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

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Rules and Regulations Federal Register

16097 

Vol. 74, No. 67 

Thursday, April 9, 2009 

1Source: Florida Agricultural Statistic Service 

(FASS), National Agricultural Statistics Service 

(NASS), USDA, ‘‘Citrus Summary 2006–2007,’’ 

February 2008. 2 Data for 2002–2006 are derived from: NASS/ 

USDA, ‘‘Citrus Fruits 2006 Summary,’’ 2006. 2007 

data are from: NASS/USDA, ‘‘Citrus Summary 

2006–2007,’’ February 2008. 3 Data for 2002–2006 are derived from: NASS/ 

USDA, ‘‘Citrus Fruits 2006 Summary,’’ 2006. 2007 

data are from: NASS/USDA, ‘‘Citrus Summary 

2006–2007,’’ February 2008. 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

7 CFR Part 301 

[Docket No. APHIS–2007–0032] 

RIN 0579–AC38 

Citrus Canker; Interstate Movement of 

Regulated Nursery Stock From 

Quarantined Areas 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Final rule. 

SUMMARY: We are adopting as a final 

rule, with one change, an interim rule 

that amended the citrus canker 

regulations to explicitly prohibit, with 

limited exceptions, the interstate 

movement of regulated nursery stock 

from a quarantined area. The interim 

rule provided two exceptions to this 

prohibition, one that allowed nursery 

stock to be moved interstate for 

immediate export under certain 

conditions and another that allowed 

calamondin and kumquat plants to be 

moved interstate in accordance with a 

protocol designed to ensure their 

freedom from citrus canker. Our 

decision to provide for the interstate 

movement of calamondin and kumquat 

plants was based on their apparent 

resistance to citrus canker infection. 

However, since the publication of the 

interim rule, we have confirmed that 47 

calamondin plants growing in an area 

quarantined for citrus canker were 

infected with the disease. Therefore, 

this final rule amends the protocol to 

exclude calamondin plants. The interim 

rule was necessary to clarify our 

regulations and to address the risk 

associated with the interstate movement 

of regulated nursery stock from areas 

quarantined for citrus canker. 

DATES: Effective Date: May 11, 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– 

8899. 

SUPPLEMENTARY INFORMATION: 

Background 

Under section 412(a) of the Plant 

Protection Act (7 U.S.C. 7701 et seq., 

referred to below as the PPA), the 

Secretary of Agriculture may prohibit or 

restrict the movement in interstate 

commerce of any plant or plant product, 

if the Secretary determines that the 

prohibition or restriction is necessary to 

prevent the dissemination of a plant 

disease within the United States. Under 

the Act, the Secretary may also issue 

regulations requiring plants and plant 

products moved in interstate commerce 

to be subject to remedial measures 

determined to be necessary to prevent 

the spread of a plant disease or 

requiring the objects to be accompanied 

by a permit issued by the Secretary prior 

to movement. 

Citrus canker is a plant disease that is 

caused by the bacterium Xanthomonas 

citri subsp. citri (referred to below as 

Xcc) that affects plants and plant parts 

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 aggressive 

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. Regulated articles are 

plants and plant parts of all species, 

clones, cultivars, strains, varieties, or 

hybrids of the genera Citrus and 

Fortunella, and all clones, cultivars, 

strains, varieties and hybrids of the 

species Clausena lansium and Poncirus 

trifoliata. Plants and plant parts include 

fruit, seed, grass clippings, plant 

clippings, tree clippings, and nursery 

stock. The regulations also provide 

conditions under which regulated fruit 

and regulated seed may be moved from 

quarantined areas. 

Preventing the spread of citrus canker 

is of great importance, and the 

regulations are therefore necessary, not 

only because of the severity of the 

disease, but also because commercial 

citrus production is of considerable 

significance to the U.S. agricultural 

economy. Since 2002, an average of 

939,360 acres within the United States 

has been devoted annually to citrus 

grown for commercial production.1

During the same time period, these acres 

have produced, on average, more than 

13 million tons of fresh citrus a year.2

The average estimated annual value of 

citrus produced in the United States 

during that time period was $2.55 

billion (packinghouse door equivalent). 

Florida accounts for the majority of 

commercial citrus produced in the 

United States, but there is substantial 

commercial citrus production in other 

States. Between 2002 and 2007, 

Arizona, California, and Texas, three 

States that the United States Department 

of Agriculture’s (USDA’s) Animal and 

Plant Health Inspection Service (APHIS) 

has designated as commercial citrusproducing areas in § 301.75–5, 

maintained, on average, 305,500 acres 

devoted to commercial citrus 

production annually and produced an 

average of more than 3.64 million tons 

of fresh citrus articles each year.3

Moreover, commercial citrus 

production in Florida has declined in 

recent years, from approximately 11.5 

million tons in 2002 to approximately 

7.8 million tons in 2006. The primary 

reason for this decline was the 

exceptionally active hurricane seasons 

of 2004 and 2005, which were 

devastating to Florida’s citrus 

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16098 Federal Register / Vol. 74, No. 67 / Thursday, April 9, 2009 / Rules and Regulations 

4 In the decade preceding the end of the 2005 

hurricane season, APHIS issued three interim rules 

(61 FR 1519–1521, Docket No. 95–086–1; 65 FR 

53528–53531, Docket No. 00–036–1; 69 FR 55315– 

55320, Docket No. 04–045–1) designating areas in 

Florida as quarantined areas. Two of these three 

rules added counties or portions of counties. 

5APHIS, Letter to Charles H. Bronson, 

Commissioner of Agriculture, Florida Department 

of Agriculture and Consumer Services, January 10, 

2006. 

6To view the interim rule and the comments we 

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

fdmspublic/component/ 

main?main=DocketDetail&d=APHIS-2006-0114. 

7APHIS, ‘‘Movement of Commercially Packed 

Citrus Fruit from Citrus Canker Disease Quarantine 

Area: Revised Risk Management Analysis,’’ 

September 2007, ppg. 25–26. To view this 

document, go to http://www.regulations.gov/ 

fdmspublic/component/ 

main?main=DocketDetail&d=APHIS-2007-0022. 

8To view the interim rule or the comments we 

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

fdmspublic/component/ 

main?main=DocketDetail&d=APHIS-2007-0032. 

production. Not only was extensive 

damage to citrus plants wrought during 

each hurricane, but the storms also 

widely disseminated diseases affecting 

citrus, including citrus canker, within 

the State. 

