This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

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the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

54431 

Vol. 74, No. 203 

Thursday, October 22, 2009 

1 To view the proposed rule and the comments 

we received, go to (http://www.regulations.gov/ 

fdmspublic/component/main?main=DocketDetail 

&d=APHIS-2009-0023). 

2 To view the November 2007 final rule, go to 

(http://www.regulations.gov/fdmspublic/ 

component/main?main=DocketDetail 

&d=APHIS-2007-0022). 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

7 CFR Part 301 

[Docket No. APHIS-2009-0023] 

RIN 0579-AC96 

Citrus Canker; Movement of Fruit From 

Quarantined Areas 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Final rule. 

SUMMARY: We are amending the citrus 

canker regulations to modify the 

conditions under which fruit may be 

moved interstate from a quarantined 

area. We are eliminating the 

requirement that each lot of finished 

fruit be inspected at the packinghouse 

and found to be free of visible 

symptoms of citrus canker and 

removing the current prohibition on the 

movement of fruit from a quarantined 

area to commercial citrus-producing 

States. We are continuing to require 

fruit moved interstate from a 

quarantined area to be treated with an 

approved disinfectant and to be packed 

in a commercial packinghouse that 

operates under a compliance agreement. 

These changes will relieve some 

restrictions on the interstate movement 

of fresh citrus fruit from quarantined 

areas while maintaining conditions that 

will prevent the artificial spread of 

citrus canker. 

EFFECTIVE DATE: October 22, 2009. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Stephen Poe, Senior Operations Officer, 

Emergency and Domestic Programs, 

Plant Protection and Quarantine, 

APHIS, 4700 River Road Unit 137, 

Riverdale, MD 20737-1231; (301) 734- 

4387. 

SUPPLEMENTARY INFORMATION: 

Background 

Citrus canker is a plant disease caused 

by the bacterium Xanthomonas citri 

subsp. citri (referred to below as Xcc) 

that affects plants and plant parts, 

including fresh fruit, of citrus and citrus 

relatives (Family Rutaceae). Citrus 

canker can cause defoliation and other 

serious damage to the leaves and twigs 

of susceptible plants. It can also cause 

lesions on the fruit of infected plants, 

which render the fruit unmarketable, 

and cause infected fruit to drop from the 

trees before reaching maturity. The A 

(Asiatic) strain of citrus canker can 

infect susceptible plants rapidly and 

lead to extensive economic losses in 

commercial citrus-producing areas. 

Citrus canker is only known to be 

present in the United States in the State 

of Florida. 

The regulations to prevent the 

interstate spread of citrus canker are 

contained in ‘‘Subpart–Citrus Canker’’ 

(7 CFR 301.75-1 through 301.75-14, 

referred to below as the regulations). 

The regulations restrict the interstate 

movement of regulated articles from and 

through areas quarantined because of 

citrus canker and provide, among other 

things, conditions under which 

regulated fruit may be moved into, 

through, and from quarantined areas for 

packing. 

On June 30, 2009, we published in the 

Federal Register (74 FR 31201-31209, 

Docket No. APHIS-2009-0023) a 

proposal1 to amend the regulations to 

modify the conditions under which fruit 

may be moved interstate from a 

quarantined area. We proposed to 

eliminate the requirement that each lot 

of finished fruit be inspected at the 

packinghouse and found to be free of 

visible symptoms of citrus canker and to 

remove the current prohibition on the 

movement of fruit from a quarantined 

area to American Samoa, Arizona, 

California, Guam, Hawaii, Louisiana, 

Commonwealth of the Northern Mariana 

Islands, Puerto Rico, Texas, and the U.S. 

Virgin Islands. (These are the 

commercial citrus-producing areas 

listed in § 301.75-5; we refer to them in 

this document as commercial citrusproducing States.) 

We proposed to continue to require 

fruit moved interstate from a 

quarantined area to be treated with an 

approved disinfectant and to be packed 

in a commercial packinghouse that 

operates under a compliance agreement. 

We proposed these changes to relieve 

some restrictions on the interstate 

movement of fresh citrus fruit from 

quarantined areas while maintaining 

conditions that would prevent the 

artificial spread of citrus canker. 

We solicited comments concerning 

our proposal for 60 days ending August 

31, 2009. We received 34 comments by 

that date. They were from citrus 

producers, citrus packers, industry 

organizations, researchers, and 

representatives of State and foreign 

governments. Twenty-three commenters 

supported the proposed rule. Two of 

these commenters also directly 

addressed issues raised in the remaining 

comments, which are discussed below 

by topic. 

Selection of an Option for Mitigating the 

Risk Associated With the Interstate 

Movement of Regulated Fruit From a 

Quarantined Area 

In a final rule2 effective and 

published in the Federal Register on 

November 19, 2007 (72 FR 65172-65204, 

Docket No. APHIS-2007-0022), we 

amended the regulations to establish 

new conditions for the interstate 

movement of regulated fruit from an 

area quarantined for citrus canker. That 

final rule eliminated a requirement that 

the groves in which fruit to be moved 

interstate is produced be inspected and 

found free of citrus canker. Instead, we 

added the packinghouse inspection 

requirement mentioned earlier. We 

retained the other requirements that had 

been in the regulations, including the 

requirement that the fruit be treated 

with a surface disinfectant and the 

prohibition on the movement of fruit 

from a quarantined area into 

commercial citrus-producing States. 

We established those conditions 

based on the conclusions of a pest risk 

assessment (PRA) and risk management 

analysis (RMA) prepared for the 2007 

rulemaking. The PRA concluded that 

asymptomatic, commercially produced 

citrus fruit, treated with a disinfectant 

and subject to other mitigations, is not 

epidemiologically significant as a 


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54432 Federal Register / Vol. 74, No. 203 / Thursday, October 22, 2009 / Rules and Regulations 

3 The term ‘‘epidemiologically significant’’ refers 

to the minimum conditions required for 

introduction of a disease into an unaffected area. 

Our judgment of whether fruit is an 

epidemiologically significant pathway for disease 

transmission is based on the likelihood that the 

fruit itself will be infected with the disease, that the 

infection will occur in a way or at a level sufficient 

for transmission of the disease, and that such an 

infected fruit will encounter the biological 

conditions required for transmission of the disease. 

pathway for the introduction and spread 

of citrus canker. 

The RMA examined the risks 

associated with both symptomatic and 

asymptomatic fruit and concluded that 

the introduction and spread of Xcc into 

other States through the movement of 

commercially packed fresh citrus fruit 

from quarantined areas is unlikely. In 

addition, the RMA concluded that a 

phytosanitary inspection would ensure, 

with high confidence, that few shipped 

fruit would have symptoms of citrus 

canker disease. However, the RMA also 

concluded that the evidence available at 

that time was not sufficient to support 

a determination that fresh citrus fruit 

produced in an Xcc-infested grove 

cannot serve as a pathway for the 

introduction of Xcc into new areas, thus 

necessitating the prohibition on 

movement of fruit into commercial 

citrus-producing States. 

In our responses to public comments 

in the Background section of the 

November 2007 final rule, we stated: ‘‘If, 

in the future, evidence is developed to 

support a determination that 

commercially packed citrus fruit (both 

symptomatic and asymptomatic) is not 

an epidemiologically significant3

pathway for the introduction and spread 

of citrus canker, we would undertake 

rulemaking to amend our regulations 

accordingly.’’ 

Since the publication of the 

November 2007 final rule, two 

publications have provided additional 

evidence regarding the potential of fruit 

to serve as a pathway for the 

introduction and spread of citrus 

canker. This new evidence addresses 

key uncertainties and caused us to 

revisit our previous findings. The first 

article, by Gottwald et al. (2009), 

documents research on the survival of 

Xcc on commercially produced and 

packed citrus fruit and the likelihood 

that such fruit could serve as a 

mechanism to spread the disease. The 

second article, by Shiotani et al. (2009), 

documents research on the survival of 

Xcc on commercially produced 

mandarin fruits and the likelihood of 

spread of Xcc to trees from harvested 

mandarins. 

Accordingly, we prepared updates to 

the PRA and RMA that had 

accompanied the November 2007 final 

rule. The updated PRA, titled ‘‘An 

Updated Evaluation of Citrus Fruit 

(Citrus spp.) as a Pathway for the 

Introduction of Citrus Canker Disease 

(Xanthomonas citri subsp. citri)’’ 

(March 2009), examines the information 

presented in Gottwald et al. (2009) and 

Shiotani et al. (2009) in the context of 

the earlier PRA. Based on the evidence 

presented in both the November 2007 

PRA and the two new publications, the 

updated PRA concludes that 

asymptomatic fruit (treated or 

untreated) is not epidemiologically 

significant as a pathway for introducing 

citrus canker. It further concludes that 

symptomatic fruit subjected to a 

packinghouse process that includes 

washing with disinfectants is also not 

epidemiologically significant as a 

pathway for introducing citrus canker. 

These conclusions led us to prepare a 

supplemental RMA, titled ‘‘Movement 

of Commercially Packed Citrus Fruit 

from Citrus Canker Disease Quarantine 

Area; Supplemental Risk Management 

Analysis’’ (May 2009). The 

supplemental RMA takes into account 

the conclusions of the updated PRA as 

well as the evidence and discussion 

presented in the November 2007 RMA. 

Like the November 2007 RMA, the 

supplemental RMA was submitted for 

peer review, in accordance with the 

Office of Management and Budget’s 

bulletin on peer review. All the 

materials associated with the peer 

review on the supplemental RMA, 

including the peer reviewers’ comments 

and our responses, are available at 

(http://www.aphis.usda.gov/ 

peer_review/peer_review_agenda.shtml). 

The peer reviewers’ comments were 

considered in developing the 

supplemental RMA. 

The supplemental RMA concludes 

that multiple lines of evidence, 

including, but not limited to, evidence 

from the two recent studies and the 

November 2007 RMA, indicate that 

commercially packed and disinfected 

fresh citrus fruit is not an 

epidemiologically significant pathway 

for the introduction and spread of Xcc, 

i.e.: 

∑ Disease management practices in 

the grove reduce, but do not eliminate, 

Xcc populations. 

∑ Commercially produced fruit 

harvested in areas where Xcc exists may 

be visibly infected or the fruit may carry 

the pathogen either on its surface or in 

wounds. 

∑ Citrus canker disease development 

between harvest and packinghouse, via 

wounding for example, is not likely. 

∑ Procedures for cleaning and 

disinfecting fruit are routinely applied 

by packinghouses. 

∑ The individual efficacy of these 

procedures for removing or destroying 

Xcc may not be known in detail, but the 

effect of packinghouse treatments 

reduces the prevalence of viable Xcc 

and therefore the level of inoculum 

associated with commercially packed 

fresh citrus fruit. 

∑ Packinghouse processing that 

includes a disinfectant treatment further 

reduces amounts of Xcc inoculum on 

infected or contaminated fruit. 

∑ The viability of bacteria on fruit and 

in lesions and wounds diminishes after 

the fruit is harvested. 

∑ The viability of Xcc bacteria that 

survive the packing process will further 

diminish during shipping. 

∑ Epiphytic populations of Xcc may 

aid in pathogen dispersal, but 

substantial evidence indicates that 

bacterial populations do not infect 

intact mature fruit. 

∑ Evidence indicates that wounds on 

harvested fruit containing Xcc inoculum 

do not lead to citrus canker lesion 

development, and Xcc populations 

generally decline rapidly, although 

wounds might occasionally retain Xcc 

populations that decline more slowly. 

∑ The cool temperatures at which 

citrus fruit are stored and shipped and 

the duration of storage reduce the ability 

of Xcc to reproduce and cause infection. 

∑ As a condition for successful 

establishment, Xcc, in amounts 

sufficient to cause infection, must 

encounter not only an environment with 

a conducive temperature, relative 

humidity, moisture, and wind events for 

infection, but also must encounter host 

plant tissue that is either at a 

susceptible growth stage or is wounded 

and then must successfully enter this 

tissue. 

∑ Despite substantial international 

trade between Xcc-infected and 

noninfected countries, there is no 

authenticated record of movement of 

diseased fruit or seeds resulting in the 

introduction of Xcc to new areas. 

In light of this evidence, the 

supplemental RMA considered five risk 

management options for the interstate 

movement of commercially packed 

citrus fruit from areas quarantined for 

citrus canker: 

∑ Option 1: Allow distribution of all 

types and varieties of commercially 

packed citrus fruit to all U.S. States, 

without packinghouse treatment with a 

disinfectant. 

∑ Option 2: Allow distribution of all 

types and varieties of commercially 

packed citrus fruit to all U.S. States, 

subject to packinghouse treatment with 

an Animal and Plant Health Inspection 

Service (APHIS)-approved disinfectant, 


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but without the current inspection 

requirement. 

