Public Comments

Academy_Comments_to_CDC_re_Standardized_National_Hypothesis_Generating_Questionnaire.pdf

Standardized National Hypothesis Generating Questionnaire

Public Comments

OMB: 0920-0997

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August	
  22,	
  2016	
  
	
  
Information	
  Collection	
  Review	
  Office	
  
Centers	
  for	
  Disease	
  Control	
  and	
  Prevention	
  
1600	
  Clifton	
  Road	
  NE.,	
  MS-­‐‑D74	
  
Atlanta,	
  Georgia	
  30329	
  
	
  
	
  
Re:	
  	
  Using	
  the	
  Standardized	
  National	
  Hypothesis	
  Generating	
  Questionnaire	
  during	
  Multistate	
  
Investigations	
  of	
  Foodborne	
  Disease	
  Clusters	
  and	
  Outbreaks	
  (Docket	
  No.	
  CDC-­‐‑2016-­‐‑0054)	
  
	
  
Dear	
  Sir	
  or	
  Madam,	
  
The	
  Academy	
  of	
  Nutrition	
  and	
  Dietetics	
  (the	
  “Academy”)	
  appreciates	
  the	
  opportunity	
  to	
  
submit	
  these	
  comments	
  to	
  the	
  Centers	
  for	
  Disease	
  Control	
  and	
  Prevention	
  (CDC)	
  
regarding	
  its	
  information	
  collection	
  “Using	
  the	
  Standardized	
  National	
  Hypothesis	
  
Generating	
  Questionnaire	
  during	
  Multistate	
  Investigations	
  of	
  Foodborne	
  Disease	
  Clusters	
  
and	
  Outbreaks”	
  (Docket	
  No.	
  CDC-­‐‑2016-­‐‑0054).	
  	
  Representing	
  more	
  than	
  100,000	
  
registered	
  dietitian	
  nutritionists	
  (RDNs),1	
  nutrition	
  and	
  dietetic	
  technicians,	
  registered	
  
(NDTRs),	
  and	
  advanced-­‐‑degree	
  nutritionists,	
  the	
  Academy	
  is	
  the	
  largest	
  association	
  of	
  
food	
  and	
  nutrition	
  professionals	
  in	
  the	
  United	
  States	
  and	
  is	
  committed	
  to	
  improving	
  the	
  
nation’s	
  health	
  through	
  food	
  and	
  nutrition	
  across	
  the	
  lifecycle.	
  	
  Every	
  day	
  we	
  work	
  with	
  
Americans	
  in	
  all	
  walks	
  of	
  life	
  —	
  from	
  prenatal	
  care	
  through	
  end	
  of	
  life	
  care	
  —	
  providing	
  
nutrition	
  care	
  services	
  and	
  conducting	
  nutrition	
  research.	
  	
  	
  
	
  
A.	
  	
  Academy	
  of	
  Nutrition	
  and	
  Dietetics’	
  Position	
  on	
  Food	
  Safety	
  
It	
  is	
  the	
  position	
  of	
  the	
  Academy	
  that	
  the	
  public	
  has	
  the	
  right	
  to	
  a	
  safe	
  food	
  supply	
  
and	
  to	
  that	
  end	
  we	
  support	
  the	
  ongoing	
  collaboration	
  among	
  food	
  and	
  nutrition	
  
professionals,	
  academics,	
  representatives	
  of	
  the	
  agricultural	
  and	
  food	
  industries,	
  
and	
  appropriate	
  government	
  agencies.2	
  	
  Reducing	
  foodborne	
  illnesses	
  is	
  one	
  of	
  the	
  
objectives	
  of	
  Healthy	
  People	
  2020	
  and	
  food	
  safety	
  is	
  recommended	
  in	
  the	
  2010	
  Dietary	
  
Guidelines	
  for	
  Americans.3	
  	
  Every	
  year,	
  over	
  48	
  million	
  Americans	
  get	
  sick,	
  128,000	
  are	
  
hospitalized,	
  and	
  3,000	
  die	
  from	
  foodborne	
  illnesses,	
  according	
  to	
  the	
  Centers	
  for	
  Disease	
  
Control.	
  	
