gina mccarthy administrator environmental protection agency 1200

Gina McCarthy Administrator Environmental Protection Agency 1200 Pennsylvania Avenue, N.W. Washington, DC 20460 March 14, 2016 Dear Administrator McCarthy, Today, Consumer Reports is releasing its results of microbial testing performed in 35 humidifier models. Based on these results, we are asking the EPA to investigate a number of the antimicrobial claims on these products as potentially misleading to consumers. We evaluated the two types of antimicrobial claims used on humidifiers: claims that have to do with preventing growth in or on the device (treated article or product protection claims), and claims that refer to the cleanliness of the emitted humidified mist (public health claims, e.g., “germ free mist”). In addition to CR’s evaluation of humidifiers for performance that was released in December 2015 on ConsumerReports.org, Consumer Reports followed up with two additional microbial tests to see whether bacteria would grow in the water reservoirs and whether bacteria added to reservoirs could then be emitted into the air. We respectively evaluated any product or public health claims made. We based our tests on three days of typical consumer use. After that time, we measured microbial growth in the reservoir and found that most, though not all, of the humidifiers had increased microbial growth compared to the original levels in tap water. The second test measured the potential for bacteria inoculated into the reservoirs to be emitted into the air. In summary, we found in our tests of 35 humidifiers that :

• 21 humidifiers made antimicrobial claims, but only seven lived up to their claims.

• 29 humidifiers had significant microbial growth in the reservoir tank. • 24 humidifiers had the potential to emit bacteria. • 15 humidifiers made antimicrobial product claims but 12 of these had

significant microbial growth in the reservoirs. • Ten humidifiers made antimicrobial public health claims but eight of these

had the potential to emit bacteria. • Of the 14 humidifiers that made no claims, one had no significant microbial

growth and four did not have to the potential to emit bacteria.

While we understand EPA has product registration exemptions for antimicrobial product protection and requirements for antimicrobial public health claims, we are concerned that our test results suggest that consumers can’t reliably purchase a humidifier based on many of the antimicrobial claims they see. We also believe that consumers may have a difficult time determining which type of claim is being made and may therefore over-‐interpret product claims to be public health claims. We did not find any EPA registration numbers on any of the humidifiers that made a public health claim. We therefore are not aware if any of the public health claims made on the humidifiers we tested received approval from EPA. Moreover, we believe further investigation into both types of claims is warranted. We have included our findings on each humidifier along with the antimicrobial claims made in the attached document, and look forward to your response. We are also happy to meet with you in person to go over our results in further detail. Sincerely, Urvashi Rangan, Ph.D. Director, Consumer Safety and Sustainability

3

Humidifiers, Box Claims and Claim Concerns Our results Claim analysis

Air-‐O-‐Swiss S450 (Vaporizer) claims: “Hygenic [sic] humidification”; “Boiling the water eliminates bacteria and retains the minerals from the water inside the device. The result is no white dust and healthy humidified indoor air. “ Claim concern: Public health claims of “hygenic [sic] humidification” and “healthy humidified indoor air”. Our tests found the potential to emit bacteria.

Significant reservoir growth?

No

Potential to emit bacteria?

Yes

Claim type

Public health claim

Appears to live up to claim?

No

Crane Germ Defense EE-‐8065 (Ultrasonic) claims: “Promotes a healthy home environment “; “Germ Free Mist”, “Germ Defense technology prevents mold and bacteria growth in water tank” Claim concern: Public health claims of “healthy home environment” and “Germ Free Mist” with “Germ Defense technology” for water tank. Our tests found significant microbial growth in the reservoir and the potential to emit bacteria.


Yes


Yes

Claim type

Public health claim


No

Crane Penguin (Ultrasonic) claims: “Clean control”; “anti-‐microbial material”; “Proven to help reduce mold and bacteria growth up to 99.96% in the humidifier base.*” and refers to “*EMSL Test Report 151305654. Reduction of mold and bacteria is based on independent laboratory testing. EMSL report 151305654 results are based on the reduction of bacteria in the humidifier base with Clean Control material, during continuous use. The humidifier base showed a reduction up to 99.96% Gram Negative – Pseudomonas Aeruginosa after 8 hours.”

Claim concern: Public health claims of “clean control” and bacteria reduction in the reservoir. Our tests found significant microbial growth in the reservoir and the potential to emit bacteria.


