37608 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

7 CFR Parts 300 and 319

[Docket No. 97–110–5]

RIN 0579–AA92

Importation of Grapefruit, Lemons, and

Oranges From Argentina

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Final rule.

SUMMARY: We are amending the citrus

fruit regulations by recognizing a citrusgrowing area within Argentina as being

free from citrus canker. Surveys

conducted by Argentine plant health

authorities in that area of Argentina

since 1992 have shown the area to be

free from citrus canker, and Argentine

authorities are enforcing restrictions

designed to protect the area from the

introduction of that disease. We are also

amending the fruits and vegetables

regulations to allow the importation of

grapefruit, lemons, and oranges from the

citrus canker-free area of Argentina

under conditions designed to prevent

the introduction into the United States

of two other diseases of citrus, sweet

orange scab and citrus black spot, and

other plant pests. These changes will

allow grapefruit, lemons, and oranges to

be imported into the continental United

States from Argentina subject to certain

conditions.

EFFECTIVE DATE: June 15, 2000. The

incorporation by reference provided for

by this rule is approved by the Director

of the Federal Register as of June 15,

2000.

FOR FURTHER INFORMATION CONTACT: Mr.

Wayne D. Burnett, Import Specialist,

Phytosanitary Issues Management Team,

PPQ, APHIS, 4700 River Road Unit 140,

Riverdale, MD 20737–1236; (301) 734–

6799.

SUPPLEMENTARY INFORMATION:

Background

The regulations in ‘‘Subpart—Fruits

and Vegetables’’ (7 CFR 319.56 through

319.56–8, referred to below as the fruits

and vegetables regulations) prohibit or

restrict the importation of fruits and

vegetables into the United States from

certain parts of the world to prevent the

introduction and dissemination of plant

pests, including fruit flies, that are new

to or not widely distributed within the

United States.

The regulations in ‘‘Subpart—Citrus

Fruit’’ (7 CFR 319.28, referred to below

as the citrus fruit regulations), restrict

the importation of the fruit and peel of

all genera, species, and varieties of the

subfamilies Aurantioideae, Rutoideae,

and Toddalioideae of the family

Rutaceae into the United States from

specified countries in order to prevent

the introduction of citrus canker disease

(Xanthomonas campestris pv. citri

(Hasse) Dye). The citrus fruit regulations

also restrict the importation of the fruit

and peel of all species and varieties of

the genus Citrus into the United States

from specified countries, including

Argentina, in order to prevent the

introduction of the citrus diseases sweet

orange scab (Elsinoe australis Bitanc.

and Jenkins) and the B strain of citrus

canker, which is referred to in the citrus

fruit regulations as ‘‘Cancrosis B.’’

On August 12, 1998, we published a

proposed rule in the Federal Register

(63 FR 43117–43125, Docket No. 97–

110–1) to amend the citrus fruit

regulations by recognizing a citrusgrowing area within Argentina as being

free from citrus canker. In that

document, we also proposed to amend

the fruits and vegetables regulations to

allow the importation of grapefruit,

lemons, and oranges from the citrus

canker-free area of Argentina under

conditions designed to prevent the

introduction into the United States of

two other diseases of citrus, sweet

orange scab and citrus black spot, and

other plant pests.

The proposed rule was followed by

three notices regarding the comment

period and public hearings for the

proposed rule. Specifically, on October

16, 1998, we published in the Federal

Register (63 FR 55559, Docket No. 97–

110–2) a notice advising the public that

we were extending the comment period

for the proposed rule by 120 days and

that we had scheduled a public hearing

in Thousand Oaks, CA, to give

interested persons the opportunity for

the oral presentation of data, views, and

arguments regarding the proposed rule.

On December 4, 1998, we published in

the Federal Register (63 FR 67011,

Docket No. 97–110–3) a notice advising

the public that we had changed the date

and location of the public hearing in

Thousand Oaks, CA. Finally, on January

13, 1999, we published in the Federal

Register (64 FR 2151, Docket No. 97–

110–4) a notice advising the public that

we had scheduled an additional public

hearing to be held in Orlando, FL.

With the extension granted in the

October 16, 1998, notice, we solicited

comments for a total of 180 days ending

on February 11, 1999. We received 332

comments by that date, including 63

comments received at the public

hearings held in Orlando, FL, and

Thousand Oaks, CA. The comments

were from foreign and domestic

producers, handlers, packers, and

processors of citrus fruit; Members of

the U.S. Congress and elected

representatives of State and local

governments; State plant protection

officials and officials from Argentine’s

national plant protection organization,

the Servicio Nacional de Sanidad y

Calidad Agroalimentaria (SENASA); and

representatives of the U.S. Citrus

Science Council (USCSC), a group

formed specifically to respond to the

proposed rule.

Seventeen of the comments were

letters requesting that we extend the

comment period for the proposed rule,

and 3 comments simply stated that any

decision should be based on sound

science. Two hundred and fifty

comments, 148 of which were form

letters offering support for the position

of the USCSC, raised concerns or made

suggestions regarding the proposed rule.

Those comments are addressed in detail

later in this document. The remaining

62 comments offered support for the

proposed rule as it was written. Those

commenters who supported the

proposed rule noted the mutual benefits

of trade, recognized the scientific basis

of the proposed rule, stated that

Argentine imports would provide

competition for citrus imports from

other countries, saw an opportunity to

increase citrus exports to Argentina,

noted that Argentine citrus has been

exported to markets in other countries—

including citrus-producing countries—

without incident, and noted the positive

economic effects that Argentine citrus

imports would have on consumers,

wholesalers, distributors, and ports of

entry.

The comments that we received in

opposition to the proposed rule focused

largely on the scientific basis and

support for the proposed mitigation

measures and on the execution and

conclusions of the risk assessment that

was used by the Animal and Plant

Health Inspection Service (APHIS) in

reaching the decision to initiate the

proposed rule. These comments, as well

as the numerous comments that we

received on other particular aspects of

the proposed rule and its supporting

documentation, are reported and

addressed in this final rule.

With regard to the proposed

mitigation measures, several

commenters questioned whether the

systems approach to phytosanitary

security explained in the proposed rule

would provide an adequate measure of

protection against the introduction of

the diseases and insect pests of concern,

especially given their understanding

that APHIS had never before used a

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37609

systems approach to mitigate the risks

presented by a pest complex that

included both insects and pathogens.

Other commenters questioned the

volume, adequacy, and accuracy of the

scientific data provided by Argentina to

support the efficacy of the proposed

mitigation measures contained in the

systems approach. As we discuss in

detail below in response to specific

comments, we believe that the

information furnished by Argentina,

when considered in conjunction with

the body of information available in the

scientific literature regarding the insects

and diseases of concern, provides the

necessary rational basis for our

determination that individual and

cumulative mitigative effects of the

systems approach serve to reduce the

risks presented by Argentine grapefruit,

lemons, and oranges produced and

imported in accordance with this rule to

a negligible level.

With regard to the pest risk

assessment prepared by APHIS, several

commenters disagreed with the manner

in which we prepared the risk

assessment, questioning basic choices

made by the risk assessors concerning

issues such as independence in the

model and our use of a shipping box as

the risk unit. Other commenters

questioned whether APHIS offered

sufficient justification for the estimates

used in section II.8 (Likelihood of

Introduction) of the risk assessment. In

this final rule, we discuss, in our

responses to specific comments on these

and other related issues, the manner in

which we prepared the risk assessment

and how we arrived at our estimates.

Our experience in examining the risks

presented by agricultural commodities

produced around the world has led us

to select the model that we used as the

framework for estimating those risks.

This model has proven itself over the

years and for several commodity/pest

combinations to be an efficient means of

estimating phytosanitary risk, and we

(and others, including the Harvard

Center for Risk Analysis) believe our

guidelines are valid. While we

acknowledge that there are alternative

ways of estimating this type of risk, we

do not believe that using a different

model would result in a substantively

different outcome.

Distribution Limitations

In the proposed rule, we discussed

the importation of grapefruit, lemons,

and oranges into the entire United

States. However, the risk assessment

that was prepared prior to the

preparation of the proposed rule only

examined the risks presented by the

importation of that fruit into the

continental United States (the 48

contiguous States, Alaska, and the

District of Columbia). Although we have

no reason to believe that the risk

associated with importing Argentine

citrus into Hawaii, Guam, the Northern

Mariana Islands, Puerto Rico, or the U.S.

Virgin Islands would differ in any

significant way from the risks associated

with the importation of that fruit into

the continental United States, the fact

remains that the risk assessment did not

consider the risks associated with the

importation of Argentine citrus into

destinations outside the continental

United States. Therefore, in this final

rule we have narrowed the area into

which the grapefruit, lemons, and

oranges may be imported by limiting the

distribution of the fruit to the

continental United States. If we were

requested to do so by Argentina or other

interested parties, we would undertake

to assess the risks associated with the

entry of Argentine citrus into areas

outside the continental United States

and initiate rulemaking to provide for

the entry of the fruit into those

additional areas if our risk assessment

supported such an action.

We continue to have confidence in

the efficacy of the systems approach for

Argentine citrus and in the conclusions

of our pest risk assessment, which

found that the risk presented by

grapefruit, lemons, and oranges

imported in accordance with that

systems approach is negligible.

However, in response to comments from

the domestic citrus industry and others

voicing concern over the use of a

systems approach in a situation where

both diseases and insect pests exist in

a foreign production area, we will

institute a limited distribution plan that

will delay the entry of Argentine citrus

into citrus-producing areas in the

continental United States until 2004.

This delay will provide an opportunity

for the efficacy of the systems approach

to be demonstrated under actual

production and distribution conditions

before Argentine citrus imports are

allowed to enter citrus-producing areas

of the continental United States. The

limited distribution plan would involve

a three-stage phase-in of Argentine

citrus imports:

• Stage 1 (the 2000 and 2001

shipping seasons). Upon the effective

date of this final rule, fruit that meets

the requirements of the export program

will be eligible for entry into 34 States

in the continental United States that are

neither buffer States nor commercial

citrus-producing States.

• Stage 2 (the 2002 and 2003

shipping seasons). When Argentina

begins shipping fruit in May or June of

2002, the fruit will be eligible for entry

into the 34 ‘‘Stage 1’’ States as well as

the 10 buffer States (Alabama, Arkansas,

Colorado, Georgia, Mississippi, Nevada,

New Mexico, Oklahoma, Oregon, and

Utah) that share borders with one or

more commercial citrus-producing

States, leaving only 5 commercial citrusproducing States (Arizona, California,

Florida, Louisiana, and Texas) as

prohibited destinations in the

continental United States.

• Stage 3 (the 2004 shipping season).

When Argentina begins shipping fruit in

May or June of 2004, the fruit will be

eligible for entry into all areas of the

continental United States.

These ‘‘rolling effective dates’’ are

built into the final rule, which

precludes the need for APHIS to initiate

rulemaking in 2002 and 2004 to expand

the area into which the fruit may be

imported. If it is determined that the

requirements of the export program are

not being observed routinely or

uniformly, APHIS will be able to act

quickly to suspend the rolling effective

dates or even the entire program, if

warranted. The export program provides

for the detection of diseased fruit at any

point in the pathway, with that

detection leading to the rejection of the

shipment containing the diseased fruit

and the removal of the grove that

produced the fruit from the export

program for the remainder of the

shipping season. Thus, the detection of

diseased fruit will not, by itself, result

in the suspension of all or part of the

export program.

To determine whether the

requirements of the export program are

being observed routinely or uniformly

and to ensure that the distribution

restrictions of this rule are being

observed, APHIS personnel will be

involved in monitoring activities in both

the United States and Argentina:

Monitoring—United States. To help

ensure that importers and distributors of

Argentine citrus are aware of the

distribution limitations of this rule,

those limitations will be included as

one of the conditions of the permit that

importers must obtain in order to import

grapefruit, lemons, or oranges from

Argentina. APHIS personnel, as well as

personnel with State regulatory agencies

and the Department’s Agricultural

Marketing Service, will be enlisted to

enforce the distribution limitations of

the rule. This will be accomplished

through market visits, inspections, and

outreach efforts directed at importers,

shippers, distributors, and retailers. The

infrastructure needed to support these

efforts is already in place.

Monitoring Argentina. The rule does

not require direct APHIS involvement in

37610 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

the supervision of the export program in

Argentina; that direct supervision is the

responsibility of SENASA, Argentina’s

national plant protection organization,

which is regarded by APHIS (and

internationally) as an efficient and

capable organization. A recent (April 24

to 28, 2000) site visit to citrus groves

and packinghouses in Argentina by

APHIS bears out this perception. In

order to evaluate whether it is

appropriate to allow each stage of the

phased-in distribution plan to occur as

scheduled, and to provide for the

ongoing evaluation of the export

program, APHIS will be conducting

inspection visits to the Argentine

production area and will maintain

contact with SENASA throughout each

year to monitor their administration of

the export program. Further, APHIS and

SENASA are currently finalizing the

details of the annual operational work

plan that will address the

administration of the program during

the current season and that will serve as

the basis for future annual work plans.

That work plan will include provisions

for active and direct monitoring of the

export program by APHIS personnel

who will conduct frequent oversight

visits to the growing areas and

packinghouses. APHIS’ monitoring

activities will include:

• Inspections of groves following the

removal of leaves and other litter,

• Review of the timing and

application of fungicidal sprays,

• Accompanying SENASA inspectors

as they conduct preharvest grove

inspections and collect samples of fruit

for laboratory examination,

• Visits to the SENASA-approved

laboratories that will be examining the

sampled fruit to review the procedures

for, and results of, the fruit incubation

protocol,

• Observing the harvesting of fruit, its

transport to the packinghouses, and the

entry control systems in place at the

packinghouses, and

• Ensuring that the required

handling, treatment, inspection,

identification, and packing

requirements of this rule are being

observed in the packinghouses.

These monitoring activities carried

out by APHIS and SENASA personnel

will provide us with a clear

confirmation of the practicability of the

systems approach under actual

production conditions, its efficacy in

preventing disease in export groves, and

the ability of the required inspections

and laboratory examinations to detect

diseased fruit. Additional evidence of

the success or failure of the export

program will be gained through the

inspections that will be conducted at

U.S. ports of entry following the arrival

of the fruit and the application of any

required cold treatments. Should

APHIS, as a result of these activities or

any other assessments of the program,

conclude that the requirements of the

export program are not being observed

uniformly and routinely, the program

will be reviewed; should APHIS

determine that there are deficiencies in

the program that cannot be remedied,

the phased-in expansion of distribution,

or even the export program itself, may

then be suspended or terminated.

Specific Regulatory Changes Regarding

Limited Distribution

To implement the limited distribution

plan, we have made several changes to

this final rule. These changes are

explained below and pertain to the

distribution limitations themselves, box

marking, stickering, and ports of entry.

Limitations on Distribution.

We have added a new § 319.56–2f(g)

to this final rule to incorporate the

distribution limitations into the

requirements of the rule. That paragraph

states that the distribution of the

grapefruit, lemons, and oranges is

limited to the continental United States

(the 48 contiguous States, Alaska, and

the District of Columbia.). That

paragraph also states that during the

2000 through 2003 shipping seasons,

the distribution of the grapefruit,

lemons, and oranges is further limited

as follows:

• During the 2000 and 2001 shipping

seasons, the fruit may be distributed in

all areas of the continental United States

except Alabama, Arizona, Arkansas,

California, Colorado, Florida, Georgia,

Louisiana, Mississippi, Nevada, New

Mexico, Oklahoma, Oregon, Texas, and

Utah.

• During the 2002 and 2003 shipping

seasons, the fruit may be distributed in

all areas of the continental United States

except Arizona, California, Florida,

Louisiana, and Texas.

For the 2004 shipping season and

beyond, the fruit may be distributed in

all areas of the continental United

States.

