Page 1 of 4 

### EPA Response to Written Comments Received from USDA

On the Proposed Rule: Declaration of Prion as a Pest under FIFRA and

Amendment of EPA’s Regulatory Defi nition of Pests to Include Prion

RIN 2070-AJ26; Docket ID No. EPA–HQ–OPP–2010–0427

Prions_NPRM_USDAcomments_EPAresponses_2010-10-18.docx



### In accordance with section 25(a) of the Fede ral Insecticide, Fungicide, and Rodenticide

Act (FIFRA), EPA submitted a draft of the prop osed rule to the Secretary of Agriculture

(USDA). Written comments received from US DA on September 7, 2010, and EPA responses to

those comments provided on September 21, 2010, are presented in this document. USDA

participated in the interagency review pro cess under Executive Order 12866, and changes made

to the proposed rule in response to all comments received during that interagency review are

documented in the docket as required by Executive Order 12866.

1. USDA Comment: The U.S. Department of Agriculture, Animal and Plant Health Inspection

Service, Veterinary Services (USDA/APHIS/VS) an ticipates that due to the expense of obtaining

a registration for these (prion-related) produc ts, no company will seek such registration.

Furthermore, in the event that a company does seek registration for one or more of these

products, the conditions of the label will not be su itable for use in agricultural settings. As a

result, there will not be a product available that we can officially use or recommend in our

programs.

EPA Response: EPA acknowledges that the cost of ge nerating efficacy data to support the

registration of a prion-relate d product present a hurdle for some companies considering

registration. If no company or federal agency applies for and obtains a registration for a

pesticide with a prion-related claim, then US DA would be correct in saying that no registered

product would be available for USDA to use or recommend, and the status quo would continue.

In response to USDA’s statement that “conditions of the label will not be suitable for use in

agricultural settings,” it appears that USDA is assuming that a regist rant would only pursue

approval of its product for use in laboratori es. USDA should understand, however, that a

company which applies for regist ration may list any use sites at which prions or prion-related

diseases could be expected to occur, includi ng veterinary laboratories , animal premises and

equipment. If registered for those uses, su ch a product certainly could be used by USDA.

2. USDA Comment: Because of the situation described in 1 above, APHIS Veterinary Services

will need to obtain Section 18 exem ptions for the use of these three products. We appreciate the

partnership EPA has demonstrated in recent years to help VS obtain such exemptions with a

minimal burden on our resources, and it is our in tention to apply for them. However, the

quarantine exemption is based on emergency co nditions. Our emergency condition is that no

registered product is available for use in our programs, and that coll ectively the presence of

animal prions in our animal populations and in the environment constitutes a threat to animal

agriculture and in the case of BS E, public health. While the EP A indicates that they currently

recognize this as a valid emergency condition, our c oncern is that this recognition is subject to

change overtime. We could face a scenario in the future where no product has been registered,

or a product has been registered but is not suitable for use in an agricultural setting, and EPA

decides not to renew the Section 18 exempti on, or implements additional requirements for

renewal.Page 2 of 4 

### EPA Response: EPA will work with USDA and the regulated community to support the

development and registration of prion-relate d products, and EPA will continue to approve

requests for emergency exemptions where it finds that the applicable regulatory criteria are met.

3. USDA Comment: The State of Californi a requires that individua ls applying pesticides

regulated under FIFRA be certified applicators. APHIS Veterinary Services is concerned that

our partner laboratories and our disease programs in this state will not be able to perform their

functions without having a certifie d applicator, which will signifi cantly increase costs and delay

decontamination of facilities. For laboratories, using a certified applicator is impractical since

these products are used numerous times per day by different personnel.

EPA Response: USDA appears to be referring to a requirement that is being imposed by the

California Department of Pesticide Regulation (CDP R) that pesticides used pursuant to a FIFRA

Section 18 emergency exemption be applied on ly by certified applicators. EPA further

understands, however, that the state of California has no such requirement for pesticide products

that are registered under FIFRA Section 3 or 24( c) (i.e., “special loca l needs”) that are not

classified for restricted use. Hence, USDA a nd its partner laboratories and disease programs in

California would not be subject to a certified applicator requi rement for any prion-related

product registered under FIFRA Section 3 or Section 24(c).