∑ Option 3: Allow distribution of all 

types and varieties of commercially 

packed citrus fruit to all U.S. States 

except commercial citrus-producing 

States, subject to packinghouse 

treatment of citrus fruit with an APHISapproved disinfectant treatment; and, 

allow distribution of all types and 

varieties of commercially packed citrus 

fruit to all U.S. States, including 

commercial citrus-producing States, 

subject to packinghouse treatment with 

an APHIS-approved disinfectant 

treatment and APHIS inspection for 

symptoms of citrus canker. 

∑ Option 4: Allow distribution of all 

types and varieties of commercially 

packed citrus fruit to all U.S. States 

other than commercial citrus-producing 

States, subject to packinghouse 

treatment with an APHIS-approved 

disinfectant. 

∑ Option 5: Leave the current 

regulations for the interstate movement 

of citrus fruit from areas quarantined for 

citrus canker unchanged. 

After considering the evidence 

presented in the updated PRA and the 

supplemental RMA and the conclusions 

of those documents, we determined that 

currently available scientific evidence 

provides additional certainty that 

commercially packed and disinfected 

fresh citrus fruit is not an 

epidemiologically significant pathway 

for the spread of Xcc. Therefore, no 

mitigations beyond treatment with an 

APHIS-approved disinfectant are 

necessary. Accordingly, we proposed to 

implement Option 2. 

Several commenters acknowledged 

that the risk associated with the 

interstate movement of regulated fruit 

from a quarantined area is low but 

stated that, if there is any risk associated 

with allowing fruit to move from areas 

quarantined for citrus canker into 

commercial citrus-producing States, 

such movement should be prohibited. 

These commenters stated that citrus 

canker has been a destructive and costly 

disease in Florida, one which spurred 

an eradication attempt that was 

ultimately unsuccessful, and that other 

commercial citrus-producing States do 

not want to be at risk for the 

introduction and establishment of the 

disease. One commenter recommended 

that we err on the side of caution in 

making changes to the regulations and 

stated that further research should be 

done before fruit from quarantined areas 

is allowed into commercial citrusproducing States. 

Two of these commenters proposed 

additional risk mitigation measures to 

address the risk they perceived to be 

associated with fruit moved interstate 

from an area quarantined for citrus 

canker. Both stated that such fruit 

should not be allowed to move into the 

eight-county Citrus Zone in south 

Texas. These commenters cited the 

suitability of Texas’ climate to citrus 

canker establishment (as demonstrated 

by previous outbreaks of citrus canker 

in Texas), the susceptibility of grapefruit 

(a common citrus crop in Texas) to 

citrus canker, and citrus canker’s effect 

on young citrus trees. One of these 

commenters additionally requested that 

fruit destined for Texas originate only 

from groves that have been certified as 

being free of citrus canker for more than 

a year, based on a survey. 

Another commenter, responding to 

some of these commenters, stated that 

no agricultural trade between States and 

countries anywhere in the world could 

be conducted if minimal risk is 

unacceptable and that the proposed rule 

would mitigate the risks to the point 

that risks are negligible. 

Our goal in restricting the interstate 

movement of plants, plant products, and 

other articles is not to achieve zero risk, 

which, as the last commenter noted, 

cannot be achieved in agricultural trade. 

Rather, we seek to impose restrictions 

on the interstate movement of such 

articles that are commensurate with the 

risk they pose and that mitigate the risk 

associated with their interstate 

movement. Based on all the available 

scientific evidence, the updated PRA 

and supplemental RMA concluded that 

commercially packed and disinfected 

fresh citrus fruit is not an 

epidemiologically significant pathway 

for the introduction and spread of Xcc. 

We received several comments on the 

two new publications that led us to 

prepare the updated PRA and 

supplemental RMA, as well as 

comments on the updated PRA and 

supplemental RMA themselves. These 

comments are discussed in further 

detail later in this document. However, 

they did not change our conclusion that 

commercially packed and disinfected 

fresh citrus fruit is not an 

epidemiologically significant pathway 

for the spread of Xcc. Accordingly, this 

final rule implements Option 2 as 

proposed. 

We are not retaining the current 

prohibition on the distribution of fruit 

from a quarantined area to commercial 

citrus-producing States, and we are not 

adding the additional mitigations 

requested by two of the commenters. 

Based on our determination that fruit is 

not an epidemiologically significant 

pathway, we have determined that those 

additional mitigations are unnecessary 

to prevent the spread of citrus canker 

via the interstate movement of fruit from 

quarantined areas. As noted, it is 

impossible to eliminate all risk 

associated with the interstate movement 

of fruit from quarantined areas; given 

the conclusions of the updated PRA and 

the supplemental RMA, following the 

recommendation that we prohibit the 

movement of fruit into commercial 

citrus-producing States unless all risk is 

eliminated would impose an 

unnecessary restriction on the 

movement of fruit. 

Under section 412(a) of the Plant 

Protection Act (7 U.S.C. § 7712), the 

Secretary of Agriculture may prohibit or 

restrict the interstate movement of any 

plant or plant product if the Secretary 

determines that the prohibition or 

restriction is necessary to prevent the 

dissemination within the United States 

of a plant pest or noxious weed. Based 

on our supplemental RMA, APHIS has 

concluded that commercially packed 

citrus fruit treated with an APHISapproved disinfectant is not an 

epidemiologically significant pathway 

for the dissemination of citrus canker 

within the United States. Accordingly, 

APHIS has determined that it is not 

necessary to prohibit the interstate 

movement of regulated fruit that is 

commercially packed and treated with 

an APHIS-approved disinfectant from 

an area that is quarantined for citrus 

canker in order to prevent the 

dissemination within the United States 

of a plant pest. This determination is 

based on the findings of the updated 

PRA and the supplemental RMA 

referred to earlier in this document and 

our judgment that the application of the 

measures we proposed will prevent the 

dissemination of plant pests within the 

United States. 

One commenter who was opposed to 

allowing the interstate movement of 

citrus fruit from a quarantined area to 

commercial citrus-producing States 

stated that California, a commercial 

citrus-producing State, is the home of 

three of the most important resources of 

citrus germplasm in the United States: 

The National Clonal Germplasm 

Repository for Citrus and Dates 

(NCGRCD), a U.S. Department of 

Agriculture-Agricultural Research 

Service (ARS) facility supplying 

budwood worldwide; the Citrus Clonal 

Protection Program, University of 

California-Riverside (UCR), the first 

citrus germplasm program in the world 

supplying budwood to California, 

Arizona, and Texas; and the UCR Citrus 

Variety Collection, perhaps the most 

diverse citrus collection in the world 

dating back to 1907. The commenter 

stated that certified disease-free 

budwood and a broad genetic basis for 


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54434 Federal Register / Vol. 74, No. 203 / Thursday, October 22, 2009 / Rules and Regulations 

variety development and improvement 

are the foundation of every successful, 

profitable, and sustainable citrus 

industry in the world and that those 

three germplasm resources are the only 

ones in the United States (if not the 

world) that have not been exposed to 

citrus canker or other devastating citrus 

diseases such as citrus greening. The 

commenter stated that taking a 

‘‘calculated’’ risk to expose these 

invaluable resources to one of the worst 

citrus diseases in the world, citrus 

canker, based on limited field and 

packinghouse practices that will not be 

inspected for compliance is 

unacceptable. This commenter also 

stated that the Florida citrus industry 

funded a project to ‘‘rescue’’ Florida 

citrus germplasm by moving it to citrus 

canker- and citrus greening-free 

California in the NCGRCD facilities. 

As we have determined that 

commercially packed and disinfected 

fresh citrus fruit is not an 

epidemiologically significant pathway 

for the introduction and spread of citrus 

canker, we do not expect that these 

facilities will be exposed to citrus 

canker as a result of the implementation 

of this final rule. 

However, it should be noted that 

germplasm facilities are devoted to the 

preservation of the germplasm within 

the facilities and thus are protected 

against potential sources of pest and 

disease introduction. Indeed, potentially 

infected germplasm from foreign 

countries is imported into these same 

facilities for screening purposes, which 

is a much more likely pathway for the 

introduction of diseases such as citrus 

canker than the interstate movement of 

regulated fruit from a quarantined area. 

Allowing citrus fruit to be moved 

interstate from quarantined areas into 

California will not decrease the efficacy 

of the biosecurity in place at these 

facilities. 

It should also be noted that, under 

this final rule, packinghouses will be 

inspected to ensure that they are 

complying with the requirements to 

treat regulated fruit with an APHISapproved disinfectant and to ensure that 

the fruit is free of leaves, twigs, and 

other plant parts, except for stems that 

are less than 1 inch long and attached 

to the fruit. With regard to the other 

commercial fruit production practices 

described in the November 2007 RMA, 

we assume that commercial growers and 

packinghouses will continue to employ 

procedures that reduce the incidence of 

citrus canker in their fruit, as citrus 

canker lesions reduce the market value 

of infected fruit. 

New Evidence We Considered in the 

Updated PRA and Supplemental RMA 

Several commenters generally 

addressed the Gottwald et al. (2009) and 

Shiotani et al. (2009) publications. We 

address these comments below. 

One commenter stated that the 

premise of both publications was to 

prove that citrus canker cannot be 

transmitted by infected or contaminated 

citrus fruit. The commenter stated that, 

scientifically, a negative premise cannot 

be proven, and the commenter cited this 

as one major flaw of these studies. 

Another commenter stated that Shiotani 

et al. (2009) did not demonstrate that 

Xcc cannot be transmitted from fruit to 

susceptible tissue, as it did not 

adequately resolve the ability of Xcc to 

spread from asymptomatic fruit. 

One commenter, responding to the 

first commenter, stated that the two 

publications never set out to prove that 

something cannot happen because, 

philosophically and scientifically, this 

is impossible. However, the commenter 

stated, both publications soundly 

proclaim that risks can very effectively, 

very simply, and very reliably be 

reduced below any reasonable and 

measurable risk of transmitting citrus 

canker disease. 

As the last commenter states, neither 

of the publications concluded that citrus 

canker cannot be spread by fruit. 

Gottwald et al. (2009) concluded that 

‘‘harvested and packinghousedisinfested citrus fruit are extremely 

unlikely to be a pathway for Xcc to 

reach and infect susceptible citrus and 

become established in canker-free 

areas.’’ Shiotani et al. (2009) concluded 

that ‘‘there is a low risk [of] 

transmission’’ of Xcc from fruit. These 

conclusions are consistent with the 

conclusions of the updated PRA and 

supplemental RMA, as described earlier. 

Two commenters stated that the 

research in the Gottwald et al. (2009) 

and Shiotani et al. (2009) publications 

should be tested and retested by others 

who were not involved in the original 

research before changing the conditions 

under which fruit is allowed to move 

from an area quarantined for citrus 

canker. Three commenters stated that a 

national task force consisting of 

scientists from citrus-producing areas 

other than Florida (and besides ARS 

personnel) should be assembled to 

address any change in current 

quarantine regulations that might result 

in the introduction of known 

destructive pathogens from known 

infected areas to noninfected areas (i.e., 

California, Arizona, Texas, etc.). 

The Gottwald et al. (2009) and 

Shiotani et al. (2009) publications were 

produced independently, published in a 

peer-reviewed journal, and came to 

similar conclusions regarding the 

epidemiological significance of fruit as 

a pathway for the spread of citrus 

canker. Among other topics they 

address, these publications provide 

valuable evidence regarding the 

potential for Xcc to spread from infected 

fruit to host plants in the field; this 

evidence is what prompted us to 

prepare the updated PRA and 

supplemental RMA. 

However, the updated PRA and 

supplemental RMA considered all the 

available evidence regarding the 

potential of fruit to serve as an 

epidemiologically significant pathway 

for the introduction and spread of citrus 

canker, not just the evidence in those 

publications. The weight of all the 

available evidence is what led us to the 

conclusion that commercially packed 

and disinfected fresh citrus fruit is not 

an epidemiologically significant 

pathway for the introduction and spread 

of Xcc. We have determined that the 

evidence provides adequate certainty 

regarding this conclusion to remove 

some restrictions on the interstate 

movement of commercially packed and 

disinfected fresh citrus fruit from an 

area quarantined for citrus canker. 

The November 2007 PRA and RMA 

and the supplemental RMA prepared for 

this rulemaking were all submitted for 

peer review in accordance with the 

Office of Management and Budget’s 

bulletin on peer review. The peer 

reviewers for the November 2007 PRA 

and RMA and the supplemental RMA 

were experts in plant pathology, 

phytobacteriology, and risk assessment. 