Box Marking

As was presented in the proposed

rule, § 319.56–2f(c)(6) of this final rule

requires the boxes in which the fruit is

packed to be marked with the SENASA

registration number of the grove that

produced the fruit. This final rule

requires that the boxes also be marked

with a statement indicating that the fruit

may not be distributed in Hawaii,

Guam, the Northern Mariana Islands,

Puerto Rico the U.S. Virgin Islands (i.e.,

destinations outside the continental

United States), or in any State (each of

which must be individually listed) into

which the distribution of the fruit is

prohibited under the limited

distribution plan. To account for the

possibility that the fruit might have to

be repackaged following its entry into

the United States, new paragraph

§ 319.56–2f(i) states that any new boxes

in which the fruit is packed must also

be marked with the limited distribution

statement required under § 319.56–

2f(c)(6).

Stickering

APHIS has found that the marking of

individual fruit is necessary for the

limited distribution scheme to be

enforceable; otherwise it would be

difficult to distinguish Argentine

grapefruit, lemons, or oranges from

domestically produced fruit or fruit

imported from other sources. Therefore,

we have amended § 319.56–2f(c)(5) in

this final rule to require that the

grapefruit, lemons, and oranges be

individually labeled with a sticker that

identifies the packinghouse in which

they were packed. We understand that

Argentina’s citrus producers routinely

label their fruit with stickers identifying

the packinghouses in which the fruit

was prepared for distribution, and we

believe that those packinghouse labels

would serve to adequately identify the

fruit since we would be able to provide

examples of each packinghouse’s sticker

to our inspectors and cooperators.

Therefore, we do not believe that this

stickering requirement will impose a

significant additional burden on

Argentine growers, packers, or

exporters.

Ports of Entry

New § 319.56–2f(h) states that the

grapefruit, lemons, and oranges may

enter the United States only through a

port of entry located in a State where

the distribution of the fruit is authorized

under § 319.56–2f(g), which, as

explained above, is the section of the

regulations that provides for the

limitations on the distribution of the

fruit. The port-of-entry restrictions of

§ 319.56–2f(h) apply to both the limited

distribution plan’s staged phase-in of

imports into the continental United

States and the prohibition on the

distribution of the fruit outside the

continental United States.

As noted above, we believe that this

limited distribution plan will provide

an opportunity for the efficacy of the

systems approach to be demonstrated

under actual production and

distribution conditions before Argentine

citrus imports are allowed to enter

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37611

citrus-producing areas of the continental

United States.

Miscellaneous Comments

Comment: In 1995, APHIS denied

Argentina’s petition to export citrus to

the United States due to the risks that

were posed by the fruit. The proposed

rule does not set forth the information

and experimentation that transpired

between 1995 and 1996 that led APHIS

to reverse its position. It is only

appropriate that the U.S. citrus industry

have the opportunity to evaluate the

basis for APHIS’ decision to reverse its

position.

Response: In our proposed rules, we

usually focus on describing and

justifying the specific regulatory

changes or additions that we are

proposing, so we do not routinely

provide the sorts of historical or

evolutionary details that the commenter

mentions. In the case of the Argentine

citrus proposed rule, we concentrated

on explaining the proposed citrus

export program set forth in the

regulatory text of the proposed rule; we

did not believe it was necessary to

examine the differences between that

program and any earlier Argentine

petitions that we had rejected. However,

the process of data gathering,

experimentation, and negotiation that

led to the proposed rule is documented

in the material contained in the

rulemaking record, and we provided

that material to several interested

parties who requested it, including

representatives of the U.S. citrus

industry.

Comment: Two documents in the

rulemaking record—a trip report

prepared after APHIS’ 1994 trip to

northwestern Argentina and a

memorandum dated May 27, 1994, that

discusses the status of Argentina’s

request to export citrus both raise

questions and concerns regarding the

Argentine petition. The May 1994

memorandum recommended two

actions: (1) That the Government of

Argentina request a thorough risk

assessment be completed, and (2) that

an expert group of pathologists from

APHIS and the Agricultural Research

Service determine what research was

needed before a regulatory decision was

made, establish tolerances for diseased

fruit in an export program and how

these can be measured, and make an

assessment of Argentina’s citrus canker

survey. While the call for a risk

assessment in point number one may

have been addressed by APHIS’ original

1995 risk assessment, the

recommendations on point number two

appear to have gone unaddressed. We

believe that all those questions must be

answered before APHIS takes any

further action on Argentina’s petition.

To that end, the proposed rule should

be withdrawn to allow for a full

scientific discussion of the questions

found in those documents.

Response: Both of the actions

recommended in the May 1994

memorandum were completed prior to

the development of the proposed rule.

As noted by the commenter, APHIS did

prepare a preliminary qualitative pest

risk assessment in 1995, and that 1995

assessment was followed up by the 1997

quantitative pest risk assessment used

as support for the proposed rule.

In September 1994, our expert group

of pathologists identified to Argentina

the areas in which we believed

additional research was needed and

requested another year’s worth of data

to substantiate their proposed mitigation

measures; that data was received in the

spring of 1996. Further, as evidenced by

the provisions of the proposed rule and

this final rule, we established tolerances

for diseased fruit in the export program

(i.e., the detection of a single diseased

fruit will result in the grove in which

the fruit was grown being removed from

the export program, and the fruit from

that grove being prohibited entry into

the United States, for the remainder of

that year’s growing and harvest season).

We have also included inspection

provisions to detect diseased fruit and

prevent its entry into the United States.

Finally, we completed our review of

Argentina’s citrus canker survey

program and have full confidence in the

efficacy of its methodology and the

accuracy of its findings. Given that all

the issues raised in the May 1994

memorandum were addressed prior to

the preparation of the proposed rule, we

do not believe it is necessary to

withdraw the proposed rule for the

reasons stated by the commenter.

Comment: In 1994, Argentina

proposed a systems approach to

suppress citrus black spot and sweet

orange scab that was based on

individual farms performing the

suppression treatment. At the time,

APHIS stated that individual farms were

too small a unit for sufficient disease

suppression and that a larger area with

clearly defined geographic boundaries

encompassing all citrus grown in the

region would be necessary. Why is

APHIS now proposing a system based

on individual farms performing the

suppression treatment?

Response: The original Argentine

proposal did not include several of the

aspects of the systems approach

required by this rule, such as the

preharvest surveys, laboratory analysis

of sampled fruit, and post-harvest

treatments. When those aspects of the

systems approach were included in later

proposals and data were made available

to support their efficacy, we concluded

that a grove-level approach to the plant

pests of concern would be appropriate.

Comment: The 1994 trip report posits

that one possible step that could be

taken in order to permit Argentine citrus

to enter the United States would be to

limit exports to Northeastern ports. A

limited distribution requirement similar

to the restrictions on the importation of

avocados from Mexico would not be a

sufficient or enforceable mitigation

measure for Argentine citrus. If the

market provides an economic reason to

ship the citrus to other States, parties

with an economic motivation to do so

will find a way to make that happen. It

is not realistic to say that APHIS has

sufficient resources to ‘‘police’’ this

requirement. The result would be the

spread of devastating diseases to citrus

growing regions. Indeed, APHIS has had

recent experience in dealing with illegal

shipments of Mexican avocados by a

large retailer. Once Argentine citrus

enters the United States, it must be

assumed that the fruit will reach every

market in the continental United States.

Thus, any potential restriction on where

the fruit can be shipped is unrealistic.

Response: That suggestion was indeed

offered during discussions that

preceded the preparation of the

proposed rule, but the proposed rule did

not include limitations on distribution.

This final rule does, however, limit the

importation of the fruit to the

continental United States and

incorporates a three-stage phase-in of

imports that limits the distribution of

the fruit during the 2000 through 2003

shipping seasons. These aspects of this

final rule are explained above under the

heading ‘‘Distribution Limitations.’’ As

noted in that section, we continue to

have faith in the efficacy of the systems

approach and in the findings of the risk

assessment, thus we continue to believe

that citrus fruit imported from

Argentina in accordance with this rule

presents a negligible risk of introducing

diseases or insect pests into any area of

the continental United States.

APHIS personnel, as well as

personnel with State regulatory agencies

and the Department’s Agricultural

Marketing Service, will be enlisted to

enforce the distribution limitations of

the rule. This will be accomplished

through market visits, inspections, and

outreach efforts directed at importers,

shippers, distributors, and retailers, and

the infrastructure and resources needed

to support these efforts are already in

place. Given the experience we have

gained through the Mexican avocado

37612 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

program and through the

implementation of our expanded

smuggling interdiction program, we

believe that we have the ability to

enforce the distribution restrictions of

this rule.

Comment: We requested a 1-year

extension of the comment period for the

proposed rule, then shortened the

requested length of the extension to 6

months. By granting only a 4-month

comment period extension and

subsequently denying our request for a

2-month postponement of the scheduled

public hearing, APHIS has denied the

affected public a fair opportunity to

comment on the proposed rule.

Response: With the original 60-day

comment period and the 120-day

extension noted by the commenter, the

proposed rule was open for public

comment from August 12, 1998, through

February 11, 1999, a total of 6 months.

We believe that this 180-day comment

period afforded the affected public a fair

opportunity to comment on the

proposed rule. Further, in denying the

commenter’s request for a 2-month

postponement of the California public

hearing, which we had already

postponed once, the Department made it

clear that it was willing to review any

new information that might surface

following the close of the comment

period. Specifically, the APHIS hearing

officer at the Thousand Oaks, CA,

hearing—which was attended by the

commenter—read the following

statement from Deputy Secretary

Richard Rominger: ‘‘Following the close

of the comment period, we will

thoroughly analyze and review the

available material and all comments in

the record to determine how best to

proceed in the rulemaking process.

However, if any new scientific

information comes to light after the

close of the comment period on

February 11, 1999, which has a material

and significant bearing on this

rulemaking proceeding, such

information will be thoroughly

considered by the Department, and the

Department will take such further action

as is appropriate.’’

Comment: We informed APHIS on

October 2, 1998, that our group was

organizing to comment on the proposed

rule and had selected a delegation of

university scientists from California,

Texas, and Florida to travel to Argentina

in order to gather information. By failing

to provide timely assistance to our

group in arranging that trip, APHIS has

denied our group and other interested

parties a meaningful opportunity to

conduct critical scientific analysis.

Response: We believe that the

correspondence exchanged between

APHIS and the commenter concerning a

site visit indicates that APHIS

cooperated with the commenter’s group

in its efforts to arrange a visit to

Argentina:

• After receiving the commenter’s

letter dated October 2, 1998, APHIS

informed the Argentine Ministry of

Agriculture of the commenter’s desire

for a site visit by university scientists.

Argentine officials responded by

requesting APHIS’ endorsement of the

visit prior to granting their consent for

a site visit.

• In a letter dated November 6, 1998,

APHIS informed the commenter of

Argentina’s response. In that letter, we

stated that we were prepared to endorse

the visit and asked for a specific

description of its objectives so that we

could pass that information along to

Argentina.

• In a letter dated December 1, 1998,

the commenter responded with the

requested information and indicated its

eagerness to work with APHIS to

arrange the trip.

• In a letter dated December 7, 1998,

we informed the commenter that we

would endorse the visit and attempt to

arrange a visit in the second week of

January 1999.

• In a letter dated December 17, 1998,

the commenter rejected the idea of a

January visit, stating that the notice was

too short and that January was not a

‘‘biologically relevant’’ time for a visit.

In that letter, the commenter’s group

informed APHIS that it wished to make

a visit in April or May, and perhaps

make another visit in July or August.

• No further progress was made on

the issue of a site visit following that

December 17, 1998, letter. In subsequent

correspondence, the commenter’s group

informed us that they would attempt to

ensure that the comment period was

extended or the record otherwise held

open in order to provide for APHIS’

consideration of any information

collected during possible future site

visits by their scientists.

We believe that the timeline provided

above shows that APHIS did in fact

provide timely assistance to the

commenter, and we disagree with the

commenter’s assertion that APHIS

denied interested parties a meaningful

opportunity to conduct critical scientific

analysis.

Comment: On September 22, 1998, we

filed a Freedom of Information Act

(FOIA) request with APHIS in which we

asked for any background materials and

correspondence relating to the 1997 risk

assessment. APHIS’ FOIA office

acknowledged that request on

September 29, 1998, but did not provide

any material or acknowledge our followup request before the end of the

comment period. APHIS has, therefore,

withheld or failed to disclose relevant

information that would allow the public

to interpret and understand the findings

in the risk assessment.

Response: Due to our FOIA staff’s

large workload, we were unable to fulfill

the commenter’s FOIA request before

the February 11, 1999, close of the

comment period. However, we did

forward the requested documents to the

commenter shortly after the close of the

comment period. As indicated in the

response to a previous comment, we

informed the commenter prior to the

close of the comment period that we are

willing to thoroughly consider, and

address as appropriate, any new

scientific information that comes to

light that has a material and significant

bearing on this rulemaking proceeding.

Comment: At the February 5, 1999,

public hearing, a member of the APHIS

panel stated that APHIS was relying on

a 1986 Plant Protection and Quarantine

(PPQ) study to support its position that

it was highly unlikely that citrus black

spot would become established by the

spores produced on infected fruit. We

believe that APHIS is using this PPQ

study as the pivotal foundation for the

proposed rule. APHIS’ failure to

disclose its reliance on this pivotal 1986

study until extremely late in the

proposed rule’s comment period is a

violation of proper administrative

procedures. APHIS has denied the

affected public the opportunity to

comment on the Agency’s rationale for

the proposal; the lack of disclosure of

this one study, in and of itself, is a

compelling reason why this proposal

must be withdrawn by APHIS.

Response: APHIS did not use the

cited 1986 study as ‘‘the pivotal

foundation for the proposed rule.’’ Most

of the APHIS employees involved in the

preparation of the proposed rule were

either unaware of or had forgotten the

1986 study. It was not until the panel

that represented APHIS at the two

public hearings was preparing for the

February 5, 1999, hearing in Orlando,

FL, that one of the panel members

recalled the existence of that study; this

was more than 5 months after the

proposed rule was published. Further,

the official transcript of the February 5,

1999, hearing indicates that the APHIS

panel member simply quoted from the

1986 study; she did not state that APHIS

was ‘‘relying on’’ the study. Because we

did not rely on the study or its findings

in the preparation of the proposed rule,

we do not believe the fact that it was not

mentioned until late in the comment

period is grounds for the withdrawal of

the proposed rule.

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37613

Comment: APHIS did not comply

with its obligations under Executive

Order 12866 in developing the proposed

rule. In particular, section 6(a) of the

Executive Order provides that each

agency should engage the impacted

public with an opportunity for informal

dialogue prior to issuing a proposed

rule. For this reason alone, APHIS

should withdraw the proposed rule to

permit the required consultations to

begin.

Response: The portion of the

executive order cited by the commenter

reads in part: ‘‘Each agency shall

(consistent with its own rules,

regulations, or procedures) provide the

public with meaningful participation in

the regulatory process. In particular,

before issuing a notice of proposed

rulemaking, each agency should, where

appropriate, seek the involvement of

those who are intended to benefit from

and those expected to be burdened by

a regulation.’’ Consistent with our

standard procedures, APHIS did in fact

informally contact representatives of the

domestic citrus industry regarding the

Argentine proposal in October 1997,

and indications at that time were that

the domestic citrus industry supported

the concept of Argentine citrus imports.

Further, a new pest list based on the

1995 risk assessment and updated with

information provided by Argentina was

sent for comment to the State plant

regulatory officials (SPRO’s) in the

citrus-producing States of Florida,

Louisiana, Texas, Arizona, and

California in the fall of 1996, and a draft

of the 1997 quantitative pest risk

assessment was sent to those SPRO’s in

the spring of 1997. Each of the SPRO’s

was encouraged by APHIS to circulate

those documents as they saw fit. We do

not believe, therefore, that the proposed

rule must be withdrawn in order to

comply with Executive Order 12866.