Before the 2004 and 2005 hurricane 

seasons, we had sought to quarantine 

those areas within the State where the 

disease was found and to promote 

eradication efforts, while allowing the 

normal movement of regulated citrus 

articles from those areas within Florida 

where the disease was not present. In 

areas quarantined for citrus canker, the 

regulations required a number of 

measures prior to the interstate 

movement of any regulated articles: 

Inspections at set intervals of all 

regulated citrus plants and trees within 

the area, except indoor house plants; 

treatment of all vehicles, equipment, 

personnel, and other articles used in 

providing inspection, maintenance, 

harvesting, or related services in any 

grove containing regulated plants or 

trees, as well as in providing 

landscaping or lawn care services on 

any premises containing regulated 

plants or regulated trees; and 

destruction of all plants and trees 

within the area that were determined to 

be infected with citrus canker, except 

plants and trees at nurseries and indoor 

house plants. 

We based this earlier approach on the 

localized nature of quarantined areas 

within Florida during that time period. 

Such areas were usually no greater than 

a county.4 Because of the relatively 

small size of these quarantined areas, 

we were confident that this approach 

would allow us to identify and 

quarantine newly infected areas quickly 

enough to prevent the further spread of 

the disease within Florida and to 

eradicate citrus canker within the State. 

However, after the hurricane seasons 

of 2004 and 2005, at one point 

approximately 75 percent of all 

commercial citrus trees in the State 

were located within 5 miles of a 

location where citrus canker had been 

detected. It thus became apparent that, 

because of the size and distribution of 

the newly affected areas, the existing 

approach would no longer be adequate 

to eradicate the disease or prevent its 

spread within Florida. Therefore, on 

January 10, 2006, APHIS announced 

that it had determined that the 

established eradication program was no 

longer a scientifically feasible option to 

address citrus canker within Florida.5

We later codified this decision in an 

interim rule 6 effective and published in 

the Federal Register on August 1, 2006 

(71 FR 43345–43352, Docket No. 

APHIS–2006–0114), in which we 

declared the State of Florida a 

quarantined area for citrus canker and 

amended the requirements for the 

movement of regulated citrus articles 

from Florida. 

Specifically, in that rule, we moved 

provisions of the regulations requiring 

inspections at set intervals of regulated 

plants and trees, except indoor house 

plants; the treatment of articles used in 

providing landscaping services; and the 

destruction of plants and trees, except 

for plants and trees at nurseries and 

indoor house plants, from § 301.75–6, 

which sets conditions that must be met 

in order for any regulated articles to be 

moved interstate from a quarantined 

area, to paragraph (d) of § 301.75–4, 

which sets out conditions that must be 

met in order for less than an entire State 

to be designated as a quarantined area. 

We stated that these provisions were 

only appropriate for a regulatory 

program focused on eradication, and 

thus were no longer applicable to 

Florida. 

After the publication of the August 

2006 interim rule, it was determined 

that the amendments that the 2006 

interim rule made to § 301.75–6 could 

be construed as allowing the interstate 

movement of citrus nursery stock from 

an area quarantined for citrus canker. 

Citrus nursery stock, however, is 

considered to be one of the most likely 

pathways for the introduction of Xcc to 

previously unaffected areas.7 Therefore, 

we determined that it was necessary to 

amend the regulations to clarify that 

such movement was not allowed. At the 

same time, we recognized that there 

were many citrus producers within 

Florida who had been adversely affected 

by the restrictions imposed by the 

interim rule. Accordingly, we also 

sought to provide them with a degree of 

regulatory relief appropriate under the 

circumstances. 

As a result, in an interim rule 8

effective March 16, 2007, and published 

in the Federal Register on March 22, 

2007 (72 FR 13423–13428, Docket No. 

APHIS–2007–0032), we amended the 

regulations to explicitly prohibit the 

movement of citrus nursery stock from 

an area quarantined for citrus canker. 

This action was necessary to clarify our 

regulations and address the risk 

associated with the interstate movement 

of nursery stock from a quarantined 

area. The interim rule also included two 

exceptions to the prohibition, one that 

allowed citrus nursery stock to be 

moved interstate for immediate export, 

subject to certain restrictions, and 

another that allowed calamondin and 

kumquat plants to be moved interstate 

under a protocol designed to ensure 

their freedom from citrus canker prior to 

movement. 

We solicited comments concerning 

the interim rule for 60 days ending May 

21, 2007. We subsequently reopened 

and extended the deadline for 

comments until June 11, 2007, in a 

document published in the Federal 

Register on May 23, 2007 (72 FR 28827, 

Docket No. APHIS–2007–0032). For 

reasons we discuss below in the section 

entitled ‘‘Comments Regarding the 

Interstate Movement of Calamondins 

and Kumquats,’’ we reopened and 

extended the deadline for comments 

once more, until February 28, 2008, in 

a document published in the Federal 

Register on January 29, 2008 (73 FR 

5085, Docket No. APHIS–2007–0032). 

We received 18 comments by that 

date, from State departments of 

agriculture, greenhouses, citrus nursery 

stock growers, brokers for stock growers, 

and a plant board. The comments are 

discussed below by topic. 

General Comments on the Interim Rule 

Two commenters stated that the 

interim rule contained no scientific 

analysis evaluating the risks associated 

with the interstate movement of citrus 

nursery stock from a quarantined area. 

In the absence of such an analysis, the 

commenters suggested that APHIS had 

not adequately examined the possible 

risks posed by such movement or the 

availability of control measures that 

may mitigate or eliminate these risks. 

Because of this, they stated that we 

ought to withdraw the interim rule. 

Similarly, two commenters stated that 

APHIS had overstated the risk of spread 

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Federal Register / Vol. 74, No. 67 / Thursday, April 9, 2009 / Rules and Regulations 16099 

9We adopted a similar protocol in a final rule 

published in the Federal Register on March 24, 

1989 (54 FR 12175–12183, Docket No. 88–105); we 

removed the protocol from the regulations, without 

giving a reason for doing so, in a final rule 

published in the Federal Register on September 11, 

1990 (55 FR 37441–37453, Docket No. 90–114). 

of citrus canker associated with the 

interstate movement of nursery stock 

from the State of Florida. 