The comments we received from these 

peer reviewers indicated that our 

analysis of the available evidence 

regarding the risk associated with the 

movement of fruit from an area 

quarantined for citrus canker was 

sound. 

It should also be noted that the 

authors of the Shiotani et al. (2009) 

publication were not affiliated with the 

State of Florida in any way, and the 

experiments in the Gottwald et al. 

(2009) publication were conducted by 

an international consortium of scientists 

working cooperatively and reaching the 

same conclusion after conducting 

similar experiments in two different 

countries, with participants from 

Argentina as well as Florida. 

Gottwald et al. (2009) 

We received several comments 

specifically addressing Gottwald et al. 

(2009). 

Some of the experiments included in 

Gottwald et al. (2009) examined the 


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Federal Register / Vol. 74, No. 203 / Thursday, October 22, 2009 / Rules and Regulations 54435 

effectiveness of treatment with a 

disinfectant at reducing Xcc populations 

on citrus fruit. One commenter stated 

that the disinfection procedures 

significantly reduced pathogen survival 

but did not completely eliminate it. The 

commenter stated that, considering the 

large amount of fruit being shipped, 

even a low survival rate of the pathogen 

poses a high risk for the introduction of 

Xcc to a disease-free area. 

This commenter also stated that the 

limitation of treatments in disinfecting 

fruit with lesions or fruit wounds 

contaminated with inoculum of the 

pathogen is well known. Oxidizing 

agents cannot effectively remove or 

reduce inoculum to acceptable levels in 

wounded tissue because of the natural 

reducing agents that occur in fruit 

tissue. Furthermore, these treatments 

would have little or no effect on 

established fruit lesions that act as 

reservoirs of inoculum. Thus, the 

commenter stated, without any 

inspections, even a few lesions on fruit 

would pose a high risk because the 

pathogen could not be eliminated using 

existing disinfection practices. 

Another commenter stated that one 

cannot in a practical sense sterilize the 

surface of fruit; it would do more harm 

than good, and there is no biological 

reason to do so. The commenter stated 

that there is an inoculum threshold 

necessary to naturally establish citrus 

canker under even the most conducive 

conditions (105 colony-forming units 

(cfu)/milliliter (ml) for intact tissue 

infection, 103 cfu/ml for wounded) and 

that fruit disinfection easily achieves 

the low levels of inoculum necessary to 

avoid the risk of disease transmission. 

The commenter stated that the concern 

that inoculum in wounds on fruit could 

not be completely eliminated overlooks 

the fact that the bacteria do not even 

cause an infection at the wound site, let 

alone become liberated to possibly 

induce a lesion elsewhere. 

The November 2007 RMA and the 

supplemental RMA both acknowledge 

the fact that disinfection treatments are 

not completely effective against Xcc 

bacteria in lesions. However, as the 

November 2007 RMA stated, there is 

abundant evidence that shows that 

packinghouse disinfection treatments 

destroy surface bacteria and reduce the 

viability of all bacteria on fruit. We did 

not rely solely on the Gottwald et al. 

(2009) publication in making our 

determination that treatment with an 

APHIS-approved disinfectant is an 

effective mitigation against the risk of 

spread of citrus canker; rather, we 

considered all the available evidence 

regarding the effectiveness of 

disinfectant treatments. 

In addition, other evidence indicates 

that bacteria that remain in lesions after 

disinfection are not epidemiologically 

significant. For example, Gottwald et al. 

(2009) provided additional evidence 

supporting the conclusion that the 

viability of bacteria on fruit and in 

lesions and wounds diminishes after the 

fruit is harvested and that the viability 

of Xcc bacteria which survive the 

packing process will further diminish 

during shipping. 

We disagree with the first commenter 

that the effectiveness of disinfectant 

treatment on bacteria in wounds is a 

concern. The second commenter is 

correct to note that Xcc bacteria in 

wounds do not cause infections at the 

wound site. As discussed in the 

supplemental RMA, evidence indicates 

that wounds on harvested fruit 

containing Xcc inoculum do not lead to 

citrus canker lesion development, and 

Xcc populations generally decline, 

although wounds might occasionally 

retain Xcc populations that decline 

more slowly. 

Finally, with respect to the first 

commenter’s concern about elimination 

of bacteria, we acknowledge that the 

surface disinfectant treatments 

approved by APHIS reduce numbers of 

Xcc cells to low or undetectable levels, 

but do not necessarily provide complete 

eradication. As the second commenter 

notes, complete eradication would be 

impractical. In any case, it is not 

necessary to completely eradicate Xcc in 

order to ensure that disinfected fruit is 

not an epidemiologically significant 

pathway. While the updated PRA and 

supplemental RMA conclude 

specifically that commercially packed 

and disinfected fresh citrus fruit is not 

an epidemiologically significant 

pathway for the introduction and spread 

of Xcc, it is not just the disinfection 

process that makes fruit not an 

epidemiologically significant pathway 

for Xcc, but also the biology of Xcc and 

the conditions that must be fulfilled in 

order for Xcc transmission from infected 

fruit to a host plant to occur, among 

other factors. 

Some commenters addressed 

experiments in the Gottwald et al. 

(2009) publication that were designed to 

investigate the likelihood that citrus 

fruit disposed of by consumers may 

serve as a source of inoculum for nearby 

host material. Gottwald et al. (2009) 

studied the transmission of Xcc from 

unprocessed, infected ‘Ruby Red’ 

grapefruit and ‘Lisbon’ lemon and 

packinghouse-processed ‘Ruby Red’ 

grapefruit in cull piles to ‘Duncan’ 

grapefruit seedlings during natural 

weather events. During the course of the 

experiments, citrus canker lesions did 

not develop on the grapefruit seedlings 

(488 seedlings total) surrounding the 

diseased fruit, in spite of extensive 

leafminer damage present on some of 

the seedlings. Xcc bacteria were not 

detected in assays of the foliage. 

Gottwald et al. (2009) repeated the 

cull pile experiment to see if 

transmission of Xcc from infected, 

unprocessed ‘Ruby Red’ grapefruit fruit 

is possible under simulated extreme 

wind and rain conditions. Infected fruit 

were either placed in a cull pile or 

suspended by vertical strings. One 

seedling 0 meters (m) downwind from 

the cull pile became infected when 

subjected to the highest wind speed (25 

m per second (m/s)) and simulated rain, 

developing 1 lesion on a single leaf 

injured by the action of the high-speed 

fan. The other 191 plants in the study 

did not develop Xcc lesions. No Xcc 

lesions developed on the 192 plants 

placed at the same distance and 

subjected to the same wind speed (0, 10, 

and 25 m/s with water) from Xccinfected grapefruit suspended from 

string. Xcc was recovered from 1 

collection screen set up 2 m from 

suspended fruit, but no Xcc was 

recovered from the other 144 collection 

screens set up at various distances (0 to 

10 m) from cull piles or suspended fruit. 

Gottwald et al. (2009) stated that this 

cull pile experiment was ‘‘a highly 

contrived situation designed to provide 

every possible opportunity for dispersal 

of Xcc and would be unlikely to occur 

in most areas, except those locations 

where hurricanes or tropical storms are 

common occurrences.’’ 

One commenter noted that one plant 

surrounding infected fruit in cull piles 

did develop the disease in one of the 

simulated wind and rain experiments, 

indicating that this pathway of 

transmission is possible. The 

commenter stated that one might think 

that this level of transmission from an 

infected fruit to a healthy plant is very 

low, but this can be interpreted as very 

high under the set of conditions 

established for the experiments. The 

commenter stated that conducting these 

studies in regions where other 

environmental conditions exist and 

with a different group of scientists may 

lead to a different conclusion. 

A second commenter stated that both 

Gottwald et al. (2009) and Shiotani et al. 

(2009) demonstrate that transmission of 

the bacterium is a difficult process to 

replicate and expressed a view that the 

natural spread of the bacterium from 

infected fruit to host plants remains 

poorly understood. The commenter 

stated that the cull pile transmission 

experiments conducted by Gottwald et 

al. (2009) do not provide conclusive 


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evidence that the risk of fruit-to-tree 

transmission is insignificant. The 

commenter stated that these trials were 

conducted with little replication and 

did not adequately represent weather 

events that are conducive to the 

transmission of the bacterium, that the 

authors did not demonstrate that Xcc 

could initiate infections under the 

experimental conditions in positive 

controls, and that the employed 

diagnostic methods were not tested in 

positive controls. 

This commenter also noted that 

transmission of Xcc from infected fruit 

to host plants did occur, despite each 

wind speed treatment being applied for 

only 5 minutes. While APHIS 

concluded that the experimental 

conditions that produced this result 

were ‘‘highly contrived,’’ the commenter 

stated, due to the small-scale nature of 

this trial, small sample sizes, short 

exposure times, and lack of adequate 

controls, the risk of transmission under 

natural conditions remains feasible and 

significant. The commenter concluded 

that the experiments by Gottwald et al. 

(2009) demonstrated the ability of Xcc 

to be spread from symptomatic citrus 

fruit. 

A third commenter stated that the 

transmission of Xcc from infected fruit 

to host plants in the simulated extreme 

wind and rain conditions was probably 

because of mechanical contact and 

injury, not from anything most people 

would consider as a natural 

transmission event. This commenter 

also noted that the cull pile in that 

experiment was composed of freshly 

picked and heavily infected fruit, not 

fruit that had been graded and 

disinfected according to packinghouse 

protocol. The commenter stated that the 

value of this experiment is that it 

demonstrates the ‘‘tipping point’’ for 

canker infection from fruit. The 

commenter stated that if the other 

commenters envision a pile of freshly 

picked canker-infected grapefruit 

suddenly arriving in a grapefruit 

orchard in Australia, Arizona, or 

California immediately adjacent to 

susceptible plants and experiencing 25 

m/s winds accompanied by rain, the 

scenario is excessively imaginary. The 

‘‘tipping point,’’ in this commenter’s 

view, identifies the dangerous 

conditions for shipping fresh fruit from 

a canker endemic area so they can be 

completely avoided. 

We agree with the first two 

commenters that it would have been 

optimal to have additional replications 

of the experiment in which Xcc was 

transmitted from infected fruit to host 

plants, to better determine the rate at 

which transmission occurs in these 

conditions. However, as noted, the 

conditions in the experiment in which 

Xcc was successfully transmitted from 

infected fruit to host plants were 

extreme conditions, designed (as the 

third commenter states) to establish 

whether transmission of Xcc from 

infected fruit to host plants is possible, 

not whether it is likely. (As the third 

commenter notes, Gottwald et al. (2009) 

concluded that the lesion that resulted 

from the simulated wind and rain cull 

pile experiment ‘‘was the result of a leaf 

wound.’’) 

In the context of the other 

experiments Gottwald et al. (2009) 

performed to assess the likelihood of 

fruit-to-plant transmission, and in the 

context of the conditions of the 

experiment, including not only the 

simulated extreme wind and rain 

conditions but also the fact that the fruit 

were unprocessed and untreated and the 

placement of those fruit directly 

adjacent to host plants, we have 

determined that this one successful 

transmission is consistent with a 

determination that commercially packed 

and disinfected fresh citrus fruit is not 

an epidemiologically significant 

pathway for the introduction and spread 

of Xcc, given all the available evidence 

about the potential for fruit to serve as 

a pathway. 

Although the first commenter is 

correct that conducting the experiments 

in other environmental conditions and 

with another group of scientists might 

lead to a different conclusion, based on 

the available science regarding the 

transmission of citrus canker, the 

environmental conditions under which 

these experiments were conducted are 

extremely suitable to the potential 

transmission of citrus canker. Fruit that 

were specifically selected for their high 

level of infection and that were 

subjected to none of the packinghouse 

processes (including disinfection) that 

are known to reduce the viability of Xcc 

infection were used in attempts to infect 

highly susceptible grapefruit plants at 

the most susceptible stage of the 

plants’development. The one trap plant 

that was infected was placed 

immediately adjacent to the infected 

fruit and subjected to simulated extreme 

wind and rain conditions that are 

unlikely to occur in most areas. We have 

determined that it is unlikely that 

studies in other regions and under other 

environmental conditions would 

produce a greater level of transmission 

of the disease from infected fruit to host 

plants. 

We have determined that the 

Gottwald et al. (2009) experiments 

adequately represented weather events 

that are conducive to the transmission 

of Xcc and represented a range of 

weather conditions as well. The trials 

were conducted both in field conditions 

that were not conducive to the 

transmission of Xcc, in Argentina, and 

that were conducive, in Florida. 