Comment: If APHIS allows Argentine

citrus to enter the United States without

adequate protective measures in place,

and the U.S. citrus industry is then

economically injured, APHIS’ actions

would rise to the level of a ‘‘taking’’ of

private property by an arm of the U.S.

Government.

Response: Because this rule places no

limitations or restrictions whatsoever on

the U.S. citrus industry or individual

U.S. growers or their property, we do

not believe that this rule constitutes a

regulatory taking.

Comment: In failing to establish

quarantine-level treatments for citrus

black spot and sweet orange scab in the

proposed rule, APHIS is failing to meet

its responsibilities for pest exclusion

under the Plant Quarantine Act and the

Federal Plant Pest Act, which clearly

charge the Secretary of Agriculture with

the responsibility for preventing the

entry of pests that are new to or not

widely established in the United States.

Response: Neither the Plant

Quarantine Act nor the Federal Plant

Pest Act state that quarantine-level

treatments are the only means through

which the Secretary may meet his

responsibilities for pest exclusion under

those acts. Rather, 106 of the Federal

Plant Pest Act (7 U.S.C. 150ee)

authorizes the Secretary to promulgate

regulations requiring the inspection of

articles imported into the United States

and may impose ‘‘other conditions upon

such movement, as he deems necessary

to prevent the dissemination into the

United States, or interstate, of plant

pests * * *.’’ Quarantine-level

treatments are not available for all

commodity/pest combinations; in the

absence of such treatments, we must

consider whether alternative measures

are available that will provide a

comparable level of quarantine security,

and we expect other nations to do the

same with respect to U.S. agricultural

exports. In this rule, we require the use

of tiered and overlapping measures that,

when combined with specified cold

treatments or host resistance, will

reduce the pest risks associated with the

importation of Argentine citrus to a

negligible level. We believe, therefore,

that we have met our responsibilities

under the acts cited by the commenter.

Comment: APHIS’ fruits and

vegetables regulations only address the

importation of fruits and vegetables

from countries where insect pests are

present; diseases are not addressed. It

appears that APHIS does not have the

authority under its regulations to permit

the entry of fruits or vegetables from

countries where one or more diseases

exist. Therefore, given that citrus

diseases exist in Argentina, it appears

that APHIS does not have the authority

under its regulations to promulgate a

regulation that allows the importation of

grapefruit, lemons, and oranges from

that country.

Response: Our regulations are not the

source of our authority to regulate the

importation of fruits and vegetables;

rather, they are a means through which

we exercise the authority derived from

statutes such as the Federal Plant Pest

Act and the Plant Quarantine Act. The

Secretary of Agriculture is provided

with the authority in the Plant

Quarantine Act to restrict the

importation of fruits and vegetables

because of ‘‘injurious plant diseases or

insect pests’’ or to prohibit such

importation because of any ‘‘disease or

of any injurious insect’’ (7 U.S.C. 159,

160). Therefore, we have clear statutory

authority to regulate the importation of

fruits and vegetables because of diseases

as well as insect pests. With respect to

our regulations implementing the

Secretary’s authority under those acts,

the commenter is correct in noting that

the fruits and vegetables regulations

contain no general provisions regarding

diseases. However, the regulations in

‘‘Subpart—Citrus Fruit’’ (§ 319.28),

which we are amending in this rule and

which was discussed in the proposed

rule, do in fact contain specific

restrictions on the importation of fruit of

citrus and citrus relatives from specified

countries due to the presence of citrus

diseases in those countries.

Comment: The April 1992 pest risk

analysis that APHIS completed for its

rulemaking regarding the importation of

citrus from South Africa states that

‘‘[i]mportation of all plant parts, except

seed, of Citrus spp. should be prohibited

from countries where the disease [black

spot] occurs’’ (Pest Data Sheet on Black

Spot of Citrus, p. 62). Yet, neither the

risk assessment nor the proposed rule

for Argentine citrus mentions that

serious concern that the Agency had so

recently expressed about citrus black

spot. It appears that APHIS is now

proposing to make an abrupt change in

its position regarding this disease and

the danger that it poses without either

articulating the reasons for this change

or including in the record substantial

evidence that could support such a

divergence from longstanding agency

policy.

Response: We disagree with the

commenter’s contention that we are

making an abrupt change in policy with

regard to the risks presented by citrus

black spot. More importantly, our

position regarding the phytosanitary

significance of citrus black spot has not

changed as drastically as the commenter

suggests. We still consider citrus

nursery stock and plant parts other than

fruit to pose a high risk as pathways for

the introduction of citrus black spot. It

is only our position relative to citrus

fruit—specifically, citrus fruit that has

been subjected to the measures required

by this rule—that has changed since the

April 1992 pest risk analysis for South

African citrus. The pest data sheet cited

by the commenter was completed more

than 5 years before we prepared the

Argentine citrus analysis and did not

consider the tiered and overlapping

measures used in the systems approach

to mitigate the risk of citrus black spot;

thus, the data sheet’s recommendations

were made in the context of an

importation scenario in which no

measures short of prohibition were

offered to mitigate the risk of citrus

black spot.

37614 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

APHIS’ reading of the relative risks

presented by citrus plants, fruit, and

other plant parts is consistent with the

current research into the epidemiology

and control of citrus black spot and the

evolving scientific understanding of the

disease. For example, Professor J.M.

Kotze of the University of Pretoria

(South Africa) reports in a Department

of Microbiology and Plant Pathology

summary of plant pathology research

focus areas that: ‘‘We have shown that

the disease [citrus black spot] spreads to

new areas through leaves of nursery

trees. The importance of the inoculum

sources was already demonstrated,

especially the fact that fruit presents no

danger to importers of citrus in Europe.’’

Fruit has been shown to be a poor

pathway for the introduction of citrus

black spot, and, as explained in the

proposed rule, the required systems

approach acts to reduce any remaining

risk to a negligible level.

Trade-Related Issues

Comment: In the proposed rule,

APHIS stated: ‘‘Maintaining a

prohibition on the importation of

grapefruit, lemons, and oranges from the

Argentine States of Catamarca, Jujuy,

Salta, and Tucuman in light of those

State’s [sic] demonstrated freedom from

citrus canker would run counter to the

United States’ obligations under

international trade agreements and

would likely be challenged through the

World Trade Organization’’ (WTO). This

is simply not true. Even if the four

involved Argentine States are free from

citrus canker, there are other potentially

devastating citrus diseases and pests

present. Under the Uruguay Round

WTO agreement, the United States has

no obligation to permit the introduction

and spread of quarantine diseases and

pests in this country. Any country is

free to adopt a ‘‘zero risk’’ standard as

its appropriate level of protection; we

submit that the current U.S. prohibition

on fruit that is infected with sweet

orange scab and citrus black spot is

entirely consistent with the Uruguay

Round’s ‘‘Agreement on the Application

of Sanitary and Phytosanitary

Measures’’ (the ‘‘S&P Agreement’’).

Argentina has not shown that the

importation of fruit from an

indisputably infected region poses no

risk that sweet orange scab, citrus black

spot, or both, may be introduced into

the United States.

Response: We understand that we are

not required to allow diseased or

infested fruit to be imported into the

United States; indeed, this rule does

nothing to alter the ‘‘current U.S.

prohibition on fruit that is infected with

sweet orange scab and citrus black spot’’

noted by the commenter. However, we

also recognize that we are obliged to use

health requirements only to the extent

necessary to meet our ‘‘appropriate level

of protection.’’ In the case of grapefruit,

lemons, and oranges from Argentina, we

believe that the tiered and overlapping

safeguards contained in this final rule

will reduce the pest risk associated with

their importation to a negligible level. If

the United States had deemed ‘‘zero

risk’’ to be its appropriate level of

protection, then it is unlikely that

Argentine citrus—and many other

commodities, for that matter—would

ever be approved for importation into

the United States. There will always be

some degree of pest risk associated with

the movement of agricultural products;

APHIS’ goal is to reduce that risk to a

negligible level.

While the one sentence quoted by the

commenter from the proposed rule

mentioned only citrus canker, we

believe that it is evident from the

content of the entire proposed rule that

we did indeed consider the presence of

other diseases and insect pests in

Argentina. It should be noted that the

sentence quoted by the commenter was

preceded by another sentence in the

proposed rule: ‘‘We have rejected that

alternative [i.e., to make no changes in

the regulations and continue to prohibit

the importation of grapefruit, lemons,

and oranges from Argentina] because we

believe that Argentina has demonstrated

that the citrus-growing areas of the

States of Catamarca, Jujuy, Salta, and

Tucuman are free from citrus canker

and because we believe that the systems

approach offered by Argentina to

prevent the introduction of other plant

pests reduces the risks posed by the

importation of grapefruit, lemons, and

oranges to a negligible level.’’

Comment: We submit that APHIS

should consult with the U.S. Congress

on the issue of the ‘‘appropriate level of

protection’’ in this situation, especially

given that the world trading community

has yet to settle the issue of what

constitutes an appropriate level of

protection. The citrus industry is far too

important to the United States economy

and trade interests for APHIS to make

critical economic and foreign policy

decisions on its own, particularly when

no international standard dictates a

particular result.

Response: The provisions of the WTO

SPS Agreement provide that it is the

sovereign right of each member to set its

own level of protection, thus it would

be inappropriate for the ‘‘world trading

community’’ to make such a

determination. In this instance, APHIS,

as the recognized regulatory authority,

is establishing a system of phytosanitary

measures that reflect the level of

protection deemed appropriate. It is our

intent to allow fresh grapefruit, lemons,

and oranges to be imported into the

continental United States from

Argentina only if they are grown,

packed, and shipped under specified

phytosanitary conditions designed to

mitigate the risk of plant pest

introduction. We are confident that the

phytosanitary measures required by this

rule will mitigate the risk presented by

Argentine citrus. Given that confidence,

we do not believe that the level of

protection afforded by this rule is a

departure from the level of protection

we demand in other commodity import

situations.

Comment: Article 6 of the S&P

Agreement recognizes that countries can

have regions that are pest- or diseasefree or have areas of low pest or disease

prevalence. However, it is envisioned

that each country claiming to have such

regions has the burden of proving that

such areas have no pests or diseases or

have low levels of pests or disease.

Argentina has not provided any

information to APHIS as to the levels of

pests or diseases that are present in the

four States that are proposed for export.

Response: Argentina claims that the

citrus-growing regions identified in this

rule are free from citrus canker, and we

believe that they have provided

sufficient documentation to support that

claim. We also believe that Argentina

submitted sufficient documentation to

support its position that the remaining

pests and diseases were of low enough

prevalence that the chemical, cultural,

and other controls of the systems

approach would prevent their

introduction into the United States on

fruit imported under the requirements

of this rule.

Comment: APHIS’ regulations in

§ 319.56–2 refer to ‘‘without risk,’’ yet

the proposed rule seems to have a

standard on ‘‘negligible risk.’’ Even if

APHIS does have the statutory authority

to adopt a ‘‘negligible risk’’ standard,

the standard is undefined and

impossible to determine. This is not

acceptable. The standard should be

capable of being independently

validated and should be set only after

rigorous peer review, in accord with

standards and guidelines adopted by

WTO with the advice of International

Plant Protection Convention (IPPC).

Response: The ‘‘without risk’’

provision selected by the commenter is

found in § 319.56–2(e) and is used in

the context of importing a fruit or

vegetable from a definite area or district

of a country that is free from some or all

of the injurious insects that attack the

fruit or vegetable when that area or

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37615

district meets the criteria for pest

freedom found in § 319.56–2(f). Section

319.56–2(e) is not applicable to this

rulemaking because the Argentine

Government has made no claims with

regard to the freedom of northwestern

Argentina with regard to injurious

insects i.e., fruit flies in this case. The

risk of diseases is addressed under the

regulations in § 319.28 (Subpart—Citrus

Fruit), which contains no such ‘‘without

risk’’ standard. In any event, we do not

believe that a policy of requiring

imports to be ‘‘without risk’’ or to

present ‘‘zero risk’’ could be sustained

by any country that wishes to engage in

international trade. There will always be

some degree of pest risk associated with

the movement of agricultural products;

APHIS’ goal is, and always has been, to

reduce that risk to a negligible level.

This goal is entirely consistent with the

standards and guidelines of the WTO

and the IPPC.

Comment: In the proposed rule,

APHIS does not offer any ‘‘reasoned

analysis’’ for departing from its

longstanding policy of not permitting

the importation of fruit from diseased

regions. In its two recent rulemakings

regarding the importation of citrus from

South Africa and Australia, APHIS

stated that it would deny the entry of

citrus from each of those countries if the

citrus was found to be infected with

citrus black spot. It appears that it was

clear to APHIS in those cases that citrus

black spot was so troubling and

dangerous that the only way to protect

the United States against importation of

this disease was to disallow the

importation of any fruit from diseased

areas. The inconsistency of APHIS’

proposed approach to Argentine fruit

with its prior, recent positions regarding

fruit from South Africa and Australia is

never mentioned or explained in the

proposed rule or the risk assessment.

Further, the differences in the

approaches applied to Argentine citrus

on one hand, and Australian and South

African citrus on the other, leaves the

United States open to challenges from

Australia and South Africa under article

2.3 of the S&P Agreement, which

requires that member countries do not

discriminate with respect to other

member countries where ‘‘similar

conditions prevail.’’

Response: In the two rulemakings

cited by the commenter regarding the

importation of citrus from Australia and

South Africa, the freedom of the

production areas from citrus black spot

formed part of the basis for allowing the

importation of citrus from those

countries. Because the importation

protocols were based largely on that

area freedom, it follows that we would

prohibit the importation of citrus from

either country if it was found to be

infected with citrus black spot. In the

case of Argentine citrus, no such claim

of area freedom is made, which is why

this rule requires control and detection

measures for citrus black spot. Because

of these differences in the bases for the

three rules in question, we do not

believe that this final rule arbitrarily or

unjustifiably discriminates between

countries where similar or identical

conditions prevail. Further, it is

important to note that this final rule,

like the Australian and South African

citrus fruit regulations, prohibits the

importation of any fruit found to be

infected with citrus black spot.

Comment: The rate of importation of

fruit into the United States should be

consistent with the rate of production of

a normal lemon farm as if trees were

planted today. If I planted a lemon tree

today, I wouldn’t receive any

production for 3 years, and then

production would increase gradually

through the tenth year. Regardless of

current Argentine production available

for importation, no lemons should be

allowed into the United States during

the first 3 years, and then only 15

percent the fourth year, 30 percent in

the fifth year, etc., until full production

is allowed.

Response: APHIS has no authority to

impose the quotas suggested by the

commenter.

Comment: APHIS should calculate the

cost per field box to the American

farmer of the cost of U.S. Government

regulation and adopt a temporary tariff

in that amount on all imported

Argentine fruit. The amount collected

by the temporary tariff would be

distributed to the American lemon

farmer based on each farmer’s field box

production until Argentina adopts the

same laws and regulations that the

American farmer must obey. The

minimum-wage law, Labor Standards

Act, and all environmental and health

safety laws are examples of such laws

and regulations.

Response: APHIS has no authority to

impose the tariff suggested by the

commenter.

Comment: APHIS has no regulations

that govern the procedure and standards

for consideration of import petitions

filed by foreign governments. Nor does

the website maintained by APHIS

provide any information on the process

for, or standards which are applied to,

such petitions. We submit that APHIS

has an obligation to establish its

procedures and standards when dealing

with plant diseases in such a way as to

provide the affected industry with

confidence that agency decisionmaking

is being conducted in a ‘‘reasoned’’ way

based upon substantial evidence in the

record and meaningful opportunity for

public comment.

Response: Foreign governments most

often broach the subject of exporting

new fruits or vegetables to the United

States through formal negotiations or

informal contacts with APHIS officials.

These requests and any subsequent

detailed proposals are reviewed by

APHIS staff experts. After that review,

APHIS staff may either recommend

approval of the petition or contact the

petitioning government with a request

for additional research, proposed

safeguards, etc. As noted by the

commenter, this government-togovernment contact is not the subject of

any procedural regulations in part 319.