  The	
  Economic	
  Research	
  Service	
  of	
  the	
  U.S.	
  Department	
  of	
  Agriculture	
  estimated	
  
that	
  in	
  2015,	
  fifteen	
  identified	
  pathogens	
  result	
  in	
  over	
  $15.5	
  billion	
  in	
  annual	
  costs	
  from	
  
	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  

1	
  The	
  Academy	
  recently	
  approved	
  the	
  optional	
  use	
  of	
  the	
  credential	
  “registered	
  dietitian	
  nutritionist	
  (RDN)”	
  

by	
  “registered	
  dietitians	
  (RDs)”	
  to	
  more	
  accurately	
  convey	
  who	
  they	
  are	
  and	
  what	
  they	
  do	
  as	
  the	
  nation’s	
  food	
  
and	
  nutrition	
  experts.	
  The	
  RD	
  and	
  RDN	
  credentials	
  have	
  identical	
  meanings	
  and	
  legal	
  trademark	
  definitions.	
  
2	
  Cody	
  MM,	
  Stretch	
  T.	
  Position	
  of	
  the	
  Academy	
  of	
  Nutrition	
  and	
  Dietetics:	
  food	
  and	
  water	
  safety.	
  J	
  Acad	
  Nutr	
  

Diet.	
  2014;114(11):1819-­‐‑29.	
  
3	
  US	
  Department	
  of	
  Health	
  and	
  Human	
  Services.	
  Food	
  safety.	
  Healthy	
  People	
  2020	
  Web	
  site.	
  	
  Available	
  at	
  

https://www.healthypeople.gov/2020/topics-­‐‑objectives/topic/food-­‐‑safety?topicid=14.	
  	
  Accessed	
  August	
  16,	
  
2016.	
  

	
  

	
  

foodborne	
  illness.4	
  	
  In	
  light	
  of	
  the	
  health	
  risks	
  and	
  financial	
  costs	
  associated	
  with	
  foodborne	
  
illness	
  and	
  to	
  assist	
  congressional	
  efforts	
  to	
  ameliorate	
  them,	
  the	
  Academy	
  adopted	
  three	
  
principles	
  for	
  federal	
  food	
  safety	
  authority:	
  
1.   Food	
  authority	
  should	
  be	
  science-­‐‑based	
  and	
  consistently	
  applied	
  to	
  all	
  foods	
  
regulated	
  by	
  all	
  agencies	
  for	
  domestic	
  and	
  imported	
  foods.	
  The	
  Academy	
  supports	
  
the	
  concept	
  of	
  a	
  single	
  food	
  safety	
  agency	
  to	
  protect	
  the	
  public’s	
  health.	
  
2.   Food	
  authority	
  should	
  be	
  collaborative	
  across	
  national,	
  state,	
  and	
  local	
  agencies	
  and	
  
between	
  government	
  and	
  industry	
  partners	
  to	
  foster	
  more	
  robust,	
  consistent,	
  
accurate	
  and	
  timely	
  communication	
  and	
  data	
  sharing	
  that	
  leads	
  to	
  efficient	
  and	
  
effective	
  decision-­‐‑making	
  processes.	
  
3.   Food	
  protection	
  should	
  include	
  statutory	
  authority	
  by	
  government	
  regulatory	
  
agencies	
  for	
  traceability	
  and	
  recall,	
  supported	
  by	
  research,	
  epidemiology	
  and	
  
inspection	
  programs.5	
  
	
  
B.	
  	
  Value	
  of	
  Proposed	
  Information	
  Collection	
  
The	
  Academy	
  supports	
  the	
  use	
  of	
  the	
  proposed	
  information	
  collection	
  questionnaire,	
  
which	
  is	
  both	
  necessary	
  and	
  will	
  have	
  both	
  short-­‐‑term	
  and	
  long-­‐‑term	
  practical	
  
utility.	
  	
  In	
  the	
  short-­‐‑term	
  the	
  questionnaire	
  standardizes	
  information	
  gathering	
  and	
  will	
  
make	
  it	
  easier	
  for	
  all	
  jurisdictions	
  to	
  cooperate	
  without	
  redundancy	
  and	
  enables	
  different	
  
units	
  to	
  uniformly	
  gather	
  information,	
  leading	
  to	
  better	
  long-­‐‑term	
  use	
  of	
  the	
  information.	
  	
