Request for OMB Review

Supporting Statement

**2005 Food Safety Survey**

**September, 2005**

Submitted by:

Consumer Studies Staff

Division of Social Sciences

Office of Regulations and Policy

Center for Food Safety and Applied Nutrition

Food and Drug Administration

Department of Health and Human Services

**FOOD SAFETY SURVEY**

**Supporting Statement for Information Collection Request**

Approval is requested for Cycle IV of the Food Safety Survey. Telephone
interviews are planned with a random sample of approximately 4000
individuals, including at least 500 Hispanics. Data from the survey will
be used in support of the Agency's regulatory policy in diverse areas
dealing with food safety and will support consumer education by enabling
the Agency to track consumer knowledge, attitudes, and practices
concerning food safety. The data will also be used to measure progress
on the Healthy People 2010 consumer objectives for food safety. The
survey methodology is largely identical to Cycle III as approved by OMB
(No. 0910-0345). The questionnaire (copy attached) has been updated to
reflect current issues for consumers and food safety.

**A. JUSTIFICATION**

**A1. Necessity for the Information Collection**

The Food and Drug Administration (FDA) has major responsibility for
assuring the safety of the nation\'s food supply. FDA has the lead
Federal food safety inspection role for produce, seafood, imported
foods, processed foods, and foods sold at retail. In addition, the
Agency works closely with State and local health departments and with
organizations such as the Conference on Food Protection (CFP), the
Interstate Shellfish Sanitation Commission (ISSC), and the Association
of Food and Drug Officials, to coordinate national and state food safety
activities. FDA also works closely with the Food Safety and Inspection
Service, U.S. Department of Agriculture (FSIS/ USDA), which has the lead
Federal food safety inspection role for meat and poultry, and with
Centers for Disease Control and Prevention (CDC) on food safety
research, including FoodNet, and outbreak investigations.

In the last few years, a high level of activity has occurred in several
sectors involved with the food safety area. FDA activities include;
preventing BSE from entering the food supply, exploring the effects of
acrylamide in food, establishing the Produce Safety Initiative (under
which was developed the Guide to Minimize Microbial Food Safety Hazards
for Fresh Fruits and Vegetables); releasing a Methyl Mercury advisory
for pregnant women and small children. The Food Safety Survey assesses
consumers' knowledge of the information promulgated by the FDA and their
perceptions of the effectiveness of these activities.

The Food Safety Survey is used to evaluate the Healthy People 2010
objectives for food safety and for allergens (1).

**Data from the 1998 Food Safety Survey was used to determine the
baseline for Healthy People 2010 objective 10-5 (Increase the proportion
of consumers who follow key food safety practices). Data from the 2001
Food Safety Survey updated these baselines, and data from the 2005 Food
Safety Survey will be used to evaluate this objective. In addition to
providing goals for the entire U.S. English- and Spanish-speaking adult
population, demographic sub-group analysis is a key component of this
Healthy People 2010 objective. Specifically, key food safety practices
are reported by: racial and ethnic groups, gender, family income level
(annual), education level, presence of children less than five in the
household, and age (at or above 60 years old or below 60 years old). We
describe below the details of which variables were used to create the
baseline measure. The same questions from the 2005 Food Safety Survey
will be used to evaluate this objective. Please find the details of this
analysis in Appendix I.**

**Data from the 2001 Food Safety Survey was used to determine the
baseline for HP 2010 sub-objective 10-4b (Reduce severe allergic
reactions to food among adults.). Data from the 2005 Food Safety Survey
will be used to evaluate this objective. Progress toward the objective
is measured by the percentage of doctor-diagnosed food allergic
respondents in the Food Safety Survey whose most recent allergic
reaction in the past 5 years was severe. Severe allergic reactions are
defined as those that require the use of an epinephrine pen, treatment
in a hospital or a doctor\'s office, or overnight stay in a hospital.
The objective is limited to adults because the Food Safety Survey sample
includes only adults. The 2001 baseline is 26% and the 2010 target is
21% (a reduction of 22%). The objective will measure the effect of
consumer food allergy awareness education programs, as well as
improvements in processing and labeling during manufacturing and retail
preparation.**

Additionally, the 2005 Dietary Guidelines Advisory Committee Report
includes a large section on guidelines for food safety (2).

The proposed 2005 Food Safety Survey is uniquely designed to meet the
information and evaluation needs of the regulatory and consumer
education food safety initiatives underway at USDA and FDA. The key
survey design feature is that the survey retains the set of core
questions used in the 1993, 1998, and 2001 surveys, which will enable
FDA to identify population trends in the quality of food handling
practices; food selection; and awareness, knowledge, and concern about
current food safety problems. Also like the previous surveys, it has
been updated to include information about important emerging areas of
consumer interest with respect to possible food safety concerns. These
areas include new, non-microbiological food safety issues such as BSE
and acrylamide. Certain areas added to the 2001 FSS have become ongoing
issues for which consumer tracking data is needed; these include
attitudes toward genetically modified foods, irradiated foods,
organically grown foods, washing practices for fresh fruits and
vegetables, reaction to FDA consumer advisories, disability status, and
perceived food allergy. **Below are some examples of related links to
FDA consumer advisories posted on the FDA website.**

-   <http://www.cfsan.fda.gov/~lrd/advice.html>

-   <http://www.fda.gov/fdac/features/2003/603_food.html>

-   <http://www.fda.gov/fdac/features/2003/303_clone.html>

-   <http://www.fda.gov/opacom/catalog/irradbro.html>

-   <http://www.fda.gov/bbs/topics/news/2005/NEW01161.html>

-   <http://www.cfsan.fda.gov/~pregnant/pregnant.html>

Because the information needs of FDA and FSIS overlap extensively, the
two agencies have cooperated to develop a single information collection
program that will serve their needs while minimizing both expense and
respondent burden. As the arena of food safety changes, the Agencies
need updated information about consumer attitudes and practices so that
Agency responses, education messages, and education campaigns can be
based on current circumstances. The 2005 Food Safety Survey will be an
invaluable tool to evaluate the impact of these education activities and
to provide practically useful information about how to better respond to
ongoing food safety challenges.