It would be difficult to develop a 

positive control for the cull pile 

experiments, as a positive control would 

require the successful transmission of 

Xcc, which Gottwald et al. (2009) were 

only able to accomplish under 

conditions described in the publication 

as ‘‘highly contrived.’’ (It should be 

noted that this was not APHIS’ 

description.) Nevertheless, it should be 

noted that the authors who performed 

the cull pile experiments have 

performed similar experiments using 

yard blowers, as documented in Bock et 

al. (2005) and Parker et al. (2005). These 

publications demonstrated that using a 

forced air source for wind and hose 

water for rain will elicit and spread Xcc 

from infected plants. In one experiment 

in Bock et al. (2005), the blower was run 

for 5 minutes, the same duration as in 

the 25-m/s artificial wind and rain cull 

pile experiment, and bacteria were 

recovered from the water to which the 

infected plants were exposed. Different 

experiments in both papers using 

different durations produced the same 

results. We would presume that using 

similar techniques to elicit and spread 

Xcc from infected fruit would be 

effective, if fruit was an 

epidemiologically significant pathway. 

The commenter correctly notes that 

the Gottwald et al. (2009) publication 

did not describe any positive controls 

for the immunostrips used in the cull 

pile experiments to determine whether 

Xcc was present. However, a personal 

communication with one of the authors 

of that publication indicates that the 

experimenters did use positive controls 

to confirm that the immunostrips were 

working properly and thus would have 

indicated that Xcc was present if it had 

been present. 

We disagree with the second 

commenter that the exposure times in 

the cull pile experiments in Gottwald et 

al. (2009) were ‘‘short.’’ The 5-minute 

exposure time in the 25-m/s artificial 

wind and rain experiment was sufficient 

to infect 1 test plant. The commenter 

also ignores the field cull pile 

experiments, which each took place for 

several weeks, at different times of year. 

Finally, it is important to note that 

our determination that commercially 

packed and disinfected fresh citrus fruit 

is not an epidemiologically significant 

pathway for the introduction and spread 

of Xcc does not rest solely upon the 

Gottwald et al. (2009) cull pile 

experiments, although they do provide 


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valuable evidence supporting that 

determination. Rather, that 

determination takes into account all the 

evidence considered in the November 

2007 RMA, the updated PRA, and the 

supplemental RMA, including evidence 

about the biology of the disease, the 

effectiveness of disinfectant treatment, 

the conditions that must be fulfilled for 

disease transmission to occur, and the 

fact that the movement of commercial 

citrus fruit has not been associated with 

an outbreak of the disease anywhere in 

the world. 

Shiotani et al. (2009) 

We also received several comments 

specifically addressing Shiotani et 

al. (2009). 

One commenter stated that, in 

Shiotani et al. (2009), proper positive 

controls proving that the polymerase 

chain reaction (PCR) detection 

technique is working were not included 

in one set of experiments. (We believe 

the commenter is referring to the 

examination of fruit collected from a 

diseased commercial orchard to 

investigate the survival of Xcc.)The 

commenter stated that the lack of 

controls casts doubts on the results of 

this research. 

The commenter correctly notes that 

there is no explicit discussion of 

controls in the ‘‘Materials and Methods’’ 

section of the paper. This does not mean 

that the proper controls were not used, 

but we cannot verify that they were. 

That said, the fact that isolations and 

bioassays made from the same material 

also yielded negative results supports 

the PCR results. 

One commenter stated that the 

Shiotani et al. (2009) experiments used 

a laboratory strain of Xcc that has not 

been shown to be pathogenic but, the 

publication stated, ‘‘is believed to be as 

robust as the wild-type.’’ The 

commenter stated that this demonstrates 

critical flaws in the experimental design 

and that the conclusions of Shiotani et 

al. (2009) can thus not be accepted 

without reasonable doubts. 

The commenter quotes from the 

‘‘Discussion’’ section of the Shiotani et 

al. (2009) publication. In the ‘‘Materials 

and Methods’’ section, the authors 

discuss the laboratory strain in more 

detail: ‘‘A marked strain of X. citri pv. 

citri (KC21Rif100) that is resistant to 

rifampicin was used as inoculum. This 

strain is a stable, spontaneously derived 

mutant from strain KC21 (Shiotani et 

al., 2008), which has been shown to be 

as pathogenic as other strains of X. citri 

pv. citri in infection studies.’’ We 

believe this information addresses the 

commenter’s concern. 

The Shiotani et al. (2009) publication 

included experiments designed to assess 

the potential for spread of Xcc from 

mature Satsuma mandarin fruit 

inoculated with the marked strain of 

Xcc mentioned above and suspended in 

polypropylene net bags in navel orange 

trees. One commenter noted that, in one 

of the four experiments conducted, 

citrus canker was transmitted from 

culled mandarin fruit to leaves of navel 

orange trees in an orchard. 

Another commenter, responding to 

the first commenter, noted that the 

infections in that experiment were not 

caused by the marked strain of Xcc but 

by the wild type. Citrus canker is 

endemic in the area where this study 

was done, so a tagged strain was used. 

That way, the commenter stated, the 

researchers have an idea where the 

inoculum is coming from. The 

commenter stated that the fact that wildtype canker bacteria occasionally are 

caught in traps or cause infection on 

plants in the experiment does not 

undermine the conclusion in any way; 

in fact, it demonstrates that conditions 

conducive to the transmission of canker 

existed, and the marked strain on and in 

fruit did not demonstrate any risks of 

disease transmission. 

We agree with the second commenter. 

One commenter stated that the 

Shiotani et al. (2009) publication does 

not provide a high degree of confidence 

that transmission of Xcc from 

contaminated fruit to host plants is not 

epidemiologically significant. Although 

no transmission of Xcc was observed, 

the commenter suggested that it is 

possible that this was due to 

unexplained variables. Rainfall data 

were provided but no information was 

provided on the growth stage of trap 

plants, insect presence in the orchard, 

potential wounds and insect damage, 

spray history within the orchard, or 

other significant wind and weather 

events. Because the experiments were 

conducted in a commercial orchard, the 

commenter stated, it would be expected 

that pest and disease management 

would have been practiced at some 

point prior to the study. 

As noted earlier, the Shiotani et 

al. (2009) experiments used a marked 

strain of Xcc because Xcc is endemic in 

the area where the experiments took 

place. The wild-type strain of Xcc 

occurred in the orchard where the 

experiments took place, throughout the 

experiments. This indicates that at least 

some plants in the orchard were at a 

susceptible growth stage, and in general 

the transmission of Xcc between trees in 

the orchard indicates that whatever 

unexplained variables may have been 

present did not impede the normal 

transmission of Xcc. 

In Shiotani et al. (2009), the authors 

state, for the initial assay of fruit from 

diseased orchards, ‘‘No chemicals had 

been sprayed to control the disease,’’ 

addressing the commenter’s concern 

about the previous employment of 

disease control methods. Disease control 

is not addressed directly for the other 

experiments, including the experiments 

regarding the potential spread of Xcc 

from Satsuma mandarin fruits. 

However, other statements in the 

publication imply that no disease 

control techniques were employed in 

the orchard: 

In September 2006, the Satsuma 

mandarin orchard in Saga was 

damaged by typhoon No. 0613. The 

typhoon brought rain with strong 

southerly winds with maximum 

speeds of 50 m/s to the orchard, 

which is located on a south-facing 

hillside. The severe meteorological 

conditions of this typhoon strongly 

facilitated spread of citrus canker, 

leading to the highest incidence of the 

disease in the orchard in the last 

decade. ... It is most likely that small 

populations of the wild strain of X. 

citri pv. citri survived in the orchard. 

Citrus canker infection caused by the 

wild strain indicated that conditions 

were also conducive for the 

establishment and spread of the 

introduced KC21Rif100 strain. The 

KC21Rif100 strain did not exude from 

lesions on Satsuma mandarin fruits 

after they were discarded in an 

orchard in October 2006, although 

conditions were conducive for the 

spread of X. citri pv. citri. 

If disease control techniques had been 

employed in the orchard, we assume 

that the authors would not have 

described the conditions as conducive 

for the spread of Xcc. 

These statements also indicate that 

information on significant wind and 

water events was provided, specifically 

with regard to typhoon No. 0613. 

Shiotani et al. (2009) did not provide 

any information on insect presence or 

pest control in the orchard. The citrus 

leafminer is known to occur in Japan, 

but we do not know whether it occurs 

in the orchard. However, it is important 

to note that insects themselves are not 

known to be vectors for Xcc; the 

presence of the citrus leafminer or 

another insect in the orchard might 

increase the severity of canker in the 

orchard, but it would not enable 

transmission of Xcc from infected fruit 

to host plants. 

The commenter stated it is likely that 

naturally infected tissues have a higher 


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ability to transmit the bacterium than 

artificially surface-inoculated fruit, 

which were used in Shiotani et 

al. (2009). 

Shiotani et al. (2009) determined that 

the bacteria in the lesions that resulted 

from the artificial inoculation were 

viable. We know of no evidence that 

suggests that bacteria in natural lesions 

are more effective than surfaceinoculated bacteria in spreading Xcc, 

and the commenter did not supply any. 

The commenter stated that another 

limitation of the design of this 

experiment is that it did not include a 

control group to demonstrate tree-to-tree 

transmission under a similar set of 

conditions. 

Tree-to-tree transmission was 

demonstrated through the incidence of 

the wild-type strain of Xcc, which the 

publication discussed. In this case, the 

wild-type strain acted as a control to 

show that transmission of Xcc within 

the orchard was possible and did occur. 

The commenter also stated that the 

uncertainties cited by the commenter 

are acknowledged by the authors, who 

suggested that conditions may have 

been unfavorable for spread of the 

bacterium. 

The statement in Shiotani et al. (2009) 

that conditions may have been 

unfavorable for disease spread referred 

to one replication of the experiment. 

The publication goes on to note that 

disease spread occurred at high levels in 

a subsequent replication: 

In the experiments started in 

November 2005 and March 2006, no 

canker symptoms were observed on 

any branches beneath the discarded 

fruits. This may be because weather 

conditions were unfavourable for 

disease spread during this period. 

During the experiment started on 

May 2006, canker lesions were 

observed on leaves of navel oranges 

located beneath the discarded 

Satsuma mandarin fruits. ...The 

severity of the disease was greater in 

2006 than in 2005. The incidence of 

citrus canker in the orchard was 36.2 

percent and severity was 18.0. The 

high incidence may be attributed to 

typhoon No. 0613 that occurred on 

September 17, 2006. 

In addition, it should be noted that 

our determination that commercially 

packed and disinfected fresh citrus fruit 

is not an epidemiologically significant 

pathway for the introduction and spread 

of Xcc does not rest solely on the 

experiments in Shiotani et al. (2009), 

although they do provide valuable 

evidence supporting that determination. 

Rather, that determination reflected our 

analysis of all the evidence considered 

in the November 2007 RMA, the 

updated PRA, and the supplemental 

RMA, as discussed earlier. 

Shiotani et al. (2009) also examined 

the survival of Xcc bacteria on the 

surface of artificially inoculated fruit 

that were retained for sampling. One 

commenter noted that viable Xcc was 

isolated from 3 canker lesions from 2 

out of 6 Satsuma mandarin fruit (a 

cultivar resistant to citrus canker), 3 

months after inoculation. Given these 

results, the commenter concluded that 

symptomatic citrus fruit (treated or 

untreated) remain a potential source of 

inoculum. 

We agree with the commenter that 

some viable bacteria may remain in 

lesions of infected fruit. However, in 

those fruits, the strain KC21Rif100 was 

found in only 3 of 14 lesions andat a 

bacterial population lower than 3 x 103

cfu per lesion. This is consistent with 

one of the findings of the November 

2007 RMA and the supplemental RMA, 

which is that the viability of bacteria on 

fruit and in lesions and wounds 

diminishes after the fruit is harvested. 

Diminishing bacterial populations are 

less likely to provide adequate 

inoculum to incite infection. 

It should also be remembered that the 

fruit that were sampled and found to 

have viable bacteria had been stored in 

protected conditions. The fruit that were 

artificially inoculated and used in the 

experiment regarding the potential of 

spread of citrus canker did not serve as 

sources of citrus canker transmission, 

even when the lesions had just been 

formed and presumably contained high 

levels of inoculum. The rinds of the 

artificially inoculated fruits retrieved 

after 3 days in the orchard did not have 

any viable bacteria. Finally, as noted 

earlier in the discussion of Gottwald et 

al. (2009), other evidence indicates that 

bacteria that remain on the fruit in 

lesions and wounds after disinfection 

are not epidemiologically significant. 