However, the public is provided the

opportunity to review the Agency’s

basis for any change in the regulations

proposed as a result of a foreign

government’s import petition. Each time

we propose to amend our regulations to

address an import request that involves

a new commodity/region combination,

we prepare a proposed rule that is

commented upon by the public. In each

case, the proposed import program,

including mitigation measures, is

clearly described in the proposed rule,

and the rationale underlying the

proposed import program is explained.

The public, which includes any

potentially affected industry, then has

the opportunity to review the proposed

rule and its supporting information and

may provide comments that must be

considered and addressed by APHIS

before any final action on a foreign

government’s import petition may be

taken.

Systems Approach

Comment: APHIS’ regulations contain

no discussion, definition, or description

of what constitutes a ‘‘systems

approach,’’ or what treatment or

treatments will qualify as an acceptable

systems approach. There are no

standards in APHIS regulations that

permit affected parties to understand or

judge the Agency’s actions to approve or

disapprove such an approach. This is

unacceptable. An agency is obligated to

set forth the standard the agency is

applying or how it is applying that

standard to the factual situation.

Response: The standard that we apply

to any potential import situation is clear

and has been well-established over the

course of numerous APHIS rulemakings

dealing with the importation of

agricultural commodities: Does the

importation of a particular commodity

from a particular region present a risk of

introducing pests into the United States,

37616 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

and, if so, can that risk be reduced to a

negligible level through the application

of phytosanitary measures? These

considerations are addressed each time

we propose to amend our regulations to

address an import request that involves

a new commodity/region combination.

In each case, the proposed mitigation

measures, which can range from

something as basic as inspection at the

port of entry to a more complicated

systems approach of tiered and

overlapping measures, are clearly stated

in the proposed rule, and the rationale

for their proposed use is explained. So,

while the general provisions of our

regulations do not discuss, define, or

describe what constitutes a systems

approach or what treatment or

treatments qualify as an acceptable

systems approach, we do not believe

that the lack of such a discussion in the

regulations detracts from the public’s

ability to understand, assess, and

comment upon the mitigation measures

proposed for a particular commodity/

region combination.

Comment: Applying a systems

approach to disease suppression for the

purpose of allowing imports from a

region with a disease that does not exist

in the United States is a fundamental

change in APHIS policy. Previously,

APHIS has always demanded that the

area in which the crop is grown be

completely free of disease and

geographically separated from regions

with the disease. This principle is

applied to citrus canker in the

northwestern region of Argentina, but is

not the case with sweet orange scab or

citrus black spot. There has not been a

full scientific discussion of the

principles that need to be fulfilled

before moving forward with such a

fundamental change in the standards for

U.S. quarantine pest protection.

Therefore:

• APHIS should identify and cite the

studies that have been used to

determine that a systems approach

provides sufficient safety from all kinds

of plant pests when importing fresh

produce into the United States;

• APHIS should establish basic

standards for the kind of data and

experiments that are needed to provide

confidence in applying the systems

approach to disease control;

• APHIS should establish standards

by which the information used to

determine the effectiveness and

practicality of the systems approach are

to be judged; and

• There needs to be a public

discussion of what level of risk is

appropriate.

Response: We believe that the

commenter is incorrect in asserting that

APHIS is fundamentally changing its

policy by not demanding that a growing

area be completely free of disease and

geographically separated from regions

where disease exists. A long-standing

precedent for the local freedom concept

is found in the citrus fruit regulations in

§ 319.28(b)(1), which allow Unshu

variety oranges to be imported into

certain areas of the United States from

Japan and South Korea if the oranges are

grown in citrus-canker-free export areas

that are surrounded by 400-meter buffer

zones. While the Unshu orange program

differs from the Argentine citrus

program in many respects, the fact

remains that the Unshu orange program

stands as an example of a successful

approach to importing fruit from regions

where a disease exists.

As noted in the response to the

previous comment, it is true that the

general provisions of our regulations do

not discuss, define, or describe what

constitutes a systems approach or what

treatment or treatments qualify as an

acceptable systems approach. However,

we do not believe that the lack of such

a discussion in the regulations detracts

from the public’s ability to understand,

assess, and comment upon the

mitigation measures proposed for a

particular commodity/region

combination because, in each case

where we propose to allow the entry of

a new commodity, we explain the

proposed mitigation measures and

provide the scientific rationale

underlying their proposed use. Thus,

the public has the opportunity to judge

each proposed importation according to

the criteria suggested by this

commenter.

The commenter states that ‘‘APHIS

should identify and cite the studies that

have been used to determine that a

systems approach provides sufficient

safety from all kinds of plant pests when

importing fresh produce into the United

States.’’ We are unaware of any studies

that examine the use of systems

approaches as broadly or definitively as

the commenter suggests; there are

simply too many possible combinations

of pests and hosts on one hand, and

biological, physical and operational

factors that could be integrated into a

systems approach on the other, to allow

for such a conclusive determination.

Thus, while it is acknowledged that

systems of practices and procedures can

be assembled to provide quarantine

security in many cases, each proposed

use of a systems approach must be

evaluated individually. We will,

however, consider the commenter’s

suggestion that we establish, to the

extent possible, general standards for

the preparation and evaluation of data

that serve to support the establishment

of systems approaches. Finally, the

commenter states that there needs to be

a public discussion of what level of risk

is appropriate; we believe that the

comments received in response to our

proposed rule are one indication that

such a discussion of the level of risk

that APHIS has determined to be

approporiate is already open and

ongoing. Given the numerous, evolving,

and unpredictable factors affecting the

perception of, and tolerance for, risk, it

appears that the ‘‘public discussion of

what level of risk is appropriate’’ will,

by necessity, be an ongoing exchange

rather than a discrete deliberation.

Comment: APHIS has never before

proposed using a systems approach for

a combination of diseases and insect

pests. What is particularly troubling

about the approach APHIS is proposing

in the Argentine rule is that the Agency

has issued this proposal with no

specific discussion of its rationale; its

only stated justification is the previous

use of system approaches. However,

previous systems approaches are similar

in only the most remote of ways and are

not at all similar in execution or in

impact. Thus, the Agency must set forth

a detailed justification supported by

sound scientific evidence for this

fundamental shift in regulatory

approach. Further, we submit that

APHIS should have adopted this

expanded use of a systems approach

only after conducting a notice and

comment process, with rigorous

scientific peer review to determine

whether a systems approach can be an

effective tool when addressing diseases.

Response: It is not true that we sought

to justify the use of a systems approach

for Argentine citrus by pointing to

previous uses of systems approaches;

indeed, the proposed rule did not

mention the use of a systems approach

in any context other than that of

Argentine citrus. Further, we disagree

with the commenter’s contention that

we issued the proposed rule ‘‘with no

specific discussion of its rationale.’’ Our

rationale for the use of a systems

approach for Argentine citrus was stated

early in the proposed rule, at the end of

the first paragraph under the heading

‘‘Importation of Grapefruit, Lemons, and

Oranges,’’ where we stated ‘‘To prevent

the introduction into the United States

of those diseases [i.e., sweet orange scab

and citrus black spot] and fruit flies, the

Government of Argentina, with the

cooperation of APHIS, has formulated a

systems approach of tiered and

overlapping measures that, when

combined with specified cold

treatments, would reduce the risks

presented by those pests to a negligible

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37617

level.’’ The proposed rule then explains

in detail each of the phytosanitary

measures that would be required in

order for citrus to be exported to the

United States from Argentina. That

explanation, we believe, constitutes the

‘‘detailed justification’’ requested by the

commenter. We do not believe that our

application of systems approach

principles to the importation of

Argentine citrus is in any way a

departure from our policy of allowing

the importation of fruits and vegetables

when the risks presented by those

commodities can be mitigated to a

negligible level.

Comment: The systems approach is

premised upon the layering of several

risk reduction measures. An effective

verification and enforcement system is

essential for the layering of risk

reduction measures to result in the

desired outcome. What will be done

when one or more of these layers beaks

down? APHIS should have a response

plan for action when a risk reduction

measure fails.

Response: The systems approach

contained in this rule, as is the case

with all systems approaches contained

in APHIS’ regulations, is indeed

premised upon the layering of several

risk reduction measures. The tiered and

overlapping nature of any systems

approach ensures that even if any one

of the elements of the systems approach

is omitted or fails, and that omission or

failure remains undetected, adequate

measures will remain to provide the

necessary level of phytosanitary

security. Further, we agree that an

effective verification and enforcement

system is essential to the success of any

systems approach. To achieve that

success, this rule requires that SENASA

actively participate in or supervise each

step of the process in Argentina to verify

and document each step’s successful

completion or application, and the

required documentation must be made

available to APHIS. Further, as

discussed earlier in this document in

the paragraph titled ‘‘Monitoring—

Argentina,’’ the operational work plan

that addresses the administration of the

export program will include provisions

for active and direct monitoring of the

program by APHIS personnel who will

conduct frequent oversight visits to the

growing areas and packinghouses in

order to observe each step of the

program in Argentina. Further, each

shipment of fruit must be accompanied

by a phytosanitary certificate issued by

SENASA that verifies that the fruit was

produced and handled in accordance

with the requirements of § 319.56–2f(a)

through (c) and that the fruit is

apparently free from citrus black spot

and sweet orange scab. Fruit that fails to

meet those requirements will not be

eligible for importation into the United

States. At the port of entry in the United

States, APHIS will inspect the fruit and

its accompanying phytosanitary

certificate and will confirm that any

required cold treatment has been

properly applied. Finally, the detection

of citrus black spot or sweet orange scab

on any grapefruit, lemons, or oranges at

any time in Argentina, during transport,

or in the United States will result in the

grove in which the fruit was grown or

is being grown being removed from the

SENASA citrus export program for the

remainder of that year’s growing and

harvest season, and the fruit harvested

from that grove being ineligible for

importation into the United States from

the time of detection through the

remainder of that shipping season.

Comment: For a systems approach to

be effective, it is essential to know the

biological interactions between the pest

and its host to understand how these

interactions affect production,

shipment, and marketing of

commodities. There is very little current

knowledge about citrus black spot or

sweet orange scab, and virtually no

work has been done on the question of

how the diseases would respond if

brought into the United States. Thus,

there is a substantial threshold question

of whether a systems approach can even

be designed to deal with citrus black

spot or sweet orange scab.

Response: As neither of those diseases

is present in the United States, it is not

unusual that most researchers in this

country who study citrus crops and

their pests have directed their efforts to

other, more immediate concerns.

However, in countries where citrus

black spot or sweet orange scab is

present and where citrus is an

economically important crop, those

diseases have been, and continue to be,

the subject of focused research. We

believe that the information on the

prevention, control, and detection of

these diseases that has been collected

over the years, combined with the

results of the field trials conducted in

Argentina, provides the necessary

degree of scientific support for the

systems approach described in this rule.

Comment: APHIS has not used a

systems approach previously in a

situation where the intended result of

the treatments is simply suppression of

the symptoms of the disease(s) in a

proposed export area. Thus, proposing

to rely on an approach which

admittedly only results in suppression

of the symptoms of the diseases is a

fundamental policy shift by APHIS. The

proposal also stands in stark contrast to

the goal of complete eradication of a

disease, which has been and remains

the objective in every situation in the

United States where a plant disease or

pest does exist. As such, any

contemplated use of such an approach

should be subjected to the most

rigorous, exhaustive, and

comprehensive level of scientific peer

review.

Response: The intended result of the

treatments, particularly the oil-copper

oxychloride sprays during the growing

season, as well as measures such as

grove cleaning to remove inoculum, is

the prevention of infection, and not

simply the suppression of symptoms as

stated by the commenter. Other required

measures are specifically designed to

detect the presence of diseased fruit and

prevent its importation into the United

States. Given that the goal of this rule

is to provide for the importation of

disease—free and not simply

asymptomatic—grapefruit, lemons, and

oranges, we do not believe that this rule

represents a departure from our policy

of allowing the importation of fruits and

vegetables when the risks presented by

those commodities can be mitigated to

a negligible level.

Comment: A publication titled

Quarantine Treatment for Pests of Food

Plants (edited by Jennifer L. Sharp and

Guy J. Hallman, Westview Press, 1994),

includes a discussion of systems

approaches that stresses the importance

of determining the level at which a pest

or disease exists in order to design an

effective systems approach. Nothing on

the record of the Argentine proposed

rule indicates the ‘‘level of infestation’’

of the host fruit by any of the diseases

or pests at issue. This infestation

information must be known before

APHIS can even consider the possibility

of designing a systems approach. Only

when this infestation level is known can

the efficacy of the proposed system be

judged. Without this information,

interested parties are unable to conduct

any meaningful review of the proposed

systems approach.

Response: The ‘‘level of infestation’’

passage noted by the commenter is

found on page 226 of the cited

publication and states ‘‘* * * [S]ystems

recognize that the commodity in

question is a host, the level of

infestation in the host being the key

component in the design of the overall

system. Systems rely on knowledge of

the infestation level of the host and

measure the impact of the various

operational procedures on removing

infested hosts, thereby reducing the

risks that infested hosts will be

shipped.’’

37618 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

For the fruit flies of concern in

Argentina, a single quarantine

treatment—cold treatment—is available

and is required by this rule, which

leaves citrus black spot and sweet

orange scab as the ‘‘diseases or pests at

issue.’’ Surveys produced by Argentina

show that disease incidence—i.e., the

‘‘level of infestation’’ referred to in the

cited publication—varies from season to

season, depending on the prevailing

environmental conditions, and can be

high in untreated groves. The results of

those surveys were reported in the risk

assessment that accompanied the

proposed rule, so there is in fact

information on the record indicating our

knowledge of disease incidence in

Argentina. Because of the known

seasonal variations in disease incidence,

the design of the systems approach for

Argentine citrus began with the

assumption of a potentially high ‘‘level

of infestation’’ and set out, through

biological and operational factors such

as buffer zones, inoculum removal,

inspections, testing, and treatments, to

reduce the risks of infected fruit being

shipped to the United States.

Comment: It is not possible to

properly assess the adequacy of a

systems approach in preventing the

introduction of pests into an importing

nation without detailed knowledge of

the circumstances under which a pest

occurs, and the frequency with which it

occurs, in the export region. APHIS’

current risk assessment is based on a

poor body of knowledge of insect

species present or potentially present in

Argentina, particularly the Anastrepha

species present in northwestern

Argentina. Further, the level of pesticide

use there could be masking the presence

of lesser-known pests that could emerge

as a problem if newer, more specific

pesticides are used in Argentina.

Therefore, extensive taxonomic research

and population surveys on fruit flies

and other insect species present in

northwestern Argentina, as well as data

on other potential hosts in that region,

are necessary in order for a proper risk

assessment to be completed on

Argentine citrus and for the systems

approach to be fully evaluated.

Response: Citrus is an economically

important crop in Argentina, and as

such has been, and continues to be, the

subject of well-supported and

vigorously pursued research into its

production and factors affecting that

production, including pests. We are

confident, therefore, that the pest list

produced by SENASA, which was

reviewed by APHIS and by agricultural

officials in the four main citrusproducing States of this country and

compared against reports from various

international sources and the scientific

literature, accurately addressed the

range of citrus pests present in

Argentina. Further, we believe that the

risks posed by those pests were

adequately considered in the risk

assessment and addressed by the

provisions of this rule.

Comment: What is the goal of the

systems approach for citrus black spot

and sweet orange scab? Some of the

statements in the rulemaking record

imply that the goal is to have diseasefree groves, while the proposed rule

seems to seek the suppression of disease

symptoms in export groves. Recent

statements by APHIS imply that it

would be acceptable for diseased fruit to

enter the United States.

Response: The goal of the systems

approach is to reduce the plant pest

risks associated with the importation of

Argentine citrus to a negligible level.

