a
developer to include certain elements in the final consultation in a standard format. Form
FDA 3665 is entitled "Final Consultation for Food Derived From a New Plant Variety
(Biotechnology Final Consultation)." The form, and elements that would be prepared as
attachments to the form, can be submitted in electronic format.
The summary information of the safety and nutritional assessment for a new plant variety
submitted to FDA (on the form and in attachments to the form) includes the following
information:
• The name of the bioengineered food and the crop from which it is derived;
• A description of the various applications or uses of the bioengineered food,
including animal feed uses;
• Information concerning the sources, identities, and functions of introduced
genetic material;
• Information on the purpose or intended technical effect of the modification, and
its expected effect on the composition or characteristic properties of the food or
feed;
• Information concerning the identity and function of expression products
encoded by the introduced genetic material, including an estimate of the
concentration of any expression product in the bioengineered crop or food derived
therefrom;

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• Information regarding any known or suspected allergenicity and toxicity of
expression products and the basis for concluding that foods containing the
expression products can be safely consumed;
• Information comparing the composition or characteristics of the bioengineered
food to that of food derived from the parental variety or other commonly
consumed varieties of the same crop with special emphasis on important nutrients,
and toxicants that occur naturally in the food;
• A discussion of the available information that addresses whether the potential
for the food derived from a bioengineered plant to induce an allergic response has
been altered by the genetic modification; and
• Any other information relevant to the safety and nutritional assessment of the
bioengineered food.
In 2001, FDA contacted 5 firms that had made one or more biotechnology consultation
submissions under the 1996 procedures. FDA asked each of these firms for an estimate
of the hourly burden to prepare a submission under the voluntary biotechnology
consultation process. Three of these firms subsequently provided the requested
information. Based on this information, FDA estimated that the average time to prepare a
submission for final consultation under the 1996 procedures is 150 hours (69 FR 68381,
November 24, 2004). The availability of FDA Form 3665, and the opportunity to
provide the information in electronic format, could reduce this estimate. However, as a
conservative approach for the purpose of this analysis, FDA is assuming that the
availability of the form and the opportunity to submit the information in electronic format
will have no effect on the average time to prepare a submission for final consultation
under the 1996 procedures.
Jointly, CVM and CFSAN received 2 final consultations in 2008, 7 final consultations in
2009, and 4 final consultations in 2010. Based on this information, we expect to receive
no more than 12 annually in the next three years, as shown in Table 1.
As requested in part III of Form 3665, section 5, this submission may incorporate by
reference information from a previous submission to FDA (biotechnology notification
file (BNF), new protein consultation (NPC), generally recognized as safe (GRAS) notice,
GRAS affirmation petition, food additive petition, and food master file). These
collections of information have been approved by OMB under the following control
numbers: new protein consultations are approved under OMB Control No. 0910-0583;
GRAS notices and affirmation petitions are approved under OMB Control No. 09100342; and, food additive petitions and food master files are approved under OMB Control
No. 0910-0016.

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12b. Annualized Cost Burden Estimate
Gathering the information discussed here and providing it to the agency may be done by
a professional employee such as a scientist. FDA estimates that the average hourly wage
for this employee would be equivalent to a GS-14/Step-1 level in the locality pay area of
Washington-Baltimore in 2015, approximately $ 51.43/hour. Doubling this wage to
account for overhead costs, FDA estimates the average hourly cost to respondents to be
$102.86/hour. The overall estimated cost incurred by the respondents is $201,605.60
(1,960 burden hours x $102.86/hr = $201,605.60). In addition, while FDA does not
charge for the use of the ESG, FDA requires respondents to obtain a public key
infrastructure (PKI) certificate in order to set up the account. This can be obtained inhouse or outsourced by purchasing a public key certificate that is valid for 1 year to 3
years. The certificate typically costs from $20-$30.
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 CFSAN directs approximately four (4) full time equivalent positions
(FTEs) to the notification procedure for human foods. CFSAN usually has the lead on
BNFs, and thus assigns more reviewers and devotes more resources to developing the
agency’s record of the consultation than CVM. FDA estimates that CVM will direct two
(2) FTEs to processing the notification procedure for animal foods. Based on an average
cost of $110,000 per fully supported position, the cost of processing consultations would
be $660,000 per year.
15. Explanation for Program Changes or Adjustments
The hour burden is unchanged.
16. Plans for Tabulation and Publication and Project Time Schedule
No statistics from the information obtained from this data collection will be published.
However, as noted above in Section 10, we do not proactively disclose evidence of a
developer’s submission until after subject completes the consultation procedure. After the
consultation is complete, we place on the FDA Internet site an electronic version of the
agency response to the company and a memorandum summarizing the submission.

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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.

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