Our prohibition on the interstate 

movement of nursery stock reflects the 

fact that the movement of citrus nursery 

stock has been considered one of the 

most likely pathways for the spread of 

citrus canker. In virtually every case 

worldwide where citrus canker has been 

introduced into a previously unaffected 

area, it is considered likely to have 

occurred through the movement of 

infected nursery stock. Moreover, USDA 

has historically prohibited the interstate 

movement of citrus nursery stock from 

areas quarantined because of citrus 

canker. The purpose of the interim rule 

was therefore to make explicit our longstanding historical practice and sciencebased policy of prohibiting the interstate 

movement of citrus nursery stock from 

areas quarantined for citrus canker. 

Because this prohibition was not new, 

we did not prepare a risk assessment for 

the interim rule. 

We also note that the dispersion of 

Xcc was widespread within the State of 

Florida as a result of the 2004 and 2005 

hurricane seasons and that there were, 

consequently, many newly infected 

citrus plants within the State, including 

citrus nursery stock. These two 

considerations had, in fact, formed the 

basis for designating the entire State of 

Florida as a quarantined area in August 

2006. 

In deciding within that same rule to 

codify a protocol that allowed the 

interstate movement of calamondin and 

kumquat plants under certain 

conditions, we relied on a peerreviewed scientific article on citrus 

canker and the long-standing, but 

informal, consensus of scientists 

regarding the strong biological 

resistance of calamondins and kumquats 

to Xcc.9 We have since obtained 

epidemiological results that indicate 

that calamondins are not as resistant to 

citrus canker as we had previously 

believed. We discuss this information in 

greater detail in the section entitled 

‘‘Comments Regarding the Interstate 

Movement of Calamondins and 

Kumquats.’’ 

Several commenters questioned the 

need for the interim rule on other 

grounds. Some stated that in Florida, 

the only State currently quarantined for 

citrus canker, nursery inspections 

mandated by Federal and State 

authorities suffice to prevent the 

movement of nursery stock infected 

with citrus canker. Others asserted that 

the biosecurity measures many nursery 

stock growers voluntarily undertake in 

order to market their plants, beyond 

those required by Federal or State 

regulations, provide adequate protection 

against the spread of citrus canker 

through the movement of nursery stock. 

There are currently no Federal 

regulations requiring the inspection of 

citrus nursery stock in Florida. When an 

entire State has been designated as an 

area quarantined for citrus canker, there 

are no Federal regulations requiring 

inspection of citrus nursery stock within 

that area. In the August 2006 interim 

rule that designated the entire State of 

Florida as a quarantined area for citrus 

canker, we had intended to remove any 

reference to inspections from § 301.75– 

6 because that provision was 

appropriate only for a program focused 

on eradication and conducted in a 

quarantined area smaller than a State. 

The provision was therefore no longer 

appropriate for Florida, given our 

January 2006 determination that the 

widespread dispersion of Xcc that had 

occurred throughout the State as a result 

of the 2004 and 2005 hurricane seasons 

had rendered an eradication-based 

approach unfeasible. Likewise, we 

recognized in 2006 that the provision 

more appropriately belonged in 

§ 301.75–4, which contains provisions 

under which an area less than an entire 

State may be designated as a 

quarantined area for Xcc. Our intention 

in the August 2006 interim rule was 

therefore to remove the provision from 

§ 301.75–6 and add it to § 301.75–4. 

While we did the latter, we did not do 

the former. Our mistake in leaving the 

inspection provision in § 301.75–6 is 

demonstrated by the fact that, after 

publication of the August 2006 interim 

rule, § 301.75–6 appeared not to require 

inspected plants to yield negative 

results for the presence of citrus canker. 

Our regulations could then be read to 

allow infected nursery stock, whether 

visibly affected or asymptomatic, to be 

transported interstate. As these 

provisions did not conform to our longstanding historical practice and sciencebased policy, we removed the 

provisions from § 301.75–6 in the March 

2007 interim rule. 

We acknowledge that the inspections 

for citrus canker mandated by Florida’s 

Department of Agriculture and 

Consumer Services/Division of Plant 

Industry (FDACS/DPI) serve to lessen 

the risk of the spread of Xcc to 

unaffected producers within the 

quarantined area. However, we have 

determined that these inspections do 

not adequately address the risk 

associated with the interstate movement 

of citrus nursery stock from Florida. 

The inspections are, however, part of 

a larger program for citrus nursery stock 

produced in the State of Florida, the 

Citrus Nursery Stock Certification 

Program. We address the program itself 

in greater detail below, in the section 

entitled ‘‘Comments Proposing Florida’s 

Citrus Nursery Stock Certification 

Program as an Alternative to 

Rulemaking.’’ 

Finally, we recognize that the 

biosecurity measures stock growers 

employ often reduce the likelihood that 

their plants may become infected with 

citrus canker. However, because these 

measures are voluntary, we cannot 

assume that all producers within 

Florida adhere to these standards. This 

is important, because, as we mentioned 

above, the movement of citrus nursery 

stock is considered to be one of the most 

likely pathways for the spread of Xcc. 

Standards and protocols that may not be 

uniformly followed do not adequately 

address the risk associated with the 

interstate movement of citrus nursery 

stock from an area quarantined for citrus 

canker. 

Several commenters suggested that 

the interim rule should be withdrawn 

because citrus canker poses no human 

health risk and is not transmissible to 

plants other than citrus. Similarly, three 

commenters stated that the rule should 

be withdrawn because, they stated, 

APHIS’ basis for issuing the rule was 

solely to protect and promote the 

economic interests of other commercial 

citrus-producing areas, rather than to 

prevent the further dissemination of Xcc 

within the United States. 

As noted above, our intent in issuing 

the interim rule was to clarify our longstanding historical practice and sciencebased policy of prohibiting the 

movement of nursery stock from areas 

quarantined for citrus canker. The 

existing prohibitions on the interstate 

movement of citrus nursery stock from 

areas quarantined because of citrus 

canker fall within the authority 

delegated to APHIS under the PPA. The 

PPA authorizes APHIS to take measures 

to prohibit or restrict movement in 

interstate commerce of any plant or 

plant product, if we determine that the 

prohibition or restriction is necessary to 

prevent the dissemination of a plant 

disease within the United States. Citrus 

canker is highly transmissible to citrus 

plants and can cause extensive damage 

to affected plants. Furthermore, as we 

mentioned above, citrus nursery stock is 

considered to be one of the most likely 

pathways for the introduction of citrus 

canker to previously unaffected areas. 