4. USDA Comment: APHIS Veterinary Services recently learned that EPA is considering a

proposed rule that will require the use of a certified applicat or when applying pesticides

regulated under FIFRA. This would create a na tionwide challenge similar to the one described

for California.

EPA Response: EPA is not considering requiring that products subject to emergency

exemptions routinely be applied by certifie d applicators only. Where EPA approves an

emergency use of a pesticide already classified fo r restricted use, the emergency use is typically

restricted to certified applicat ors as well. However, EPA has no intention of routinely requiring

that pesticides subject to emer gency exemptions be applied only by certified applicators.

5. USDA Comment: EPA has suggested that the label cl aim for these products can be a generic

statement that the product has been shown to reduce prion infectivity with a parenthetical

statement describing the prion type used to dem onstrate its efficacy. APHIS Veterinary Services

supports this approach. We woul d be concerned if the label claim has to be more specific, for

example that sodium hydroxide has been show n to reduce infectivity on BSE contaminated

surfaces. Such a label claim would restrict the use of the product to BSE-related

decontamination.

EPA Response: EPA’s draft guidance for efficacy testi ng of prion-related products contains an

example of an acceptable label claim that reads, “H as been demonstrated to reduce infectivity of

prions based on testing using hams ter-adapted scrapie.” Such a claim is intended to include the

type of prion against which the product was test ed but also allow application of the product for

reducing the infectivity of any type of prion. EPA appreciates the USDA’s support of the way in

which EPA has worded an acceptable cl aim for a prion-related product.

6. USDA Comment: The U.S. Department of Agricu lture, Agricultural Research Service

(USDA/ARS) believes that EPA ha s jurisdiction in this matter and it seems that it would be up to

the federal attorneys to challenge this if USDA disagrees further. EPA will change the preamblePage 3 of 4 

### to the proposed rule to clarify th at they do not consider prions a ssociated with scrapie or CWD to

be human pathogens, which is appropriate. The issue then becomes the impact of the rule.

EPA Response : As discussed with USDA, EPA will revi se the draft preamble to clarify that

prions associated with scrapie or CWD are only linked to animal diseases.

7. USDA Comment: The first use is decontamination of hard surfaces and equipment used in

diagnostic laboratories. EPA appears to be re assuring USDA that the "prionicides" currently

used might continue to be available under a "quarantine exemption" so that NVSL and the

network of veterinary laboratories could continue to work as th ey do now. APHIS would need to

comment on that section if they are still concerned. Another c oncern is that as of May 28, 2010,

Steris will no longer sell Environ LpH (see attachment ). This means that if the rule were enacted

and prions were declared to be a pest unde r FIFRA, then there would be no EPA approved

(registered) or section 18 exempt prionicide. It would be a pest without an approved pesticide.

This also means the assumption that other compan ies will rush to register their material is

probably not valid. The producers of bleach and/or sodium hydroxide were never expected to

push for registration of their compounds. It is hi ghly likely that there will be no EPA approved

prionicides. If the market for prionicide s is not large enough to justify the expense

manufacturing and selling a product, then it is too small to regi stering a product and maintaining

that product’s registration. The USDA can ask for an emergency exemption and it may be

granted, but this is usually a temporary solutio n. How long will the EPA emergency exemption

last?

EPA Response: EPA will work with USDA and the regulated community to support the

development and registration of prion-relate d products, and EPA will continue to approve

requests for emergency (quarantine) exemptions where it finds that the applicable regulatory

criteria are met. Regarding USDA’s comment that Environ LpH is no longer being sold and “the

assumption that other companies will rush to regist er their material,” EPA has, in fact, made no

such assumption. EPA’s Economic Analysis for this proposed rule assumed, for purposes of

calculating possible economic impact s of the proposed rule, that th ree companies might apply for

registration of the three curren tly unregistered pr ion-related products—Environ LpH, sodium

hypochlorite and sodium hydroxide. EPA acknowledges that the cost of generating efficacy data

to support the registration of a pr ion-related product could presen t a hurdle for some companies

considering registration. If no co mpany or federal agency applies for and obtains a registration

for a pesticide with a prion-related claim, then USDA is correct in sayi ng that no registered

product would be available for USDA (or anyone else) to use or recommend. However,

quarantine exemptions may be issued to USDA a nd/or states and subseq uently renewed, if EPA

finds that the applicable re gulatory criteria are met.