The authority for the FDA to collect these data derives from the FDA
Commissioner\'s authority, as specified in 21USC393. A copy of that
section is provided in Attachment A.

**A2. How, By Whom, and the Purpose for Collecting This Information**

Data will be collected using an independently drawn and randomized,
nationally representative telephone survey method with an over-sample of
Hispanics. The sample will be drawn, and data collected, by Synovate, a
large marketing firm.

The primary users of the data will be staff in the Division of Social
Sciences (DSS) of the Center for Food Safety and Applied Nutrition and
staff in FSIS/USDA. DSS staff will analyze the data in consultation with
other units of the Center including the food safety educators, risk
assessors and risk communicators. Survey questions on food handling
behaviors and food allergies will serve as measures of progress toward
the Healthy People 2010 goals and will be provided to the Healthy People
2010 subcommittee on food safety.

Staff in FDA and FSIS will use the data to track, and to better
understand, consumers' food handling and preparation practices, food
consumption practices related to food safety (such as consumption of raw
or undercooked foods of animal origin) and related attitudes, concerns,
knowledge, and sources of information. Because many of the questions
were asked in the 1993, 1998, and 2001 Food Safety Surveys, staff will
compare the results over time to estimate extent and nature of changes
that occurred in any of these areas. Trend analysis will also be
conducted by demographic characteristics to evaluate disparities in
practices and attitudes over time. Current estimates of the safety of
consumer food handling and consumption practices will be used in risk
assessments. **Since the 2005 data will be used for trend analysis, an
effort was made to keep the wording of key questions the same as that
used in previous years. For example, the term "germs" has been used for
numerous questions on this survey since 1988. For that reason, we have
decided that it would be best to use the same terminology in the 2005
survey. Also, "germs" is a general term that describes many types of
organisms that can cause foodborne and waterborne illnesses. The term
germs includes bacteria, viruses, fungi, and protozoa. Therefore, we
propose to use the term "germ" as opposed to the term bacteria.**

The data from the 2005 Food Safety Survey will be widely used. The 1993,
1998, and 2001 Food Safety Surveys were used by numerous researchers,
policy makers, and consumer education specialists outside of FDA; these
people are familiar with the earlier data bases, have been consulted
regarding the new proposed collection, and will know how they can use
the new collection. Some examples of use of the 1998 and 2001 Food
Safety Survey data follow.

**The data is used by food safety educators at FDA. One educator said,
"The FSS \[Food Safety Survey\] has enabled us to track the progress of
our education efforts to consumers about food safety practices that
helps us use resources most effectively.  By following trends over time,
the FSS identifies which programs have been a success and allows us to
identify topics and behaviors where further education is needed.  The
FSS also helps us with devising strategies for this education.... For
another example, the FSS provides demographic information that allows us
to better target audiences when results indicate that education is
needed by consumers of a certain age, sex, or located in a particular
geographic area." Food safety educators and other policy makers at FDA
often use the data in a global sense, such as to confirm anecdotal
evidence that there is a new unsafe consumer practice among a targeted
group, such as consumption of raw, unpasteurized cheese by Hispanic
pregnant women.**

Results from previous waves of the Food Safety Survey were used by FDA's
Center for Food Safety and Applied Nutrition to provide an assessment of
the level of safety of consumer food preparation and consumption
practices, and levels of awareness, concern, and knowledge related to
food safety. Data from the 2001 Food Safety Survey were used as baseline
estimates of consumer food preparation, consumption behaviors, and food
allergen reactions for Healthy People 2010. **Data from previous waves
of the Food Safety Survey were made available to the staff working on
such food safety and nutrition initiatives as the 2005 Dietary
Guidelines, the FightBac campaign, and the Shell Egg Carton Labeling
Regulations. DSS staff researchers are often asked to provide informal
analyses to answer ad hoc questions about food safety.**

**We are planning to oversample Hispanics for three reasons: 1) We need
a large enough sample of Hispanics to adequately report their scores on
the key food safety objectives for Healthy People 2010 Goal 10-5; 2) We
would like to better understand the consumption of soft, unpasteurized
cheese by Hispanics. Consumption of this type of cheese has been linked
to cases of Listeriosis in pregnant women. Studies show that pregnant
Hispanic women *may* have a higher incidence of Listeriosis than
pregnant non-Hispanic women. (See "While You\'re Pregnant," available
at** **<http://www.cfsan.fda.gov/~pregnant/whillist.html>); and 3) We
would like to better understand the link between consumption of raw
oysters and *Vibrio vulnificus* in the Hispanic community (See "The U.S.
Food And Drug Administration Launches Educational Campaign Warning The
Hispanic Community About Risks Of Eating Raw Oysters," available at
<http://www.cfsan.fda.gov/~lrd/fpoyvib.html>).**

In addition, presentations were made at the annual meeting of the
American Public Health Association (2002), and presented at internal FDA
workshops. One paper from the 2001 data has been published.

