[Federal Register Volume 83, Number 139 (Thursday, July 19, 2018)]
[Notices]
[Pages 34101-34103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15462]



[[Page 34101]]

-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2018-0021]


Notice of Request for a New Information Collection: (Consumer 
Research on the Safe Handling Instructions Label for Raw and Partially 
Cooked Meat and Poultry Products and Labeling Statements for Ready-to-
Eat and Not-Ready-to-Eat Products)

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice and request for comments.

-----------------------------------------------------------------------

SUMMARY: In accordance with the Paperwork Reduction Act of 1995 and 
Office of Management and Budget (OMB) regulations, the Food Safety and 
Inspection Service (FSIS) is announcing its intention to collect 
information in the form of consumer research that will include a web-
based experimental study and a behavior change study to help inform 
potential revisions to the current Safe Handling Instructions (SHI) 
label and assess whether a label revision would improve consumer food 
safety behaviors. FSIS also will collect information on consumer use 
and understanding of the labeling on ready-to-eat (RTE) and not-ready-
to-eat (NRTE) meat and poultry products, in particular consumers' 
ability to discern between the two types of products and to ensure that 
NRTE products that may appear to be ready to eat are thoroughly cooked.

DATES: Submit comments on or before September 17, 2018.

ADDRESSES: FSIS invites interested persons to submit comments on this 
Federal Register notice. Comments may be submitted by one of the 
following methods:
     Federal eRulemaking Portal: This website provides the 
ability to type short comments directly into the comment field on this 
web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the on-line instructions at that site for 
submitting comments.
     Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S. 
Department of Agriculture, Food Safety and Inspection Service, 1400 
Independence Avenue SW, Mailstop 3758, Room 6065, Washington, DC 20250-
3700.
     Hand- or courier-delivered submittals: Deliver to 1400 
Independence Avenue SW, Room 6065, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2018-0021. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.
    Docket: For access to background documents or comments received, 
call (202) 720-5627 to schedule a time to visit the FSIS Docket Room at 
1400 Independence Avenue SW, Room 6065, Washington, DC 20250-3700.

FOR FURTHER INFORMATION CONTACT: Gina Kouba, Office of Policy and 
Program Development, Food Safety and Inspection Service, USDA, 1400 
Independence Avenue SW, Room 6065, South Building, Washington, DC 
20250-3700; (202) 720-5627.

SUPPLEMENTARY INFORMATION: 
    Title: Consumer Research on the Safe Handling Instructions Label 
for Raw and Partially Cooked Meat and Poultry Products and Labeling 
Statements for Ready-to-Eat and Not-Ready-to-Eat Products.
    Type of Request: New information collection.
    Abstract: Safe handling instructions are required on the labels of 
raw or partially-cooked (i.e., not considered RTE) meat and poultry 
products, if the product is destined for household consumers or 
institutional uses (9 CFR 317.2(l) and 9 CFR 381.125(b)). FSIS first 
required the SHI label for raw and partially cooked meat and poultry 
products in 1994 (54 FR 14528). Since that time, the required design of 
the SHI label has not been changed.
    When the SHI label was developed in 1994, the minimal internal 
temperature requirements for determining whether a meat or poultry 
product was cooked enough to be safe varied by product. Given this, as 
well as product and label size limitations, FSIS concluded that ``Cook 
Thoroughly'' was the only simple, single statement appropriate to use 
for all products (54 FR 14538). FSIS now recommends on its website four 
internal minimal temperatures: One for all poultry (165 [deg]F), one 
for ground meat (160 [deg]F), one for all whole-muscle meat (145 [deg]F 
and hold for 3 minutes), and one for fish (145 [deg]F). With only four 
temperature recommendations, the information could be more easily 
incorporated into the SHI requirements. Other possible changes to the 
SHI label include incorporating updated icons and providing a web link 
or phone number for more information.
    In response to inquiries from consumer groups and other 
stakeholders about potential changes to SHI requirements, FSIS gathered 
input from members of academia, industry, and consumer stakeholders in 
November 2013. FSIS presented these suggestions to the National 
Advisory Committee on Meat and Poultry Inspection (NACMPI) in January 
2014. The NACMPI Subcommittee on Food Handling Labels recommended that 
FSIS pursue changes in the existing SHI label and conduct consumer 
research to determine the effectiveness of any revisions to the SHI 
label.
    In 2015, FSIS conducted six consumer focus groups (OMB No. 0583-
0166; 11/30/2017) to evaluate understanding of the current SHI label 
and responses to possible revisions. The focus groups revealed that 
consumers would find certain revisions to the SHI label useful. 
Participants suggested changes to improve comprehension and adherence 
to recommended safe handling practices (e.g., add recommendations to 
use a food thermometer and endpoint temperatures for different cuts of 
meat and poultry). Based on the results of these focus groups, FSIS 
determined that additional research using more rigorous, quantitative 
approaches with a larger sample of consumers was needed to help inform 
potential revisions to the current SHI label and assess whether a label 
revision would improve consumer food safety behaviors.
    In addition, during the March 2016 NACMPI meeting, the national 
advisory committee reviewed and discussed whether FSIS should pursue 
proposing mandatory features on the label of processed NRTE products 
that may appear to be fully cooked (e.g., are breaded or have grill 
marks). The committee recommended that FSIS require statements, such as 
``Raw, ``Uncooked,'' or ``Ready to Cook,'' on the labels of raw 
products that may appear RTE, so it is clear that these products 
require cooking to a proper internal temperature before eating. The 
committee also recommended that FSIS conduct consumer research to 
understand the optimal messaging and design of packaging to ensure 
consumers properly understand that NRTE products that may appear to be 
fully cooked need to be cooked for lethality. The committee stated that 
such labeling may help consumers properly distinguish between NRTE 
products, which require a lethality step, and RTE products, which do 
not require a lethality step; thus, the committee stated that this 
labeling may help consumers safely prepare NRTE products. Specifically, 
the committee suggested that FSIS conduct consumer research to evaluate 
the effectiveness of possible locations for point of purchase labeling 
information and various color

