Bill Overview
Title: Donor Milk Safety Act
Description: This bill treats human milk that has gone through a bioburden reduction process (e.g., pasteurized donor milk) as an exempt infant formula (i.e., specialized infant formula) for purposes of certain regulatory standards.
Sponsors: Rep. DeLauro, Rosa L. [D-CT-3]
Target Audience
Population: Individuals who rely on donor milk and related parties
Estimated Size: 500000
- The bill is about regulating donor milk making it safer for consumption.
- Infants who rely on donor milk for nutrition will directly be impacted.
- Parents who use donor milk will benefit from safety regulations.
- Donor milk banks and organizations will be affected by new safety standards.
Reasoning
- The primary group impacted by this policy consists of parents of infants who rely on donor milk, which includes a significant subset of premature infants.
- This policy will also impact donor milk banks and related personnel, who will have to adapt to new regulations, potentially affecting their operations and costs.
- With a budget of $15,000,000 in year 1 and $136,750,000 over 10 years, the policy must be efficiently managed to support a substantial number of infants without exceeding its financial constraints.
- Interviews include individuals from a range of socioeconomic backgrounds and locations in the US to capture diverse perspectives on the policy's impact.
- Some individuals in the population will not be affected by the policy if they do not use donor milk.
Simulated Interviews
Software Engineer (New York, NY)
Age: 29 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 7/20
Statement of Opinion:
- I feel much more secure knowing that the donor milk is being more strictly regulated.
- As a mother, safety is my top priority and this policy helps me feel assured about what I'm feeding my baby.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 7 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 5 | 5 |
Data Analyst (San Francisco, CA)
Age: 32 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 2.0 years
Commonness: 5/20
Statement of Opinion:
- Ensuring donor milk safety should be standard everywhere.
- Initial concerns over cost increases, but willing to absorb for the safety advantage.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 5 | 4 |
| Year 5 | 5 | 4 |
| Year 10 | 4 | 4 |
| Year 20 | 3 | 4 |
Milk Bank Coordinator (Austin, TX)
Age: 45 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 4/20
Statement of Opinion:
- We're excited to implement these standards as it'll put parents' minds at ease.
- It will require training and some changes in our processes, but it's worth it for safety.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 6 | 7 |
| Year 5 | 6 | 7 |
| Year 10 | 6 | 6 |
| Year 20 | 5 | 6 |
Healthcare Policy Consultant (Chicago, IL)
Age: 38 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- The policy fills a critical safety gap in the current regulation environment.
- Long-term impact will be beneficial but keeping administrative costs down will be crucial.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 8 | 8 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 7 | 7 |
College Student (Miami, FL)
Age: 23 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 5.0 years
Commonness: 6/20
Statement of Opinion:
- As a student, any additional support through safety assurance is much needed.
- I'm concerned about potential price hikes though.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 4 |
| Year 2 | 6 | 4 |
| Year 3 | 6 | 4 |
| Year 5 | 5 | 4 |
| Year 10 | 4 | 4 |
| Year 20 | 3 | 3 |
Lactation Consultant (Seattle, WA)
Age: 50 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 2.0 years
Commonness: 5/20
Statement of Opinion:
- Policy is a step in the right direction but needs to be accompanied by public education.
- Potential backlash from misinformation could impact perception.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 6 | 6 |
| Year 10 | 6 | 5 |
| Year 20 | 5 | 5 |
Biotech Entrepreneur (Denver, CO)
Age: 40 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 2/20
Statement of Opinion:
- Regulation offers opportunities to innovate and ensure milk safety.
- Market expansion potential with increased demand for safer donor milk.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 7 | 7 |
Nurse (Charlotte, NC)
Age: 28 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 5/20
Statement of Opinion:
- Parents will be relieved with stricter safety regulations.
- Still, some remain skeptical about any costs passed onto them.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 6 | 6 |
| Year 20 | 5 | 6 |
Stay-at-home Parent (Portland, OR)
Age: 35 | Gender: other
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 4/20
Statement of Opinion:
- We depend on donor milk, so this policy greatly reassures us.
- Hope the policy integrates diverse community needs and remains accessible.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 7 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 5 | 5 |
Retired Pediatrician (Boston, MA)
Age: 60 | Gender: male
Wellbeing Before Policy: 9
Duration of Impact: 7.0 years
Commonness: 1/20
Statement of Opinion:
- This policy is necessary to ensure infant health when mother's milk is unavailable.
- Should be part of broader educational programs for parents about nutrition.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 9 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 8 | 8 |
| Year 10 | 8 | 7 |
| Year 20 | 7 | 7 |
Cost Estimates
Year 1: $15000000 (Low: $12000000, High: $18000000)
Year 2: $14500000 (Low: $11500000, High: $17500000)
Year 3: $14000000 (Low: $11000000, High: $17000000)
Year 5: $13500000 (Low: $10500000, High: $16500000)
Year 10: $13000000 (Low: $10000000, High: $16000000)
Year 100: $10000000 (Low: $7000000, High: $13000000)
Key Considerations
- The bill does not create a new market but regulates an existing one.
- Long-term savings in healthcare due to healthier infant outcomes may offset initial compliance costs.
- The small size of the target population limits large-scale economic impacts.
- Economic impacts will mostly be within the niche market of donor milk production and distribution.