Chung-Tung Jordan Lin, Kimberly L. Jensen, Steven T. Yen. [Awareness of
foodborne pathogens among US consumers.]{.underline} Food Quality and
Preference. 2004 (in press).

**In addition to the Lin (2004) article, there have been three other
journal articles:**

-   **Altekruse, Sean F., Debra A. Street, Sara B. Fein, and Alan S.
    Levy. Consumer Knowledge of Foodborne Microbial Hazards and
    Food-Handling Practices. Journal of Food Protection. 59(3):287-294.
    1996**

-   **Fein, Sara B., Jordan Lin, and Alan S. Levy. Foodborne Illness:
    Perceptions, Experience, and Preventive Behaviors in the United
    States. Journal of Food Protection. 58(12):1405-1411. 1995.**

-   **Klontz, Karl., Bab Timbo, Sara B. Fein., and Alan S. Levy.
    Prevalence of Selected Food Consumption and Preparation Behaviors
    Associated with Increased Risks of Food-borne Disease. Journal of
    Food Protection. 58(8): 927-930. 1995.**

The PDFs of these articles are included at the end of this document.

**There has also been one press release on the FDA website with regard
to trends in food handling practices and eating potentially risky foods.
See "Food Safety Survey: Summary of Major Trends in Food Handling
Practices and Consumption of Potentially Risky Foods," available at
<http://www.cfsan.fda.gov/~dms/fssurvey.html>.**

Results from the 1998 and 2001 Food Safety Survey were used by FSIS,
particularly by their consumer education staff, to aid in the
development of consumer education materials, to update their staff about
current consumer food handling issues, and to provide material for
presentations at various meetings.

**A.3 Use of Information Technology to Reduce the Burden on the Public**

The computer-assisted telephone interviewing (CATI) methodology proposed
for the survey is the most cost-effective approach to acquiring the
needed information and duplicates the method used for the 1993, 1998,
and 2001 surveys, with which the data will be compared. Telephone
interviews are less intrusive than face-to-face interviews and are
considerably less expensive. Self-administered surveys sent by mail are
not appropriate for questionnaires with skip patterns such as used here
and generally have a much lower response rate than telephone interviews.

**A.4 Identification and Use of Duplicative Information**

Because the Food Safety Survey is widely accepted as a unique data base
on consumer food handling practices, food safety-related knowledge and
attitudes, FDA staff members have been consulted on many related data
collections conducted in recent years by either government or academic
researchers**. Some recent related studies include the FoodNet
Population Study, and a study conducted by Dr. Shogren using Knowledge
Network's panel on food safety practices**.

**Consumer Studies Staff members are on the Food Net population survey
working group. This survey, which is administered through the states,
tracks the number of foodborne illnesses in the United States. It does
not, in the current draft, ask about consumer perceptions and knowledge
of food safety. It does ask about consumption of risky food, but asks
about consumption in the past week as opposed to the past 12 months. We
have made the working group aware of our study and the CDC will look to
FDA to provide unique data on consumer food safety knowledge and
perceptions.**

**Dr. Shogren's study is a very interesting experimental design looking
at consumers' awareness and risk perception of food safety behaviors.
The study will test the effect of food safety information on consumers'
attitudes and behaviors. While this study is very interesting and its
results will complement those of the Food Safety Survey, it is not
nationally representative and does not cover all of the topics of
interest to the FDA and USDA. It will not provide national population
statistics. It is not a substitute for the Food Safety Survey. Consumer
Studies Staff members have been in contact with Dr. Shogren, and we look
forward to discussing his results with him.**

The Food Safety Survey is a unique survey instrument. The value of
asking the core Food Safety Survey questions with the same sampling
method as the previous waves of the Food Safety Survey has increased
substantially, now that three data collections have been completed.
Thus, none of the recent consumer surveys of consumer food handling
practices can satisfy the criteria needed to provide current national
estimates of consumer food handling practices, knowledge and attitudes
or to enable a comparison with the previous Food Safety Survey results.
The collaboration between FDA and FSIS avoids duplication that would
result from independent surveys.

**A.5 Methods to Minimize Burden on Small Business**

No small business will be involved in this collection.

**A.6 Consequence of Not Conducting the Collection**

Without this data collection, national estimates of current knowledge,
attitudes, and the safety of consumer food handling practices will not
be available. This is important because the 2001 Food Safety Survey
results most likely do not adequately reflect the current state of
consumer knowledge, attitudes, and practices in regard to food safety.

A data collection in 2005 will also serve the early data needs of
Healthy People 2010. Baseline measures for the consumer food preparation
objective and allergen developmental objectives are calculated from the
2001 FSS data; having an update shortly after the beginning of the
initiative will provide a timely estimate with which to compare progress
during the decade.

**A.7 Special Circumstances Explanation**

This collection fully complies with 5 CFR 1320.5.

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

This Information Collection Request was written prior to receiving
public comments. Public comments will also be solicited and considered
in the final version of the survey. Additionally, FDA will be conducting
cognitive interviews to further refine this survey questionnaire.

FDA notified several interested parties that the data collection is
being planned and asked for comments. These include staff at the Center
for Food Safety and Applied Nutrition, staff at FSIS and at ERS in USDA,
several interested university researchers. The comments received have
been incorporated into a draft of the survey.

The following individuals outside the Center for Food Safety and Applied
Nutrition (CFSAN) have been consulted regarding the questionnaire for
this study.