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16100 Federal Register / Vol. 74, No. 67 / Thursday, April 9, 2009 / Rules and Regulations 

10To view Florida’s regulations implementing the 

Citrus Nursery Stock Certification Program, go to 

http://www.flrules.org/gateway/ 

ChapterHome.asp?Chapter=5B-62. 

Moreover, we note that it was 

likewise appropriate for APHIS, in 

particular, to take such measures, since 

it was in keeping with our mission as an 

Agency to protect American agriculture. 

One commenter stated that the 

interim rule should be withdrawn 

because APHIS lacked adequate 

personnel to enforce it and should be 

replaced with a risk-based approach that 

assigns personnel to the pathways 

through which citrus canker is most 

likely to travel. 

We are confident that we have 

adequate personnel to effectively 

enforce this rule, which does not 

impose new prohibitions on the 

interstate movement of citrus nursery 

stock but rather clarifies our longstanding historical practice and sciencebased policy of prohibiting the 

movement of nursery stock from areas 

quarantined for citrus canker. 

Comments Proposing Florida’s Citrus 

Nursery Stock Certification Program as 

an Alternative to Rulemaking 

Several commenters stated that 

APHIS had not adequately considered 

less stringent measures to prevent the 

spread of citrus canker through the 

interstate movement of citrus nursery 

stock. Many of the commenters asserted 

that Florida’s Citrus Nursery Stock 

Certification Program, which is 

designed to prevent the spread of citrus 

canker and citrus greening within and 

from that State and which was enacted 

by the State of Florida on December 26, 

2006, would provide an effective, yet 

less restrictive, alternative to the 

regulations established by the interim 

rule.10 They pointed out that: 

• The certification program requires 

all citrus nursery stock propagations 

after January 1, 2007, to be made within 

structures approved by FDACS/DPI to 

prevent the introduction of citrus 

canker, citrus greening, and the Asian 

citrus psyllid, a vector of citrus 

greening; 

• The program contains provisions to 

prohibit the sale and distribution of 

nursery stock not grown in a structure 

and a site approved by FDACS/DPI; 

• The program requires all nurseries 

in which citrus nursery stock is grown 

after December 26, 2006, to be fenced 

and to limit access to those areas within 

the nursery which contain citrus 

nursery stock; 

• The program requires the 

decontamination of all personnel and 

equipment before entering a nursery; 

• The program requires all parent 

trees from which propagations are taken 

after December 26, 2006, to be tested 

and found free of citrus canker, citrus 

greening, and other citrus pathogens 

that are transmissible through grafting; 

and 

• The program requires nurseries to 

be inspected every 30 days, and 

allocates funds and personnel to this 

end. 

The commenters asserted that these 

safeguards, collectively, provide 

adequate phytosanitary security to allow 

the interstate movement of citrus 

nursery stock from the quarantined area. 

To consider these comments, we 

examined the various provisions of the 

certification program. We determined 

that certain provisions of Florida’s 

program did not adequately address the 

risk of the spread of citrus canker or 

citrus greening from Florida. For 

example, the program exempts retail 

outlets and retail sales areas having 

fewer than 500 citrus plants in stock at 

any given time from having to place 

nursery stock in screened enclosures or 

even segregate it from other plants onsite; does not regulate citrus plants 

propagated in nurseries prior to 

implementation of the program, 

regardless of the phytosanitary 

conditions under which the plants were 

propagated; and does not require that all 

such plants be inspected for freedom 

from citrus canker or citrus greening 

prior to sale. Moreover, the State 

regulations that implement the Citrus 

Nursery Stock Certification Program do 

not provide a scientific rationale for not 

addressing the risk associated with 

these provisions. For these reasons, we 

came to the conclusion that Florida’s 

program was not an adequate alternative 

to the restrictions on the interstate 

movement of nursery stock in our 

regulations. 

In response to this determination, 

Florida requested APHIS’ assistance in 

crafting a systems approach that would 

provide adequate phytosanitary 

measures to allow the interstate 

movement of citrus nursery stock from 

areas quarantined for citrus canker, 

citrus greening, and Asian citrus 

psyllid, a vector of citrus greening, to 

areas of the United States that APHIS 

has not designated as commercial citrusproducing areas. To this end, APHIS 

convened a technical working group, 

which recommended sourcing from a 

pest-exclusionary production facility 

and testing for all germplasm and 

budwood destined for propagation in 

nurseries within the State, construction 

and maintenance of pest-exclusionary 

production facilities and buffer zones, 

safeguarding, routine inspections, 

cleaning and disinfection protocols, and 

other measures that would be sufficient 

to address the concerns raised in our 

earlier evaluation. 

As a result of this collaboration with 

APHIS, FDACS/DPI presented a draft 

systems approach to us for evaluation in 

December 2008. The mitigation 

measures proposed in that systems 

approach appear consistent with the 

recommendations of the technical 

working group; therefore, we have 

reason to believe that they may provide 

a basis for allowing the limited 

interstate movement of citrus nursery 

stock from Florida. However, because 

citrus nursery stock is known to be a 

high-risk pathway for citrus canker and 

citrus greening, we have decided to 

initiate a formal assessment of the risk 

associated with interstate movement of 

citrus nursery stock under the 

provisions of the systems approach. If 

the assessment finds the systems 

approach to provide effective mitigation 

measures, we will initiate rulemaking to 

codify the approach. Until such time, 

we will retain the existing prohibition 

on the interstate movement of citrus 

nursery stock from areas quarantined for 

citrus canker. Therefore, we are making 

no change in response to these 

comments. 

One commenter suggested that if we 

did not recognize Florida’s program as 

an alternative to rulemaking, we needed 

to amend the regulations to establish a 

similar, federally regulated certification 

program. The commenter stated that, 

without such a program, our citrus 

canker regulations would be 

inconsistent with APHIS regulations 

governing other plant diseases, such as 

Ralstonia solanacearum and 

Phytophthora ramorum, which allow 

the importation or interstate movement 

of plants or plant parts from an area 

quarantined for a disease if the plants 

have been produced under conditions 

that prevent those plants from being 

infected with that disease. 

We implemented those certification 

programs based on an examination of 

the severity and prevalence of each 

specific disease, its likelihood of 

transmission, and the efficacy of various 

mitigation measures at preventing its 

spread. As noted above, we are 

currently conducting such an 

examination for the interstate movement 

of citrus nursery stock for areas 

quarantined for citrus canker and citrus 

greening. 