  	
  
However,	
  we	
  are	
  concerned	
  that	
  CDC’s	
  estimate	
  of	
  the	
  burden	
  of	
  the	
  proposed	
  information	
  
collection	
  may	
  not	
  consider	
  the	
  nature	
  of	
  the	
  shared	
  burden	
  on	
  all	
  those	
  collecting	
  this	
  
complex	
  information.	
  	
  Specifically,	
  we	
  question	
  whether	
  the	
  collection	
  poses	
  a	
  greater	
  than	
  
intended	
  burden	
  on	
  local	
  units	
  in	
  the	
  event	
  of	
  an	
  outbreak,	
  because	
  the	
  data	
  collection	
  will	
  
begin	
  at	
  the	
  local	
  level	
  where	
  this	
  sporadic	
  event	
  may	
  not	
  be	
  presently	
  budgeted.	
  
	
  
C.	
  	
  Recommendations	
  for	
  Enhancing	
  Proposed	
  Information	
  Collection	
  
The	
  Academy	
  respectfully	
  offers	
  several	
  recommendations	
  below	
  for	
  enhancing	
  the	
  quality,	
  
utility	
  and	
  clarity	
  of	
  information	
  to	
  be	
  collected:	
  
1.   The	
  CDC	
  needs	
  to	
  establish	
  a	
  national	
  training	
  module(s)	
  for	
  individuals	
  who	
  will	
  
collect	
  and	
  use	
  the	
  collected	
  information.	
  	
  Some	
  sections	
  of	
  the	
  form	
  require	
  
judgment	
  as	
  to	
  where	
  to	
  include	
  information	
  (e.g.,	
  multiple	
  uses	
  of	
  “deli”);	
  in	
  some	
  
cases,	
  unanticipated	
  follow-­‐‑up	
  questions	
  may	
  be	
  helpful.	
  	
  We	
  encourage	
  CDC	
  to	
  
consider	
  whether	
  enhanced	
  training	
  could	
  address	
  these	
  issues.	
  	
  Specifically,	
  online	
  
training	
  and	
  certificate	
  training	
  could	
  be	
  very	
  helpful	
  because	
  it	
  would	
  train	
  the	
  
potential	
  interviewer	
  and	
  possibly	
  offer	
  continuing	
  education	
  to	
  the	
  professional	
  
	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  
4	
  Economic	
  Research	
  Service.	
  	
  Economic	
  Burden	
  of	
  Major	
  Foodborne	
  Illnesses	
  Acquired	
  in	
  the	
  United	
  States	
  

(May	
  2015).	
  	
  Available	
  at	
  http://www.ers.usda.gov/media/1837791/eib140.pdf.	
  	
  Accessed	
  August	
  16,	
  2016.	
  
5

	
  Cody	
  MM,	
  Stretch	
  T.	
  Position	
  of	
  the	
  Academy	
  of	
  Nutrition	
  and	
  Dietetics:	
  food	
  and	
  water	
  safety.	
  J	
  Acad	
  Nutr	
  
Diet.	
  2014;114(11):1819-­‐‑29.	
  

	
  

	
   2	
  

completing	
  the	
  training,	
  and	
  the	
  training	
  could	
  be	
  completed	
  at	
  convenient	
  times.	
  	
  
Training	
  could	
  also	
  be	
  updated	
  as	
  new	
  issues	
  arise,	
  thereby	
  keeping	
  the	
  training	
  
“fresh.”	
  	
  “Fresh”	
  training	
  is	
  especially	
  important	
  at	
  the	
  local	
  level,	
  as	
  that	
  is	
  likely	
  
where	
  the	
  first	
  interviewers	
  start	
  the	
  process	
  and	
  because	
  it	
  may	
  not	
  be	
  practical	
  to	
  
train	
  every	
  sanitarian,	
  environmental	
  health	
  specialist,	
  and	
  other	
  worker	
  in	
  advance	
  
of	
  an	
  outbreak.	
  	
  
2.   As	
  noted	
  in	
  the	
  instrument,	
  the	
  individual	
  responding	
  to	
  the	
  questionnaire	
  could	
  be	
  
the	
  patient	
  or	
  a	
  surrogate.	
  	
