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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 Definition 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 Federal Insecticide, Fungicide, and Rodenticide 

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

(USDA). Written comments received from USDA 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 process 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) anticipates that due to the expense of obtaining 

a registration for these (prion-related) 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. 

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

registration of a prion-related 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 USDA 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 registrant would only pursue 

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

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

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

equipment. If registered for those uses, such 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 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 valid emergency 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. 
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EPA Response: EPA will work with USDA and the regulated community to support the 

development and registration of prion-related 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 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. 

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

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

Section 18 emergency exemption be applied only 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 local needs”) that are not 

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

California would not be subject to a certified applicator requirement 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 applicator when applying pesticides 

regulated under FIFRA. This would create a nationwide 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 certified applicators only. Where EPA approves an 

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

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

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

5. USDA Comment: 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. 

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

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

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

type of prion against which the product was tested 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 claim for a prion-related product. 

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

(USDA/ARS) believes that EPA has 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 
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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. 

EPA Response: As discussed with USDA, EPA will revise 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 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 

(registered) 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?

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

development and registration of prion-related 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 register 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 impacts of the proposed rule, that three companies might apply for 

registration of the three currently unregistered prion-related products—Environ LpH, sodium 

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

to support the registration of a prion-related product could 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 USDA is correct in saying that no registered 

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

quarantine exemptions may be issued to USDA and/or states and subsequently renewed, if EPA 

finds that the applicable regulatory criteria are met. 

8. USDA Comment: USDA/ARS 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. 

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

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

$1,000,000. The proposed rule would not have a cost 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., scrapie, CWD) to be tested and the specific test protocol were 
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known. EPA acknowledges that the costs associated with developing data sufficient to support 

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

 

9. USDA Comment: USDA/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. 

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

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

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

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

protocols to assure that the test 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 valid
emergency 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 28, 2010

STERIS Corporation ● 9260 Progress Parkway ● Mentor, OH 44060 USA ● +1 440 354-2600

Subject: Environ®LpH® Germicidal Detergent Withdrawal

Product Numbers 6405-08 and 6405-08CA

Dear Valued Customer:

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

6405-08 and 6405-08CA). At historical demand, 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 liquid 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-Step Germicidal 

Detergent

product number 6390-08

Coverage 256® One Step Cleaner 

Disinfectant

product number 6370-08CA

T.B.Q.® Hard Surface Disinfectant

product number 6345-08

1-Stroke Environ® Germicidal Detergent

Product number 6310-08CA

LpH® One-Step Germicidal Detergent

product number 6466-08

We appreciate your continuing support for STERIS products and please contact your local 

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

Best regards,

_____________________________

Jon McCabe 

Sr. Global Product Manager, Critical Environments