Two commenters suggested that, in 

greatly restricting the movement of 

citrus nursery stock from Florida, 

APHIS had effectively encouraged 

States that are not commercial citrusproducing States and that have few or 

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Federal Register / Vol. 74, No. 67 / Thursday, April 9, 2009 / Rules and Regulations 16101 

13See 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. Available at http:// 

www.plantmanagementnetwork.org/pub/php/ 

review/citruscanker/. 

no regulations governing citrus products 

to promote commercial citrus 

production. As evidence, one of the 

commenters stated that Georgia has 

initiated plans to produce citrus nursery 

stock within that State as a result of the 

interim rule without also establishing 

production requirements equivalent to 

those required by the State governments 

of other commercial citrus-producing 

areas. Poorly regulated production of 

citrus nursery stock, both commenters 

asserted, constitutes a significant 

pathway for the spread of citrus canker 

and other citrus diseases. 

The temperate climate of most States 

not listed in the regulations as 

commercial citrus-producing States 

renders outdoor commercial citrus 

production impracticable. Current 

indoor citrus production in those States, 

whether commercial or noncommercial, 

is minimal. 

We do recognize that Georgia and 

several other States that are not listed in 

the regulations as commercial citrusproducing States contain areas whose 

climates may be conducive to outdoor 

commercial citrus production. However, 

if these States begin commercial citrus 

production, we will designate them as 

commercial citrus-producing areas in 

our regulations and if citrus canker or 

any other quarantine disease of citrus is 

discovered in any of these States, we 

will take appropriate measures to 

eradicate the disease or control its 

spread. 

Comments Proposing Changes to the 

Interim Rule 

Several commenters suggested that 

APHIS should allow movement of 

regulated citrus nursery stock to States 

with a temperate climate that are not 

designated as commercial citrusproducing States. Citrus nursery stock 

moved to these States, they asserted, is 

primarily destined for outdoor use 

during the summer months or for 

ornamental, indoor use. If destined for 

outdoor use, diseased nursery stock 

would not survive the winter in an area 

with a temperate climate, and both the 

plant and Xcc would perish. If destined 

for indoor use, the possibility for 

disease aggregation or dispersion would 

be minimal. 

We are making no changes to the 

interim rule in response to these 

comments. Allowing the movement of 

citrus nursery stock to areas of the 

United States not designated as 

commercial citrus-producing areas does 

not preclude the subsequent movement 

of the plants to commercial citrusproducing areas. Since nursery stock is 

not intended for immediate 

consumption, and can survive for years 

after it leaves the commercial 

distribution system, the possibility of 

this subsequent movement must be 

taken into consideration. Nor does the 

commenters’ suggestion address the 

possible airborne dispersion of Xcc 

while the plants are being moved. When 

blown by the wind, the bacteria 

associated with citrus canker have been 

shown to survive at distances of more 

than 100 feet from their host.13

Moreover, while we are confident that 

we have sufficient personnel to ensure 

that producers in the quarantined area 

are adhering to the provisions of this 

rule, we do not have sufficient 

personnel to monitor every possible 

commercial or non-commercial pathway 

in each State that could result in the 

movement of infected but asymptomatic 

citrus nursery stock to other areas of the 

country. 

Several commenters suggested that 

the final rule be amended to explicitly 

forbid the smuggling of nursery stock 

from an area quarantined for citrus 

canker. 

Any movement of citrus nursery stock 

other than those movements authorized 

by the regulations is prohibited. 

Individuals who engage in such 

movements may be subject to both civil 

and criminal penalties. 

Another commenter expressed 

concern about the exception in the 

interim rule allowing the regulated 

movement of nursery stock for 

immediate export. Such movement, the 

commenter suggested, appears to 

present a risk of introducing citrus 

canker into unaffected areas of the 

United States or other countries where 

the disease is not known to occur. The 

commenter suggested that APHIS either 

prohibit such movement or allow the 

interstate movement of citrus nursery 

stock, subject to the same disease 

control measures that allow its 

exportation. 

In the August 2006 interim rule that 

quarantined the entire State of Florida 

for citrus canker, we established 

provisions under which citrus fruit and 

nursery stock from an area quarantined 

for citrus canker could be moved 

interstate for immediate export. We 

adopted these provisions to provide a 

degree of regulatory relief to growers, 

packers, and others who were adversely 

affected by new restrictions on the 

movement of citrus articles imposed by 

the rule. 

Any nursery stock moved interstate 

for immediate export must be 

accompanied by a limited permit and 

must be moved in a sealed conveyance 

directly to the port of export. We have 

determined that these requirements 

adequately address the risk of disease 

spread while the articles are in transit 

within the United States to their port of 

export. 

Foreign countries set their own 

requirements for importing 

commodities, including citrus nursery 

stock, from the United States, and thus 

may choose whether or not to accept 

nursery stock from areas quarantined for 

citrus canker. 

Two commenters expressed concern 

that nursery stock imported into the 

United States could be infected with 

citrus canker or harbor vectors of the 

disease. These commenters suggested 

that APHIS consider restricting or 

prohibiting the importation of citrus 

nursery stock and other citrus products 

into the United States. 

The regulations in 7 CFR 319.19 

prohibit the importation of citrus 

nursery stock from other countries, 

unless the nursery stock is imported for 

experimental or scientific purposes or 

imported into Guam. Similarly, the 

regulations in 7 CFR 319.28 prohibit the 

importation of citrus fruit and peels 

from most countries quarantined for 

citrus canker, with certain, limited 

exceptions. 

Comments Regarding the Interstate 

Movement of Calamondins and 

Kumquats 

In the interim rule, we allowed the 

interstate movement of calamondin and 

kumquat plants under a protocol 

designed to ensure that they were free 

of the disease prior to movement. The 

protocol allowed interstate movement if 

the following conditions were met: 

• The plants are own-root-only, and 

have not been grafted or budded. 

• The plants are started, are grown, 

and have been maintained solely at the 

nursery from which they will be moved 

interstate. 

• If the plants are not grown from 

seed, then the cuttings used for 

propagation of the plants are taken from 

plants located on the same nursery 

premises or from another nursery that is 

eligible to produce calamondin and 

kumquat plants for interstate movement 

under the requirements of the 

regulations. Cuttings may not be 

obtained from properties where citrus 

canker is present. 

