**Information Collection Request Supporting Statement**

for

Focus Group Study of Radiation Disclosure Statement Options for Foods
Treated with Ionizing Radiation

0910-0468

March 19, 2001

# 

# Information Collection Request Supporting Statement

The purpose of this supporting statement is to verify that the
collection of information encompassed by this request complies with the
Paperwork Reduction Act of 1995. The supporting statement shows that
this information collection is necessary to determine if there is a need
to revise the current regulatory requirements for disclosure on the
product label when a food product has been subjected to irradiation, and
if so, what approach should be followed.

FDA issued an Advance Notice of Proposed Rulemaking in February, 1999,
"Irradiation in the Production, Processing and Handling of Food" in
response to the direction given in the Joint Explanatory Statement of
the Committee of Conference that accompanied the Food and Drug
Administration Modernization Act of 1997. A number of comments to the
ANPR, citizen petitions, and other submissions from individuals and
various organizations recommended various options for revising current
radiation labeling requirements. Many of the recommendations are based
on assumptions about how consumers will interpret the current labeling
requirement and different possible versions of a radiation disclosure
statement. Unfortunately, virtually all comments and other
recommendations received by the Agency do not take account of likely
marketplace circumstances that will be the realistic context for
consumer exposure to the radiation disclosure statement.

In order to make a determination if the existing requirements should be
changed and how they should be changed, FDA must know more about how
consumers interpret radiation disclosure statements in realistic
contexts where they appear in conjunction with promotional and
educational messages about irradiated products and irradiation
technology. Because of FDA's commitment to Congress to finalize any
regulatory changes by March 2002, there is an urgent need to conduct
this research within the next few months so that the results will be
available to support in a timely way the ongoing policy development
process. The need to file an information collection request to conduct
the proposed focus group research was not anticipated under our previous
internal procedures. Emergency processing of this information collection
request is required to meet our commitment to Congress to complete
regulatory changes by 2001 and to accommodate the changes in our
internal procedures.

A focus group approach is proposed for this study because it can
approximate the richness of context, in the sense of surrounding
promotional and educational messages, that will characterize the likely
consumer experience with the required (or proposed) labeling statements
that are currently being subjected to regulatory review. The purposes of
this information collection are to (1) evaluate whether and under what
conditions the current labeling requirement is an obstacle to consumer
acceptance of irradiated foods and (2) to determine whether there is
better nomenclature than what is presently prescribed for the disclosure
statement. The focus group findings will allow us to see how the
disclosure requirement and its variations are understood under more
realistic marketplace conditions than have been studied previously,
which will provide a firmer basis for policy decisions than is currently
available.

As required by the Office of Management and Budget, Section A of this
supporting statement provides a justification for this information
collection, while Section B provides information about the statistical
methods employed by this information collection.

A. JUSTIFICATION

### A.1 Circumstances

Currently, FDA's regulations require that the label and labeling of
retail packages or displays of food treated with ionizing radiation
include both the radura logo (the international symbol that indicates
radiation treatment) and a disclosure statement (21 C.F.R. Section
179.26\[c\]). In response to the direction given in the Joint
Explanatory Statement of the Committee of Conference that accompanied
the Food and Drug Administration Modernization Act of 1997, FDA issued
an Advance Notice of Proposed Rulemaking, "Irradiation in the
Production, Processing and Handling of Food" (64 Fed. Reg. 7834 (Feb.
17, 1999)). A number of comments to the ANPR, citizen petitions, and
other submissions from individuals and various organizations have been
received that recommend various options for revising current radiation
labeling requirements. Many of the recommendations are based on
assumptions about how consumers will interpret the current labeling
requirement and different possible versions of a radiation disclosure
statement.

The (FDA), which includes the Center for Food Safety and Applied
Nutrition, is mandated to provide consumers with truthful and
nonmisleading information on food labels that will enable consumers to
make informed product choices and to promote honesty and fair dealing in
the marketplace. The rationale for the 1986 rule was based on the
determination that "irradiation is a form of processing that can produce
significant changes in certain characteristics of a food, such as the
organoleptic (e.g., taste, smell, texture) or holding properties, in a
manner that is not obvious to the consumer in the absence of labeling.
That is, in the absence of labeling indicating the food has been
irradiated, the implied representation to consumers is that the food has
not been processed."