With regard to citrus black spot and

sweet orange scab, the systems approach

is designed to accomplish that goal

through both prevention and detection;

the grove cleaning and growing season

spraying requirements are designed

specifically to prevent fruit from

becoming infected in the first place, and

subsequent surveys, inspections, and

testing provide multiple opportunities

for the detection of infected fruit. If a

single infected fruit is found at any

point in the process, including

inspections conducted after the fruit has

arrived in the United States, the grove

in which that fruit was grown will be

removed from the SENASA citrus

export program and the fruit harvested

from that grove may not be imported

into the United States from the time of

detection through the remainder of the

shipping season. Thus, the commenter’s

impression that we would find it

acceptable for diseased fruit to enter the

United States is incorrect.

Comment: The record of data

supplied by Argentina, as provided to

the public by APHIS, is completely

inadequate to assess the efficacy of the

individual measures, let alone the

systems approach, for citrus black spot

and sweet orange scab. Either APHIS

has not maintained a complete record of

the information Argentina supplied, or

the Agency is basing its risk estimates

on ambiguous data because of

inadequate reporting by Argentina.

Response: We have, in fact,

maintained a complete record of the

information supplied by Argentina, and

we did share that information with the

commenter, although we were unable to

provide the information that was the

subject of the commenter’s FOIA request

until after the close of the comment

period. Further, it is important to note

that our assessment of the risks

presented by Argentine citrus and of the

efficacy of specific measures was not

based solely on the material provided by

Argentina; information gathered from

other sources and the expert judgment

of subject matter specialists also played

a role. This is the norm when

conducting probabilistic assessments to

inform decisions regarding importation

of agricultural commodities. When data

that represent ‘‘direct evidence’’ do not

exist, which is often the case in

probabilistic risk assessments, available

information is reviewed and applied

through the use of professional

judgment. APHIS bases the estimates

needed for its probabilistic commodity

risk assessments on pest interception

records, the known biology of the

organism being assessed (or the known

biology of related taxa) as represented in

the scientific literature, expert judgment

based on laboratory experience with the

pest or related organisms, expert

judgment based on field experience

with the pest or related organisms,

expert judgment based on experience

conducting commodity inspections at

ports of entry or in the exporting

country, and experience working with

export programs and export-quality

commodities. Thus, we believe that the

entire body of information available is,

in fact, sufficient to support the efficacy

of the measures required by this rule

and our analysis of the risks associated

with Argentine citrus.

Comment: The following items are

examples of the type of data or

information that appear to be missing

from the rulemaking record. No

information is provided as to what the

climatic conditions were in the tested

groves during the spraying program.

Similarly, no information is provided on

how the spraying program would be

affected by different climatic conditions

in different growing areas, such as the

northwestern versus the southern part of

Tucuman, and Tucuman as compared to

Salta, etc. Accordingly, it was

impossible to answer many critical

questions: Was it a year of light

incidence of the disease, and thus the

spraying was very effective? What

would happen in a year of heavy

incidence? What were the ages and

varieties of the trees in the program?

What was the protocol that was

followed? How would different climatic

conditions affect the spraying program?

Would the same results have been

achieved if the trees had been 10 years

older? Neither the risk assessment nor

the rulemaking record addresses or

answers any of these questions. APHIS

must require much more extensive tests

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37619

covering multiple variables before

further considering the Argentine

petition. Variables that should have

been included in tests before approving

the Argentine petition would include,

but are not limited to: Multiple and

differing climatic situations (i.e., drier

versus more humid areas; more humid

years versus drier years); differing ages

of trees, since citrus black spot is more

often seen in older trees and in ripe

fruit; differing sizes of groves; whether

the grove was virtually surrounded by

untreated groves; whether the trees had

been under any type of stress; etc.

Response: The bioecological factors

affecting citrus black spot development

that were considered in the design of

the field testing conducted in Argentina,

the protocols for the field tests, and the

results of those tests are among the

material provided to the commenter in

Note S.P. 338 of December 5, 1995, and

its three annexes (‘‘Bioecology of Black

Spot in Citrus,’’ ‘‘Field Assays for the

Control of Black Spot in Citrus,’’ and

‘‘Results of the Postharvest Assays

Carried Out up to the Present’’). These

documents demonstrate that Argentina

recognized, and took into account, that

factors such as climate, humidity, fruit

susceptibility, and the presence of

inoculum have an effect on the presence

of the disease. The Argentine field tests

were conducted during growing seasons

marked by both dry conditions with

light disease incidence in control trees

and prolonged rainy conditions with a

heavy incidence of disease in control

trees. This information, which was used

in the design of the systems approach,

was also considered by the experts who

prepared the risk assessment. As noted

elsewhere in this document, the systems

approach is designed to mitigate the risk

of citrus black spot during years in

which the disease is likely, which is

why this rule requires in part that the

timing of the fungicidal sprays be

determined by SENASA using an expert

system that takes climatic data, as well

as fruit susceptibility and the presence

of disease inoculum, into account. We

believe that the body of information

contained in the rulemaking record,

including the research and testing data

provided by Argentina, provides the

necessary scientific and rational basis

for our regulatory decisionmaking.

Comment: The evidence that APHIS

has made available to date is inadequate

to support the proposed rule. The

Secretary should appoint an

independent scientific team to travel to

the proposed Argentine production area

when climatic conditions are

appropriate, and that team should be

given access to the production and

packing facilities, as well as to the

transportation and port operations that

would be utilized for the export

program. The Secretary should direct

that team to report its findings to the

Department and Congress.

Response: APHIS, under the authority

of the Plant Quarantine Act and the

Federal Plant Pest Act, has reviewed the

Argentine petition and has made the

determination that phytosanitary

measures that comprise the systems

approach reduce the pest risk to a

negligible level. The systems approach

that is the subject of this rule was

developed in Argentina by that

country’s plant health officials and

citrus interests and was presented, along

with its supporting data, to APHIS for

review. APHIS rejected Argentina’s

initial proposal on the grounds that it

did not sufficiently mitigate the pest

risk presented by Argentine citrus. It

was only after Argentina included

additional phytosanitary measures in its

systems approach and provided what

we determined to be an adequate

amount of additional efficacy data that

APHIS accepted the Argentine proposal.

The Secretary is not required to appoint

an independent scientific team as

suggested by the commenter, nor do we

believe that one is needed in light of the

review already conducted by APHIS.

Comment: The 1997 risk assessment

states that the level of visible incidence

of citrus black spot can be extremely

high in Argentina—as high as 82

percent and can vary greatly year to

year. This level of disease incidence is

disturbingly high. Further, this data

does not address the phenomenon of

symptoms that remain latent. Based on

the current state of science, we submit

that no fruit from such highly diseased

areas should be allowed to enter the

United States.

Response: The section of the risk

assessment cited by the commenter

stated that in untreated export-area

orange groves, field surveys for citrus

black spot in 1994 and 1995 found 14

percent and 82 percent, respectively, of

sampled fruit were infected with the

citrus black spot fungus, and a similar

1996 survey found that 56 percent of the

sampled trees in an untreated lemon

grove bore fruit with citrus black spot

symptoms. The risk assessment further

states, however, that in the 1994 survey,

citrus black spot incidence was reduced

from 14 percent in control groves to 0

percent in treated orange groves; in the

1995 survey, citrus black spot incidence

was reduced from 82 percent to 11

percent; and in the 1996 lemon survey,

none of the trees sampled in treated

groves bore fruit with citrus black spot

symptoms. These tests show that the

incidence of citrus black spot can be

significantly reduced by orchard

treatments, which is just one aspect of

the systems approach, even when the

level of disease in the area is high. The

issue of asymptomatic, latently infected

fruit is addressed by the rule’s

requirement that a sample of fruit

collected according to a statistically

valid sampling protocol be held for 20

days under conditions that are ideal for

producing symptoms in infected fruit.

We believe that this rule provides an

array of effective measures to reduce to

a negligible level the risk of introducing

citrus black spot into the United States.

APHIS Involvement

Comment: The proposed rule does

not provide for APHIS personnel to

perform any of the required inspections

in Argentina. APHIS personnel should

inspect all groves according to a

detailed protocol, and the Argentines

should pay all costs associated with

such inspections.

Response: APHIS routinely relies

upon the national plant protection

organizations of exporting countries to

provide the supervision or certification

of phytosanitary measures that might be

required for specific agricultural

commodities, just as other countries rely

upon APHIS to provide such services.

We have had the opportunity to work

with SENASA on numerous

phytosanitary issues in the past and, as

a result, we have every confidence in

SENASA’s ability to administer and

supervise the citrus export program

established by this rule. SENASA, as the

national plant protection organization of

Argentina, has a well-established

infrastructure in place throughout the

country. Also, SENASA personnel were

involved at every step in the

development of the systems approach,

so they are as familiar as APHIS with its

requirements. Further, SENASA

personnel possess a level of familiarity

with Argentine groves, growers, and

citrus production that APHIS personnel

do not. Given these considerations, we

do not believe that any appreciable

advantage would be gained, from a plant

protection/risk reduction perspective,

by requiring Argentina to pay for APHIS

to establish a new operational presence

in that country. However, as discussed

earlier in this document in the

paragraph titled ‘‘Monitoring—

Argentina,’’ the operational work plan

that addresses the administration of the

export program will include provisions

for active and direct monitoring of the

program by APHIS personnel who will

conduct frequent oversight visits to the

growing areas and packinghouses in

order to observe each step of the

program in Argentina.

37620 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

Comment: APHIS does not have a

sufficient number of employees

stationed in Argentina to provide an

adequate level of monitoring for the

proposed export program.

Response: As noted in the response to

the previous comment, we have every

confidence in SENASA’s ability to

administer and supervise the citrus

export program established by this rule.

Accordingly, this rule does not require

direct APHIS supervision of the

activities of the citrus export program

carried out in Argentina, so APHIS

staffing in that country is not an issue.

While APHIS personnel will travel to

the production areas in order to monitor

the progress of the export program,

especially during the first season, this

rule provides for the direct supervision

of the measures required in Argentina to

be carried out by SENASA.

Origin Requirement

Comment: The proposed rule does

not provide for annual surveys on citrus

canker. Such surveys should be made,

records should be kept, and audits

should be required.

Response: Argentina has an ongoing

monitoring program, as well as

quarantine protection systems, for citrus

canker that have been in place since

1992. Because Argentina’s monitoring

program is conducted in accordance

with United Nations’ Food and

Agriculture Organization (FAO)

standards, which include reporting and

recordkeeping requirements, we do not

believe that it is necessary for this rule

to impose additional or redundant

requirements regarding citrus canker

surveys.

Comment: If APHIS allows the

importation of Argentine citrus, it

should impose movement restrictions

on Argentine citrus similar to those of

its domestic citrus canker regulations.

Response: Our domestic citrus canker

regulations apply to fruit grown or

packed in areas that are quarantined due

to the presence of citrus canker. Because

it has been established in accordance

with international standards that

northwestern Argentina is free of citrus

canker, such movement restrictions are

neither necessary nor justifiable.

Comment: According to the risk

assessment, the median chance of citrus

canker becoming established in the

United States with no pest mitigation

program is estimated as 1 chance in 4

trillion per year. The extremely low

value for this risk estimate can partially

be attributed to the fact that

northwestern Argentina is assumed to

be free of citrus canker. However, even

if it is assumed that 100 percent of the

boxes of fruit were initially infected

(instead of the average of 0.05 percent

assumed in the risk assessment), the

likelihood of citrus canker establishing

itself in the United States would be 1 in

2 billion per year, according to the

analysis performed by APHIS. If it is

really this improbable that citrus canker

will become established in the United

States, why does the risk assessment

even address citrus canker? Why does

the United States currently prohibit the

importation of citrus fruit from

countries where citrus canker occurs

and regulate the interstate movement of

citrus fruit from infested areas of the

United States? On the one hand, APHIS

states that no outbreak of citrus canker

has ever been traced to the importation

of fruit, and hence estimates a very low

probability that citrus canker will occur.

In contrast, the risk assessment’s pest

data sheet indicates that citrus canker

can potentially move long distances on

diseased fruit, that at least three

outbreaks of citrus canker have occurred

in the United States within the past 100

years, and that there is currently citrus

canker in Florida. This information

seems to indicate a risk greater than 1

in 2 billion per year, and suggests that

the quantitative estimate is incorrect.

Response: The fact that northwestern

Argentina has been demonstrated to be

free of citrus canker in accordance with

international standards was an

important factor in our assigning an

‘‘extremely low value for this risk

estimate.’’ Another important factor in

that risk estimate is the evidence that

the long-distance spread of citrus canker

has occurred primarily through the

movement of infected planting and

propagating materials. The commenter

reports that the pest data sheet indicates

that the pathogen could potentially

move long distances on diseased fruit,

but omits the second half of the

sentence in which that statement

appears, wherein we report that there is

no authenticated example of a disease

outbreak that initiated from diseased

fruit. Given the preponderance of

evidence and expert opinion that longdistance spread occurs primarily

through the movement of infected

planting and propagating materials, and

given the absence of documented cases

of citrus canker outbreaks attributable to

the movement of infected fruit, we

believe that the probability calculated

by the commenter is actually not

unreasonable and our assessment of the

risk posed by citrus fruit from the citruscanker-free States of northwestern

Argentina is appropriate. The larger

question of whether citrus canker may

be spread long distances on diseased

fruit has not been answered to the

satisfaction of some in the citrus

production and research communities,

which accounts for our continuing

restrictions on the importation and

interstate movement of citrus fruit from

areas where the disease occurs.

Comment: If the fruit from

northwestern Argentina passes through

that country’s eastern regions, which are

not free from citrus canker, it is possible

that the fruit could be contaminated by

airborne citrus canker bacteria during

transport.

Response: As stated in the pest data

sheet for citrus canker provided in the

risk assessment, short-distance dispersal

of the pathogen in groves occurs

primarily by wind-driven rain (rain and

wind in excess of 6—8 m/sec) that

causes the water soaking in leaves

necessary for infection and causes

entrance wounds when shoots are

injured by wind whipping. The pest

data sheet also notes that overhead

irrigation may also play a role in short

distance spread, as may mechanical

equipment used in grove maintenance

(Ferguson, et al., 1985; Swings &

Civerolo, 1993). Given that citrus fruit

traveling from the packinghouses in the

production areas will be boxed, with

those boxes being protected from the

elements to prevent damage, we do not

believe that there is any appreciable risk

of the fruit being contaminated by

airborne citrus canker bacteria during

transport.

Comment: In a 1994 report that is part

of the rulemaking record, APHIS

personnel who visited Argentina stated

that they had concerns regarding an

apparent lack of inspection at the local

airports with regard to citrus canker.

Has this issue been satisfactorily

addressed?

Response: This issue was addressed

following APHIS’ 1994 trip. Argentina

has established quarantine control

stations at all main entrances to the

citrus-canker-free States, including

quarantine checkpoints at local airports.

Comment: Although it is claimed that

the four States of northwestern

Argentina listed in the proposed rule are

free from citrus canker, it may be that

citrus canker does actually exist in those

States but is inhibited by warm

temperatures and dry climate.

Response: Argentina’s monitoring

system for citrus canker consists of

inspections and systematic sampling

carried out annually in all production

areas as well as in urban areas and

nurseries. The collected samples are

analyzed at university and research

center laboratories using a highsensitivity immunofluorescence

serologic technique. Since this

monitoring system was implemented in

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37621

1992, no evidence of citrus canker has

been found. We are, therefore, confident

that citrus canker is not present in the

four northwestern Argentine States.

Grove Requirements

Comment: The 150-meter buffer zone

appears to be inadequate for mitigating

the spread of citrus black spot spores

dispersed long distances by the wind.

Response: The buffer zone is designed

to reduce to an insignificant level the

possibility that ascospores from an

infected grove would reach a grove

producing fruit for the U.S. market. The

ascospores are the only wind-dispersed

propagule of black spot and are

produced in leaves on the ground,

usually under the tree canopy.