• All citrus plants at the nursery 

premises have undergone State 

inspection and have been found to be 

free of citrus canker by State authorities 

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16102 Federal Register / Vol. 74, No. 67 / Thursday, April 9, 2009 / Rules and Regulations 

14See footnote 13. 

no less than three times, at 30- to 45-day 

intervals, prior to movement, with the 

most recent inspection being within 30 

days of the date on which the plants are 

removed and packed for shipment. 

• All vehicles, equipment, and other 

articles used in providing inspection, 

maintenance, or related services in the 

nursery, as well as all personnel 

employed in providing inspection, 

maintenance, or related services in the 

nursery, must be treated in accordance 

with the regulations before entering the 

nursery in order to prevent the 

introduction of citrus canker. 

• If citrus canker is found in the 

nursery, all regulated plants and plant 

material must be removed from the 

nursery and all areas of the nursery’s 

facilities where plants are grown and all 

associated equipment and tools used at 

the nursery must be treated in 

accordance with the regulations in order 

for the nursery to be eligible to produce 

calamondin and kumquat plants to be 

moved interstate under the protocol. 

Fifteen days after these actions are 

completed, the nursery may receive new 

calamondin and kumquat seed or 

cuttings from a nursery that is eligible 

to produce calamondin and kumquat 

plants for interstate movement. 

• The plants, except for plants that 

are hermetically sealed in plastic bags 

before leaving the nursery, are 

completely enclosed in containers or 

vehicle compartments during movement 

through the quarantined area. 

• The plants are accompanied by a 

limited permit displayed on a plastic or 

metal tag attached to the outside of the 

articles or the outside of their 

containers, stating that they are not to be 

distributed to commercial citrusproducing areas. The statement must 

also be displayed on the outside of the 

shipping containers used to transport 

the plants, and the limited permit must 

be attached to the bill of lading or any 

other shipping document. 

In the interim rule, we stated that we 

had implemented a substantively 

similar protocol in 1989, which we 

removed from the regulations in 1990 

without giving a reason for doing so. We 

also stated that, in issuing our August 

2006 interim rule quarantining the 

entire State of Florida for citrus canker, 

we had reexamined the movement of 

calamondin and kumquat plants and 

decided to allow their movement. We 

allowed this movement through 

administrative action. Our intent, 

therefore, was to modify this 1989 

protocol slightly and codify it in the 

regulations, in order to provide stock 

growers with a degree of relief 

appropriate under the circumstances 

from restrictions imposed by the interim 

rule and to mitigate the economic 

impact associated with the August 2006 

quarantine. 

In deciding to reinstitute the protocol, 

we cited a peer-reviewed article on 

citrus canker.14 Although we did not 

cite it in the interim rule, we also relied 

upon the views of a 1987 panel of plant 

pathologists and other experts in the 

field of diseases affecting citrus 

regarding the high degree of biological 

resistance to Xcc that the calamondin 

and kumquat plants appeared to 

possess. 

Several commenters expressed 

concerns regarding the protocol. Noting 

that the scientific literature cited in the 

interim rule did not indicate that 

calamondins and kumquats are entirely 

immune to citrus canker, one 

commenter suggested that APHIS had 

effectively adopted a risk-based 

approach for the interstate movement of 

these two plants. The commenter stated 

that APHIS had provided no evidence in 

the interim rule that the calamondin 

and kumquat protocol precludes the 

artificial spread of citrus canker through 

the interstate movement of these plants, 

nor had APHIS considered similar 

protocols by which other citrus articles 

more susceptible to citrus canker might 

be moved interstate. The same 

commenter stated that calamondins and 

kumquats are not as resistant to citrus 

canker as the interim rule suggested. 

Two other commenters reiterated this 

last point, and added that most 

nurseries do not take more restrictive 

biosecurity measures to limit the 

exposure of calamondins and kumquats 

to citrus canker than they impose on 

other citrus nursery stock. All three 

commenters suggested that APHIS 

reevaluate the protocol or consider 

similar protocols to allow the interstate 

movement of other citrus nursery stock. 

In response to these comments, 

APHIS reexamined the results of 

surveys and inspections conducted on 

citrus nursery stock within the 

quarantined area and on calamondin 

and kumquat plants growing in groves 

and residential settings within that area. 

While no infected kumquat plants were 

reported, in March 2006, State officials 

and PPQ inspectors had reported 

finding a nursery with several 

calamondin plants infected with citrus 

canker. Plant pathologists from FDACS/ 

DPI subsequently conducted laboratory 

testing of 48 samples from these plants. 

These tests confirmed the presence of 

citrus canker in 47 of the samples. 

In July 2007, in order to 

independently assess the accuracy of 

FDACS/DPI’s testing, APHIS collected 

samples from 15 of the infected plants 

and sent them to PPQ’s Center for Plant 

Health Science and Technology for 

corroborative testing. Officials there 

examined the samples using two 

different standard diagnostic methods. 

Under both methods, each sample tested 

positive for citrus canker. In addition, 

the infected plants were confirmed to be 

calamondin plants. 

The protocol codified in the interim 

rule, as well as the 1989 protocol on 

which it was modeled, had been 

predicated on calamondin and kumquat 

plants being highly resistant to Xcc. As 

a result of these positive samples, we 

determined that calamondins were not 

highly resistant, and that the interstate 

movement of calamondin nursery stock, 

even under the conditions of the 

protocol, was a possible pathway for the 

spread of citrus canker. Accordingly, we 

decided that it would be prudent to 

amend the regulations to remove 

calamondin nursery stock from the 

protocol in a final rule. 

However, in order to provide the 

public with an opportunity to comment 

on this possible change, we reopened 

the comment period for the interim rule, 

in a document published in the Federal 

Register on January 29, 2008 (73 FR 

5085, Docket No. APHIS–2007–0032). In 

that document, we specifically asked for 

comments regarding calamondin plants 

and the interstate movement protocol. 

Several commenters pointed out that 

the State inspections that discovered the 

infected calamondin plants were 

conducted before the implementation of 

Florida’s Citrus Nursery Stock 

Certification Program. The commenters 

stated that calamondin plants grown 

under the provisions of the program 

cannot become infected with Xcc and 

that calamondin plants should therefore 

not be removed from the protocol. 

As we mentioned above, we have 

found the Citrus Nursery Stock 

Certification Program does not 

sufficiently address the risk associated 

with the interstate movement of nursery 

stock from the State of Florida, but we 

are currently evaluating the adequacy of 

a draft systems approach proposed by 

the State. While we conduct our 

evaluation, we consider it necessary to 

maintain our long-standing policy 

prohibiting the interstate movement of 

citrus nursery stock from areas 

quarantined for citrus canker. In 

accordance with that policy and based 

on our findings, we must consider 

calamondin plants to be a host of citrus 

canker and thus must prohibit their 

interstate movement. 