The commenter is correct to note that 

Satsuma mandarin is a resistant variety 

of citrus. As noted in the supplemental 

RMA, the Gottwald et al. (2009) and 

Shiotani et al. (2009) publications used 

citrus cultivars that represented the 

extremes of susceptibility from highly 

susceptible (grapefruit) to less 

susceptible varieties (lemon, 

mandarins). APHIS assumes cultivars 

not specifically studied would fall 

within this range of susceptibility and 

the results are therefore applicable to all 

citrus cultivars. In any case, the 

supplemental RMA and November 2007 

RMA consider many different sources of 

evidence in making the determination 

that the viability of bacteria on fruit and 

in lesions and wounds diminishes after 

the fruit is harvested, not just the 

Shiotani et al. (2009) publication. 

One commenter noted that the 

authors of Shiotani et al. (2009) state: ‘‘It 

is possible that bacterial cells of 

KC21Rif100 strain could not grow and 

colonize the surface of the contaminated 

fruits due to lack of nutrients.’’ The 

commenter stated that, considering that 

at least a small percentage of fruit is 

always decaying during shipment and 

marketing, this decayed fruit can 

contaminate other fruit with nutrients 

that will make survival of the bacteria 

more likely. 

The commenter provided no evidence 

suggesting that this would occur, and 

we are aware of none. The available 

evidence suggests that rotting fruit 

would not provide nutrients that would 

make survival of Xcc bacteria more 

likely. For example, Fulton and 

Bowman (1929) demonstrated that 

canker does not survive on rotting fruit. 

In addition, decaying fruit would be 

decaying due to the presence of other 

organisms, and Xcc does not compete 

well with other organisms, as described 

in Fulton and Bowman (1929) and Leite 

(1990). 

One commenter stated that, at the end 

of the Shiotani et al. (2009) publication, 

the authors indicate that navel oranges 

are more susceptible to canker than 

mandarins. The commenter stated that 

this indicates that their pathogen 

survival studies on mandarins will not 

reflect the true risk of transmission of 

the pathogen/disease. Two other 

commenters echoed this concern and 

stated that, because California’s growing 

situation is quite different than those in 

the research areas, there are serious 

issues about the extrapolation of data 

from study of only a few varieties. 

Another commenter, approaching this 

issue differently, suggested that 

restrictions on the interstate movement 

of different varieties of citrus fruit could 

vary based on the variety’s resistance to 

citrus canker. 

The Shiotani et al. (2009) publication 

does not actually state that Satsuma 

mandarins are more resistant to Xcc 

than navel oranges, although this is 

widely acknowledged to be true. In any 

case, as noted earlier, the Gottwald et al. 

(2009) and Shiotani et al. (2009) 

publications used citrus cultivars that 

represented the extremes of 

susceptibility from highly susceptible 

(grapefruit) to less susceptible varieties 

(lemon, mandarins). APHIS assumes 

cultivars not specifically studied would 

fall within this range of susceptibility 

and the results are therefore applicable 

to all citrus cultivars. The commenters 

did not provide any specific reasons to 

question this assumption. 


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In general, although we recognize that 

there are limitations in extrapolating 

from results achieved with Satsuma 

mandarins, the Shiotani et al. (2009) 

provides valuable evidence supporting 

our determination that commercially 

packed and disinfected fresh citrus fruit 

is not an epidemiologically significant 

pathway for the introduction and spread 

of Xcc. We took this evidence into 

account along with the Gottwald et al. 

(2009) publication and the other 

evidence cited in the November 2007 

RMA and the supplemental RMA in 

making this determination. 

Other Issues in the Updated PRA and 

Supplemental RMA 

One of the conclusions in the updated 

PRA is that standard packinghouse 

procedures and post-harvest treatments 

will remove and/or devitalize epiphytic 

populations of Xcc. This conclusion is 

echoed in the supplemental RMA. 

One commenter stated that the 

conclusion in the updated PRA that Xcc 

has a low survival potential is in 

contrast to earlier research by 

Golmohammadi et al. (2007), who 

reported that Xcc was frequently 

detected on fruit with canker-like 

symptoms in commercial consignments 

of citrus from Uruguay and Argentina 

into Spain. These consignments were 

accompanied by phytosanitary 

certification stating that fruit had been 

treated with postharvest bactericides, 

including chlorine and sodium 

orthophenylphenate. The presence of 

Xcc on these samples was confirmed by 

molecular and pathogenicity testing. 

Pathogenicity assays on grapefruit 

leaves confirmed that Xcc cells 

remained viable and were able to 

produce symptoms despite the 

application of postharvest treatments 

and low temperature storage. 

Both the updated PRA and the 

supplemental RMA addressed 

Golmohammadi et al. (2007). The 

updated PRA and supplemental RMA 

state that the results in Golmohammadi 

et al. (2007) indicate that disinfection 

protocols are not 100 percent effective. 

Some samples were only positive by 

PCR protocols. The authors concluded 

this was probably due to the 

disinfection treatments, which would 

reduce bacterial populations, and may 

induce the noncultivable state in the 

analyzed lesions. They further suggested 

that the bacterial cells in the lesions 

could be stressed after the fruit 

treatments (washing, disinfection, 

chemical treatments, transport, and 

storage at low temperatures for variable 

periods of time). Pathogenicity tests 

were successfully conducted only by 

artificial laboratory inoculations; the 

epidemiological significance of these 

results was not evaluated. 

Pathogenicity tests of bacteria in the 

laboratory do not indicate whether the 

bacteria would actually be able to infect 

host plants in a field setting, where 

conditions are likely to be less favorable 

than in a laboratory. The fact that 

Golmohammadi et al. (2007) concluded 

that bacterial cells in the lesions could 

be stressed after the fruit treatments 

suggests that the bacteria would not 

have been able to do so, particularly 

given the results of the experiments 

Gottwald et al. (2009) and Shiotani et 

al. (2009) conducted that addressed the 

transmission of Xcc from infected fruit 

to host plants in the field. Since 

Gottwald et al. (2009) and Shiotani et 

al. (2009) both used untreated fruit in 

their experiments, and Golmohammadi 

et al. (2007) concluded that 

packinghouse processing and 

disinfection treatment further reduce 

the viability of the bacteria, we have 

determined that the results of 

Golmohammadi et al. (2007) are 

consistent with the determination that 

commercially packed and disinfected 

fresh citrus fruit is not an 

epidemiologically significant pathway 

for the introduction and spread of Xcc. 

One commenter, specifically noting 

the detections of Xcc on fruit with 

canker-like symptoms in commercial 

consignments of citrus from Uruguay 

and Argentina into Spain, stated that 

standard harvesting and packinghouse 

procedures may not effectively 

eliminate infected fruit from the export 

pathway. 

Both the November 2007 RMA and 

the supplemental RMA acknowledge 

this. However, these procedures do 

reduce the prevalence of viable Xcc in 

commercial consignments of fruit, thus 

bolstering the conclusion that 

commercially packed and disinfected 

fresh citrus fruit is not an 

epidemiologically significant pathway 

for the introduction and spread of Xcc. 

One commenter stated that the 

supplemental RMA claims that the 

‘‘uncertainties’’ recognized in the 

November 2007 RMA are now 

answered, but the question of additional 

‘‘uncertainties’’ is completely 

disregarded. 

The supplemental RMA has an 

extensive discussion of remaining 

uncertainties in the discussion of 

options at the end of the document. The 

commenter did not identify any specific 

uncertainties that the supplemental 

RMA did not address. 

One commenter stated that, in the 

supplemental RMA, there is not a single 

biological reference to fruit pests such 

as the peel miner and to the fact that 

there is no scientific work/information 

for its impact on diseases such as citrus 

canker. The supplemental RMAsimply 

disregards this classic epidemiological 

factor under the general assumption 

‘‘Vectors do not have a role in disease 

epidemiology and if they do, it is not 

subject to regulation.’’ The commenter 

stated that this disregard of valid, 

researchable questions is highly 

disturbing. 

The role of insects in citrus canker 

outbreaks was discussed in the 

November 2007 RMA. The 

supplemental RMA does not recreate or 

revise the entire body of evidence cited 

in the November 2007 RMA, but rather 

builds on that body of evidence and 

evaluates those areas of evidence 

addressed by the new research. Because 

none of the newer research cited in the 

supplemental RMA addressed the role 

of insects in citrus canker outbreaks, we 

did not update the discussion in the 

November 2007 RMA. 

With regard to the issue of vectors, 

one commenter stated that canker is a 

local lesion disease that does not invade 

the vascular system and is not 

transmitted by sucking insects or mites, 

including citrus leafminer and peel 

miner. The commenter stated that citrus 

leafminer is not a vector for the canker 

bacterium. 

The November 2007 RMA indicates 

that injuries caused by the Asian 

leafminer can produce wounds that 

serve as infection courts in leaves and, 

to a lesser extent, fruit, but the leafminer 

itself is not known to be a vector for the 

spread of citrus canker. In the November 

2007 final rule, we discussed the peel 

miner, stating that injuries from the peel 

miner would be likely to increase the 

susceptibility of fruit to infection, and 

increase the severity of the infection if 

they became infected. In terms of overall 

spread of citrus canker, however, the 

peel miner would not likely be as 

epidemiologically significant as the 

Asian leafminer, since leaves of citrus 

trees and plants are more susceptible to 

citrus canker infection than the peels of 

citrus fruit. 

We also note that there exists no 

evidence indicating that the peel miner 

is a vector for citrus canker, and we 

would presume that the peel miner is 

not a vector, for the reasons cited by the 

second commenter. 

Comments on the November 2007 RMA 

The November 2007 RMA contained a 

discussion of the potential for 

introduction and establishment of Xcc 

in various climatic conditions. 

One commenter stated that the idea 

that California has unfavorable 

environmental conditions for pathogen 


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54440 Federal Register / Vol. 74, No. 203 / Thursday, October 22, 2009 / Rules and Regulations 

establishment is simply untrue. The 

commenter stated that summer 

monsoons commonly go through the 

Imperial Valley, and thunderstorms 

with high winds occasionally occur in 

the Central Valley (both important 

citrus-producing areas of California), 

while humidity can reach adequate 

levels for canker establishment in the 

coastal areas of Ventura County (lemonproducing areas). 

The November 2007 RMA states: 

‘‘Using hourly wind speed and 

precipitation, monthly average 

temperature, and annual and seasonal 

precipitation data to determine the 

expected incidence and severity of 

citrus canker if introduced into 

California, Borchert et al. (2007) 

concluded that favorable events in 

California citrus growing areas occurred 

‘... predominantly during the winter 

season when precipitation is greatest, 

but temperatures are less conducive for 

infection activity and citrus growth. 

This would likely result in low 

incidence and severity of citrus canker 

in California if the disease were 

introduced...’ ...The ‘Mediterranean’ 

climate (dry summers) typical of most of 

California and the arid climate of 

Arizona make [Xcc] establishment less 

likely in those States. However, in 

microclimates with highly susceptible 

cultivars such as along the California 

coast between San Diego and Ventura 

establishment is still possible, as 

demonstrated by the occurrence of 

citrus canker disease in Iran and the 

Arabian Peninsula on a highly 

susceptible variety of Mexican lime.’’ 

We acknowledge that, as the 

commenter stated, summer monsoons 

and thunderstorms occur in California, 

but that is not inconsistent with the 

discussion in the November 2007 RMA. 

The information presented by the 

commenter has not led us to change the 

conclusions in the November 2007 RMA 

regarding the suitability of California’s 

climate for the establishment of citrus 

canker. 

One commenter stated that we should 

have more solid information on the 

source of previous outbreaks before 

making the changes we proposed. 

The November 2007 RMA also 

analyzed the information available on 

the source of previous outbreaks. It 

concluded, ‘‘In summary, there is an 

unfortunate lack of conclusive 

information regarding the origins of 

previous outbreaks. Most published 

accounts are speculative. However, 

whatever the lack of certainty may be 

regarding the theories of [Xcc] 

introduction pathways, they all agree 

that trees or propagative tree parts are 

most likely the original source of [Xcc] 

introduction. Conclusive evidence that 

fresh fruit is a pathway for the 

introduction of [Xcc] has never been 

presented.’’ The November 2007 RMA 

also noted, and the supplemental RMA 

repeated, that ‘‘no canker outbreaks 

have ever been associated with the entry 

of fruit into the United States or 

anywhere in the world, nor has the 

ability of fruit to serve as a pathway of 

[Xcc] dissemination ever been 

demonstrated in any scientific 

experiment, and it seems very unlikely 

that fruit would be an epidemiologically 

significant pathway.’’ 

The evidence that has been developed 

and presented in the two studies that 

prompted the preparation of the 

updated PRA and supplemental RMA is 

consistent with the historical record on 

the source of citrus canker outbreaks, 

which largely ties them to the 

movement of infected nursery stock 

rather than the movement of infected 

fruit. 