Yes


Yes

Claim type

Public health claim


No

4

Crane Warm Mist Humidifier EE-‐5200 (Vaporizer) claims: “Produces pure bacteria free vapors”; “Germ free mist” Claim concern: Public health claims of “bacteria free vapors” and “Germ free mist”. Our tests found the potential to emit bacteria.


No


Yes

Claim type

Public health claim


No

Honeywell HWM-‐340 (Vaporizer) claims: “Up to 95% Bacteria Free Mist (4)”; “The boiling chamber heats the water, producing up to 95% bacteria free steam (4)” and refers to “(4) Based on Intertek Testing Services NA Inc Independent Laboratory Testing Report 100982403COL-‐001. Results are based on the reduction of the following bacteria after 2 hours of continuous use: -‐E. Coli up to 99.3% after 2 hours of continuous use; -‐S. epidermis up to 99.9% after 2 hours of continuous use; -‐P. Flourescens up to 95.6% after 2 hours of continuous use” Claim concern: Public health claims of “95% Bacteria Free Mist”. Our tests found significant microbial growth in the reservoir and the potential to emit bacteria.


Yes


Yes

Claim type

Public health claim


Unclear

5

Vicks V3900 (Evaporative) claims: “GermFree”; “Kills up to 99.9% of bacteria, mold, fungus and virus in the water(3)”; “Patented germicidal ultraviolet chamber “; “The Vicks Germ Free Cool Moisture Humidifier's scientifically proven process uses a patented Ultraviolet light technology to kill up to 99.9% of bacteria, mold, fungus and virus in the unit's water after 2 hours of continuous use on high.(3) This provides the assurance that the moisture the humidifier emits is virtually free of germs.”; “ultra-‐violet light which kills up to 99.9% of the mold, bacteria, fungus and virus in the unit's water.”; “sanitized water”; “After 2 hours of continuous use on high, up to 99.9% Germ Free moisture is emitted into the air as a fine invisible mist.”; and refers to “(3) Based on Independent Laboratory Testing Report #ETL Test Report No. 3163185COL-‐001 Results are based on the reduction of the following: -‐ i. Kills up to 99.9% of listed bacteria, mold, fungus and virus that can exist in tap water; a. E. coli: 99.9% after 2 hours of continuous use; b. P. citrinum: 99.9% after 2 hours of continuous use; c. A. niger: 99.9% after 2 hours of continuous use; d. MS2: 99.9% after 2 hours of continuous use”; “EPA Establishment Number #073348-‐CNN-‐001”; “Pure, Sanitized Cool Mist for easier breathing and a good night sleep.” Claim concern: None. Assume that water enters filter after the reservoir and prior to emission. Humidifier did not have the potential to emit bacteria.


Yes


No

Claim type

Public health claim


Yes

6

Air-‐O-‐Swiss U200 (Ultrasonic) claims: “Ag+ Ionic Silver Technology Inside”; “…healthy room climate” Claim concern: Public health claims of a “healthy room climate” and vague treated article reference to “ionic silver technology”. Our tests found significant microbial growth in the reservoir and the potential to emit bacteria.


Yes


Yes

Claim type

Public health and

product claim


No –

neither claim type

HoMedics UHE-‐CM25 (Ultrasonic) claims: “Clean Mist Technology”; “Clean Mist Technology Prevents the Growth of Mold & Mildew on the Surface of the Tank” Claim concern: Although these antimicrobial treated article claims are limited to mold and mildew, our findings suggest that microbial loads in reservoirs can grow and bacteria has the potential to be emitted, raising questions about the use of the claim “clean mist technology”. Our tests found significant microbial growth in the reservoir and bacteria has the potential to be emitted.


Yes


Yes

Claim type

Public health and

product claim


No –

neither claim type

HoMedics UHE-‐CM45 (Ultrasonic) claims: “Clean Mist Technology”; “Clean Mist Technology Prevents the Growth of Mold & Mildew on the Surface of the Tank” Claim concern: Although these antimicrobial treated article claims are limited to mold and mildew, our findings suggest that microbial loads in reservoirs can grow and bacteria has the potential to be emitted, raising questions about the use of the claim “clean mist technology”. Our tests found significant microbial growth in the reservoir and bacteria has the potential to be emitted.