1.  Holly McPeak

Food Safety and Inspection Service / USDA

5601 Sunnyside Avenue

Beltsville, MD 20705-5200

(301)-504-0168

2.  Katherine Ralston and Tanya Roberts

> Economic Research Service/ USDA
>
> 1800 M St. NW

Washington, DC 20036-5831

\(202\) 694-5463 (Ralston)

\(202\) 694-5463 (Roberts)

3.  Mario Teisl, Ph.D.

> Department of Resource Economics and Policy
>
> University of Maine
>
> Orono, ME 04469
>
> (207)581-3162

4.  Sandria Godwin, Ph.D., R.D.

> Tennessee State University
>
> 3500 John A. Merritt Blvd.
>
> Box 9598
>
> Nashville, TN 37209-1561
>
> \(615\) 963-5619

In accordance with 5 CFR 1320.8(d), on December 2, 2004 in Volume 69,
No. 231, pages 70147-70148, a 60-day notice for public comment
(Attachment B) was published in the Federal Register.

In the Federal Register of December 2, 2004 (69 FR 70147), FDA published
a 60-day notice requesting public comment on the information collection
provisions. Seven comments were received.   Four comments did not
address the information collection provisions.  Two comments supported
the proposed collection of information while one comment contended that
it is a waste of government funds.  The supporting comments requested
that data from the survey be made more widely available.  None of the
comments included any specific suggestions for the questionnaire or
survey methodology.\
\
FDA disagrees that the Food Safety Survey is a waste of government
funds.  The data from the 2005 Food Safety Survey will be used to
evaluate the Healthy People 2010 objectives for food safety and for
allergens.  Data from the 2001 Food Safety Survey served as the baseline
for the Healthy People 2010 food safety and allergen objectives.  
Results from previous Food Safety Surveys were also used by FDA's Center
for Food Safety and Applied Nutrition to provide an assessment of the
level of safety of consumer food preparation and consumption practices,
and levels of awareness, concern, and knowledge related to food safety.\
\
FDA agrees that the data from the Food Safety Survey should be
distributed publicly through peer review journal articles and though
government publications.  It is anticipated that for the first 6 months
after collection, the data will be analyzed internally.  After 6 months
a summary will be produced and made available to the public.  Peer
reviewed journal articles are planned following the summary.

**A.9 Payment or Gifts to Respondents**

Recent research has shown that providing respondents with a small
incentive (such as a dollar bill, jar gripper, or letter opener) can
increase response rate. Respondents at telephone numbers that can be
matched to addresses will receive a pre-notification letter letting them
know they have been selected to participate in the survey. A rubber jar
gripper valued at approximately \$0.40 will be included in the letter
(3) (4). A jar gripper was chosen as the incentive since it is
light-weight, flat, practical, and appropriate to the subject of the
survey without introducing a bias. Additionally, we plan on including an
**additional small incentive, a small packet with 2 single use
applications of hand sanitizer (valued at approximately \$0.50),** in
the refusal conversion letter sent to all respondents who initially
refuse to participate and whose address and telephone number can be
matched.

**A.10 Assurance of Confidentiality**

All data for the Food Safety Survey will be collected with an assurance
that the respondents\' answers will remain confidential. A statement to
this effect will be read before each interview. Confidentiality is
further 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.

Identifying information will not be included on the data files delivered
to FDA. The contractor, Synovate, has standard procedures for assuring
the confidentiality of survey respondents. All of the contractor\'s
employees sign a statement agreeing to maintain confidentiality of data.
The data will be collected by a computer-assisted telephone interviewing
system (CATI) and will be maintained in an automated information system.
Access to the CATI files can only be gained through the use of a
password. Telephone numbers will be retained only until validation and
editing are complete; they will be stripped from the data base before
the data are sent to FDA.

All computer data will be maintained in a manner which is consistent
with the Department of Health and Human Services ADP Systems Security
Policy as described in DHHS ADP Systems Manual, Part 6, chapters 6-30
and 6-35. All data will also be maintained in consistency with the FDA
Privacy Act System of Records #09-10-0009 (Special Studies and Surveys
on FDA Regulated Products).

**A.11 Sensitive Questions**

The survey includes no questions of a sensitive nature.

**A.12 Hour Burden Estimates**

**FDA estimates that the survey will require an average of 20 minutes
per respondent and that the variation in burden across respondents will
be small. This estimate is based on average interview times for the 2001
Food Safety Survey.** **Additionally, the results of cognitive testing
done in March 2005 support an estimate of 20 minutes per respondent.**
**During these interviews, participants were given the survey over the
phone prior to in-depth questioning. These test surveys tended to last
about 20 minutes.** Prior to the survey being fielded, as small pre-test
of 27 individuals each lasting half an hour will be conducted (See
section B4). The proposed number of respondents is 4000, each of whom
will be asked to complete a one-time telephone interview that requires
no preparation time. Additionally, 200 initial non-respondents will be
asked to participate in a short version of the survey to conduct a
non-response analysis. The screener is estimated to take 1 minute or
less per response for a total screener burden of 4000 (respondents) +
6000 (ineligibles screened) x .0167 hours = 167 hours. Therefore, the
estimated public reporting burden is 1401 hours. The annualized cost to
respondents for the hour burden for the interview is \$18,563 at \$13.25
per hour.

The annualized burden costs to the respondents assuming an hourly rate
of \$13.25. 1401 \* 13.25 = 18,563.