Compliance Agreements and Leaves 

In addition to the requirement for 

treatment with an APHIS-approved 

disinfectant, we proposed to retain the 

requirement that regulated fruit moved 

interstate from an area quarantined for 

citrus canker be free of leaves, twigs, 

and other plant parts, except for stems 

that are less than 1 inch long and 

attached to the fruit. We proposed to 

retain this requirement because other 

plant parts pose different risks than fruit 

does; canker lesions on leaves, for 

example, typically have much higher 

bacterial populations than canker 

lesions on fruit. 

In the Background section of the 

proposed rule, we stated that, under the 

proposed rule, APHIS inspectors would 

no longer be on site at packinghouses to 

enforce the requirements for treatment 

and removal of leaves, twigs, and other 

plant parts. We would require in our 

compliance agreements with 

commercial packinghouses that these 

activities be conducted in accordance 

with the regulations, and inspections 

would be conducted to ensure that 

treatment is being performed properly 

and that no leaves, twigs, or other plant 

parts are being included in containers of 

fruit moved interstate. 

Two commenters stated that 

eliminating mandatory inspection of 

fruit to be moved interstate for visible 

symptoms of citrus canker raises 

questions about how APHIS will assure 

adherence to compliance agreement 

requirements. 

As stated, we will continue to inspect 

commercial packinghouses that pack 

fruit to be moved interstate to verify that 

they are adhering to the requirements in 

the regulations, as agreed to in the 

compliance agreement. These 

inspections will be conducted regularly. 

Inspectors will check treatments to 

ensure that they are being performed in 

accordance with the regulations (for 

example, verifying the pH level and the 

concentration in a sodium hypochlorite 

treatment). Inspectors will also open 

and inspect a random sample of packed 

boxes of fruit to verify that the packed 

fruit is free of leaves, twigs, and other 

plant parts. We have experience 

successfully enforcing compliance 

agreements with similar requirements 

for many other domestic quarantine 

programs. 

One commenter stated that 

inadvertent citrus leaves included in 

packed boxes of fruit may also carry the 

pathogen/disease from one location to 

another. 

Another commenter stated that, in the 

very unlikely event that a lesioned leaf 

would be present in a fruit load, 

conclusions that fruit is not an 

epidemiologically significant pathway 

can confidently be extended to aging 

and drying leaves. The commenter 

stated that it is unlikely that this source 

of inoculum would represent any 

different risk than fruit for inoculum 

production and disease transmission. 

Although the second commenter may 

be correct, we have not undertaken a 

thorough assessment of the risks 

associated with allowing the interstate 

movement of leaves of regulated species 

from a quarantined area. We would 

need to do so before allowing the 

interstate movement of leaves. 

Therefore, we proposed to retain the 

requirement discussed earlier. 

The first commenter is correct that 

leaves could inadvertently be moved in 

boxes of packed fruit. However, the 

requirement that fruit be free of leaves 

serves to mitigate that risk, as 

packinghouse employees will need to 

check to make sure that leaves are not 

inadvertently packed so that the 

packinghouse will be able to pass 

inspections conducted under the 

compliance agreements and continue to 

pack fruit for interstate movement. In 

addition, leaves are commonly removed 

from boxes of packed citrus fruit as part 

of commercial production practices. 

Given these conditions, we have 

determined that it is not necessary to 

provide for any further restrictions on 

the interstate movement of fruit in order 

to prevent the inadvertent interstate 

movement of leaves. 

Citrus Greening 

One commenter stated that we should 

consider ongoing research on evaluating 

citrus fruit as a potential source for the 


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Federal Register / Vol. 74, No. 203 / Thursday, October 22, 2009 / Rules and Regulations 54441 

Asian citrus psyllid (ACP), the vector of 

citrus greening, to acquire citrus 

greening. 

Restrictions on the movement of 

certain articles due to the presence of 

citrus greening have been put in place 

under separate Federal orders; the 

initial order was issued on 

September 16, 2005, and was last 

updated on September 21, 2009. The 

September 21, 2009, Federal Order does 

not restrict the interstate movement of 

fruit from an area quarantined for ACP, 

except to require that the fruit be 

cleaned using normal packinghouse 

procedures. These procedures are 

sufficient to remove ACP. Fruit itself 

has not been shown to be a potential 

pathway for the spread of citrus 

greening. 

The commenter did not cite any 

specific research that is ongoing 

regarding ACP’s ability to acquire citrus 

greening directly from fruit, and we are 

not aware of any. However, if we 

determine that additional restrictions 

need to be placed on the interstate 

movement of fruit from areas 

quarantined for ACP, we would include 

those restrictions in a new Federal 

Order or in separate citrus greening 

regulations, not in the citrus canker 

regulations. 

Illegal Movement of Nursery Stock 

Section 301.75-6 of the regulations 

prohibits, with limited exceptions, the 

interstate movement of citrus nursery 

stock from an area quarantined for citrus 

canker. Three commenters stated that 

the potential illegal movement of 

nursery stock was the most risky 

pathway for the introduction of citrus 

canker into commercial citrusproducing States other than Florida. 

One recommended that, given the 

limited resources available to plant 

health regulatory programs, resources 

should be concentrated on this pathway. 

This commenter requested additional 

resources to deal with the pathway. 

One stated that adoption of the 

proposed rule would likely increase the 

illegal movement of Florida citrus 

nursery plants into Texas, simply 

because the general public may 

conclude it is safe to transport citrus 

nursery plants as well. 

Two of the commenters stated that 

efforts should be undertaken to increase 

public awareness of the prohibition 

against moving nursery stock interstate 

from citrus canker quarantined areas. 

Both of these commenters also 

requested that enforcement efforts 

against this illegal movement continue; 

one requested increased resources for 

those efforts. 

We agree with these commenters that 

the illegal movement of nursery stock is 

a high-risk pathway. We have several 

efforts underway to prevent the spread 

of citrus canker and citrus greening 

through the illegal movement of nursery 

stock. In fiscal year 2009, we conducted 

enforcement activities that included: 

∑ Monitoring of retail markets and 

wholesale distributors in commercial 

citrus-producing States; 

∑ Monitoring the Internet for the sale 

and distribution of citrus plants from 

quarantined areas; 

∑ Monitoring retail and wholesale 

establishments in States other than 

commercial citrus-producing States for 

citrus plants and plant products from 

quarantined areas; and 

∑ Conducting operations in concert 

with State officials at State checkpoints 

to ensure that shipments moving out of 

Florida do not contain plants or plant 

products whose movement is prohibited 

and that shipments entering commercial 

citrus-producing States do not contain 

such products. 

We are also sampling nursery stock 

that is found moving illegally to 

determine whether it is infected with a 

citrus disease. In all these activities, we 

work with State and local agencies, and 

we notify them of whatever violations 

we discover. 

We are also conducting extensive 

outreach efforts regarding the movement 

of nursery stock from quarantined areas. 

The Web site (http:// 

www.saveourcitrus.org) provides a 

public clearinghouse of information on 

safeguarding U.S. citrus resources and 

preventing the illegal movement of 

citrus plants from quarantined areas. We 

will continue to employ resources on 

enforcement and outreach as necessary 

and as budget constraints allow. 

We disagree with the commenter who 

stated that the proposed rule would 

likely increase introduction of illegal 

Florida citrus nursery plants into Texas. 

Although regulated fruit has been 

allowed under the regulations to move 

interstate to States other than 

commercial citrus-producing States, 

regulated nursery stock, except kumquat 

plants produced under conditions 

designed to prevent their infection with 

citrus canker, is not allowed to move 

interstate. Thus, the difference between 

the allowable movement of regulated 

fruit and regulated nursery stock already 

exists, and our enforcement and 

outreach efforts take it into account. 

International Trade 

Two commenters expressed concern 

regarding trade issues. Both expressed 

concern that the rule might result in 

trading partners imposing additional 

restrictions on the export of citrus fruit 

from the United States. One stated that 

we should not finalize the proposed rule 

until we know that the European Union 

(EU) agrees with the science that serves 

as a basis for the rule, citing fears of 

trade interruptions. 

Another stated that the objective of 

the rule was to demonstrate to our 

trading partners that there is no risk of 

spread of citrus canker via fruit, thus 

allowing Florida to export fresh fruit to 

countries that currently restrict or 

prohibit such importations. This 

commenter stated that jeopardizing 

citrus-producing areas in the United 

States so that Florida can trade with 

citrus-producing areas around the world 

is unacceptable. 

Regulated fruit from Florida is 

currently exported to other countries, 

including the EU, in accordance with 

those countries’ regulatory 

requirements. We proposed to relieve 

restrictions on the interstate movement 

of fruit from an area quarantined for 

citrus canker based on our 

determination that commercially packed 

and disinfected fresh citrus fruit is not 

an epidemiologically significant 

pathway for the introduction and spread 

of citrus canker, not as part of an 

attempt to reduce or remove restrictions 

on the exportation of Florida citrus fruit 

to other countries. Other countries are 

not obligated to change their 

requirements for the importation of 

plant products based on changes in our 

regulations on the interstate movement 

of plant products. 

We are willing to have exchanges 

with foreign national plant protection 

organizations to discuss our findings, 

but because we have determined the 

restrictions that have been in place on 

the movement of fruit from a 

quarantined area are no longer justified 

by the scientific evidence, we are 

removing restrictions that are no longer 

warranted. 

Kumquats 

One commenter requested that we 

remove kumquats from the list of 

regulated articles in § 301.75-3(a), thus 

allowing kumquat fruits to be moved 

interstate from the quarantined area 

with leaves and stems, as they are 

commonly marketed. The commenter 

stated that there has not been any citrus 

canker found in Pasco County, FL, 

where all of the commenter’s kumquats 

are grown, and that there has been no 

citrus canker found in commercial 

kumquat groves. The commenter also 

stated that a professor at the University 

of Florida’s horticulture department has 

stated that ‘‘Nagami kumquats and 

citrus canker are incompatible...Far 


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54442 Federal Register / Vol. 74, No. 203 / Thursday, October 22, 2009 / Rules and Regulations 

from acting as a host, the Nagami 

kumquats suppress it by causing the 

inoculated tissue to die and the affected 

leaves to fall off.’’ 

Although there are numerous 

references stating that kumquats are 

highly resistant to citrus canker (see 

Gottwald et al. (2002) and Francis et al. 

(2009)), we are aware of no references 

that state that citrus canker does not 

infect kumquats, or that kumquats are 

incompatible with citrus canker. For 

that reason, we list kumquat plants and 

plant parts (including fruit, leaves, and 

stems) as regulated articles in § 301.75- 

3(a). If evidence is developed that 

indicates that citrus canker does not 

infect kumquats, we will amend the list 

of regulated articles accordingly. 

With respect to the commenter’s 

specific concern, we note that if 

kumquats were removed from the list of 

articles regulated for citrus canker, 

kumquat leaves would still be 

prohibited from moving interstate from 

Florida under the September 21, 2009, 

Federal order on citrus greening, which 

prohibits the interstate movement of 

plants and plant parts other than fruit 

from species that are hosts of citrus 

greening. 

Regulatory Impact Analysis 

Addressing the preliminary regulatory 

impact analysis and initial regulatory 

flexibility analysis we prepared for the 

proposed rule, two commenters stated 

that the document devotes almost 18 

pages to the expected impacts of the 

proposed rule on the Florida industry. 

In the 2c pages addressing the expected 

effects for the other commercial citrusproducing States, it is noted that APHIS 

expects ‘‘the primary effect of the rule 

would be to preserve Florida’s fresh 

market in the long run.’’ The 

commenters noted that the analysis 

states that ‘‘...a reduction in the packout 

rate for fresh market fruit in the other 

commercial citrus-producing States due 

to citrus canker infestation would likely 

have a larger economic impact than has 

been experienced by Florida, due to 

their greater reliance on fresh citrus 

sales, especially of oranges.’’ The 

analysis also states that ‘‘in the event 

that citrus canker were to spread to 

other commercial citrus-producing 

States, we do not anticipate that other 

commercial citrus-producing States 

would find profitable alternative 

markets for fruit that could not be sold 

on the fresh market.’’ The commenters 

stated that this rule change is clearly for 

the benefit of the Florida citrus 

industry, and the interstate movement 

of citrus fruit from areas quarantined for 

citrus canker into commercial citrusproducing States should not be allowed 

as the risks to the citrus industry in 

other commercial citrus-producing 

States are too high. 