[[Page 34102]]

options, font, and other display options. FSIS has not previously 
conducted research on this topic.
    To assess whether revisions are needed to the SHI label required on 
all raw and partially cooked products and to evaluate the ability of 
consumers to properly discern between NRTE and RTE products and how 
labeling for these products can be improved, FSIS is requesting 
approval for a new information collection to conduct consumer behavior 
research. This research will include a web-based experimental study, as 
well as a behavior change study, which includes three components: An 
observational meal preparation experiment, an eye-tracking study, and 
in-depth interviews (IDIs). The research will help inform potential 
revisions to the current SHI label and assess whether a label revision 
would be likely to improve consumer behaviors related to safely 
preparing raw and partially cooked meat and poultry products. The study 
will also collect information on consumer use and understanding of 
labeling for RTE and NRTE meat and poultry products.
    FSIS has contracted with RTI International to conduct the web-based 
experimental study and the behavior change study. For the web-based 
experimental study, a selected sample of online consumer panel members 
will be invited to participate in the study via email. Inbound sampling 
will be used to select a sample of respondents with demographic 
characteristics (e.g., age, education level, race, and ethnicity) 
similar to the U.S. population. The primary aim of the web-based 
experimental study is to test 25 mock SHI labels that vary by visual 
design elements (e.g., borders, white space, spatial arrangement) to 
determine which labels are most salient to consumers. Label salience 
(i.e., participants' degree of attention to the label) will be assessed 
using a limited-time exposure approach with cued recall questions. 
Secondary aims of the study include assessing comprehension of safe 
handling instructions and safe handling icons and measuring the 
participants' motivation to comply with safe handling messages. The 
data from the experimental study will be analyzed to identify the five 
SHI labels that best attract respondents' attention, and from these, 
three labels will be selected for further testing in the behavior 
change study.
    To assess and compare consumer behavior in response to the current 
SHI label (control) and the three alternative SHI labels, a behavior 
change study will be conducted in test kitchen facilities located in 
four different locations (one in each of four Census regions). 
Participants will be recruited using convenience sampling (e.g., by 
posting ads on social media). The study will ensure a diverse sample of 
participants with respect to race, ethnicity, age, education level, and 
presence of a child (0-17 years) in the household. The study will use a 
fully randomized experimental design with participants randomly 
assigned to one of three treatment groups (that will be used to assess 
three alternative SHIs) or a control group (that will be used to assess 
the current SHI). Participants will be given recipes and ingredients, 
including two raw meat products bearing the assigned SHI label and 
asked to prepare two meat dishes and a salad. To assess attention to 
the SHI label during meal preparation, participants will wear a mobile 
eye-tracking device. Research staff will video-record meal preparation 
and clean-up. Trained researchers will subsequently view the videos and 
use a coding rubric to assess adherence to the recommended safe 
handling instructions (e.g., washing hands before meal preparation and 
after touching raw meat). Statistical analysis comparing the 
differences in handling behavior scores between the control (current 
SHI label) and treatment groups will be conducted to identify the label 
that may most effectively lead to participants' following the safe 
handling practices on the label.
    Following meal preparation, participants will be directed to 
examine each of six mock meat and poultry products (i.e., stimuli) 
while wearing the eye-tracking device: Two RTE products, two NRTE 
products that appear ready to eat, and two raw products. Participants 
will be asked to complete a series of search tasks to determine which 
version of the SHI label (three treatment versions or the current 
label) is most often attended to on a meat and poultry package and to 
assess whether participants can properly distinguish between RTE and 
NRTE products that appear to be ready to eat. Eye-tracking metrics for 
each area of interest (AOI), including total time spent viewing each 
AOI, will be produced and used in statistical analyses to determine the 
label that best captures participants' attention.
    Lastly, participants will take part in an IDI and be asked 
debriefing questions regarding the meal preparation experiment and 
questions to understand how consumers determine whether a meat or 
poultry product needs to be cooked before eating it. The data will be 
analyzed by analysts using a thematic content analysis approach.
    Estimate of Burden: For the pretest for the web-based experimental 
study, it is expected that 1,700 individuals will receive email 
invitations to complete the study and that 100 will be eligible and 
subsequently complete the study. For the web-based experimental study, 
it is expected that 70,000 individuals will receive email invitations 
to complete the study and that 3,600 will be eligible and subsequently 
complete the study. The invitation email for the pretest and the full-
scale study is expected to take 2 minutes to read (0.033 hour). The 
survey is expected to take 20 minutes to complete. The total estimated 
burden of the web-based experimental study is 3,623.3 hours.
    For the behavior change study, it is expected that 1,695 
individuals will complete the screener and that 565 will be eligible 
and subsequently be contacted by phone to schedule an appointment. Of 
these, it is assumed that 480 will take part in the study. Each 
screening is expected to take 8 minutes (0.133 hour). It is expected to 
take 7 minutes (0.117 hour) to read or listen to each appointment call/
confirmation email/reminder call. It is expected to take 10 minutes 
(0.167 hour) to read the informed consent form and watch the 
instructional video. Taking part in the behavior change study will take 
a total of 140 minutes (2.333 hours), which includes an observational 
meal preparation experiment (80 minutes), an eye-tracking component (30 
minutes), and IDIs (30 minutes). The estimated annual reporting burden 
for the behavior change study is 1,491.9 hours, which is the sum of the 
burden estimates for each component of the study (including the burden 
for individuals who initially complete the screener but are not 
eligible or do not agree to participate).
    For all components of the information collection, the estimated 
total number of individuals to be screened is 73,395, and the estimated 
total number of individuals to complete the web-based experimental 
study, including pretest, and the behavior change study is 4,180. The 
estimated total burden for the information collection is 5,115.2 hours.