[]{.mark}

FDA estimates the burden of this collection of information as follows:

Table 1. Estimated Reporting Burden[^1]

  --------------- ------------- -------------- ----------- ------------ --------
  Questionnaire   No. of        Frequency per  Total       Hours per    Total
                  Respondents   Response       Responses   Response     Hours

  Pretest         27            1              27          0.5          14

  Screener        10,000        1              10,000      .0167        167

  Survey          4,000         1              4,000       .30          1,200

  Non-response    200           1              200         .10          20

  Total                                                                 1,401
  --------------- ------------- -------------- ----------- ------------ --------

(Footnote) There are no capital costs or operating and maintenance costs
associated with the collection of information.

**A.13 Total Annual Cost Burden to Respondents Excluding Hours Burden
Shown in Sections A.12 and A.14**

All cost burden to respondents is reflected in A12.

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

The estimated cost to the Federal Government for this information
collection is \$225,000 for Agency staff for the years 2004-2006: 0.5
FTE for 2 GS 13 professional staff to manage the project, analyze the
data, and write reports from the data analysis, and costs of the
contractor of \$254,313 for data collection. The total estimated cost is
\$479,313.

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

This survey is a repeat, with modifications, of the 2001 Food Safety
Survey, OMB Control Number 0910-0345, which expired in February 2004.
Thus, this is a new collection for the purposes of the OMB inventory.

**A.16 Project Schedule and Plan for Analysis**

Following OMB approval, the contractor will draw the sample, conduct the
survey, and prepare the deliverables in accordance with the Quick
Turnaround Research Services contract. However, the time allotted for
interviewing will be extended from the usual 45 days to 75 days to allow
time for letters to be sent to those household telephone numbers that
can be matched with addresses (see Section B3). Data and all other
deliverables shall be received by the Project Officer within 150 days of
written notification to the contractor that OMB approval has been
granted. **FDA will disseminate the results of this study in accordance
with the agency's \"Guidelines for Ensuring the Quality of Information
Disseminated to the Public.\" The agency anticipates disseminating the
results of the study after the final analyses of the data are completed,
reviewed, and cleared. The exact timing and nature of any such
dissemination has not been determined, but may include presentations and
articles at trade and academic conferences, publications, and Internet
posting.**

The data will be tabulated and analyzed to address the issues covered in
the questionnaire. These issues include various stages required in order
for a consumer to follow the food safety principles recommended by
experts: awareness of food safety issues, knowledge needed to follow the
principles, motivations or barriers to following the principles, concern
about food safety issues, and reported food safety practices. Estimates
will also be made for the new areas covered, such as awareness of BSE
and acrylamide. Because the sample will be a national probability
sample, with an over-sample of Hispanics, the weighted frequencies will
be used for national estimates. Comparisons over time will be made for
the questions repeated from the 1988, 1993, 1998, and 2001 surveys.

Regression analysis, logit analysis, or contingency table analysis will
be used to examine bivariate and multivariate relationships between
awareness, knowledge, sources of food safety information, motivation,
perceived sources of food contamination, food safety concern, food
safety practices, food consumption practices, foodborne illness
experience, and the demographic variables. Multivariate analyses will
also be used to compare relationships between major variables over time.
Sub-population analysis will be done for Hispanics.

**A.17 Displaying the OMB Approval Expiration Date**

No exemption is requested.

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

No exceptions are requested.

**B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS**

**B.1 Universe and Sampling**

The respondent universe for this survey is all telephone households in
the United States. Eligible households are defined as those containing
one or more adults who have the following characteristics: aged 18 years
or older, speak English or Spanish, sufficiently good health for a
telephone interview. According to 2000 census estimates, 97.6 percent of
households in the U.S. have a telephone (5). **According to 2000 census
estimates, 98.2 percent of the U.S. population can speak either English
or Spanish very well, or well. (6)**

Households will be selected using a Random Digit Dialing (RDD) procedure
by employing GENESYS, an in-house database-assisted sampling
methodology. The GENESYS system uses a database of working residential
telephone banks for the entire United States to produce a single-stage
random sample of residential telephone numbers. RDD samples from the
GENESYS system eliminate the reduction in precision caused by the
multi-stage cluster designs of traditional RDD procedures. GENESYS
samples are widely accepted because of their methodological rigor and
efficiency.

The GENESYS database is constructed from three sources: a master list of
area code-exchange combinations obtained from BELLCORE, a summary file
of listed telephone numbers in the continental United States obtained
from Donnelly, and a summary file obtained from CATI and other sources
that cross-reference zip codes to telephone exchanges. The telephone
numbers in these sources are matched and analyzed to produce a database
of two-digit banks that contain at least 99 percent of the eligible
telephone numbers in the continental U.S. (A two-digit bank consists of
the first eight digits of a 10-digit telephone number within which up to
100 telephone numbers could be assigned, e.g. 703/790-90xx). The
database is used to generate a random sample in which every telephone
number, whether listed or not, has an equal probability of selection.
The sample, unlike a traditional RDD sample, has no design effect
associated with clustering of telephone numbers within telephone
exchanges.