8. USDA Comment: USDA/ARS could support the regist ration of Bleach and/or sodium

hydroxide. While it would be permanent, it would also take time to collect the data and it would

be expensive (EPA estimates (~ $ 1,000,000 or more for both). Enacting this rule will put a

significant burden on the prion rese arch community and on the USDA.

EPA Response: For the Economic Analysis, EPA obt ained cost estimates from several

laboratories for developing efficacy data for pr ion-related products that ranged from $100,000 to

$1,000,000. The proposed rule would not have a co st impact on USDA unless it chose to

develop the efficacy test data needed to support registration of bleach or sodium hydroxide. If

the USDA were to undertake such testing, it is difficult to estimate what the cost to USDA might

be unless the type of prion (e.g., sc rapie, CWD) to be tested and the specific test protocol werePage 4 of 4 

### known. EPA acknowledges that the costs associated with developing data sufficient to support

registration could be substantial, but so are the risks associated w ith ineffective prion treatment.

9. USDA Comment: USDA/ARS is not sure EPA has c onsidered the issue of premises

decontamination (important for Scrapie and CW D). The sheep and captive cervid industries

have both expressed a strong intere st in ARS research in the matte r of premises decontamination

because the current methods are expensive and di fficult for producers. If ARS develops a lower

cost method for premises treatment to meet th e industry needs, moving this product to market

with an estimated $ 5 million pr ice tag (includes research costs) seems counterproductive. The

issues of "standard for testing effectiveness of the products" and the costs therein are therefore a

concern.

EPA Response: USDA could include premises decontam ination in its request for quarantine

exemptions. The proposed rule does not preven t ARS from developing lower cost methods for

animal premises decontamination. If the new me thod would involve a product that might require

registration under FIFRA, then EPA would encourag e ARS to consult with EPA on the draft test

protocols to assure that the te st results would be useful for regulatory decision-making. EPA

could also provide guidance to the USDA on how it could pursue registration of a product of its

own most efficiently and economically.

Attachment:

Incoming Written Comments from USDA, 09/07/2010

## 09/07/2010

USDA Response to EPA Proposed Rule, adding “prion” to the list of pests under

40 CFR 152.5.

Issue:

EPA intends to publish a proposed rule that would amend 40 CFR 152.d to include prions as a pest to be

regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). A consequence of this

action is that any product intended to inactivate any prion on inanimate surfaces would be considered a

pesticide and would be regulated as such. If finalized in its current form, the proposed rule would

adversely affect APHIS prion disease programs.

The use of sodium hydroxide (lye), sodium hypochlorite (bleach), and Environ LPH is an important

element in three APHIS Veterinary Services prion disease programs: scrapie; chronic wasting disease

(CWD); and bovine spongiform encephalopathy (BSE). These products are used in the decontamination

protocols on farms that have been contaminated with animal prions and in the diagnostic laboratories

that test animal samples.

The effectiveness of sodium hydroxide and sodium hypochlorite in reducing prion infectivity has been

well documented in studies dating back to the 1980s (Brown et al, 1986, Diringer et al, 1989, Kimberlin

et al, 1983, Pruisner et al, 1984, Taguchi et al, 1991, Tamai et al, 1988, and Taylor, 1994, 1997, and

2000). Additionally, these products are recommended by the World Health Organization for prion

disinfection (WHO, 2000). Environ LpH has also been reported in the literature to reduce prion

infectivity (Ernst and Race, 1993). Therefore, in the current environment there is a process for reducing

the infectivity of prions that has been demonstrated to have a reasonable level of effectiveness, and is

commonly used in both human and animal health settings.