At the time of the 1986 rule, the expectation was that without the
required disclosure statement consumers would not know whether a food
was irradiated. It was assumed that only as more irradiated foods
entered the marketplace, would consumers become increasingly able to
recognize such foods, eventually reducing the need for a disclosure
statement. This expectation has not been met in several respects.
Relatively few irradiated food products have been offered to consumers,
and the likelihood that they would be offered without accompanying
explanation of the benefits to consumers seems much more remote than in
1986. Meanwhile the value of irradiation as a food safety technique has
become increasingly apparent to food safety professionals. Much of the
present concern about irradiation labeling is due to the apparent gap
between the limited availability of irradiated products in the
marketplace and the great potential of irradiation to improve food
safety. Attempts to explain the benefits of food irradiation to
consumers are usually effective in controlled studies, and limited
market tests demonstrate that radiated foods can be marketed effectively
when consumers are informed about food safety benefits of food
irradiation. The concern today is not that consumers will be unable to
recognize differences between irradiated and nonirradiated products, but
that the required disclosure statement will interfere with explaining
the benefits of radiated products to consumers.

It is this shift in concern that requires the evaluation of various
labeling options in the context of promotional and educational messages.

### A.2 Use of Information

The responsible program offices in the Center for Food Safety and
Applied Nutrition will be the primary users of the information gathered
in the study. They need the information to (1) evaluate whether and
under what conditions the current labeling requirement is an obstacle to
consumer acceptance of irradiated foods and (2) to determine how other
proposed versions of the disclosure statement might have different
effects on consumer acceptance. The information will supplement the
comments received in response to the ANPR because it will be based on
direct observation of consumer responses in a realistic communication
context rather than on opinion of what consumers are likely to do or
understand in hypothetical situations.

These focus groups will be organized to determine (1) the role of prior
knowledge in mediating the impact of the label disclosure statement; (2)
how consumers react to the disclosure statement in the context of the
likely kinds of messages they may get from manufacturers and potential
critics about the pros and cons of irradiated foods; and (3) how
consumers perceive the differential effectiveness of various labeling
approaches and alternative suggested nomenclatures in realistic
communication situations.

Macro International will provide a moderator, develop a detailed
moderator's guide, and conduct 6 focus groups at 3 sites (two groups at
each site). Groups will consist of individuals screened for self
perceived familiarity with food irradiation such that at each site one
group will be made up of individuals who think of themselves as well
informed about food irradiation while the other will be made up of
individuals who profess not to know very much about food irradiation.

### A.3 Use of Information Technology

Focus group studies are directed group discussions that do not produce
quantitative data, but which enable skilled observers to infer the
underlying views and assumptions of the group that are expressed in the
discussion. To facilitate interpretation, discussions are recorded and
videotaped so that both a visual record and a written transcript of the
discussion are available for review.

### A.4 Duplication Identification

Based on FDA's review of comments to the ANPR, and of related petitions
and reports submitted to the Agency, and a search of published
literature by the Consumer Studies Team of FDA's Center for Food Safety
and Applied Nutrition, the Agency concluded that there was virtually no
information available that addressed how radiation disclosure labeling
might work in a realistic communication context that contained relevant
promotional and education messages as would likely occur in the
marketplace. The proposed focus group study addresses this need and will
significantly improve our ability to anticipate the likely impact of
radiation disclosure labeling in realistic marketplace conditions.

### A.5 Minimize Burden to Small Entities

Not Applicable

### A.6 Consequences of Not Conducting Collection

FDA will collect data only once to provide information to support the
policy deliberations about the current labeling requirement for a
radiation disclosure statement. This is not a periodic data collection.
Without this data collection, the existing disagreements within the
stakeholder community about how to proceed in this matter will be much
harder to resolve. Without additional information of the kind that would
be provided by the study, large segments of the stakeholder community
will likely be unsatisfied with whatever option is adopted. Only by
feeding information about the likely consumer impacts of different
labeling options back into the policy dialogue, will it be possible to
bridge the gaps between stakeholders and arrive at a mutually acceptable
policy decision. Ultimately, the speed and level of marketplace adoption
of food radiation as an acceptable food safety technique will depend on
the policy decision.

### A.7 Special Circumstances Explanation

No special circumstances require additional explanations*.*

### A.8 Public Comments and Consultation Outside the Agency

The emergency *Federal Register* notice will provide an opportunity for
comment. FDA has reviewed the comments to the ANPR and a number of
related petitions and studies submitted to the Agency. It has consulted
about its proposed research plans with the National Food Processors
Association (NFPA), the Center for Science and the Public Interest
(CSPI), and the International Food Information Council (IFIC). IFIC has
agreed to coordinate a project advisory group consisting of
representatives from both industry and consumer groups to review and
provide comment on the study approach and materials.

### A.9 Payment or Gift to Respondents

Each respondent will be paid \$45. It is standard practice to reimburse
focus group respondents for their time.

### A.10 Assurance of Confidentiality

The confidentiality of respondents will be assured by using an
independent contractor to collect the information, by enacting
procedures to prevent unauthorized access to respondent data, and by
preventing the public disclosure of the responses of individual
participants.