Environmental conditions must be

correct for ascospores to be dispersed

(i.e., rain to promote the release of the

ascospores followed by sufficient wind

to move the ascospores from under the

overhanging canopy of the tree). The

combination of the prevention of longdistance movement by the canopy itself

and the presence of a 150-meter buffer

that, like the export area of the grove,

must be cleaned of all fallen leaves and

other debris before blossom, will

significantly reduce the unlikely

possibility that ascospores from outside

the area of production will reach the

production area. Additionally, because

environmental conditions are monitored

and control methods are utilized during

periods when the developing fruit is

susceptible to infection, the likelihood

of successful infection is negligible.

Comment: The risk assessment claims

all new citrus stock in the canker-free

area must originate within the zone

(which we assume to mean the cankerfree area) or be tissue culture that has

passed through quarantine, whereas the

proposed rule only requires new citrus

stock planted within the export groves

to meet those requirements. Does the

risk assessment therefore overestimate

the protection offered by this measure?

Response: The citrus stock origin

requirements referred to by the

commenter as being in the risk

assessment are existing requirements

established and enforced by SENASA as

part of that agency’s program to

maintain the citrus-canker-free status of

the northwestern Argentine States.

SENASA’s citrus stock origin

requirements apply to all groves in the

citrus-canker-free area of Argentina;

therefore, the risk assessment’s

characterization of those requirements is

correct and does not overestimate the

protection offered by those

requirements. Because the requirements

of this rule pertain only to groves that

produce fruit for export to the United

States, the rule does not extend those

requirements to other groves producing

fruit for other export markets or for

domestic consumption within

Argentina.

Comment: The proposed rule

provides that any new citrus planting

stock used in a certified grove must

originate from one of the four States or

from a SENASA-approved propagation

center (§ 319.56–2f(b)(3)). It is not clear

whether this requirement goes only to

citrus canker, or whether it also applies

to citrus black spot and sweet orange

scab. If it does not apply to citrus black

spot and sweet orange scab, what

precautions will be taken to insure that

planting stock does not carry these

diseases from within the approved

areas? Evidence must be included in the

record that such precautions will be

effective.

Response: As explained in the

response to the previous comment, the

citrus stock origin requirements are part

of SENASA’s program to maintain the

citrus-canker-free status of northwestern

Argentina. Thus, those requirements

apply only to citrus canker, and not to

citrus black spot or sweet orange scab.

Because this rule is not based on the

four northwestern Argentine States

being a free area for citrus black spot or

sweet orange scab, it was not necessary

to include provisions for the freedom of

planting stock from those two diseases.

Comment: The preamble to the

proposed rule states that domesticorigin citrus plants must meet ‘‘strict

phytosanitary requirements’’ before they

may enter the four States that will be

allowed to export. Is this reference to

the SENASA requirements for a

propagation center?

Response: Yes. The requirements

referred to in the preamble of the

proposed rule pertain to the testing and

grow-out regimen conducted at

SENASA-approved citrus stock

propagation centers for citrus stock that

has been imported into Argentina and

for any domestic-origin citrus plants

from outside the four citrus-canker-free

States. As stated in the proposed rule,

citrus plants from sources outside the

citrus-canker-free area ‘‘must meet strict

phytosanitary requirements before they

may enter the States of Catamarca,

Jujuy, Salta, or Tucuman. Under

SENASA supervision, such citrus plants

are officially tested to ensure their

freedom from quarantine pests and

diseases, and are grown in quarantine

before being released for use in the

citrus canker-free area of Argentina.’’

Comment: The preamble implies that

nursery stock will be ‘‘tested.’’ However,

citrus black spot is a latent disease. Can

it be successfully detected years in

advance of when it appears? If tests

cannot be carried out, what precautions

will be taken to ensure that stock that

may be from groves infected with sweet

orange scab or citrus black spot is not

planted in noninfested groves? Answers

to these questions do not appear in the

rulemaking record. Without such

answers, APHIS should not proceed

with the proposed rule.

Response: As noted previously,

SENASA’s requirements, and the

requirements of this rule, pertaining to

planting stock are intended to prevent

the introduction of citrus canker into

the citrus-canker-free area of

northwestern Argentina; because the

four Argentine States are not a free area

for citrus black spot or sweet orange

scab, those measures are not intended to

provide protection against citrus black

spot or sweet orange scab introduction

via nursery stock. The risks presented

by those two diseases are instead

mitigated by the pre-and post-harvest

treatment and inspection requirements

of this rule.

Comment: The risk assessment speaks

only of the removal of fallen fruit and

leaves in the grove, but implies

immediate and continuous removal. The

proposed rule considers fallen fruit,

leaves, and branches in both grove and

buffer zone, but specifies removal only

before blossoming in the grove (but not

necessarily before blossoming in the

buffer zone, or in any regions outside

the buffer zone). If the buffer zone

contains fruit blossoming earlier than

the grove, the fruit is more likely to

become infected if there is contaminated

material remaining on the ground, but

such infection is less likely to be

observed/reported.

Response: The buffer zone

immediately surrounds the grove—

indeed, it would be part of the grove if

the owner was not producing fruit for

export to the United States—so it is not

likely that the trees in the buffer area

will be blossoming any earlier or later

than the trees in the export portion of

the grove.

Comment: The proposed requirement

for the removal of all fallen fruit, leaves,

and branches from the orchard floor and

the buffer area is not a biological, welljustified safeguard. Research on

attempts to decrease incidence in other,

similarly dispersed diseases through

cleaning of groves indicated that, while

leaf and fruit removal could remove

about 90 percent of the inoculum, the 10

percent of inoculum still present was

more than sufficient to maintain the

presence of the disease. It is very likely

that ascospore inoculum will remain in

the ground and any out-of-season or

37622 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

late-hanging fruit will supply additional

inoculum.

Response: The removal of fruit,

leaves, and branches from the orchard

floor and buffer area is a biologically

justified safeguard. Because the

ascospores of citrus black spot are

produced only in fallen leaves, the

removal of this debris will significantly

reduce the inoculum level. This is a part

of a control strategy that is used by plant

pathologists for diseases for which

inoculum is produced in fallen debris.

Because this is only one part of a

systems approach, it is designed to

reduce the likelihood of infection, not

prevent it entirely. Therefore, we have

taken into account in the risk analysis

the possibility that debris may remain

on the ground or in late season fruit.

Comment: The proposed rule requires

that export groves be cleaned of debris,

leaves, and fallen fruit before bloom to

remove the main sources of disease

inoculum. Argentine researchers

monitored leaf fall during a whole

season and found that for all three citrus

species in Salta, the majority of leaves

fell between August and November,

while fruit set occurred from September

to October. Thus, the maximum leaf fall

is occurring during bloom and fruit set.

Furthermore, the summer rains, which

are needed for development of citrus

black spot on the dead leaves, tend to

start in October. If decreasing inoculum

through removal of fallen leaves is the

goal to protect the developing fruit, then

there must be continuous cleaning of

the grove throughout the maximum leaf

fall period, otherwise fruit will be

developing in the presence of leaf litter

as a potential source of inoculum.

Response: A thorough cleaning of the

grove and buffer area prior to blossom

will remove a significant amount of

potential inoculum. Any ascospores on

leaves that fall after the cleaning of the

grove will not form ascocarps until 40

to 180 days after blossom, depending on

the frequency of wetting; by that time,

the preventive oil-copper oxychloride

sprays will be in use to protect the

developing fruit from infection. If the

removal of fallen fruit, leaves, and

branches was the only measure

employed to reduce the risk of citrus

black spot infection during the growing

season, additional cleaning would likely

be advisable, but given the additional

requirements of this rule, we do not

believe that is necessary.

Comment: The proposed requirement

for the removal of all fallen fruit, leaves,

and branches from the orchard floor and

the buffer area would be difficult, if not

impossible, to satisfy. We suggest that

the word ‘‘substantially’’ be inserted

before the word ‘‘all’’ to make this

requirement more realistic.

Response: Although the grove/buffer

sanitation requirement may be difficult

to meet, SENASA and the growers in

northwestern Argentina have indicated

their willingness to comply with that

requirement. Further, it would likely

prove difficult to establish a standard

for what is meant by ‘‘substantially all.’’

Comment: The proposed grovecleaning would be a difficult, if not

impossible, task to complete. The

proposed rule does not explain what

criteria will be used to verify the

orchard floor cleaning and how it can be

verified at a later date.

Response: The proposed rule and this

final rule state that SENASA must

inspect the grove and buffer area before

blossom to verify that all fallen fruit,

leaves, and branches have been removed

from the ground. In the phytosanitary

certificate required by paragraph (d) of

the regulations, SENASA must confirm

that the fruit was produced in

accordance with the requirements of the

regulations; the grove and buffer area

sanitation measures are one of those

requirements. SENASA will keep

records regarding its inspection of each

export grove and buffer area, and APHIS

may request to review those records.

Further, as noted previously in this final

rule, the operational work plan

governing the administration of the

export program will provide for the

active and direct monitoring of the

export program by APHIS personnel;

that monitoring will include verification

of the required grove sanitation

measures.

Comment: The risk assessment states

that groves are inspected for disease

symptoms prior to fungicide

applications, and fruit with possible

disease symptoms is sent to a laboratory

for analysis. The timing of fungicide

applications is determined by ‘‘an

expert system.’’ In section 8.f. P1 of the

risk assessment, it indicates that the

export groves would have a ‘‘minimum

of two or three additional applications’’

of fungicide, as opposed to the total of

at least two specified in section 8.a. of

the risk assessment and in the proposed

rule. The proposed rule states that

SENASA will determine timing of

fungicide applications ‘‘during the

growing season,’’ based on monitoring

of climatic data, fruit susceptibility, and

the presence of disease inoculum, and

will monitor for correct fungicide

application. There is no requirement in

the proposed rule for inspection of the

groves for pests at times of fungicide

application, nor for laboratory analysis

of suspect fruit at this time (if there is

any fruit at the times of spray

application). There is no discussion of

what is meant by ‘‘presence of disease

inoculum.’’ There is no requirement that

the fungicide treatment include any

fruit, leaves, or branches on the ground

that have not been removed. It is not

required by the proposed rule that

SENASA use an expert system to

determine fungicide application times.

Response: After the risk assessment

was prepared, and before the provisions

that formed the basis of the proposed

rule were fully developed, SENASA

suggested that the inspections be

conducted after the fungicide

treatments, when there is a better

chance of detecting the disease; this

accounts for the difference between the

risk assessment (which speaks to

inspection before fungicide treatment)

and the proposed rule on this subject.

The oil-copper-oxychloride treatments

will be applied during the period of

greatest susceptibility of the fruit to

infection (i.e., from the time that three

quarters of the petals have fallen to the

time the fruit have reach 3 cm in

diameter). Given that disease symptoms

are unlikely to be manifested at that

stage of fruit development, the proposed

rule did not, and this final rule does not,

call for inspections prior to the

application of those treatments or the

laboratory inspection of suspect fruit at

that time.

With regard to the number of oilcopper-oxychloride applications,

section 8.f P1 of the risk assessment did,

as noted by the commenter, state that

groves would receive ‘‘a minimum of

two or three additional applications of

fungicide,’’ while elsewhere in the risk

assessment and in the proposed rule the

number of applications was

characterized as ‘‘two or more’’ and ‘‘at

least twice.’’ However, the way in which

the number of applications was

characterized did not have any effect on

our estimation of the mitigation value of

the fungicidal sprays. Our estimates

were not based on any finite,

predetermined number of sprays; rather,

the risk assessment assumed that the

timing and number of sprays would be

determined using SENASA’s expert

system, with the optimal number of

sprays being applied to prevent

infection.

With regard to the term ‘‘expert

system,’’ which was used in the risk

assessment, we chose to describe the

components of the system in the

proposed rule (i.e., monitoring of

climatic data, fruit susceptibility, and

the presence of disease inoculum) rather

than simply use the term itself. The risk

assessment and the proposed rule are,

therefore, referring to the same thing.

We have included the term ‘‘expert

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37623

system’’ in § 319.56–2f(b)(5) of this final

rule to make that clear.

With regard to what is meant by

‘‘presence of disease inoculum,’’

SENASA’s monitoring of the presence of

disease inoculum considers both the

presence of fallen leaves within the

grove, as leaves have been identified as

the primary source of inoculum, as well

as the incidence of disease in the area

surrounding each grove.

We did not include provisions for the

spraying of fruit, leaves, or branches

that may be on the ground because the

oil-copper-oxychloride treatment is

intended to prevent infection in the

developing fruit itself and because the

required grove sanitation measures are

intended to leave the ground in the

grove free of such debris.

Comment: Eureka-type lemons, which

are commonly planted in Argentina, do

not have a very distinct start and finish

of flowering, depending on climatic

conditions. Under mild winter

conditions, flowering can occur year

round; indeed, some reports indicate

that lemons are harvested year round in

Tucuman province. In one report,

Argentine researchers observed both

immature and mature lemons on the

sampled trees at the same time in Salta

and noted that the presence of different

aged fruit provides for an additional risk

of fruit infection. How can a grove be

certified as having been cleaned prior to

bloom when bloom is not specifically

seasonal?

Response: While there may be

multiple blooms in a year under mild

winter conditions, Argentina reports

that there is, as occurs in the United

States, a main spring flush during which

most of the trees will bloom, and it is

the fruit from those trees that will be

exported to the United States. Therefore,

the blossoming period in the Argentine

production areas is distinct enough to

allow for the cleaning and inspection of

the groves and buffer areas prior to

blossom.

Comment: The timing of flowering in

not necessarily distinct in some

common lemon varieties, and it is not

clear how the timing of the oil-copperoxychloride treatments will be

determined when flowering and fruit set

occur over several months. The efficacy

studies of the fungicide treatments need

to provide for careful testing of timing

of the treatments to deal with the

different bloom lengths, fruit set,

rainfall patterns, and disease incidence

in the different citrus species and the

different regions.

Response: The timing of each

treatment application will be

determined by SENASA using an expert

system that considers climatic data

(including temperature and rainfall

patterns), fruit susceptibility (which is

dictated in part by the timing and length

of bloom, when fruit set occurred, and

the relative disease susceptibility of

each species), and the presence of

disease inoculum (which takes into

account both the presence of fallen

leaves within the grove, as leaves have

been identified as the primary source of

inoculum, and the incidence of disease

in the area surrounding each grove). The

goal of the expert system is to maximize

the effectiveness of the oil-copperoxychloride treatments in preventing

the fruit from becoming infected.

Whether or not that goal has been met

will become apparent during the

laboratory incubation and examination

of the 20-day preharvest sample, as well

as through the grove and packinghouse

inspections.

Comment: The proposed rule fails to

require that certified groves keep

detailed records of the various blooms

and required program steps (e.g., when

the spraying and debris-clearing

programs are carried out). Any program

which APHIS develops should be

subject to further public comment.

Response: There is no need for APHIS

to develop a recordkeeping program as

suggested by the commenter. As stated

in the proposed rule and in this final

rule, SENASA is responsible for

inspecting the registered groves prior to

blossom to ensure that the required

sanitation measures have been

accomplished, as well as for

determining the timing of the oilcopper-oxychloride treatments and

monitoring their application. SENASA

will maintain records of these activities

as part of its citrus fruit export program,

and will make those records available to

APHIS during program reviews or when

otherwise necessary.

Comment: From the APHIS–SENASA

correspondence, it is clear that APHIS

had wanted an inspection of the orchard

prior to the fungicide treatments.

However, SENASA requested that the

inspection for disease occur after the

treatments. APHIS must explain its

reasoning for why the inspection of a

grove for disease before fungicide

applications was not included in the

proposed rule.

