United States Department of Agriculture

Animal and
Plant Health Inspection
Service

Policy and Program Development

Environmental and
Risk Analysis Services, Unit 149
4700 River Road
Riverdale

, MD
20737 

# USDA 

# iiiiii

Ms. TaWanda Maignan, Section 18 Team Leader

Risk Integration, Minor Use, and Emergency Response Branch

Office of Pesticide Programs (7505P)

U.S

. Environmental Protection Agency

1200 Pennsylvania Avenue, N.W.

Ariel Rios Building Washington, DC 20460

ATTN: Ms

. TaWanda Maignan, Section 18 Team Leader ENQL 7-1 CY13

PERMANENT

Retire 03118

March 26, 2013

Risk Integration, Minor Use, and Emergency Response Branch

SUBJECT: Request to Renew Ethylene Oxide Quarantine Exemption (EPA File SymbollO-DA-01)

Dear Ms. Maignan:

The United States Department of Agriculture (USDA) Animal and Plant Health Inspection

Service (APHIS) is requesting to renew their ethylene oxide quarantine exemption (EPA File Symbol10-DA-Ol) approved for use on March 11, 2010

. This exemption allowed for the

sterilization of interior surfaces of enclosed animal isolator units used at USDA National Veterinary Services Laboratories (NVSL) and the National Animal Disease Center (NADC)

in Ames, Iowa (EPA File Symbol10-DA-01).

NVSL and NADC provide diagnosis for animal diseases and diagnostic support for disease

control and eradication. Without the ability to sterilize animal isolators, NVSL and NADC

would not be able to conduct studies of national importance. Ethylene oxide is an effective sterilizer, yet is non-corrosive on delicate instruments and electrical equipment.

Oxyfume ® 2000 (EPA Registration Number 67470-8) was the only product approved for use under the previous exemption. This product will only be available for use up until December 31, 2014

. Prior to this date, APHIS intends to submit an amendment request and replace Oxyfume ® 2000 with an alternate product.

If you have any questions regarding this application, please contact Samantha Bates Floyd at (301) 851-3053 or e-mail Samantha.B.Floyd@aphis

. usda.gov.

Sincerely,**ff~** 

### a.

.**n~:~:_...** -F'trr**,r- ·**  David S. Reinhold Chief, Environmental and Risk Analysis Services Policy and Program Development

Attachment

APHIS Safeguarding American Agriculture 

### .o::;::;e::;; APHIS is an agency of USDA ' s Marketing and Regulatory**Pr~grams**

... An Equal Opportunity Provider and EmployerMs. Maignan Page 2

cc: R. Stoker, USDA, APHIS, Ames, IA

DS file: Section 18 / Ethylene Oxide (10-DA-01) renewal/FY2013TYPE OF EXEMPTION BEING REQUESTED

QUARANTINE EXEMPTION

CONTACT PERSON AND QUALIFIED EXPERT

Name: Samantha Bates Floyd
Title: Biological Scientist Organization: U.S. Department of Agriculture

, Animal and Plant Health Inspection Service
Address: 4700 River Road, Unit 149 Riverdale, MD 20737
Phone: (301) 851

- 3053
E

- mail: Samantha.B.Floyd@aphis.usda.gov

DESCRIPTION OF PESTICIDE REQUESTED

Product Name: Oxyfume® 2000 (until December 31 , 2014) Active Ingredient: Ethylene Oxide, CAS No. 75

- 21

- 8; C 2 H 4 O 4 EPA Registration Number : 67470

- 8 % Active Ingredient(s) , Formulation(s) : 8.6 %
Manufacturer: Honeywell, 101 Columbia Road

, Morristown, NJ 07962

- 1053

DESCRIPTION OF PROPOSED USE

Sites and area to be treated :

Gnotobiotics is the scientific study of animals or other organisms raised in environments that are free of germs or that contain only specifically known germs. Scientists compare gnotobiotic animals with ordinary animals whose bodies carry many bacteria, viruses, and parasites. In this way, scientists can determine more precisely how specific germs affect the body. Scientists also use these germ

- free unit s to raise animals for antibody production and the subsequent collection of their sera.

