Public Comments

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To: Jeffrey M. Zirger, Information Collection Review Office, CDC
From: Mitchell Berger, (comments made in personal capacity), [email protected], 8.1.26
Re: Use of the Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ) During
Investigations of Foodborne Disease Clusters and Outbreaks 2026-11011, Proposed Data Collection
Submitted for Public Comment and Recommendations, [Docket No. CDC-2026-0925].
Dear Dr. Zirger: In reference to this notice, I respectfully offer the following recommendations to
reduce respondent burden, improve data quality, and strengthen the questionnaire's usefulness for
future investigations. Please note that comments reflect solely my personal views and not those of an
agency, organization, or other individual. Thank you for your consideration.
Consider modularizing the questionnaire: The current CNHGQ is lengthy and administered to all
case‑patients, requires approximately 45 minutes to complete, according to the Federal Register
notice. CDC could substantially reduce respondent burden by dividing the questionnaire into three
modules:
•
•
•

Core module (asked of all respondents): symptoms, onset date, demographics, interview
metadata.
Produce module (Cyclospora specific): herbs, salad kits, berries, leafy greens, multiingredient dishes.
Retail traceback module (only if relevant produce was consumed): shopper cards, receipts,
store names, brand/lot/date codes.

This modular approach would reduce the number of questions asked of every interview respondent
and improve interview efficiency. Checkbox grids and skip logic could further reduce interview time
by presenting detailed follow-up questions only for foods that were actually consumed.
Focus on consumption of high‑risk produce: The current questionnaire includes long lists of fruits
and vegetables. Based on recent outbreak sources,1 CDC could condense these sections to focus on
produce most likely linked to Cyclospora outbreaks, including cilantro, basil, salad kits, bagged leafy
greens, and berries. These items have been recurrent vehicles in recent investigations. When
respondents report consuming one of these higher-risk items, follow-up questions could collect
structured information on the brand, package type, purchase location, and lot or date code obtained
from packaging or receipts.

1

Main drinking water source (public system, private well, bottled).
Any bottled water consumed in the 14 days before illness.
Any recreational water exposure (pool, splash pad, lake, river).

Hadjilouka A, Tsaltas D. Cyclospora Cayetanensis-Major Outbreaks from Ready to Eat Fresh Fruits and Vegetables. Foods. 2020 Nov
20;9(11):1703. doi: 10.3390/foods9111703; https://www.cdc.gov/cyclosporiasis/outbreaks/07-26/investigation.html
2
Naganathan T et al., The prevalence of Cyclospora cayetanensis in water: a systematic review and meta-analysis. Epidemiol Infect. 2021 Dec
10;150:e15. doi: 10.1017/S0950268821002521.

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•
•

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Add a brief water‑exposure module: Although recent U.S. outbreaks have been primarily
foodborne, Cyclospora is highly prevalent in water globally and can be transmitted through
contaminated drinking water, beverages, or recreational water.2 A short module could include:

These questions would add minimal burden and potentially identify less common exposure pathways.
Add a short host‑factor module: Individuals who are immunocompromised or immunosuppressed
may face higher risks of infection or complications. 3 Certain medications, such as proton pump
inhibitors (PPIs) and GLP‑1 receptor agonists, may influence susceptibility due to reduced stomach
acidity or delayed gastric emptying. 4 While pregnancy does not inherently increase Cyclospora risk,
prolonged dehydration and diarrhea can pose concerns. 5
CDC could include a brief yes/no host‑factor module asking whether the interviewee:
•
•
•
•
•
•

has an immunocompromising condition (e.g., HIV/AIDS, cancer, organ transplant)
uses immunosuppressive medications (e.g., steroids, biologics, transplant medications)
uses acid-suppressing medications (PPIs)
uses GLP-1 receptor agonists (e.g., semaglutide, liraglutide)
uses tirzepatide
is pregnant (if applicable)

Although additional research may be needed regarding some of these factors, collecting this data
could facilitate epidemiologic analyses without greatly increasing the interview burden.
Improve traceback detail: The current questionnaire relies heavily on free-text fields for brand, lot,
and purchase information. Data quality and consistency could be improved by using structured fields
for:
•
•
•
•

brand name(s)
package type(s) (checkboxes)
lot or date codes
purchase date using a standardized format (MM/DD/YYYY)

Structured data elements would improve data quality, facilitate analysis, and support more efficient
traceback investigations. These changes would improve data quality and reduce interview time. With
these revisions, the CNHGQ would be better positioned to meet the needs of current and future
Cyclospora outbreak investigations.
Digitally signed by Mitchell Berger
DN: cn=Mitchell Berger, c=US,
[email protected]
Date: 2026.08.01 13:23:03 -04'00'

Mitchell Berger
Note/Disclosure: I am submitting these suggestions solely in my personal/private capacity. The views
expressed are mine only and should not be imputed either to other individuals or to any public or
private entity.
3

Ghorbani A, et al., Prevalence and Associated Risk Factors of Cyclospora cayetanensis in Immunocompromised Patients: A Systematic Review
and Meta-Analysis. Can J Infect Dis Med Microbiol. 2025 Aug 28;2025:8837624. doi: 10.1155/cjid/8837624;
https://www.autoimmuneinstitute.org/research_updates/cyclospora-outbreak-and-autoimmune-disease/
4
Tian L, et al., Proton pump inhibitors may enhance the risk of digestive diseases by regulating intestinal microbiota. Front Pharmacol. 2023 Jul
17;14:1217306. doi: 10.3389/fphar.2023.1217306; Jalleh RJ, et al., Clinical Consequences of Delayed Gastric Emptying With GLP-1 Receptor
Agonists and Tirzepatide. J Clin Endocrinol Metab. 2024 Dec 18;110(1):1-15. doi: 10.1210/clinem/dgae719.
5
https://www.babycenter.ca/a25053974/should-pregnant-women-be-worried-about-the-recent-cyclospora-outbreak

2

Mitchell
Berger

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Sincerely,