**Using GENESYS, the U.S. population can be stratified into high
incidence versus low incidence strata. This approach produces unique
geo-demographic sample designs. Synovate will use this methodology to
obtain an over-sample of Hispanics by generating a stratified
probability sample.**

**As proposed, the sample design will use the GENESYS sampling system to
generate random samples of telephone numbers.  The GENESYS system uses
listed telephone numbers to identify blocks of working telephone
numbers.  At the same time, it records the geographic location of the
telephone and associates it with known U.S. Census information such as
the Census Tract.  With this assignment, the GENESYS system can provide
estimates of demographics characteristics for an area code and telephone
exchange combination such as the number of households, population size,
number of Hispanics, number of Blacks or African-Americans, etc. 
Synovate will use this information to create the sampling plan. 
Although it is not finalized, the sampling plan is likely to include
five strata -- one stratum of all the area code and exchanges with high
concentrations of Hispanic population and four additional strata for the
remainder of the U.S. population -- one for each U.S. Census region. An
advantage of the GENESYS system is that does not introduce clustering
into the design; therefore, the only contribution to the design effect
will be the allocation of the sample to strata.**

** **

**If the design were to allocate the sample to strata proportionate to
the population size, the design effect would be one -- no effect.  The
number of Hispanics desired by the study, 500 out 4,000 interviews, is
12.5%.  This is the approximate proportion of Hispanics in the
population.  However, a simple random sample usually yields only 8-10%
Hispanics in the sample due to differential response propensity, access
to telephones, multiple lines per household, differential household
composition (more than one family unit per household), among other
reasons.  The stratified approach allows us to control for this and
ensure the proper number of Hispanic respondents by allocating slightly
more than the amount needed for a proportionate allocation.  This means
that the sample design itself will have a design effect around 1.045 or
the design will only be 95.5% efficient due to the Hispanic
oversampling.**

** **

**The process for accounting for the oversample in the weights is
covered in the steps already documented for the Food Safety Study in
2002 --** ***"Food Safety Study Sample Weight Documentation \-- 2002
Recalculation for the 1988, 1993, 1998 and 2001 Waves."*  The final
weight in the FSS is a post-stratified weight to adjust the sample
distribution to match the population distribution for**

> **¨       Gender (2 categories);**
>
> **¨       Educational attainment (4 categories); and**
>
> **¨       Race/ethnicity (4 categories). **

** **

**The final weight is**

** **

![](media/image1.png){width="4.052083333333333in"
height="0.2604166666666667in"}

![](media/image2.png){width="2.1145833333333335in" height="0.46875in"}

** **

**Here P~i~ is the proportion of the population in weight cell i that
contains respondent j, E~i~ is the proportion in the sample calculated
using the design weight, and K~FW~ normalizes the weights to the sample
size.   FINALWT is interpreted as the design weight multiplied by (the
proportion of population in weight cell i divided by the proportion of
design-weighted sample in weight cell i) and normalized to the sample
size n.   Note that K~FW~ is a constant because both n and the divisor,
which is a sum over the entire sample, are constants.   The properties
of these weights are that they sum to the sample size and the average
weight is one. The design weight, *d~j~* , will be a combination of the
household size, the number of telephone lines and the weight for the
stratum. **

** **

**This process describes how the oversample of Hispanics will get
incorporated into weights.  This approach follows well-accepted
statistical survey sampling approaches.**

**A sample size of 4,000 is needed to adequately perform all of the
sub-analyses that are needed for Healthy People 2010 Objective 10-5.
This sub-objective requires that we look at disparities in safe food
handling habits among different populations. Some of these sub-analyses
of interest include showing change over time for: Blacks or
African-Americans, older adults (60+), and households with young
children (\<5 years old). A power analysis was conducted to determine
the sample size needed to analyze changes in these sub-groups. A sample
size of 4,000 was deemed adequate for these purposes. For example, with
a total sample of 4000, at an 80% power level, we expect to have enough
Blacks or African-Americans in our sample to detect a change from 70%
performing safe behavior in 2001 to 79% performing safe food handling
behavior (the population goal for Health People 2010).**

Identification of the designated respondent (DR) will be achieved by
using a method described by Rizzo, Brick, and Park (7). Once household
eligibility has been established, interviewers will ask the person who
answers the phone, called the initial respondent (IR), how many adults
age 18 and over are in the household. If there is only one adult, that
person will be selected. If there are more than one adult in the
household, then it will be randomly determined (using a computer
programmed random number generator) if the IR is selected. The
probability of IR being selected is equal to the 1 divided by the number
of adults in the household. If the IR is selected, then the interview
can proceed. If the IR is not selected and there are only two adults in
the household, then the interviewer will ask to speak to the other adult
in the household. If there are more than two adults in the household and
the IR is not selected, then the interviewer will ask to speak with the
other adult in the household who has the most recent birthday. The DR
will be selected prior to starting any of the survey questions, and no
substitutions will be allowed. If the DR is unavailable throughout the
study period, the household will become ineligible.

The response rate for the 2001 Food Safety Survey was 46.6% based on the
American Association for Public Opinion Research (AAPOR) Response Rate 5
(8). **This included the screener used to determine eligibility.** The
response rate for the 2005 data collection is expected to be better
because additional methods will be used to increase the response rate.
These methods are outlined in section B3.

**B.2 Information Collection Procedures**

The Food Safety Survey will be conducted using computer-assisted
telephone interviewing (CATI) technology. The interview will consist of
two parts: the household screener and the extended interview. (See
Attachments C) The household screener will be used to locate eligible
households and to identify a DR as described in section B.1 above. Only
one respondent per household will be interviewed.

Data will be collected by experienced and specifically trained telephone
interviewers. Quality control will be assured by periodic monitoring of
on-going interviews throughout the study. This monitoring replaces the
previously used validation interview, which required maintaining the
name and telephone number of the respondent until the validation
interview could be completed.

**B.2.1 Statistical methodology for stratification and sample
selection**

The sampling procedure, described above, will yield a simple random
sample with an over-sample of Hispanics.