The United States Department of Agriculture, Animal and Plant Health Inspection Service’s National Veterinary Services Laboratories ( USDA APHIS NVSL) provides diagnos e s for animal diseases and diagnostic support f or disease control and eradication of programs of national importance. As such, NVSL conducts animal research requiring the use of a germ

- free environment. The National Animal Disease Center (NADC) is co

- located with NVSL in Ames, IA. The NADC is the large st federal animal
disease center in the United States . The NADC conducts research to solve animal health and food safety problems faced by livestock producers and the public. There are animal experiments at the NADC that require a germ

- free environment.

Under this Section 18, ethylene oxide would be used to sterilize the interior surfaces of self

- enclosed
animal isolator units used in NVSL and NADC in Ames, I A . The animal isolator units are composed of plastic material with PVC pipe connections and some stainless steel connections. The photographs
locate d at http://www.cbclean.com/isolators/34875

- 2x.jpeg (see a ppendix 1 ) are representation s of animal
isolator units . The isolator units used by APHIS and the Agricultural Research Service ( ARS ) in AmesDESCRIPTION OF PROPOSED USE are tub isolators suitable for baby pigs or a calf. Pig isolators made of PVC plastic are 26” by 43” by 32”
in size and fit over a 24” by 42” by 24” stainless steel base. A second (au xiliary isolator) is used to store feed and supplies during an animal experiment. Items are transferred from the auxiliary isolator to the animal isolator through a sleeve between both isolators. The secondary isolator is 30” by 48” by 30” in
size. The bas e of the calf isolator (also made of stainless steel) is 50” by 25” by 16” and the plastic cover is 90” by 34” by 32”.

Method of application : S ix pounds of Oxyfume® 2000 i s added to each animal isolator unit using a compressed gas cylinder

. The scale used to measure the addition of ethylene oxide gas to isolator units has a welded base and securing mechanism to ensure the ethylene oxide cylinder does not inadvertently tip over. Oxyfume®
2000 will be added to each isolator ( 6 lbs to the animal isolator and an additional 6 lbs to the auxiliary isolator) through a hose coupling (i.e., injection port ).

Rate of application (in terms of active ingredient and formulated product) : As described above in the section on the method of applic ation, 6 lbs. of Oxy fume® 2000 is applied to
each animal isolator unit.

Maximum number of applications:
Animal isolator units will be sterilized 5 to 7 times with Oxyfume® 2000 over the 3

- year term of this exemption ; a maximum of 9 tub isolators for pigs, 9 auxiliary isolators that attach to the tub isolators for pigs, 2 tub isolators for calves, and 2 auxiliary isolators that attach to the tub isolators for calves would be sterilized under this Section 18 per year. Alt ernatively, a total of 13 auxiliary isolators may be used to isolate mice while operating 2 calf isolators at the same time.

Total amount of pesticide to be used (in terms of active ingredient and formulated product) : A total of approximately twelve poun ds of product to fumigate one tub isolator for pigs hooked up to one auxiliary isolator. The same amount is used to fumigate one tub isolator for a calf attached to an auxiliary
isolator.

Additional restrictions, user precautions, and requirements, qualif ications of applicators, etc. :

To be used only by persons experienced in Oxyfume® 2000 sterilization and fumigation. The produc t may be used safely to sterilize animal isolators and the equipment and supplies placed within isolators.

Oxyfume® 2000 may be used only in facilities that meet the requirements of 29 CFR 1910.1047. The product may be used only by persons who have been trained in accordance with 29 CFR 1910.1047

.