Response: Until the fruit has matured

somewhat and has begun to color, the

symptoms of citrus black spot will not

be apparent. Since the fruit would be

too small and would not have colored

yet prior to the fungicide applications,

we concurred with SENASA’s

suggestion that the inspections be

conducted after the treatments, when

there is a better chance of detecting the

disease.

Comment: No specific rate for the

copper oxychloride sprays is provided

in the proposed rule. It appears that the

Argentine researchers found that a rate

of 0.36 percent was more effective in

preventing the disease, but SENASA has

stated that a rate of 0.18 percent would

be used for the export program, which

may be ineffective at least some of the

time or on some fruit, according to the

information in the record. APHIS

should determine why the lower copper

oxychloride rate was chosen by

SENASA, even though the data showed

the higher rate to be more effective.

Response: The lower oil-copperoxychloride application rate was

recommended by SENASA based on its

studies that showed that the 0.36 and

0.18 percent application rates were both

effective in preventing disease in test

plots when the disease was evident in

the control plots. Given that the 0.18

percent application rate was shown to

be effective in preventing disease, and

given that this rule requires at least two

applications of the fungicide during the

growing season, we have accepted

SENASA’s recommendation that the

0.18 percent application rate be used.

Comment: It appears that Argentine

researchers performed only one test to

assess the effectiveness of the in-season

fungicide treatments for sweet orange

scab and that only one test was

conducted using both in-season

fungicide treatments and post-harvest

chemical treatments. This limited

testing is not sufficient to determine the

effectiveness of the proposed measures.

APHIS should provide or cite efficacy

data for the proposed copper

oxychloride sprays on the incidence of

sweet orange scab.

Response: The American

Phytopathological Society’s Citrus

Compendium (Whiteside et al., 1988),

which was cited in the body of the risk

assessment (p. 57) and in the pest data

sheet for sweet orange scab (p. 101),

indicates that copper sprays are

effective protectants to prevent the

infection of susceptible fruit by sweet

orange scab.

Comment: While the risk that sweet

orange scab might be introduced into

the United States may be reduced by

timely, reliable, and negative surveys,

there are still some unresolved

taxonomic issues surrounding the

Elsinoe species complex. The less than

distinct differentiation between possible

strains/biotypes strongly suggests that

additional systematic research is needed

to fully understand this pest complex.

Response: While there may be room

for additional systematic research in

order to fully differentiate between

possible strains/biotypes of Elsinoe spp.,

37624 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

we do not believe that any of those

taxonomic issues need to be resolved in

order for the survey, inspection, and

treatment provisions of this rule to be

effective in reducing the risk of sweet

orange scab being introduced into the

United States.

Comment: A more detailed

description of how an orchard will be

inspected or sampled (location in grove,

timing, etc.) for sweet orange scab is

necessary.

Response: The freedom of the fruit

from sweet orange scab will be verified

through the inspections required by this

rule, i.e., the visual inspection of the

grove and buffer area required by

§ 319.56–2f(b)(6) and the packinghouse

inspections required by § 319.56–

2f(c)(4) and (c)(5). Given that the

symptoms of sweet orange scab are

readily detectable on infected fruit, and

given that the detection of the disease in

a single fruit will result in a grove’s

losing its ability to export fruit to the

United States for the remainder of the

current growing and shipping season,

we believe that the 20-day preharvest

survey and the subsequent

packinghouse inspections will

effectively mitigate the risk of fruit

infected with sweet orange scab being

imported into the United States.

Comment: Copper-based fungicides

are preventative, i.e., they only prevent

new infections and do not stop already

established infections. Thus, timing is

extremely critical to ensure that

developing fruit is continuously

protected from infections. Other

fungicides, such as preharvest

applications of Benomyl (benlate), not

only prevent, but also stop infections

that are already present, and newer

chemistry fungicides (triazoles,

strobilurins, etc.) may provide better

control of already infected fruit and

allow rotation of fungicides.

Response: Copper oxychloride is a

well-established preventative treatment

for citrus black spot and sweet orange

scab, and its efficacy has been

demonstrated in a variety of studies on

the control of these diseases (for

example, as referenced in Whiteside et

al., 1988, as cited in the risk

assessment). We would, however,

certainly consider allowing the use of

other fungicides if the Argentine

growers or SENASA were to request that

we do so and were to provide

information supporting the efficacy of

the alternative treatments.

Comment: Since the packinghouse

treatments have little or no impact on

citrus black spot infections, any citrus

black spot present in the fruit must have

been prevented or detected by the time

of harvest. The keys to the proposed

program for Argentina are successful

prevention and successful detection of

any infection. The proposed

preventative fungicide treatments are

not 100 percent effective, so the

successful detection of treatment

failures is critical, but the latency of

citrus black spot makes that detection

very difficult. Given that difficulty, it

appears there is a near certainty that

latently infected fruit will be imported

into the United States.

Response: As explained in detail later

in this document, we have modified the

protocol for sampling the grove and

buffer area in response to comments on

the subject. This final rule requires the

sampling of 4 fruit from each of 298

randomly selected trees in each 800

hectares of grove and buffer area, which

yields at least a 95 percent confidence

level of detecting an infection rate of 1

percent or greater. In addition, the

modified sampling protocol requires

that the fruit be chosen from the portion

of the tree most likely to have infected

fruit. Given those requirements, there is

almost no chance that infection could

exist in a grove without infected fruit

being included in the sample subjected

to laboratory examination. Further,

during the required 20-day sample

holding period, the fruit will be held

under conditions that are ideal for the

expression of symptoms in any infected

fruit (i.e., 27 °C, 80 percent relative

humidity, and permanent light). Finally,

this rule requires that the detection of

symptoms in a single fruit will result in

a grove being removed from the export

program and all fruit from that grove

being prohibited from entering the

United States. Given those

considerations, we believe that the risk

of latently infected fruit being imported

into the United States is negligible.

Comment: The risk assessment claims

the buffer zone receives the same

‘‘treatment, inspections, sanitation, etc.’’

as the grove, but the proposed rule only

calls for full inspections of fruit from

the grove, not from the buffer zone.

Thus if citrus black spot or sweet orange

scab is detected on fruit from the buffer

zone at or after harvest, there is strictly

no requirement to remove that grove

from the program. Indeed, there are no

requirements in the proposed rule for

any inspection or reporting on diseases

in the buffer zone after the 20 days

preharvest inspection.

Response: This final rule, as did the

proposed rule, calls for the removal of

fallen fruit, leaves, and branches from

both the grove and the buffer area,

inspection of both the grove and the

buffer area to ensure the cleaning

requirements have been met, spraying of

oil-copper oxychloride in both the grove

and the buffer area, and a visual

inspection of both the grove and the

buffer area 20 days before harvest.

While the proposed regulations did not

specifically state where the sample of

fruit for laboratory examination was to

be collected, the samples must be taken

from both the grove and the buffer area.

(This is made clear in § 319.56–

2f(b)(6)(ii) in the regulatory text of this

final rule.) This is consistent with the

risk assessment’s statement that the

buffer zone will receive the same

‘‘treatment, inspections, sanitation, etc.’’

as the grove. After harvest, the

packinghouse treatments and

inspections are limited to the fruit from

the grove itself because, as stated in

§ 319.56–2f(b)(2), no fruit from the

buffer zone may be offered for

importation to the United States.

Comment: There is no definition of

‘‘laboratory,’’ or any requirement for

certification of such laboratories, nor is

there any requirement that the

laboratory examination be certified or

carried out by SENASA.

Response: The laboratory testing

required by § 319.56–2f(b)(6)(ii), as is

the case with the other surveys and

inspections that must be conducted in

Argentina under this rule, must be

conducted under the direct supervision

of SENASA, and records relating to

testing and test results will be available

for review by APHIS.

Post-harvest Requirements

Comment: The risk assessment (8.a.)

claims that packinghouses will be used

for export to the United States only. The

preamble of the proposed rule states

that packinghouses cannot accept fruit

from ‘‘nonregistered export groves

during the time that fruit intended for

export to the United States is being

handled in the packinghouse.’’ The

proposed rule requires that ‘‘[d]uring

the time that a packinghouse is used to

prepare grapefruit, lemons, or oranges

for export to the United States, the

packinghouse may accept fruit only

from groves that meet the requirements

of paragraph (b) of this section.’’ The

risk assessment (8.a.) requirement is

stricter than the proposed rule, and the

preamble of the proposed rule indicates

that packinghouses could accept

nonregistered, nonexport fruit. The

proposed rule allows for some

possibility of admixture, since no timescale is specified; one could alternately

process nonexport and export fruit in

separate batches.

Response: While the risk assessment’s

narrative description of the systems

approach and the proposed rule’s

description of packinghouse

requirements differed in their approach,

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37625

we do not believe that the two

documents contradict one another. The

statement in the risk assessment that

packinghouses in the program will only

be used for export to the United States

reflected the risk assessors’

understanding that there would be no

commingling of fruit from registered

and nonregistered groves in the

packinghouses. This is entirely

consistent with our statement in the

preamble of the proposed rule that

‘‘[b]arring the entry of fruit from

nonregistered groves into the

packinghouse would ensure that the

fruit intended for export is not

commingled with or potentially infected

by fruit that was grown in a grove that

has not been subject to the same

sanitation, inspection, and treatment

measures that would be required for

export groves.’’ This statement from the

proposed rule’s preamble also makes it

clear that we were not indicating, as the

commenter asserts, that packinghouses

would be able to accept fruit from

nonregistered groves during the time

that fruit was being prepared for export

to the United States.

To address the commenter’s concerns

that ‘‘no time-scale is specified’’ with

regard to when batches of export fruit

and nonexport fruit could be processed,

we have modified the wording in

§ 319.56–2f(c)(2) to reflect our intent

that there be no commingling of fruit

from registered and nonregistered

groves in the packinghouse. That

paragraph now states: ‘‘During the time

that any grapefruit, lemons, or oranges

from groves meeting the requirements of

paragraph (b) of this section are in the

packinghouse, no fruit from groves that

do not meet the requirements of

paragraph (b) of this section may enter

the packinghouse.’’ To support this

requirement, and to prevent the

‘‘possibility of admixture’’ raised by the

commenter, a SENASA-registered

technician will be present at each

packinghouse to verify the origin of all

fruit entering the packinghouse. In its

correspondence with APHIS during the

development of the proposed rule,

SENASA had stated that a registered

technician would be present at each

packinghouse for that purpose, but this

consideration was not explicitly set

forth in the text of the proposed rule.

We also are amending § 319.56–2f(c)(2)

to make it clear that a packinghouse

technician registered with SENASA

must verify the origin of all fruit

entering the packinghouse.

Comment: What steps will be taken to

ensure there is no commingling of fruit

from certified and uncertified groves at

the packinghouse? For example, records

would have to be kept of the arrival of

each load. These records would have to

be available for auditing.

Response: As noted in the response to

the previous comment, a technician

responsible for the packinghouse, who

will be approved by and registered with

SENASA, will be on hand to verify the

origin of all lots of fruit entering the

packinghouse. These technicians are

required by SENASA to maintain

accurate records, and SENASA will

make those records available to APHIS

upon request.

Comment: The proposed rule and risk

assessment do not mention the need for

measures to prevent the contamination

of export groves, packinghouses, or

storage facilities by workers or

equipment that have been in untreated

groves or that have been in contact with

untreated fruit. Such measures are

necessary to prevent the artificial spread

of disease inoculum. APHIS should

consider establishing sanitation

measures for workers and equipment

moving between nonregistered groves

and those producing fruit destined for

export to the United States. The

requirements would have to be set forth

in detail in the regulation, and strict

audit and inspection procedures would

have to be implemented to ensure that

disease is not transmitted to export

groves. If such requirements are not

established, APHIS should discuss why

such measures are not needed, given the

characteristics of the two diseases of

concern. Similarly, APHIS should

establish sanitation measures for

packinghouses and storage facilities to

use between runs of U.S.-bound citrus

and fruit bound for other markets.

Response: The spores produced in

fruit infected with sweet orange scab

and citrus black spot are nonpigmented

and are thus short-lived when removed

from their host tissue. It is, therefore,

unlikely that any ‘‘free’’ spores that

might be found on workers or

equipment moving from an untreated

grove into an export grove,

packinghouse, or storage facility would

remain viable long enough to cause

infection. Similarly, because of the

short-lived nature of ‘‘free’’ spores, there

is little risk that export fruit would

become contaminated during processing

at a packinghouse that had previously

handled fruit from nonregistered groves.

In any event, that export fruit will be

mature fruit, and thus not susceptible to

infection. Furthermore, that fruit will be

surface-sterilized and waxed in the final

processing steps before being packed in

boxes, thereby rendering nonviable any

spores contaminating the surface of the

fruit. That surface-sterilization and

waxing is a routine measure applied to

all fruit in Argentine packinghouses,

including nonexport fruit, so it is

unlikely that export fruit would be

contaminated after packing even if it

was stored with nonexport fruit.

Comment: The proposed rule does not

specify what happens to other fruit in

the packinghouse if infected fruit from

some other grove that simultaneously or

recently went through the same

packinghouse is detected.

Response: We believe that it is

unlikely that infected fruit would

proceed undetected as far as the

packinghouse, given this rule’s

requirements for the removal of

potential sources of inoculum from the

groves, the treatment of developing

fruit, and the sampling and testing of

mature fruit prior to harvest. However,

if infected fruit was identified in the

packinghouse or at a later time, we

believe that the non-susceptibility of the

mature fruit that will be handled in the

packinghouses, when combined with

the short-lived nature of ‘‘free’’ spores

and the required surface-sterilization

and waxing, make it unlikely that fruit

will be contaminated as a result of

contaminated fruit having recently

passed though the same packinghouse.

This rule’s requirement that the identity

of the origin of the fruit be maintained

during its time in the packinghouse will

prevent fruit from two different groves

being processed simultaneously.

Comment: The risk assessment claims

that at the prepacking inspection stage,

any blemished fruit are culled. There is

no requirement in the proposed rule for

culling of blemished fruit, although that

presumably would be a commercial

necessity; the proposed rule only

requires SENASA to examine fruit for

any evidence of disease.

Response: The commenter is correct

in presuming that the culling of

blemished fruit is a commercial

consideration. As such, our proposed

rule did not include a requirement for

the culling of blemished fruit, per se,

but instead focused on SENASA

inspecting the fruit prior to packing to

verify its freedom from citrus black spot

and sweet orange scab. However, as

explained in the response to the next

comment, we have included the culling

of blemished fruit in the provisions of

this rule set forth in § 319.56–2f(c)(4)

relating to the 4-day packinghouse

holding period.

Comment: The proposed rule called

for the holding of all harvested fruit for

4 days at room temperature before

sorting and packing, but there is no

evidence in the record that this is an

adequate time for latent citrus black

spot symptoms to develop. The

Argentine researchers stated that they

held sampled fruit for 20 days at 27 °C,

37626 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

80 percent relative humidity, and in

permanent light in order for latent citrus

black spot infections to develop enough

for detection. In addition, the risk

assessment assumes that the fruit

sampled from the orchard shortly before

harvest will be held for 20 days at room

temperature, which would allow latent

citrus black spot infections to show up

in the samples. However, the proposed

regulations do not explicitly state a 20-

day holding period at room temperature,

nor do they define what constitutes

‘‘room temperature.’’ APHIS should

conduct studies to determine the

optimum time, temperature, and other

environmental conditions for detection

of the latent citrus black spot infections;

if APHIS cannot provide data that

demonstrates the effectiveness of the 4-

day holding period, a longer holding

period should be required. Further,

steps must be taken to ensure that all

packinghouses are able to hold the

harvested fruit at the required

temperatures for citrus black spot

development in order to assess the

practicability of this measure. Finally,

the requirements for Argentine citrus

should explicitly state that fruit

sampled from the grove 20 days before

harvest must be held under conditions

conducive to citrus black spot

development.