Yes


Yes

Claim type

Public health and

product claim


No –

neither claim type

7

Honeywell HCM-‐350 (Evaporative) claims: “Ultra Violet Germ-‐Free Patented Germ Killing Process (title)”; “Continuously Kills up to 99.9% of Bacteria, Mold, Fungus and Virus in the unit's water”; “Up to 99.9% Germ-‐Free Cool Moisture Humidification”; “The Honeywell Germ Free Humidification scientifically proven process uses a patented Ultra-‐Violet light technology to kill up to 99.9% of bacteria, mold fungus and virus in the unit's water after 2 hours of continuous use on high. This provides the assurance that the moisture the humidifier emits is virtually free of germs”; “Untreated tap water flows from the water tank into the UV water path where it is exposed to ultra-‐violet light which kills 99.9% of mold, virus, fungus and bacteria.”; “The sanitized water enters the base where it is absorbed by the wicking filter. “; “After 2 hours of continuous use on high, up to 99.9% Germ Free moisture is emitted in to the air as a fine invisible mist. “; refers to “(1) Based on Independent Laboratory Testing Report #ETL Test Report No. 3175067COL-‐001 Results are based on the reduction of the following: i. Kills up to 99.9% of listed bacteria, mold, fungus and virus that can exist in tap water a. E. coli: 99.9% after 2 hours of continuous use b. P. citrinum 99.9% after 2 hours of continuous use c. A. niger: 99.9% after 2 hours of continuous use d. MS2: 99.9% after 2 hours of continuous use (5) The antimicrobial agent contained in the filter is intended to prolong filter life only by inhibiting the growth of unsightly mold, mildew and algae, as well as controlling odor for odor causing bacteria. The antimicrobial agent in the filter does not protect the user or others against bacteria, germs, viruses or other disease causing organisms. Always, follow manufacturers instructions regarding cleaning, maintenance and service of your humidifier. Estimated filter life 1-‐2 months based on water quality. “ Claim concern: None. Humidifier did not have significant microbial growth in the reservoir and did not have the potential to emit bacteria.


No


No

Claim type

Public health and

product claim


Yes

8

Air-‐O-‐Swiss 7135 (Ultrasonic) claims: “Ag+ Ionic Silver Technology Inside “; “Water and Hygiene -‐ The plastic housing of the demineralization cartridge is silver treated (Ag+ Ionic Silver Technology). That inhibits microbial growth on the surface of the cartridge to maximize filter life.” Claim concern: Unclear-‐Treated article antimicrobial claims are limited to the filter where the water goes after the reservoir but before emissions. Bacteria did have the potential to emit although there was no significant growth in the reservoir tank.


No


Yes

Claim type

Product claim


Unclear

Pureguardian H900 (Ultrasonic) claims: “Silver Clean Technology Fights the Growth of Mold and Mildew on the Surface of the Water Tank”; “Silver Clean Technology pureguardian Ultrasonic Humidifiers use Silver Clean technology to reduce the growth of mold and mildew on the surface of the water tank, a common problem with traditional humidifiers” Claim concern: Although these antimicrobial treated article claims are limited to mold and mildew, our findings suggest that microbial loads in reservoirs can grow and bacteria has the potential to be emitted, raising questions about the use of the claim “silver clean”. Our tests found significant microbial growth in the reservoir.


Yes


Yes

Claim type

Product claim


No

9

Stadler Form Aquila (Ultrasonic) claims: “Accessories Ionic Silver Cube”; “Ionic Silver Cube with patented technology reliably protects the water from germ contamination”; “Ionic Silver Cube prevents the growth of bacteria and germs -‐ Insert in the base before attaching water tank. It must be replaced every season.” Claim concern: Treated article claim of “ionic silver cube...reliably protects the water from germ contamination”. Our tests found significant microbial growth in the reservoir.


Yes


Yes

Claim type

Product claim


No

Vicks V5100NS (Ultrasonic) claims: “Includes free demineralization cartridge to help trap impurities in water “; “The water tank feeds water into the misting tray passing through the demineralization cartridge to trap impurities in the water and help prevent white dust. “ Claim concern: Treated article claim about trapping impurities in water. Our tests found significant microbial growth in the reservoir.


Yes


Yes

Claim type

Product claim


No

Holmes HM1761 (Evaporative) claims: “Antimicrobial Product Protection“ Claim concern: Bacteria did grow in reservoir (though humidifier did not have the potential to emit bacteria)


Yes


No

Claim type

Product claim


No

10

Holmes HM495 (Ultrasonic) claims: “Antimicrobial Protection”; “Antimicrobial protection is infused into the plastics to help prevent the growth of bacteria that can cause stains and odors or adversely affect performance.*” and refers to “*This information is based upon standard laboratory tests and is provided for comparative purposes to substantiate antimicrobial activity for nonpublic health applications. Antimicrobial additive is not designed to protect users from disease causing microorganisms. Antimicrobial additive inhibits the growth of microorganisms that cause stains and odors. Antimicrobial action limited to product surface.” Claim concern: Treated article claim of antimicrobial protection of plastics. Our tests found significant microbial growth in the reservoir.