As discussed in the updated PRA and 

supplemental RMA, commercially 

packed and disinfected fresh citrus fruit 

is not an epidemiologically significant 

pathway for the introduction and spread 

of Xcc. We prohibit the interstate 

movement from a quarantined area of 

plants and plant products that are more 

likely pathways, such as grass clippings, 

plant clippings, tree clippings, and 

nursery stock, which (as other 

commenters noted) is the highest-risk 

pathway for the spread of citrus canker. 

We acknowledge that citrus produced 

in other commercial citrus-producing 

States is produced primarily for the 

fresh market; for that reason, protecting 

the appearance of the fruit is critical for 

citrus production in for those States. We 

are committed to protecting against the 

spread of citrus canker to other 

commercial citrus-producing States, as 

evidenced by the mitigations required 

by the final rule for the interstate 

movement of fresh fruit from 

quarantined areas and the other 

movement restrictions in the 

regulations. 

Consistent with the requirements of 

the Regulatory Flexibility Act (RFA), 

our preliminary regulatory impact 

analysis and initial regulatory flexibility 

analysis focused on any significant 

impacts the proposed rule could have 

on small entities. We determined that 

significant impacts on small entities, if 

they occur as a result of this final rule, 

are most likely to be experienced in 

Florida; the economic effects of 

allowing freer movement of Florida 

citrus are likely to be distributed among 

consumers in other States, as discussed. 

Miscellaneous Change 

We proposed to revise the definition 

of commercial packinghouse in 

§ 301.75-1 to read: ‘‘An establishment in 

which space and equipment are 

maintained for the primary purpose of 

disinfecting and packing citrus fruit for 

commercial sale. A commercial 

packinghouse must also be licensed, 

registered, or certified with the State in 

which it operates and meet all the 

requirements for the license, 

registration, or certification that it 

holds.’’ 

In this final rule, we are changing the 

proposed definition to indicate 

specifically in the second sentence that 

the commercial packinghouse must be 

licensed, registered, or certified for 

handling citrus fruit. The proposed 

definition could have been interpreted 

as referring to any type of license, 

registration, or certification; indicating 

that the license, registration, or 

certification of a commercial 

packinghouse must be specifically for 

handling citrus fruit provides additional 

specificity and clarifies the intent of the 

definition. 

Therefore, for the reasons given in the 

proposed rule and in this document, we 

are adopting the proposed rule as a final 

rule, with the change discussed in this 

document. 

References 

Bock, C. H. (2005). Effect of simulated 

wind-driven rain on duration and 

distance of dispersal of Xanthomonas 

axonopodis pv. citri from cankerinfected citrus trees. Plant Disease 

89:71-80. 

Borchert, D., Thayer C., Brown L., 

Jones N., and Magarey R. (2007). Citrus 

Canker Ad Hoc Project, USDA-APHISPPQ-CPHST-PERAL (internal 

document). 

Francis, M. I., Pena, A., Kostenyuk, I., 

Burns, J., and Graham, J. H. (2009). HRlike resistance of kumquat (Fortunella 

spp.) to citrus canker caused by 

Xanthomonas citri sbsp. Citri. 

Phytopathology 99:S36. 

Fulton, H. R. & Bowman, J. J. (1929). 

Infection of fruits by Pseudomonas citri. 

J Agric Res 39, 403-426. 

Golmohammadi, M., J. Cubero, J. 

Pen ̃ alver, J. M. Quesada, M. M. Lo ́pez, 

and P. Llop. (2007). Diagnosis of 

Xanthomonas axonopodis pv. citri, 

causal agent of citrus canker, in 

commercial fruits by isolation and PCRbased methods. Journal of Applied 

Microbiology 103:2309-2315. 

Gottwald, T. R., Graham, J. H., and 

Schubert, T. S. (2002). Citrus canker: 

The pathogen and its impact. Plant 

Health Progress. doi:10.1094/PHP-2002- 

0812-01-RV.):34. 

Gottwald, T., Graham, J., Bock, C., 

Bonn, G., Civerolo, E., Irey, M., Leite, R., 

Lo ́pez, M. M., McCollum, G., Parker, P., 

Ramallo, J., Riley, T., Schubert, T., 

Stein, B., and Taylor, E. (2009). The 

epidemiological significance of postpackinghouse survival of Xanthomonas 

citri subsp. citri for dissemination of 

Asiatic citrus canker via infected fruit. 

Crop Protection 28:508-524. 

Leite Jr., R. P. (1990). Cancro citrico; 

prevencao e controle no Parana. 

Londrina, IAPAR. 

Parker, P. E., Bock, C. H., and 

Gottwald, T. R. (2005). Comparison of 

techniques to sample Xanthomonas 

axonopodis pv. citri in windblown 

spray. Plant Disease 89:1324-1330. 

Shiotani, H., Uematsu, H., Tsukamoto, 

T., Shimizu, Y., Ueda, K., Mizuno, A. & 

Sato, S. (2009). Survival and dispersal of 

Xanthomonas citri pv. citri from 


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Federal Register / Vol. 74, No. 203 / Thursday, October 22, 2009 / Rules and Regulations 54443 

4 ‘‘Fresh Shippers Report: 2007-08 Season 

Through July 31, 2008,’’ Citrus Administrative 

Committee, August 8, 2008. (http:// 

www.citrusadministrativecommittee.org/) 

5 Ibid. 

6 Source: SBA and 2007 Census of Agriculture. 

infected Satsuma mandarin fruit. Crop 

Protection 28:19-23. 

Effective Date 

This is a substantive rule that relieves 

restrictions and, pursuant to the 

provisions of 5 U.S.C. 553, may be made 

effective less than 30 days after 

publication in the Federal Register. 

Immediate implementation of this rule 

is necessary to provide relief to those 

persons who are adversely affected by 

restrictions we no longer find 

warranted. The shipping season for 

Florida citrus fruit is in progress. 

Making this rule effective immediately 

will allow interested producers and 

others in the marketing chain to benefit 

during this year’s shipping season. 

Therefore, the Administrator of the 

Animal and Plant Health Inspection 

Service has determined that this rule 

should be effective upon publication in 

the Federal Register. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This final rule has been reviewed 

under Executive Order 12866. The rule 

has been determined to be not 

significant for the purposes of Executive 

Order 12866 and, therefore, has not 

been reviewed by the Office of 

Management and Budget. 

We have prepared an economic 

analysis for this rule. The economic 

analysis provides a cost-benefit analysis, 

as required by Executive Order 12866, 

and an analysis of the potential 

economic effects of this action on small 

entities, as required by the RFA. The 

economic analysis is summarized 

below. Copies of the full analysis are 

available on the Regulations.gov Web 

site (see footnote 1 in this document for 

a link to Regulations.gov) or by 

contacting the person listed under FOR

FURTHER INFORMATION CONTACT. 

APHIS has determined that this final 

rule will continue to prevent the spread 

of citrus canker from quarantined areas 

while allowing the interstate movement 

of fruit and lessening the compliance 

burden associated with the fruit 

movement regulations. The rule will 

remove the risk of lot rejection of fresh 

fruit intended for interstate shipment 

solely because the fruit exhibits citrus 

canker symptoms, thereby supporting 

the long-term preservation of domestic 

fresh fruit markets for Florida’s 

commercial packinghouses and growers. 

Fresh citrus fruit will no longer require 

diversion to other uses or markets 

because of citrus canker symptoms. In 

addition, APHIS is removing the current 

prohibition on the movement of 

Florida’s fresh citrus fruit to other 

commercial citrus-producing States. We 

do not anticipate that citrus production 

in these States will be significantly 

affected by Florida’s market reentry. 

While the lots rejected during the 

2008-09 season were successfully 

diverted for processing or to fresh fruit 

markets within Florida or outside the 

United States, affected citrus producers 

and commercial packinghouses incurred 

revenue declines because of elimination 

charges and the lower prices received 

due to product diversion. The cost of 

producing citrus fruit intended for the 

fresh market is greater than the cost of 

production for the processed market, 

where the physical appearance of the 

fruit is not important. 

Impact on Small Entities 

The RFA requires that agencies 

consider the economic impact of rule 

changes on small businesses, 

organizations, and governmental 

jurisdictions. Section 605 of the RFA 

allows an agency to certify a rule if the 

proposed rulemaking will not have a 

significant economic impact on a 

substantial number of small entities. 

Following is the factual basis for such 

certification in this case. 

Based on the determination that fresh 

citrus fruit treated using an APHISapproved disinfectant is not an 

epidemiologically significant pathway 

for transmission of the disease, this final 

rule will remove the requirement of an 

APHIS inspection of fresh packed citrus 

intended for the domestic market for 

symptoms of citrus canker disease. The 

final rule will require the treatment of 

fresh citrus from a commercial 

packinghouse with an APHIS-approved 

disinfectant. The final rule will relieve 

prohibitions associated with the current 

limited permit requirement, and allow 

the reentry of fresh citrus fruit from 

Florida into other commercial citrusproducing States. This action is being 

taken to relieve restrictions on the 

Florida citrus industry that we believe 

are no longer warranted while 

continuing to prevent the spread of 

citrus canker to other commercial citrusproducing States and territories. 

Florida’s citrus commercial 

packinghouses and fresh citrus 

producers comprise the industries that 

will be directly affected by this final 

rule. The small business size standard 

for citrus fruit packing, as identified by 

the Small Business Administration 

(SBA) based upon the North American 

Industry Classification System (NAICS) 

code 115114 (Postharvest Crop 

Activities) is $6.5 million or less in 

annual receipts. There are currently 174 

commercial packinghouses in Florida 

under APHIS Packinghouse Compliance 

Agreements, 56 of which are registered 

with the Florida Department of 

Agriculture and Consumer Services’ 

Division of Fruit and Vegetables. While 

the classification of all of these 

establishments by sales volume is not 

available, it is estimated that 

approximately 40 of the 56 registered 

commercial packinghouses are the topgrossing citrus commercial 

packinghouses. The remaining 

packinghouses are small establishments 

known primarily as gift packers. At least 

95 percent of Florida fresh citrus 

shipments are packed by the top 40 (23 

percent) commercial packinghouses in 

the State.4 The Fresh Shippers Report, 

as reported by the Citrus Administrative 

Committee, details quantities of fresh 

citrus shipped by the top 40 shippers 

each season.5 During the 2007-08 

season, annual sales for 14 of the top 40 

shippers (35 percent) were below the 

SBA size standard of $6.5 million. It is 

estimated that at least 82 percent of 

Florida’s citrus packers, including the 

small gift packers, will be considered 

small according to the SBA size 

standards. 

The final rule is also expected to 

positively affect producers of fresh 

citrus in Florida currently facing an 

increasing number of lots rejected at the 

packinghouse level each season. 

Packing and elimination charges for 

growers are higher for fruit diverted to 

the within-State or export markets, or to 

processing plants. In addition, fruit 

diverted to processing yields lower 

revenues for growers who have already 

borne the higher costs of producing fruit 

intended for the fresh market. 

A majority of the Florida citrus 

producers that will be affected by the 

final rule are small, based on 2007 

Census of Agriculture data and SBA 

guidelines for entities classified within 

the farm categories Orange Groves 

(NAICS 111310) and Citrus (except 

Orange) Groves (NAICS 111320). SBA 

classifies producers in these categories 

with total annual sales of not more than 

$750,000 as small entities. According to 

2007 Census data, there were a total of 

6,061 citrus farms in Florida in 2007. Of 

this number, 90 percent had annual 

sales in 2007 of less than $500,000, 

which is well below the SBA’s smallentity threshold of $750,000.6 Any costs 

associated with the final rule are 

expected to be minimal, especially 

given the producers’ gains from fewer 


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54444 Federal Register / Vol. 74, No. 203 / Thursday, October 22, 2009 / Rules and Regulations 

7 Go to (http://www.regulations.gov/fdmspublic/ 

component/main?main=DocketDetail 

&d=APHIS-2009-0023). The environmental 

assessment and finding of no significant impact will 

appear in the resulting list of documents. 

rejections of fresh citrus lots destined 

for the domestic market. 

Producers of fresh fruit in other 

commercial citrus-producing States may 

also be impacted by the rule to the 

extent that the reintroduction of Florida 

fresh citrus changes the supply in these 

States. However, APHIS does not 

anticipate significant increases in fresh 

citrus supplies into these markets as a 

result of this final rule as indicated by 

historic data on Florida fresh citrus 

shipments. According to 2007 Census 

data, there were a total of 15,658 citrus 

farms in the United States in 2007. Of 

this total, 329 were located in Arizona, 

7,358 in California, 884 in Hawaii, 210 

in Louisiana, and 750 in Texas. In each 

State, at least 91 percent of all farms had 

annual sales in 2007 of less than 

$500,000 and are classified as small 

entities according to SBA guidelines. 