  The	
  Academy	
  suggests	
  broadening	
  the	
  scope	
  beyond	
  
“your	
  (your	
  child’s)”	
  to	
  include	
  spouses,	
  parents,	
  or	
  other	
  individuals	
  for	
  whom	
  the	
  
respondent	
  may	
  be	
  the	
  caretaker	
  and	
  additionally	
  to	
  include	
  the	
  relationship	
  of	
  the	
  
respondent	
  to	
  the	
  patient	
  on	
  the	
  form.	
  	
  We	
  also	
  respectfully	
  suggest	
  that	
  it	
  would	
  be	
  
useful	
  to	
  include	
  the	
  time	
  spent	
  by	
  the	
  caretaker	
  with	
  the	
  patient	
  during	
  the	
  week	
  
for	
  which	
  data	
  are	
  collected.	
  
3.   The	
  Academy	
  offers	
  the	
  below	
  suggestions	
  for	
  improving	
  particular	
  sections	
  of	
  the	
  
instrument:	
  
a)   Section	
  2,	
  Question	
  3:	
  Consider	
  adding	
  “c.	
  Ongoing.”	
  
b)   Section	
  4,	
  Question	
  4:	
  Include	
  “liquids”	
  in	
  the	
  listing.	
  	
  We	
  note	
  this	
  might	
  
include	
  supplements	
  such	
  as	
  Ensure®,	
  Boost®,	
  energy	
  drinks,	
  or	
  sports	
  
drinks.	
  	
  CDC	
  should	
  consider	
  whether	
  such	
  an	
  inclusion	
  would	
  be	
  more	
  
common	
  than	
  the	
  listing	
  “teas.”	
  
c)   Section	
  5:	
  	
  Add	
  “Meals	
  on	
  Wheels”	
  to	
  the	
  list	
  of	
  sources	
  of	
  food	
  at	
  home.	
  	
  Meals	
  
on	
  Wheels	
  and	
  similar	
  programs	
  deliver	
  a	
  significant	
  number	
  of	
  foods	
  to	
  at-­‐‑
risk	
  populations	
  and	
  should	
  be	
  included.	
  
d)   Section	
  6:	
  	
  Add	
  the	
  following	
  to	
  the	
  list	
  of	
  foods	
  outside	
  the	
  home:	
  	
  “Italian”	
  
and	
  other	
  ethnic	
  foods	
  representing	
  the	
  cultural	
  diversity	
  of	
  the	
  United	
  States;	
  
expand	
  the	
  category	
  “School	
  or	
  other	
  institutional	
  setting”	
  to	
  specifically	
  
include	
  “Hospital,	
  Senior	
  Congregate	
  Meal	
  Center;”	
  and	
  add	
  “Vending	
  machine”	
  
and	
  “Eating	
  in	
  other	
  people’s	
  homes”	
  as	
  categories.	
  
e)   Section	
  7:	
  	
  
i.   We	
  question	
  whether	
  brand	
  names	
  for	
  deli-­‐‑sliced	
  items	
  eaten	
  outside	
  
the	
  home	
  would	
  typically	
  be	
  known	
  by	
  the	
  patient;	
  if	
  not,	
  this	
  would	
  
likely	
  require	
  follow-­‐‑up	
  at	
  the	
  place	
  of	
  purchase	
  and	
  may	
  be	
  confusing	
  
to	
  the	
  patient.	
  
ii.   For	
  Question	
  10,	
  the	
  question	
  asks	
  if	
  the	
  meat	
  consumed	
  was	
  pink.	
  	
  	
  We	
  
note	
  that	
  this	
  same	
  question	
  would	
  applies	
  to	
  patties	
  formed	
  at	
  
home,	
  which	
  is	
  the	
  question	
  that	
  follows	
  the	
  preformed	
  patty	
  
question.	
  	
  	
  Instead,	
  asking	
  a	
  simple	
  question	
  at	
  the	
  end	
  of	
  this	
  section	
  
such	
  as	
  "Do	
  you	
  or	
  your	
  child	
  (surrogate)	
  eat	
  your	
  burgers	
  without	
  
cooking	
  (tasting	
  during	
  prep)	
  or	
  with	
  a	
  pink	
  or	
  red	
  center?”	
  would	
  
apply	
  to	
  both	
  questions.	
  