Animal and Plant Health Inspection Service, Veterinary Services has five points of concern regarding the

impact of this proposed rule.

1. We anticipate that due to the expense of obtaining a registration for these products, no

company will seek such registration. Furthermore, in the event that a company does seek

registration for one or more of these products, the conditions of the label will not be suitable for

use in agricultural settings. As a result, there will not be a product available that we can

officially use or recommend in our programs.

2. Because of the situation described in 1 above, APHIS Veterinary Services will need to obtain

Section 18 exemptions for the use of these three products. We appreciate the partnership EPA

has demonstrated in recent years to help VS obtain such exemptions with a minimal burden on

our resources, and it is our intention to apply for them. However, the quarantine exemption is

based on emergency conditions. Our emergency condition is that no registered product is

available for use in our programs, and that collectively the presence of animal prions in our

animal populations and in the environment constitutes a threat to animal agriculture and in the

case of BSE, public health. While the EPA indicates that they currently recognize this as a validemergency condition, our concern is that this recognition is subject to change overtime. We

could face a scenario in the future where no product has been registered, or a product has been

registered but is not suitable for use in an agricultural setting, and EPA decides not to renew the

Section 18 exemption, or implements additional requirements for renewal.

3. The State of California requires that individuals applying pesticides regulated under FIFRA be

certified applicators. APHIS Veterinary Services is concerned that our partner laboratories and

our disease programs in this state will not be able to perform their functions without having a

certified applicator, which will significantly increase costs and delay decontamination of

facilities. For laboratories, using a certified applicator is impractical since these products are

used numerous times per day by different personnel.

4. APHIS Veterinary Services recently learned that EPA is considering a proposed rule that will

require the use of a certified applicator when applying pesticides regulated under FIFRA. This

would create a nationwide challenge similar to the one described for California.

5. EPA has suggested that the label claim for these products can be a generic statement that the

product has been shown to reduce prion infectivity with a parenthetical statement describing

the prion type used to demonstrate its efficacy. APHIS Veterinary Services supports this

approach. We would be concerned if the label claim has to be more specific, for example that

sodium hydroxide has been shown to reduce infectivity on BSE contaminated surfaces. Such a

label claim would restrict the use of the product to BSE

‐ related decontamination.

Agricultural Research Service’s comments on the rule.

1. EPA feels that they have jurisdiction in this matter and it seems that it would be up to the

federal attorneys to challenge this if USDA disagrees further. EPA will change the preamble to

the proposed rule to clarify that they do not consider prions associated with scrapie or CWD to

be human pathogens, which is appropriate. The issue then becomes the impact of the rule.

2. The first use is decontamination of hard surfaces and equipment used in diagnostic

laboratories. EPA appears to be reassuring USDA that the "prionicides" currently used might

continue to be available under a "quarantine exemption" so that NVSL and the network of

veterinary laboratories could continue to work as they do now. APHIS would need to comment

on that section if they are still concerned. Another concern is that as of May 28, 2010, Steris will

no longer sell Environ LpH (see attachment). This means that if the rule were enacted and

prions were declared to be a pest under FIFRA, then there would be no EPA approved or section

18 exempt prionicide. It would be a pest without an approved pesticide. This also means the

assumption that other companies will rush to register their material is probably not valid. The

producers of bleach and/or sodium hydroxide were never expected to push for registration of

their compounds. It is highly likely that there will be no EPA approved prionicides. If the market

for prionicides is not large enough to justify the expense manufacturing and selling a product,

then it is too small to registering a product and maintaining that product’s registration.The

USDA can ask for an emergency exemption and it may be granted, but this is usually a

temporary solution. How long will the EPA emergency exemption last?

3. USDA could support the registration of Bleach and/or sodium hydroxide. While it would be

permanent, it would also take time to collect the data and it would be expensive (EPA estimates

(~ $ 1,000,000 or more for both). Enacting this rule will put a significant burden on the prion

research community and on the USDA.4. ARS is not sure EPA has considered the issue of premises decontamination (important for

Scrapie and CWD). The sheep and captive cervid industries have both expressed a strong

interest in ARS research in the matter of premises decontamination because the current

methods are expensive and difficult for producers. If ARS develops a lower cost method for

premises treatment to meet the industry needs, moving this product to market with an

estimated $ 5 million price tag (includes research costs) seems counterproductive. The issues of

"standard for testing effectiveness of the products" and the costs therein are therefore a

concern.