[[Page 34103]]



                          Estimated Annual Reporting Burden for the Web-Based Experimental Study and the Behavior Change Study
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                  Estimated        Annual
               Study component                    Number of    frequency  per   Total annual               Hours per response               Total hours
                                                 respondents      response        responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Web-Based Experimental Study
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest invitation...........................           1,700               1           1,700  0.033 (2 min.)...........................            56.7
Pretest......................................             100               1             100  0.333 (20 min.)..........................            33.3
Survey invitation............................          70,000               1          70,000  0.033 (2 min.)...........................         2,333.3
Survey.......................................           3,600               1           3,600  0.333 (20 min.)..........................         1,200.0
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................         3,623.3
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Behavior Change Study
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screening questionnaire......................           1,695               1           1,695  0.133 (8 min.)...........................           226.0
Appointment phone script, confirmation email,             565               1             565  0.117 (7 min.)...........................            65.9
 reminder phone script.
Consent form and video.......................             480               1             480  0.167 (10 min.)..........................            80.0
Meal Preparation, eye-tracking & in-depth                 480               1             480  2.333 (140 min.).........................         1,120.0
 interviews.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................         1,491.9
                                              ----------------------------------------------------------------------------------------------------------
        Total................................  ..............  ..............  ..............  .........................................         5,115.2
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Respondents: Consumers.
    Estimated Number of Respondents: 73,395.
    Estimated Number of Annual Responses per Respondent: 1.
    Estimated Total Burden on Respondents: 5,115.2 hours.
    Copies of this information collection assessment can be obtained 
from Gina Kouba, Office of Policy and Program Development, Food Safety 
and Inspection Service, USDA, 1400 Independence Avenue SW, Room 6065, 
South Building, Washington, DC 20250-3700; (202) 720-5627.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of FSIS's 
functions, including whether the information will have practical 
utility; (b) the accuracy of FSIS's estimate of the burden of the 
proposed collection of information, including the validity of the 
method and assumptions used; (c) ways to enhance the quality, utility, 
and clarity of the information to be collected; and (d) ways to 
minimize the burden of the collection of information, including through 
the use of appropriate automated, electronic, mechanical, or other 
technological collection techniques, or other forms of information 
technology. Comments may be sent to both FSIS, at the addresses 
provided above, and the Desk Officer for Agriculture, Office of 
Information and Regulatory Affairs, Office of Management and Budget, 
Washington, DC 20253.
    Responses to this notice will be summarized and included in the 
request for OMB approval. All comments will also become a matter of 
public record.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS web page located at: 
http://www.fsis.usda.gov/federal-register.
    FSIS also will make copies of this publication available through 
the FSIS Constituent Update, which is used to provide information 
regarding FSIS policies, procedures, regulations, Federal Register 
notices, FSIS public meetings, and other types of information that 
could affect or would be of interest to our constituents and 
stakeholders. The Update is available on the FSIS web page. Through the 
web page, FSIS is able to provide information to a much broader, more 
diverse audience. In addition, FSIS offers an email subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export 
information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves, and have the option to password 
protect their accounts.

USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination any person in the United States under any program or 
activity conducted by the USDA.

How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:
    Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.
    Fax: (202) 690-7442.
    Email: [email protected].
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

Paul Kiecker,
Acting Administrator.
[FR Doc. 2018-15462 Filed 7-18-18; 8:45 am]
 BILLING CODE 3410-DM-P