**B.2.2 Estimation procedure**

Each interviewed person will receive a basic sampling weight equal to
the reciprocal of his or her probability of selection. The basic
sampling weight will be adjusted for multiple telephone numbers in
households, household size, and nonresponse. Households with more than
one residential telephone number have a greater chance of selection;
therefore, sampling weights will be adjusted by the reciprocal of the
number of residential telephone numbers on which the household receives
calls, excluding cell phone numbers. The weights will also be adjusted
to take into account the differential probability of selection depending
on household size. For example, a person living alone would be selected
with certainty, whereas a person living in a household with four other
adults would have a one in four chance of being selected. To compensate
for under coverage and non-response and to reduce the mean square error
of the estimates, the basic sampling weight will be adjusted to match
recent Census totals for sex, education, and race. All estimates will be
reported using the sampling weights. Separate weights will be calculated
for the oversample of Hispanics.

**Cell phones are purposely excluded from the sampling frame to comply
with the Federal Telephone Consumer Protection Act (TCPA).**

**Cell phones are eliminated from RDD samples by using a number of
strategies, including eliminating from the sample all telephone
exchanges that are known to only contain cell phone numbers, as well as
subscribing to commercial services that identify landline numbers that
have been transformed to wireless (i.e., cell phone) numbers. While for
any RDD sample there is not a specific percentage of cell phones, the
proportion tends to be very small.**

**It is estimated that approximately 5% of all households do not have a
land line and thus will be excluded from the sampling framework.**

**B.2.4 Unusual problems requiring specialized sampling procedures**

**Synovate, our contractor, frequently designs and executes targeted
telephone sampling plans in order to over-sample hard to reach
populations as part of a Random Digit Dialing (RDD) sample design.
Synovate's preferred method is to use the GENESYS sampling system.
GENESYS supports RDD telephone sampling for any geographic area down to
the census tract level within the United States. This includes state,
county, metropolitan statistical area (MSA), ZIP Code, time zone, etc.
The GENESYS system also contains telephone exchange-level estimates for
over 48 demographic variables such as age, race, ethnicity, and income
distributions.**

**Using GENESYS, the nation can be stratified into high incidence versus
low incidence strata. This approach produces unique geo-demographic
sample designs. Synovate will use this methodology to obtain an
over-sample of Hispanics by generating a stratified probability
sample.**

**Synovate will draw a targeted RDD sample from all telephone exchanges
in the United Sates with higher than average concentrations of
Hispanics. In this case, telephone exchange areas are overlaid with
Census data on race and ethnicity. Exchanges will be selected from areas
in which the density of Hispanic population meets a certain percentage
(typically, Synovate has used 30%). This significantly increases the
likelihood of reaching Hispanic households.**

**B.2.5 Any use of periodic (less frequent than annual) data collection
cycles to reduce**

**burden**

The survey is a one-time data collection.

**B.3 Methods to Maximize Response Rate and Deal with Non-Response**

After the sample is drawn, all households for which an address can be
matched to the telephone number will be sent a letter letting them know
that they have been selected to participate in the survey. The letter
will contain a small incentive, a jar gripper, as encouragement to
participate. We anticipate that the combination of a prenotification
letter and small incentive will be effective in increasing the response
rate. In the 2001 Food Safety Survey, an experiment was conducted to on
the effectiveness of a prenotification letter without an incentive.
Households that received the prenotification letter were more likely to
participate in the survey than those that did not. A comparison of
response rates for households that received an advance letter and
households for which an address was not available reveal that, as
expected, letter recipients were more cooperative than non-recipients
(52.9% vs. 40.7%). The tougher standard of comparison, households with
an address match, but no letter, also had a lower response rate (43.9%),
suggesting that the prenotification letter was indeed helpful in getting
respondents to recognize the importance of the Food Safety Survey and
participate.

**A reasonable number of call attempts will be made to determine whether
an \"initial contact\"---the establishment of the identity of a
telephone number (residential or non-residential)---is made.  For
example, if the first 3 attempts received no response and the fourth
attempt received a busy signal, the number will be called for a few more
times to try to make an initial contact because the fourth attempt
suggests this number has the potential of being a residential number. 
Only when there is certainty that a number is not a residential number
will the limit of five attempts be applied.  If a voicemail or answering
machine indicates the number is residential, then an initial contact is
considered made**. No-answers after these attempts at initial contact
will be regarded as non-households and eliminated from the sample.
Households that initially refuse to participate will be sent a letter
acknowledging the initial contact and asking again for the household's
participation. Addresses will be obtained through a commercial list of
known telephone number/address combinations. The letter will identify
FDA as the sponsor of the survey, give a brief explanation of the study
topic, and stress the importance of participation. Refusal conversion
calls will be scheduled several days after the letters are sent out, in
order to give the letter ample time to arrive, but close enough to the
arrival date to be remembered by the respondent.

When possible, household screening and extended interviews with
designated respondents will be completed during the same call. If the DR
is not available at the time of the screening call, up to 25 callbacks
will be made in an effort to complete the interview. DRs who are not
reached will be included in the denominator for the calculation of the
response rate. DR\'s who initially refuse will be sent a letter
encouraging participation if an address match can be made.