Under these circumstances, the 

Administrator of the Animal and Plant 

Health Inspection Service has 

determined that this action will not 

have a significant economic impact on 

a substantial number of small entities. 

Executive Order 12372 

This program/activity is listed in the 

Catalog of Federal Domestic Assistance 

under No. 10.025 and is subject to 

Executive Order 12372, which requires 

intergovernmental consultation with 

State and local officials. (See 7 CFR part 

3015, subpart V.) 

Executive Order 12988 

This final rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. This rule: (1) Preempts 

all State and local laws and regulations 

that are inconsistent with this rule; (2) 

has no retroactive effect; and (3) does 

not require administrative proceedings 

before parties may file suit in court 

challenging this rule. 

National Environmental Policy Act 

An environmental assessment and 

finding of no significant impact have 

been prepared for this final rule. The 

environmental assessment provides a 

basis for the conclusion that the 

interstate movement of citrus fruit 

under the conditions specified in this 

rule will not have a significant impact 

on the quality of the human 

environment. Based on the finding of no 

significant impact, the Administrator of 

the Animal and Plant Health Inspection 

Service has determined that an 

environmental impact statement need 

not be prepared. 

The environmental assessment and 

finding of no significant impact were 

prepared in accordance with: (1) The 

National Environmental Policy Act of 

1969 (NEPA), as amended (42 U.S.C. 

4321 et seq.), (2) regulations of the 

Council on Environmental Quality for 

implementing the procedural provisions 

of NEPA (40 CFR parts 1500-1508), (3) 

USDA regulations implementing NEPA 

(7 CFR part 1b), and (4) APHIS’ NEPA 

Implementing Procedures (7 CFR part 

372). 

The environmental assessment and 

finding of no significant impact may be 

viewed on the Regulations.gov Web 

site.7 Copies of the environmental 

assessment and finding of no significant 

impact are also available for public 

inspection at USDA, room 1141, South 

Building, 14th Street and Independence 

Avenue SW., Washington, DC, between 

8 a.m. and 4:30 p.m., Monday through 

Friday, except holidays. Persons 

wishing to inspect copies are requested 

to call ahead on (202) 690-2817 to 

facilitate entry into the reading room. In 

addition, copies may be obtained by 

writing to the individual listed under 

FOR FURTHER INFORMATION CONTACT. 

Paperwork Reduction Act 

This final rule contains no new 

information collection or recordkeeping 

requirements under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 et 

seq.). 

List of Subjects in 7 CFR Part 301 

Agricultural commodities, Plant 

diseases and pests, Quarantine, 

Reporting and recordkeeping 

requirements, Transportation. 

■ Accordingly, we are amending 7 CFR 

part 301 as follows: 

PART 301–DOMESTIC QUARANTINE 

NOTICES 

■ 1. The authority citation for part 301 

continues to read as follows: 

Authority: 7 U.S.C. 7701-7772 and 7781- 

7786; 7 CFR 2.22, 2.80, and 371.3. 

Section 301.75-15 issued under Sec. 

204, Title II, Public Law 106-113, 113 

Stat. 1501A-293; sections 301.75-15 and 

301.75-16 issued under Sec. 203, Title 

II, Public Law 106-224, 114 Stat. 400 (7 

U.S.C. 1421 note). 

■ 2. In § 301.75-1, the definition of 

commercial packinghouse is revised to 

read as follows: 

§ 301.75-1 Definitions. 

* * * * * 

Commercial packinghouse. An 

establishment in which space and 

equipment are maintained for the 

primary purpose of disinfecting and 

packing citrus fruit for commercial sale. 

A commercial packinghouse must also 

be licensed, registered, or certified for 

handling citrus fruit with the State in 

which it operates and meet all the 

requirements for the license, 

registration, or certification that it holds. 

* * * * * 

§ 301.75-4 [Amended] 

■ 3. Section 301.75-4 is amended as 

follows: 

■ a. In paragraph (d)(2)(ii)(D), by 

removing the first sentence. 

■ b. By removing paragraph (d)(6). 

■ 4. Section 301.75-7 is revised to read 

as follows: 

§301.75-7 Interstate movement of 

regulated fruit from a quarantined area. 

(a) Regulated fruit produced in a 

quarantined area or moved into a 

quarantined area for packing may be 

moved interstate with a certificate 

issued and attached in accordance with 

§ 301.75-12 if all of the following 

conditions are met: 

(1) The regulated fruit was packed in 

a commercial packinghouse whose 

owner or operator has entered into a 

compliance agreement with APHIS in 

accordance with § 301.75-13. 

(2) The regulated fruit was treated in 

accordance with § 301.75-11(a). 

(3) The regulated fruit is free of 

leaves, twigs, and other plant parts, 

except for stems that are less than 1 inch 

long and attached to the fruit. 

(4) If the fruit is repackaged after 

being packed in a commercial 

packinghouse and before it is moved 

interstate from the quarantined area, the 

person that repackages the fruit must 

enter into a compliance agreement with 

APHIS in accordance with § 301.75-13 

and issue and attach a certificate for the 

interstate movement of the fruit in 

accordance with § 301.75-12. 

(b) Regulated fruit that is not eligible 

for movement under paragraph (a) of 

this section may be moved interstate 

only for immediate export. The 

regulated fruit must be accompanied by 

a limited permit issued in accordance 

with § 301.75-12 and must be moved in 

a container sealed by APHIS directly to 

the port of export in accordance with 

the conditions of the limited permit. 

(Approved by the Office of 

Management and Budget under control 

number 0579-0325) 


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Federal Register / Vol. 74, No. 203 / Thursday, October 22, 2009 / Rules and Regulations 54445 

1For editorial reasons, Part B (Consumer 

Products) and Part C (Commercial Equipment) of 

Title III of EPCA were redesignated as Parts A and 

A–1, respectively, in the United States Code. 

Done in Washington, DC, this 15th 

day of October 2009. 

Kevin Shea 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E9–25328 Filed 10–21–09: 8:45 am] 

BILLING CODE 3410–34–S 

DEPARTMENT OF ENERGY 

10 CFR Part 430 

[Docket No. EERE–2008–BT–TP–0007] 

RIN 1904–AB77 

Energy Conservation Program: Test 

Procedures for Fluorescent Lamp 

Ballasts (Standby Mode) 

AGENCY: Office of Energy Efficiency and 

Renewable Energy, Department of 

Energy. 

ACTION: Final rule. 

SUMMARY: The U.S. Department of 

Energy (DOE) is amending its test 

procedures for fluorescent lamp ballasts 

under the Energy Policy and 

Conservation Act. These amendments 

address the measurement of energy 

consumption of fluorescent lamp 

ballasts in the standby mode. These 

amendments do not address energy 

consumption in off mode, because DOE 

has determined that these products do 

not operate in off mode. 

DATES: This rule is effective November 

23, 2009. The incorporation by reference 

of certain publications listed in this rule 

was approved by the Director of the 

Federal Register on November 23, 2009. 

ADDRESSES: You may review copies of 

all materials related to this rulemaking 

at the U.S. Department of Energy, 

Resource Room of the Building 

Technologies Program, 950 L’Enfant 

Plaza, SW., Suite 600, Washington, DC, 

(202) 586–2945, between 9 a.m. and 4 

p.m., Monday through Friday, except 

Federal holidays. Please call Ms. Brenda 

Edwards at the above telephone number 

for additional information regarding 

visiting the Resource Room. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Linda Graves, U.S. Department of 

Energy, Office of Energy Efficiency and 

Renewable Energy, Building 

Technologies Program, EE–2J, 1000 

Independence Avenue, SW., 

Washington, DC 20585–0121. 

Telephone: (202) 586–1851. E-mail: 

Linda.Graves@ee.doe.gov. 

Mr. Eric Stas, U.S. Department of 

Energy, Office of the General Counsel, 

GC–72, 1000 Independence Avenue, 

SW., Washington, DC 20585. Telephone: 

(202) 586–5827. E-mail: 

Eric.Stas@hq.doe.gov. 

SUPPLEMENTARY INFORMATION: This final 

rule incorporates by reference into 

Appendix Q of Subpart B of Title 10, 

Code of Federal Regulations, part 430, 

the following industry standards from 

the American National Standards 

Institute (ANSI): 

1. ANSI Standard C82.2–1984, 

Revision of ANSI C82.2–1977 

‘‘American National Standard for Lamp 

Ballasts—Methods of Measurement,’’ 

October 21, 1983; and 

2. ANSI Standard C82.2–2002, 

Revision of ANSI C82.2–1994 (R1995) 

‘‘American National Standard for Lamp 

Ballasts—Methods of Measurement of 

Fluorescent Lamp Ballasts,’’ June 6, 

2002. 

Copies of the ANSI standards can be 

obtained from the American National 

Standards Institute, 25 W. 43rd Street, 

4th Floor, New York, NY 10036, (212) 

642–4900, or http://www.ansi.org. One 

can also view a copy of these standards 

at the U.S. Department of Energy, 

Resource Room of the Building 

Technologies Program, 950 L’Enfant 

Plaza, SW., 6th Floor, Washington, DC 

20024, (202) 586–2945, between 9 a.m. 

and 4 p.m., Monday through Friday, 

except Federal holidays. 

Table of Contents 

I. Authority and Background 

II. Summary of the Final Rule 

III. Discussion 

A. Definitions 

1. Active Mode 

2. Standby Mode 

3. Off Mode 

B. Scope of Applicability 

1. Types of Ballasts Covered 

2. Relationship to Other Rulemakings 

C. Approach 

1. Overview of Test Procedure 

2. Definitions 

3. Test Conditions 

4. Test Method and Measurements 

5. Test Procedure Measurements and 

Burden 

IV. Regulatory Review 

A. Executive Order 12866 

B. National Environmental Policy Act 

C. Regulatory Flexibility Act 

D. Paperwork Reduction Act 

E. Unfunded Mandates Reform Act of 1995 

F. Treasury and General Government 

Appropriations Act, 1999 

G. Executive Order 13132 

H. Executive Order 12988 

I. Treasury and General Government 

Appropriations Act, 2001 

J. Executive Order 13211 

K. Executive Order 12630 

L. Section 32 of the Federal Energy 

Administration Act of 1974 

M. Congressional Notification 

V. Approval of the Office of the Secretary 

I. Authority and Background 

Title III of the Energy Policy and 

Conservation Act (42 U.S.C. 6291 et 

seq.; EPCA or the Act) sets forth a 

variety of provisions designed to 

improve energy efficiency. Part A 1 of 

Title III (42 U.S.C. 6291–6309) 

establishes the ‘‘Energy Conservation 

Program for Consumer Products Other 

Than Automobiles,’’ which covers 

consumer products (all of which are 

referred to below as ‘‘covered 

products’’), including fluorescent lamp 

ballasts (ballasts). (42 U.S.C. 6291(1)–(2) 

and 6292(a)(13)) 

The program consists essentially of 

testing, labeling, and Federal energy 

conservation standards. The testing 

requirements consist of test procedures 

that manufacturers of covered products 

must use as the basis for certifying to 

DOE that their products comply with 

EPCA energy conservation standards 

and for representing the energy 

efficiency of their products. 

Section 323(b) of EPCA (42 U.S.C. 

6293 (b)) authorizes DOE to amend or 

establish new test procedures as 

appropriate for each covered product. It 

states that ‘‘[a]ny test procedures 

prescribed or amended under this 

section shall be reasonably designed to 

produce test results which measure 

energy efficiency, energy use, * * * or 

estimated annual operating cost of a 

covered product during a representative 

average use cycle or period of use, as 

determined by the Secretary [of Energy], 

and shall not be unduly burdensome to 

conduct.’’ (42 U.S.C. 6293(b)(3)) In 

addition, EPCA states that DOE ‘‘shall 

determine, in the rulemaking carried out 

with respect to prescribing such 

procedure, to what extent, if any, the 

proposed test procedure would alter the 

measured energy efficiency * * * of 

any covered product as determined 

under the existing test procedure.’’ (42 

U.S.C. 6293(e)(1)) If DOE determines 

that the amended test procedure would 

alter the measured efficiency of a 

covered product, DOE must amend the 

applicable energy conservation standard 

accordingly. (42 U.S.C. 6293(e)(2)) 

For ballasts, the test procedures must 

be ‘‘in accord with ANSI Standard 

C82.2–1984 or other test procedures 

determined appropriate by the 

Secretary.’’ (42 U.S.C. 6293(b)(5)) DOE’s 

existing test procedures for ballasts, 

adopted pursuant to the above 

provisions, appear at Title 10 of the 

Code of Federal Regulations (CFR) part 

430, subpart B, appendix Q (‘‘Uniform 


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