### A.11 Sensitive Sexual, Religious, or Private Information

Not applicable.

### A.12 Hour Burden Estimates

The time required for participation will be 1.5 hours per participant.
There will be a total of 54 participants in the 6 groups, producing a
total estimated respondent burden of 81 hours (Table 1).

Table 1. Estimated Annual Reporting Burdena

  --------------- -------------- --------------- -------------- --------------
  **Number of     **Annual       **Total Annual  **Hours per    **Total
  Respondents**   Frequency\     Respondents**   Respondent**   Hours**
                  per                                           
                  Respondent**                                  

  54              1              54              1.5            81
  --------------- -------------- --------------- -------------- --------------

aThere are no capital costs or operating and maintenance costs
associated with this collection of information.

### A.13 Total Annual Cost Burden to Respondents or Recordkeepers Excluding Hours Burden Shown in Items 12 and 14

Not applicable. Respondents will have no additional burden beyond the
hours burden shown in item A.12. Respondents will not need capital
equipment, ongoing recordkeeping operations, or services to complete the
information collection.

### A.14 Annual Cost to the Federal Government

FDA estimates the total cost to the Federal Government for this
information collection to be approximately \$35,000 as detailed in
Appendices 1 and 2.

### A.15 Explanation of Program Changes or Adjustments

This is a new collection.

### A.16 Publication of Results

Macro will prepare an interpretive report about the focus group
discussions that addresses the findings relevant to the information
objectives laid out in A.1 and A.2.

This study is a one-time collection of information to determine the
communication impact of possible labeling options for irradiated foods.
Target dates are listed in Table 2.

### A.17 Explanation of Inappropriateness of Displaying OMB Approval Expiration Date

No exemption is requested.

### A.18 Exceptions to the Certification Statement of OMB Form 83.I

No exceptions requested.

Table 2. Schedule

  ------------------------------------------- ------------- -------------
  **Activity**                                **Start       **End Date**
                                              Date**        

                                                            

  *Federal Register* notice preparation of    3/20/2001     3/26/2001
  publication                                               

  OMB approval                                3/26/2001     4/11/2001

  Data collection                             4/18/2001     5/9/2001

                                                            

  Final report                                5/10/2001     5/25/2001
  ------------------------------------------- ------------- -------------

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS

> Focus group studies are not statistical data collections. The
> rationale and general approach to how focus groups are to be treated
> with respect to the statistical method requirements of OMB information
> collection requests will be laid out in FDA's generic submission
> currently under preparation. This emergency approval request comes in
> the interim before the applicable guidelines have been formulated.
> Without guidance as to how to answer this section on statistical
> methods, we will assume it is not applicable to the present
> information collection request.

### Appendix 1. COST ESTIMATE, CONTRACTOR

Focus Group Study of Radiation Disclosure Statement Options

For Food Treated with Ionizing Radiation

March 19, 2001

  ------------------------------------------ ---------- -------- ----------
  Direct Labor                               Rate       Hours    Amount

  a\. Project Director                       \$40.62    40       \$1,625

  b\. Moderator                              \$16.59    120      1,991

  c\. Logistics                              \$15.79    60       947

  Subtotal                                                       4,563

                                                                 

  Fringe Benefits \@34.5%                    1,574               

  Overhead \@63.5%                           3,897               

  Total Labor                                10,034              

                                                                 

  Consultant/Contractor Labor                                    

  a\. Recruitment (\$800/group x 6 groups)   4,800               

  b\. Transcription (\$400/group x 6 groups) 2,400               

                                                                 

  Travel and Subsistence (estimate for       1,500               
  typical cities)                                                

                                                                 

  Per Diem for Moderator (3 sites, including 600                 
  hotel, ground transportation, meals)                           

                                                                 

  Training and Meeting Costs                                     

  a\. Facility Rental (\$500 per site/day x  3,000               
  6 groups)                                                      

  b\. Incentives/Stipends (\$45 per          2,430               
  respondent, 9 respondents/group, 6 groups)                     

                                                                 

  Subtotal Other Direct Costs                14,730              

                                                                 

  Total Costs (Labor and Other Direct Costs) 24,764              

  General and Administrative Expense @ 11.5% 2,848               

  Subtotal Without Fee                       27,612              

  Fee/Profit @ 8%                            2,209               

  Total                                      \$29,821            
  ------------------------------------------ ---------- -------- ----------

### Appendix 2. COST ESTIMATE, GOVERNMENT

Focus Group Study of Radiation Disclosure Statement Options

For Food Treated with Ionizing Radiation

March 19, 2001

  ------------------------------------------ ----------------------------
  Travel                                     \$3,000

  Labor                                      2,200

  Total Cost                                 \$5,200
  ------------------------------------------ ----------------------------