Other commenters suggested that we 

should allow calamondin nursery stock 

to be shipped to areas of the country 

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Federal Register / Vol. 74, No. 67 / Thursday, April 9, 2009 / Rules and Regulations 16103 

15Source: USDA, NASS, July 2004. ‘‘Nursery 

Crops 2003 Summary.’’ Washington, DC. 

16Source: Florida’s Department of Agricultural 

and Consumer Services/Bureau of Plant and Apiary 

Inspection. Correspondence with APHIS, November 

2007. 

17 Ibid. 

18To view the Federal Order, go to http://www/ 

usda.gov/plant_health/plant_pest_info/ 

citrusgreening/downloads/pdf_files/federalorder01-11-2008.pdf. 

that have not been designated as 

commercial citrus-producing areas. 

We address the substantial risk 

associated with the shipment of citrus 

nursery stock to such areas above, in the 

section entitled ‘‘Comments Proposing 

Changes to the Interim Rule.’’ 

Accordingly, we are amending 

§ 301.75–6 in this final rule to remove 

calamondin from the protocol. 

Wherever the text of that section has 

referred to ‘‘calamondin and kumquats,’’ 

it will now refer only to ‘‘kumquats.’’ 

We are also amending § 301.75–12 in a 

similar manner to reflect the removal of 

calamondin. 

Comments Concerning the Economic 

Impact of the Interim Rule 

Many commenters stated that the rule 

had had a substantive effect on their 

operations, or appeared to 

disproportionately impact small 

entities, and asked that APHIS include 

such impacts in the economic analysis 

in the final rule. 

The interim rule codified existing 

policies, but did not establish new 

procedures for quarantine operations. 

We determined that the rule therefore 

had no new economic effect on any 

entities. 

Rather, it was our August 2006 

interim rule quarantining the entire 

State of Florida for citrus canker that 

resulted in new economic effects on 

entities involved in the production, 

packing, and movement of citrus fruit 

and nursery stock in that State. The 

August 2006 interim rule included a 

preliminary economic analysis of the 

effects of the State-wide quarantine; 

when we publish a final action 

following that interim rule, we will 

provide an updated and more 

comprehensive analysis of those 

economic effects. 

However, this final rule does make a 

substantive change in the regulations by 

removing calamondins from eligibility 

for interstate movement. Accordingly, 

we examine the economic effects of that 

action in this final rule under the 

heading ‘‘Executive Order 12866 and 

Regulatory Flexibility Act.’’ 

Therefore, for the reasons given in the 

interim rule and in this document, we 

are adopting the interim rule as a final 

rule, with the changes discussed in this 

document. 

This final rule also affirms the 

information contained in the interim 

rule concerning Executive Orders 12372 

and 12988. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This 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. 

This final rule follows an interim rule 

that amended the citrus canker 

regulations by explicitly prohibiting, 

with limited exceptions, the interstate 

movement of regulated citrus nursery 

stock from an area quarantined for citrus 

canker. In the interim rule, we allowed 

calamondin and kumquat plants to be 

moved interstate from a quarantined 

area in accordance with a protocol 

designed to ensure their freedom from 

citrus canker. In this final rule, we have 

amended the protocol to exclude 

calamondin plants. 

According to Small Business 

Administration (SBA) criteria, a nursery 

(North American Industry Classification 

System code 111422) is considered to be 

a small entity if its annual receipts are 

not more than $750,000. In 2003, there 

were 1,360 nursery operators in the 

State of Florida, 88 percent of which 

were classified as small entities.15 Of 

these 1,360 nurseries, 57 produced fruit 

and nut nursery stock. Citrus nursery 

stock producers fall within this larger 

category of fruit and nut nursery stock 

producers. 

Although APHIS has not yet been able 

to confirm the number of citrus nursery 

stock producers in the State of Florida 

currently engaged in calamondin 

nursery stock production, 

correspondence with State officials has 

suggested that there are nine such 

producers.16 There are, moreover, at 

least five nurseries in the State that 

engage exclusively in calamondin 

propagation.17

The average size of the affected 

nurseries is unknown. However, it is 

reasonable to assume that most of the 

nurseries are small entities, since the 

vast majority of all nursery operators in 

the State of Florida are small entities, 

according to SBA standards. 

On January 11, 2008, APHIS issued a 

Federal Order designating the State of 

Florida as an area quarantined for citrus 

greening.18 In order to prevent the 

spread of citrus greening to unaffected 

areas of the United States, the order also 

prohibited the interstate movement of 

all citrus plants from the State of 

Florida, as well as other citrus articles 

that could serve as potential host 

material for the citrus greening 

bacterium, unless the articles were 

destined for immediate export. Because 

the interstate movement of calamondin 

nursery stock other than for immediate 

export is already prohibited under that 

order, and because this rule does not 

regulate the intrastate movement of 

calamondin nursery stock, we expect 

that the impact of this rule on those 

producers will be minimal, at most. 

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. 

Paperwork Reduction Act 

The March 2007 interim rule 

contained information collection 

requirements. On March 27, 2007, the 

Office of Management and Budget 

(OMB) approved the collection of 

information with respect to the interim 

rule under OMB control number 0579– 

0317 (expires November 30, 2010). 

E-Government Act Compliance 

The Animal and Plant Health 

Inspection Service is committed to 

compliance with the E-Government Act 

to promote the use of the Internet and 

other information technologies, to 

provide increased opportunities for 

citizen access to Government 

information and services, and for other 

purposes. For information pertinent to 

E-Government Act compliance related 

to this rule, please contact Mrs. Celeste 

Sickles, APHIS’ Information Collection 

Coordinator, at (301) 851–2908. 

List of Subjects in 7 CFR Part 301 

Agricultural commodities, Plant 

diseases and pests, Quarantine, 

Reporting and recordkeeping 

requirements, Transportation. 

■ Accordingly, the interim rule 

amending 7 CFR part 301 that was 

published at 72 FR 13423–13428 on 

March 22, 2007, is adopted as a final 

rule with the following changes: 

PART 301—DOMESTIC QUARANTINE 

NOTICES 

■ 1. The authority citation 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). 