Duration of the proposed use: As needed in preparation for experiments in veter inary research. The use of an isolator is dependent on the length of the last animal study and logistics (i.e., the time for an animal order and necessary experimental supplies to come and time to clean and fumigate the bubble).ALTERNATIVE METHODS O F CONTROL (Efficacy data and/or other information included as a separate attachment)

Registered Alternative Pesticides : A lternative sterilizers containing ethylene oxide are available

, but none contain the specific percentage of ethylene oxide and other refrigerant chemicals that Oxyfume ® 200 0 contains.

Ethylene oxide is non

- corrosive on delicate instruments and electrical equipment. There are no good
alternative methods of control. The possibility of using Clidox, Vaporized Hydrogen Peroxide (VHP)

, and Paraformaldehyde was considered, but these substances are not viable alternatives. C lidox would
corrode the stainless steel portion of the isolator

, VHP would only provide surface dec ontamination

, and

p araformaldehyde would leave a residue that would be potentially detrimental to the animals in the
isolator.

Alternative Control Practices : Cleaning th e anim al isolator units with general cleaning products provides some level of reduction of the microbial load, but it is not as effective as general cleaning followed by sterilization with ethylene oxide. Due to the nature of the experiments being conducted, assurance of a sterile environment is critical.

EFFICACY OF USE PROPOSED UNDER SECTION 18 (Efficacy data and/or other information included as a separate attachment) Ethylene oxide is a sterilant that destroys or eliminates all forms of microbial life in the inanimate environment, including all forms of vegetative bacteria, bacterial spores, fungi, fungal spores, and viruses. All registered ethylene oxide products making sterilization claims have passed efficacy tests for their registered uses.

EPA

- registered uses of ethylene oxide already exist to sterilize hospit al items; to treat processed spices and seasonings; and to treat commercial food processing, handling, and storage facilities. When used directly in the gaseous form or in non

- explosive gaseous mixtures, ethylene oxide can act as a disinfectant, fumigant, sterilizing agent, and insecticide.

As of September 14, 2006, EPA’s Pesticide Document Management System contains 73 citations for efficacy data submitted on ethylene oxide products. We believe the efficacy of ethylene oxide against the target pests as d escribed in this Section 18 application is well documented.

EXPECTED RESIDUE LEVELS IN FOOD (Residue data included as a separate attachment)

This is a nonfood/feed use that will be applied in a manner that will not contaminate food, feed, or water.DISCUSSION OF RISK INFORMATION (Potential risks to human health, endangered or threatened species, beneficial organisms, and the environment) Description of application sites, including proximity to residential areas, aquatic systems, endangered or threatened species habitats, soil types, etc .: When used as proposed on this Section 18 application, ethylene oxide would be used to sterilize the
interior surfaces of self

- enclosed animal isolator units

. These animal isolator units are located within

re search areas of USDA APHIS veterinary research laboratories in Ames, Iowa. These laboratories are located inside the buildings. The composition of the compressed gas is 10% e thylene oxide and 90% freon. A freon monitor will be used to detect any potentia l leakage. Animal isolators are located in negative pressure rooms in an animal containment facility. Floor drains lead to a wastewater pretreatment facility on site, but may be capped if necessary during the application of ethylene oxide to
isolators.

EPA

- registered uses of ethylene oxide already exist to sterilize hospital items; to treat processed spices and seasonings; and to treat commercial food processing, handling, and storage facilities. When used directly in the gaseous form or in non

- explosive gaseous mixtures, ethylene oxide can act as a disinfectant, fumigant, sterilizing agent, and insecticide.

Possible risks posed by use : General risks: Pesticides have the potential to produce long

- term damage to the environment if not used and disposed of in accordance with label instructions and other local, State and/or Federal statutes. However, damage to the environment from short

- term use of pesticides during emergency pest eradication and prevention campaigns is not expected because of their limi ted and infrequent use.

If not used correctly according to all applicable label language concerning use, transport, handling and disposal, pressurized gas containers are potentially hazardous

.