Yes


Yes

Claim type

Product claim


No

Honeywell HCM-‐750 (Evaporative) claims: Antimicrobially treated filter helps remove impurities from the water(3)”; and refers to “(3) The antimicrobial agent contained in the filter is intended to prolong filter life only by inhibiting the growth of unsightly mold, mildew and algae, as well as controlling odor from odor causing bacteria. The antimicrobial agent in the filter does not protect the user or others against bacteria, germs, viruses or other disease causing organisms. Always follow manufacturers instructions regarding cleaning, maintenance and service of your humidifier. Estimate filter life 1-‐2 months based on water quality. “ Claim concern: None. Assume that water enters filter after the reservoir and prior to emission. Humidifier did not have the potential to emit bacteria.


Yes


No

Claim type

Product claim


Yes

11

Kenmore 3688 (Evaporative) claims: “Antimicrobial Protection Helps prevent growth of bacteria on product surface**”; “Antimicrobial Protection Added to the product's surface to help prevent the growth of bacteria that can cause stains and odors or adversely affect product performance.**” and refers to “**This information is based upon standard laboratory tests and is provided for comparative purposes to substantiate antimicrobial activity for nonpublic health applications. Antimicrobial additive is not designed to protect users from disease-‐causing microorganisms. Antimicrobial additive inhibits the growth of microorganisms that cause stains and odors. Antimicrobial action limited to product surface. “; “EPA Est. 064914-‐CHN-‐001” Claim concern: None. Assume that water enters filter after the reservoir and prior to emission. Humidifier did not have the potential to emit bacteria.


Yes


No

Claim type

Product claim


Yes

ProCare PCCM-‐840 (Evaporative) claims: “Water is then absorbed by the wicking filter trapping minerals and other impurities”; “It helps capture minerals and impurities in the water.” Claim concern: None. Assume that water enters wicking filter after the reservoir and prior to emission. Humidifier did not have the potential to emit bacteria.


Yes


No

Claim type

Product claim


Yes

12

Stadler Form William (Ultrasonic) claims: “Ionic Silver Cube prevents the growth of bacteria and germs” Claim concern: None. Treated article claim that “Ionic Silver Cube prevents the growth of bacteria and germs” and is placed in base of tank. No significant bacteria growth in reservoir tank.


No


Yes

Claim type

Product claim


Yes

Vicks V3700 (Evaporative) claims: “Water is then absorbed by the wicking filter trapping minerals and other impurities.” Claim concern: None. Assume that water enters wicking filter after the reservoir and prior to emission. Humidifier did not have the potential to emit bacteria.


Yes


No

Claim type

Product claim


Yes

Crane Drop (Ultrasonic)


Yes


Yes

Claim type

No claim


NA

13

Crane Elephant (Ultrasonic)


Yes


Yes

Claim type

No claim


NA

Crane Frog (Ultrasonic)


Yes


Yes

Claim type

No claim


NA

Crane Owl (Ultrasonic)


Yes


Yes

Claim type

No claim


NA

Honeywell HUT-‐300 (Ultrasonic)


Yes


Yes

Claim type

No claim


NA

14

Safety 1st Ultrasonic 360 (Ultrasonic)


Yes


Yes

Claim type

No claim


NA

SPT SU-‐3750 (Ultrasonic)


Yes


Yes

Claim type

No claim


NA

SPT SU-‐4010 (Ultrasonic)


Yes


Yes

Claim type

No claim


NA

SPT SU-‐9210 (Evaporative)


Yes


No

Claim type

No claim


NA

15

Vicks V150SGN (Vaporizor) claims: none


No


No

Claim type

No claim


NA

Vicks V4600 (Ultrasonic)


Yes


Yes

Claim type

No claim


NA

Vornado EVAP2 (Evaporative)


Yes


No

Claim type

No claim


NA

Vornado EVAP3 (Evaporative)


Yes


No

Claim type

No claim


NA

16

Vornado Ultra1 (Ultrasonic)


Yes


Yes

Claim type

No claim


NA

gina mccarthy administrator environmental protection agency 1200

Documents