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16104 Federal Register / Vol. 74, No. 67 / Thursday, April 9, 2009 / Rules and Regulations 

§ 301.75–6 [Amended] 

■ 2. Section 301.75–6 is amended as 

follows: 

■ a. In paragraph (a), by removing the 

words ‘‘calamondin and’’. 

■ b. In the introductory text of 

paragraph (b), by removing the words 

‘‘Calamondin (Citrus mitus) and 

kumquat’’ and adding the word 

‘‘Kumquat’’ in their place. 

■ c. In paragraph (b)(3), by removing the 

words ‘‘calamondin and’’. 

■ d. In paragraph (b)(6), by removing the 

words ‘‘calamondin and’’. 

■ e. In paragraph (b)(8), by removing the 

words ‘‘calamondin or’’. 

§ 301.75–12 [Amended] 

■ 3. In § 301.75–12, the introductory 

text of paragraph (b)(1) is amended by 

removing the words ‘‘calamondin and’’. 

Done in Washington, DC, this 6th day of 

April 2009. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E9–8103 Filed 4–8–09; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

9 CFR Part 392 

[Docket No. 00–019F; FDMS Docket No. 

FSIS–2005–0020] 

RIN 0583–AC81 

Petitions for Rulemaking 

AGENCY: Food Safety and Inspection 

Service, USDA. 

ACTION: Final rule. 

SUMMARY: The Food Safety and 

Inspection Service (FSIS) is amending 

its administrative regulations to add a 

new part that establishes regulations 

governing the submission to FSIS of 

petitions for rulemaking. The new 

regulations supersede existing guidance 

on the submission of petitions to FSIS 

to issue, amend, or repeal its 

regulations. FSIS is taking this action to 

help ensure the filing of well-supported 

petitions that contain information that 

the Agency needs to proceed with 

consideration of the requested 

rulemaking in a timely manner. 

DATES: Effective Date: June 8, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Edelstein, Director, Policy 

Issuances Division, Office of Policy and 

Program Development, Food Safety and 

Inspection Service, U.S. Department of 

Agriculture; (202) 720–5627. 

SUPPLEMENTARY INFORMATION: 

Background 

On January 12, 2006, FSIS published 

a proposal in the Federal Register to 

establish regulations governing the 

submission to FSIS of petitions to issue, 

amend, or repeal a regulation 

administered by the Agency (71 FR 

1988). As discussed in that proposed 

rulemaking, FSIS had previously 

published guidelines in 1993 on how to 

submit petitions for rulemaking to the 

Agency (58 FR 63570, December 2, 

1993). Despite the existence of this 

guidance, rulemaking petitions are 

submitted to FSIS in various forms, 

often without adequate data and 

supporting documentation for FSIS to 

properly evaluate the merits of the 

requested action. The measures 

proposed in the January 12, 2006, 

proposed rule are designed to encourage 

the filing of well-supported petitions 

that contain information that the 

Agency needs to evaluate a requested 

rulemaking in a timely manner. The 

comment period for the proposed rule 

closed on March 12, 2006. 

Comments and FSIS Response 

FSIS received only one comment in 

response to the January 12, 2006, 

proposal. The comment was generally 

supportive of the proposed regulations 

but also expressed the view that when 

preparing Notices and Directives, FSIS 

should provide an opportunity for 

public comment prior to the issuance of 

these documents. According to the 

comment, FSIS Notices and Directives 

may have the same effect on the 

industry as regulations. The comment 

recommended that FSIS adopt a rule 

that would specifically provide 

opportunity for stakeholders to 

participate in the development of these 

documents. 

The January 12, 2006, proposed rule 

proposed to establish regulations for the 

submission to FSIS of petitions for 

rulemaking. Establishing a new process 

for making draft FSIS Notices and 

Directives available for comment is 

outside the scope of this rulemaking. 

Under this final rule, however, persons 

may certainly petition the Agency to 

issue, amend or repeal such documents. 

The comment also stated that, when 

evaluating petitions for rulemaking, 

FSIS must take into account that small 

and very small establishments have 

limited resources and may not have 

access to all of the data that FSIS 

considers necessary to evaluate a 

petition for rulemaking. 

In the preamble to the proposed rule, 

FSIS acknowledged that some small 

entities may not have access to certain 

data that is readily available to large 

companies or industry trade 

associations. As stated in the preamble, 

the Agency will take these limitations 

into consideration when it evaluates 

petitions submitted by small entities. 

The Final Rule 

In this final rule FSIS is establishing 

regulations governing the submission to 

FSIS of petitions for rulemaking. As 

noted above, the one comment 

submitted in response to the January 12, 

2006, proposed rule raised no objections 

that were within the scope of the 

proposed rulemaking. Therefore, FSIS is 

finalizing the proposed rule without 

changes. 

As was proposed, FSIS is adding a 

new part 392—Petitions for rulemaking 

to title 9, subchapter D of the CFR. As 

stated in § 392.1, part 392 contains 

provisions governing the submission to 

FSIS of petitions for rulemaking and 

applies to all requests to initiate 

rulemaking, except to the extent that 

other provisions in the FSIS regulations 

prescribe procedures for submitting 

requests to amend a regulation. As 

discussed in the preamble to the 

proposed rule, § 392.1 includes this 

exception because FSIS’ regulations 

already contain procedures on how to 

submit requests to amend certain 

sections of the regulations. For example, 

as noted in the proposal, a request to 

amend the regulations to authorize a 

new Reference Amount or Product 

Category identified in 9 CFR 317.312(b) 

and 381.412(b) must be submitted as a 

labeling application in accordance with 

the provisions of 9 CFR 317.312(g) and 

381.412(g). 

Section 392.2 defines a ‘‘petition’’ as 

a written request to issue, amend, or 

repeal a regulation administered by the 

Agency. Section 392.2 also provides that 

a request to issue, amend, or repeal a 

document that interprets a regulation 

administered by the Agency, such as an 

FSIS Directive, Notice, or compliance 

guide, may be made by petition. 

Section 392.3 describes the 

information that a petition is required to 

contain to be considered by FSIS. 

Section 392.3(a) requires that a petition 

include the name, address and 

telephone number, and e-mail address 

(if available) of the person submitting 

the petition. Section 392.3(b) requires 

that a petition contain a full statement 

of the action requested by the petitioner, 

including the citation and exact 

wording of any existing regulation 

affected by the requested action. Section 

392.3(c) requires that a petition include 

a statement of the factual and legal basis 

for the requested action, including all 

relevant information known to the 

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