References:

Brown, P., Rohwer, R.G. & Gajdusek, D.C. (1986). Newer data on the inactivation of scrapie virus or

Creutzfeldt

‐ Jakob disease virus in brain tissue. Journal of Infectious Diseases 153

, 1145

‐ 1148.

Diringer, H. & Braig, H.R. (1989). Infectivity of unconventional viruses in dura mater. Lancet i

, 439

‐ 440.

Ernst, D.R. & Race, R.E (1993). Comparative analysis of scrapie agent inactivation. Journal of Virological

Methods 41

, 193

‐ 202.

Kimberlin, R.H., Walker, C.A., Millson, G.C., et al (1983). Disinfection studies with two strains of mouse

passaged scrapie agent. Journal of Neurological Science 59

, 355

‐ 369.

Pruisner, S.B., McKinley, M.P., Bolton, D.C., et al (1984). Prions: methods for assay, purification, and

characterization. In Methods in Virology

, vol viii, eds. K. Maramorosch & H. Koprowski, New York:

Academic Press, pp. 293

‐ 345.

Taguchi, F., Tamai, Y., Uchida, K., et al (1991). Proposal for a procedure for complete inactivation of the

Creutzfeldt

‐ Jakob disease agent. Archives of Virology 119

, 297

‐ 301.

Tamai, Y., Tacuchi, F. & Miura, S. (1988). Inactivation of the Creutzfeldt

‐ Jakob disease agent. Annals of

Neurology 24, 466

‐ 467.

Taylor, D.M., Fraser, H., McConnell, I., et al (1994). Decontamination studies with the agents of bovine

spongiform encephalopathy and scrapie. Archives of Virology 139

, 313

‐ 326.

Taylor, D.M., Fernie, K. & McConnell, I. (1997). Inactivation of the 22A strain of scrapie agent by

autoclaving in sodium hydroxide. Veterinary Microbiology 58

, 87

‐ 91.

Taylor, D.M. (2000). Inactivation of Transmissible Degenerative Encephalopathy Agents: A Review. The

Veterinary Journal 159

, 10

‐ 17.

World Health Organization (WHO) (2000). Decontamination Methods for Transmissible Spongiform

Encephalopathies. Report of a WHO consultation: Geneva, Switzerland, March 23

‐ 26, 1999.May 2 8 , 2010

STERIS Corporation ● 9260 Progress Parkway ● Mentor, OH 44060 USA ● +1 440 354

- 2600 Subject: Environ ® LpH ® Germicidal Detergent Withdraw al

Product Numbers 6405

- 08 and 6405

- 08CA

Dear Valued Customer:

STERIS Corporation will no longer offer Environ LpH Germicidal Detergent (product number s

6405

- 08 and 6405

- 08CA ) . At historical deman d, we anticipate that we will be able to fill orders

through August 20, 2010 (actual availability may vary)

.

On behalf of STERIS, I apologize for any inconvenience this withdrawal may cause, but we do

have a full line of concentrated and ready

- to

- use li quid disinfectants with comparable efficacy

claims. We are certain that one of our many products will be an excellent replacement. For

example, we recommend:

United States Canada

Process NPD ® One

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Detergent

product number 6390

- 08 Coverag e 256 ® One Step Cleaner

Disinfectant

product number 6370

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T.B.Q. ® Hard Surface Disinfectant

product number 6345

- 08 1

- Stroke Environ ® Germicidal Detergent

Product number 6310

- 08CA

LpH ® One

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product number 6466

- 08

We apprec iate your continuing support for STERIS products and p lease contact your local

STERIS account manager or me if you have any additional questions.

Best regards,

_____________________________ Jon McCabe

Sr. Global Product Manager, Critical Environments