Proposals to mitigate risks: A copy of the EPA

- approved label , material safety data sheet, and technical information sheet for Oxyfume® 2000 is contained in a ppendix 2 , 3, and 4, respectively . Th e product should only be handled and applied by persons experienced in Oxyfume® 2000 sterilization and fumigation. The product may be used only in facilities that meet the requirements of 29 CFR 1910.1047. The product may be used only by persons who have been trained in accordance with 29 CFR 1910.1047

.

Personnel using ethylene oxide must receive annual Occupationa l Safety and Health Administration (OSHA) required training (Title 29, Code of Federal Regulations, Part 1910.1047). The individual adding sterilant gas to each isolator will wear a full

- face, in

- line supply respirator with a 5 or 10

- minute escape bottle. A second individual serves as an observer immediately outside of the room where animal isolators are located. Although the need is not anticipated

, this person is available to summon emergency assistance. This person is also required to receive annual e th ylene oxide training.

With strict adherence to the label's application instructions and applicable worker monitoring and safety requirements, the Environmental Protection Agency believes that

, no unreasonable adverse health effects
will occur from use of this chemical.

Ethylene oxide personal breathing zone sampling using passive dosimetry will take place twice a year. NOTE: Apply this product as specified by the Federal label and all applic ation methods described under the terms of this quarantine exemption.COORDINATION WITH OTHER AFFECTED FEDERAL, STATE, AND LOCAL AGENCIES

EPA regulates ethylene oxide under the Clean Air Act; Comprehensive Environmental Response, Compensation, and Liability Act; Federal Insecticide, Fungicide, and Rodenticide Act; Resource Conservation and Recovery Act; Superfund Amendments and Reauthorizati on Act; and the Toxic Substances Control Act. OSHA regulates ethylene oxide under Title 29, Code of Federal Regulations,
Part 1910.1047.

Because of the limitations of the use proposed in this Section 18 application, no impacts to threatened or endangered species are anticipated. No coordination with the U.S. Fish and Wildlife Service is anticipated for this Section 18.

ACKNOWLEDGEMENT BY REGISTRANT

See a ppendix 5 for letter of acknowledgement from Oxyfume® 2000 manufacturer, Honeywell

.

ENFORCEMENT PROGRAM (Explanation of legal authority and program resources for enforcement)

Use data will be collected and reported as required to EPA per the requirements outlined in 40 CFR 166.32. Treatments conducted out of compliance with applicable APHIS Veterinary Services memoranda, directives

, or legal authorities are reported to Veterinary Services to be addressed by
management.

REPEAT USES (If use being requested is a repeat use, and final report has not been filed, interim final report included as a separate attachment)

Interim and final report will be filed at the appropriate time.NAME OF PEST(S)

Under the use described in this Section 18 application, the pesticide will be used to inactivate forms of
microbial life in the inanimate environment, including all forms of vegetative bacteria, bacterial spores, fungi, fungal spores, and viruses

.

ORIGIN OF INTRODUCED PEST(S)

Origin of pest, means of introduction, and spread into the area (if known) :

The target pests described in this application are ubiquitous in the environment

. It is not possible to determine the origins of the pests or the means of introduction. If not controlled by pesticides, the spread of the pests takes place via the defined reproductive mech anisms of the bacteria, fungi or virus.

IMPACT OF THE PEST

Anticipated impact of not controlling pest, and other information pertinent to economic importance of this pest :

Gnotobiotic research at the NVSL and NADC consists primarily of the use of CDCD (cesarean derived

– colostrum deprived) pigs and calves. Raised in a germ

- free animal isolator

, the use of CDCD animals ensures scientists can focus on specific microbes, antibodies, metabolic pathways, and other criteria that impact on the diagnosis and control of animal diseases in the United States and abroad.

Without the ability to sterilize animal isolators

, the NVSL and NADC are not able to conduct animal disease research as it relates to the diagnosis and control of these diseases.