	
  

	
   3	
  

f)   Section	
  11,	
  Question	
  3:	
  	
  Most	
  individuals	
  are	
  unlikely	
  to	
  be	
  able	
  to	
  name	
  a	
  type	
  
or	
  variety	
  of	
  grape	
  purchased	
  at	
  a	
  market,	
  but	
  may	
  be	
  able	
  to	
  identify	
  the	
  color	
  
(green,	
  red,	
  black)	
  grape	
  they	
  purchased.	
  	
  	
  
4.   The	
  Academy	
  suggests	
  including	
  questions	
  related	
  to	
  consumption	
  of	
  bananas,	
  rice	
  
and	
  beans,	
  and	
  fermented	
  vegetables	
  such	
  as	
  sauerkraut	
  or	
  kimchi.	
  
5.   The	
  Academy	
  encourages	
  the	
  CDC	
  to	
  consider	
  the	
  use	
  of	
  an	
  online	
  form	
  completed	
  
directly	
  by	
  the	
  consumer	
  as	
  an	
  alternative	
  to	
  the	
  proposed	
  instrument.	
  	
  The	
  existing	
  
form	
  provides	
  much	
  needed	
  information	
  for	
  those	
  able	
  and	
  willing	
  to	
  complete	
  it	
  on	
  
a	
  phone	
  interview.	
  	
  	
  However,	
  we	
  note	
  that	
  the	
  existing	
  form	
  is	
  lengthy,	
  which	
  could	
  
be	
  problematic	
  for	
  individuals	
  being	
  interviewed	
  who	
  have	
  multiple	
  competing	
  
distractions	
  (e.g.,	
  young	
  children,	
  dinner	
  preparation,	
  work	
  obligations).	
  	
  We	
  
encourage	
  the	
  CDC	
  to	
  ascertain	
  whether	
  providing	
  the	
  instrument	
  in	
  a	
  format	
  that	
  
could	
  be	
  emailed	
  might	
  enhance	
  completion	
  for	
  those	
  expressing	
  an	
  interest	
  in	
  
receiving	
  it	
  electronically.	
  	
  In	
  addition,	
  the	
  proposed	
  questionnaire	
  anticipates	
  that	
  
the	
  patient	
  or	
  surrogate	
  can	
  recall	
  intakes	
  over	
  a	
  seven-­‐‑day	
  period,	
  but	
  we	
  note	
  that	
  
even	
  24-­‐‑hour	
  recall	
  surveys	
  administered	
  by	
  a	
  trained	
  professional	
  may	
  present	
  
reliability	
  concerns.	
  	
  
	
  
C.	
  	
  Conclusion	
  
The	
  Academy	
  sincerely	
  appreciates	
  the	
  opportunity	
  to	
  offer	
  comments	
  on	
  the	
  proposed	
  
information	
  collection	
  to	
  CDC’s	
  Standardized	
  National	
  Hypothesis	
  Generating	
  
Questionnaire,	
  and	
  we	
  would	
  welcome	
  the	
  opportunity	
  to	
  discuss	
  the	
  above	
  issues	
  with	
  
CDC	
  in	
  the	
  future.	
  	
  Please	
  contact	
  either	
  Jeanne	
  Blankenship	
  by	
  telephone	
  at	
  312-­‐‑899-­‐‑1730	
  
or	
  by	
  email	
  at	
  [email protected]	
  or	
  Pepin	
  Tuma	
  by	
  telephone	
  at	
  202-­‐‑775-­‐‑8277	
  ext.	
  
6001	
  or	
  by	
  email	
  at	
  [email protected]	
  with	
  any	
  questions	
  or	
  requests	
  for	
  additional	
  
information.	
  	
  	
  
Sincerely,	
  	
  
	
  

	
   	
  
Jeanne	
  Blankenship,	
  MS	
  RDN	
  	
  
	
  
Vice	
  President	
  
	
  
	
  
	
  
Policy	
  Initiatives	
  and	
  Advocacy	
  
	
  
Academy	
  of	
  Nutrition	
  and	
  Dietetics	
  	
  
	
  

	
  

	
  
	
  
	
  
	
  
	
  

	
  
	
  
	
  
	
  
	
  

	
   4	
  

	
  
	
  
Pepin	
  Andrew	
  Tuma,	
  Esq.	
  
Senior	
  Director	
  
Government	
  &	
  Regulatory	
  Affairs	
  	
  
Academy	
  of	
  Nutrition	
  and	
  Dietetics	
  


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