To determine if there are any systematic differences between those who
participate in the FSS and non-responders, FDA will conduct a
non-response analysis. Two hundred initial refusals (i.e.,
non-respondents) who have refused to participate twice; once when first
called and a second time when called back, will be asked to take a
shortened questionnaire consisting of core questions and a subset of the
demographic questions. (Attachment E)

**The contractor will implement the following additional procedures to
obtain the highest possible response rate:**

-   **In addition to general training, all interviewers and supervisors
    will be trained on the specifics of the survey by a member of the
    project\'s professional staff. This will include an explanation of
    the importance and purpose of the survey, as well as a thorough
    review and practice reading of the entire survey instrument.**

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-   **A Spanish-speaking interviewer will re-contact all households in
    which the interview could not be completed because of a language
    barrier. Households in which neither English nor Spanish are spoken
    sufficient to allow for completion of the interview will be
    excluded.**

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-   **All interviews are continuously monitored by telephone supervisors
    who listen to a portion of each call to ensure that each interview
    is conducted properly. Production rates and sample dispositions will
    be monitored each day to detect and resolve any problems or
    discrepancies quickly.**

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-   **The contractor will provide detailed descriptions of procedures
    for assuring quality control, for identifying interviewers who are
    having difficulties, and for dealing with problems.**

**To ensure quality control, the contractor will maintain complete call
disposition records on every household contacted. In no case will
telephone numbers be abandoned prior to achieving one of the
following:**

> **\* Completed interview;**
>
> **\* Completed conversion attempt or refusal;**
>
> **\* Exhaustion of callbacks (up to 25);**
>
> **\* Determination that a household is not eligible; or**
>
> **\* Exhaustion of initial contact attempts.**

**When a household is determined to be ineligible, the basis for the
determination will be recorded.**

**All non-institutionalized adults who are 18 and older, live in a
household with a land line, speak English or Spanish, and are in good
enough health to participate in a phone survey are eligible.**

**The AAPOR Response Rate 3 from the 2001 survey is 35.8%.**

The response rate for this study will be defined as follows according to
AAPOR Response Rate 5:

[Completed Interviews]{.underline}

Completions + Terminations + Interview Refusals + Screening Refusals +
Callbacks Exhausted + Respondent not available

**B.4 Test of Procedures**

Three small pretests of the Food Safety Survey will be conducted with
fewer than 10 respondents shortly after OMB approval of the information
collection is expected. Scheduling the pretest close to the beginning of
data collection will gain efficiency by using interviewer training for
both the pretest and the complete data collection. Because the survey is
based largely on questions from the 2001 survey, three pretests of nine
people should be adequate to estimate the time required to complete the
interview, to assure clarity of the added or changed instructions,
questions, and response categories, and to check the CATI programming
for correct skips and other procedures.

Representatives of FDA and the contractor will monitor the pretest
interviews. Few changes to the questionnaire are expected from the
pretest, because we want to compare responses with identical questions
asked on previous surveys. OMB will be provided with copies of the final
questionnaires prior to implementation of the study.

**B.5 Consulting Statistician and Contractor**

The contractor, Synovate, will collect the data for the Food Safety
Survey on behalf of the Food and Drug Administration, Center for Food
Safety and Applied Nutrition and the U.S. Department of Agriculture,
Food Safety and Inspection Service, as a task order under the
Quick-Turn-Around Research Services contract. Leigh Seaver, Ph.D., is
the Senior Study Director for Synovate, telephone (703) 790-9099. Amy
Lando, MPP, HFS-727 is the Project Officer, telephone (301) 436-1996,
and Susan Conley is the FSIS representative, telephone (301) 504-9605.
The data analysis will be primarily conducted by staff on the Consumer
Studies Staff, Center for Food Safety and Applied Nutrition, under the
coordination of Amy Lando.

References

1.  U.S. Department of Health and Human Services. [Healthy People
    2010]{.underline}. (Conference Edition, in Two Volumes). Washington,
    DC: January 2000.

2.  U.S. Department of Health and Human Services. [2005 Dietary
    Guidelines Advisory Committee Report]{.underline}. Washington, DC:
    2004.

3.  Dillman, Don A. 2000. [Mail and Internet Surveys: The Tailored
    Design Method.]{.underline} New York: Wiley and Sons

4.  Singer, Eleanor. 2002. "The Use of Incentives to Reduce Nonresponse
    in Household Surveys." Pages 163- 177 in [Survey
    Nonresponse.]{.underline} Edited by R.M.Groves, D.A. Dillman, J.L.
    Eltinge, and R.J.A. Little. New York: John Wiley & Sons, Inc.

5.  U.S. Bureau of the Census:
    <http://www.census.gov/hhes/www/housing/census/historic/phone.html>.
    Accessed on 10-14-04.

6.  U.S Bureau of the Census:
    <http://www.census.gov/prod/2003pubs/c2kbr-29.pdf>. Accessed on
    8-25-05.

7.  Rizzo, L., Brick, JM., Park, I. "A Minimally Intrusive Method for
    Sampling Persons in Random Digit Dial Surveys." Public Opinion
    Quarterly. Summer 2004, pages 267-274.

8.  American Association for Public Opinion Research. Standard
    Definitions: Final Disposistions of Case Codes and Outcomes for
    Surveys. 2004. <http://www.aapor.org/pdfs/standarddefs2004.pdf>.
    Accessed on 12-13-04

List of Appendices

A.  Authorizing legislation

B.  Federal Register 60-day notice

C.  2005 Food Safety Survey questionnaire

D.  Main differences between the 2001 and 2005 Food Safety Surveys

E.  Non-response Questionnaire

F.  List of questions taken out of the 2001 Food Safety Survey

G.  Initial Letter to Respondents

H.  Refusal Conversion Letter

I.  Details of Analysis for Healthy People 2010 Goal 10-5 from the 2001
    Food Safety Survey

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