Response: We acknowledge that the

proposed rule did not fully explain the

procedure to be used during the 20-day

laboratory examination period of the

sampled fruit. We further acknowledge

that the proposed rule incorrectly stated

that the purpose of the 4-day holding

period was to allow for symptom

expression of citrus black spot in the

event that latent infection exists in the

fruit. We have corrected both of these

issues in the text of the final rule.

As noted by the commenter, the

laboratory procedure to be used to

promote the expression of symptoms in

the fruit sampled 20 days prior to

harvest will be to hold the fruit for 20

days at 27 °C, 80 percent relative

humidity, and in permanent light. These

conditions have been shown to be ideal

for latent citrus black spot infections to

develop enough for detection. Although

this protocol was omitted from the

proposed rule, the protocol was, as

evidenced by the commenter’s remarks,

explained fully in documents made

available following the publication of

the proposed rule.

If none of the sampled fruit manifest

symptoms of citrus black spot during

the 20-day laboratory examination

period, the remaining fruit in the grove

will be harvested and taken to the

packinghouse, where it will be held at

room temperature—i.e., not

refrigerated—for 4-days. This 4-day

holding period is a standard practice in

the Argentine citrus industry that

provides sufficient time for bruises or

other damage on the fruit to become

plainly evident, thus providing an

opportunity for that blemished fruit to

be culled. For the purposes of this rule,

that 4-day holding period will also

provide an opportunity for SENASA

inspectors to examine the harvested

fruit for signs of infection.

We have, therefore, amended the

requirements set forth in the rule

portion of this document in order to

fully explain these requirements. The

requirements pertaining to the

laboratory examination are set forth in

§ 319.56–2f(b)(6)(ii), and the provisions

relating to the 4-day holding period and

the culling of damaged fruit in the

packinghouse are set forth in § 319.56–

2f(c)(3) and (c)(4).

Comment: Section 8.a of the risk

assessment claims 4–5 days holding

time (for all fruit) to allow expression of

citrus black spot. Section 8.f P3 of the

risk assessment claims a ‘‘20-day

preharvest sample and incubation

period’’ that may have been derived

from the 20-day preharvest inspection,

or may be a confusion between

inspection and this packinghouse

holding time. Section 8.f P3 of the risk

assessment also confuses matters since

it refers to a ‘‘sample’’ holding time, but

then refers to the likelihood of

packinghouse detection, but the fruit in

the packinghouse would not have had

the 20-day holding time. The preamble

and proposed rule require just 4 days

holding time at room temperature,

followed by SENASA inspection.

Response: The commenter has

identified that, like the proposed rule,

the risk assessment’s narrative

description of the systems approach

(Section 8.a) incorrectly characterizes

the purpose of the 4-day holding period.

The intended purpose of both the 4-day

holding period and the 20-day

laboratory examination period are

explained in the response to the

previous comment and in paragraphs

(b)(6), (c)(3), and (c)(4) of § 319.56–2f in

this final rule. In light of that

explanation, it can be seen that the

reference to ‘‘a 20-day preharvest

sample and incubation period’’ in

section 8.f P3 of the risk assessment

accurately portrays what is required by

this rule. Section 8.f P3 of the risk

assessment links the sample holding

time and the likelihood of packinghouse

detection (which the commenter states

‘‘confuses matters’’) because that node

P3, ‘‘Pathogen not detected at packing

house inspection’’ is the portion of the

risk assessment where the 20-day

holding period is addressed. As stated

in Section 8.f. P3: ‘‘Also considered in

making our estimates for this node in

the mitigated scenario, was the orchard

sampling 20 days prior to harvest and

the incubation of this sample at room

temperature to observe post harvest

symptom development.’’

Comment: The risk assessment claims

in section 8.a that blemished fruit are

culled during harvest and claims in

section 8.f. P2 that diseased fruit would

be detected and culled at harvest;

section 8.f P2 also stated that this

detection would be improved for citrus

black spot ‘‘under the proposed

workplan’’ due to its ‘‘more rigorous

export standards and [the] reduced

frequency of latent infection,’’ although

no specific measures are mentioned for

harvest time. The preamble and

proposed rule have no harvest

requirements whatever, and it appears

from the correspondence on the record

that the Argentines do not know what

‘‘blemished fruit’’ means.

Response: As noted in our response to

a previous comment, the culling of

blemished fruit was not specifically

addressed in the proposed rule, but

requirements for the culling of

blemished fruit in the packinghouse

have been added to this rule. While

pickers can be expected to cull

obviously blemished fruit during

harvest, the best opportunity for the

removal of blemished fruit will come

after the fruit has been held for 4 days

at room temperature. Given that the 4-

day holding period will provide an

opportunity for bruises and other

damage on the fruit to become more

readily apparent, we consider this postharvest culling to be an improvement

over the reliance on pickers to cull

blemished fruit that was envisioned in

the risk assessment. Finally, we have

explained to SENASA what we mean by

the term ‘‘blemished fruit.’’

Comment: The proposed systems

approach envisions chemical treatment

after the 4-day holding period, followed

by a further inspection before packing.

Does APHIS believe such treatment will

have any impact on citrus black spot? If

so, what is the evidence? The literature

on citrus black spot would indicate that

such treatment would have no impact.

We believe that the data provided by

Argentina demonstrates the chemical

treatment envisioned in the proposed

systems approach, to be applied prior to

packing of the fruit, will not have any

impact on the virulence of the citrus

black spot spores.

Response: The post-harvest treatment

is designed to render nonviable any

spores contaminating the surface of the

fruit, and these post-harvest treatments

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37627

are mainly to prevent post-harvest

decay. In the risk assessment, our

estimates took into account the fact that

post-harvest treatments have little effect

on citrus black spot infections (a

reduction from 0.64 to 0.50).

Comment: The proposed rule does not

specify any concentrations or other

conditions for the immersion in

orthophenilphenate of sodium, nor any

application rate for the spray with

imidazole or application of 2–4 thiazalil

benzimidazole and wax. Thus, it

appears that any concentrations or

application rates—including ineffective

ones—would meet the requirements of

the proposed rule.

Response: Argentina’s environmental

protection authority, like our

Environmental Protection Agency,

requires that products such as those

called for in this rule be applied in

accordance with their label instructions.

For orthophenilphenate of sodium, the

concentration is 200 L per 2,000 L of

water; for imidazole, it is 200 cm3 per

100 L of water; and for 2–4 thiazalil

benzimidazole, it is 0.5 L per 200 L of

water. By not including these

concentrations in the text of the rule

itself, we avoid the need for future

amendments to the rule should the label

instructions change.

Comment: The risk assessment (8.f.

P4) states that the treatment program

incorporates a dip in 200 parts per

million sodium hypochlorite for 2

minutes. The preamble and rule

portions of the proposed rule spell out

the required chemical treatments, but do

not include any mention of time for the

sodium hypochlorite immersion.

Response: The commenter is correct;

the proposed rule should have stated

that the immersion in sodium

hypochlorite be for 2 minutes as

described in the risk assessment. We

have corrected that omission in

§ 319.56–2f(c)(4)(i) of this final rule.

Comment: There is no explicit

mention that the packed boxes of fruit

may not contain any plant parts other

than the fruit to be exported. Leaves and

twigs are suitable vectors for diseases

and several insects pests (e.g., brown

citrus aphid). While a prohibition on

inclusion of leaves, twigs, or other plant

parts in packing boxes is included as a

general requirement for imported fruits

and vegetables in 7 CFR 319.56–2(a), the

requirements for Argentine citrus

should explicitly prohibit any plant

parts other than the fruit itself.

Response: The commenter is correct

in noting that § 319.56–2(a) requires that

‘‘[a]ll importations of fruits and

vegetables must be free from plants or

portions of plants, as defined in

§ 319.56–1.’’ Plants or portions of plants

is defined in § 319.56–1 as ‘‘[l]eaves,

twigs, or other portions of plants, or

plant litter or rubbish as distinguished

from clean fruits and vegetables, or

other commercial articles.’’ We agree

that this is an important requirement

and have added language to the

requirements in § 319.56–2f(c)(5) to

make it clear that SENASA inspectors

must ensure that all stems, leaves, and

other portions of plants have been

removed from the fruit prior to packing.

Comment: All packing boxes sent to

commercial citrus-growing areas of the

United States should be required to be

destroyed upon reaching their

destination, and records of such

destruction should be kept.

Response: We are unaware of any

risks presented by packing boxes used

to ship citrus fruit produced in

accordance with this rule that would

make it necessary to require their

destruction, and we do not believe that

any meaningful reduction in risk would

be realized by imposing such a

requirement.

Fruit Flies, Other Pests, and Treatments

Note: On May 19, 2000, we received a

letter from the California Citrus Research

Board (CCRB) informing APHIS that the

CCRB had contracted with U.S. Department

of Agriculture’s (USDA’s) Agricultural

Research Service (ARS) to conduct a research

program to determine the suitability of

lemons as a host of tephritid fruit flies. The

CCRB letter reported that the preliminary

results of the initial tests call into question

the current regulatory assumption that

lemons at any stage of maturity are not a

viable fruit fly host. When contacted by

APHIS for additional information, ARS

reported that the preliminary results were

similar to the results published in 1984 by

ARS scientists (i.e., the Spitler, et al. research

discussed below) in which a limited number

of Medfly pupae were recovered in similarly

conducted tests. ARS reports that, at the

present time, it is reluctant to extend the

findings of these preliminary laboratory cage

studies to lemons in a commercial field

setting where there might be other, more

preferred fruit fly hosts present. Further, ARS

points out, some species of fruit are known

to be much more infestable after harvest than

before as a result of a rapid ripening process

initiated when the fruit is separated from the

tree; ARS states that fruit that can be stored

on the tree, such as citrus, may fall into this

category. ARS has stated that they will

provide APHIS with a full report upon the

conclusion of the studies. If the results of the

studies lead to a recommendation that

quarantine measures such as cold treatment

should be required for lemons, we will take

action to amend both our foreign and

domestic quarantine regulations to require

that the appropriate treatment be applied to

lemons as a condition of importation or

interstate movement.

Comment: APHIS should require a

fruit fly trapping program in the export

area and should require spraying of the

groves if population levels exceed a set

threshold. If the spraying proves

ineffective at eradicating the fruit flies,

exports should be cut off, even with

cold treatment.

Response: Argentina reports that

populations of Medfly and the South

American fruit fly (Anastrepha

fraterculus) are not present at

economically important levels and

periodically confirms their low

population levels through trapping.

Further, Argentina maintains that A.

obliqua and A. serpentina are not

present in Argentina despite reports to

the contrary, and that both species of

fruit fly are considered quarantine pests

in Argentina. Given the economic

importance of the citrus industry in

Argentina, it is in that country’s best

economic interests to ensure that fruit

fly populations remain low. The lack of

significant fruit fly population pressure,

combined with the nonhost status of

smooth-skinned lemons and this rule’s

requirement for a probit 9 level (99.997

percent mortality or 1 survivor per

33,333) cold treatment for grapefruit,

oranges, and lemons other than smoothskinned lemons, has led us to conclude

that trapping and spraying provisions

are not a necessary element of the

Argentine citrus export program.

Comment: There is no discussion in

the proposed rule of fruit fly detection

in Argentina, nor what, if any,

prevalence of fruit flies would be

sufficient to prevent import. Thus, any

analysis must take account of the

possibility of very high prevalence of

fruit flies.

Response: Our risk assessment did

take into account the presence of fruit

flies in Argentina and concluded that

the nonhost status of smooth-skinned

lemons and the post-harvest cold

treatments for other citrus fruit would

reduce the risk of Argentine citrus

introducing fruit flies into the United

States to a negligible level.

Comment: The proposed rule, the risk

assessment, and the PPQ Treatment

Manual (which is used by APHIS

personnel as a guide for the application

of quarantine treatments) do not

consider the issue of ‘‘preconditioning

phenomenon,’’ which could render cold

treatment ineffective in preventing the

transmission of fruit fly pests into the

United States via Argentine citrus.

Research indicates that fruit fly larvae

and eggs can develop increased

tolerance to quarantine cold treatment if

the infested fruit is exposed to sublethal

temperatures in the field or in storage

prior to the initiation of an approved

cold treatment. In order to preclude the

possibility of preconditioning

37628 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

phenomenon, the PPQ Treatment

Manual should explicitly state that the

fruit should not be held at sublethal

chilling temperatures prior to initiation

of cold treatment. In addition, further

research should be conducted to

determine whether it may be necessary

to require fruit subjected to cold field or

storage conditions to undergo longer

quarantine chilling periods.

Response: In a publication titled

Temperature Sensitivity in Insects and

Application in Integrated Pest

Management (edited by Guy J. Hallman

and David L. Denlinger, Westview Press,

1998), it is noted that any technique

used to reduce chilling injury (e.g.,

holding the fruit for several days at

temperatures several degrees above the

quarantine treatment temperature,

which is referred to as ‘‘pretreatment’’

or ‘‘preconditioning’’) can also be

suspected of favoring the survival of the

pest inside the fruit. However, Dr. Guy

Hallman, one of the editors of that

publication, indicated to APHIS that no

references in the literature were found

for this ‘‘preconditioning phenomenon’’

with regard to quarantine pests,

although it has been demonstrated with

flesh flies, house flies, Drosophila, and

other laboratory species. It was Dr.

Hallman’s opinion that because cold

treatments are so extreme and

infestation rates in commercial fruit are

so low, the issue of ‘‘preconditioning

phenomenon’’ is not likely to be a

serious practical concern. This opinion

is borne out by the consistently

successful use of quarantine cold

treatments around the world over many

years on numerous commodity/pest

combinations.

Comment: APHIS’s position that

lemons cannot be a host to

Mediterranean fruit fly is not consistent

with published scientific literature on

the subject, which demonstrates clearly

that lemons can become a host to this

pest in certain circumstances. While

lemons are not a preferred host to the

Medfly, they have been found to be a

host when insect pressure is applied to

ripe or damaged fruit. If tree-ripe fruit

is shipped to the United States, this

increases the risk of Medfly

introduction into the United States

dramatically. The studies APHIS cites to

support the nonhost status of lemons

(Spitler et al. 1984) are based on lemons

picked green to partially ripe, which is

how lemons are picked in commercial

production in the United States. It is not

clear from the proposed rule at what

stage the Argentine lemons will be

picked for export to the United States,

but we believe the Argentines pick

lemons by maturity, since much of their

fruit goes to processing and currently

they do not have the ‘‘curing’’ facilities

to ripen lemons during storage. APHIS

should establish maximum maturity

standards for lemons for export, in the

absence of cold treatments. If the

maturity standard is exceeded, then

either a cold treatment should be

required or the shipment of ripe lemons

should be rejected for export. Further,

APHIS needs to consider the impact of

harvesting lemons at earlier stages on

the ability to detect any citrus black spot

infections.

Response: While the commenter refers

to lemons in general, it is only smoothskinned lemons that are exempted from

the cold treatment requirements of this

rule. In the research conducted by

Spitler et al. (J. Econ. Entomol. 77:

1441–1444, 1984), both green and

yellow Eureka and Lisbon variety

smooth-skinned lemons were used. In

their discussion of the results of the

study, the researchers report: ‘‘Although

maturity of the lemon (green or yellow)

had no noticeable effect on the number

of flies collecting on the fruit, more

punctures (707 green vs. 805 yellow per

10 fruit) and eggs (23 [green] vs. 46

[yellow]) per egg cavity were found in

the more mature yellow fruit. Even in a

thin-skinned lemon with 57 ovipositor

wounds, no larvae or pupae (i.e., our

criterion of survival) were recovered.’’

So, while the researchers did observe

that oviposition was more likely in the

more mature yellow fruit, they found

that in only one case—in which the

ripest fruit used in the study was left in

the infestation cage for 3 days in an

attempt to have egg survival—did any

larvae or pupae survive (5 survivors out

of a very conservatively estimated

population of 31,800). In the other 12

lots tested, in which the percentage of

yellow lemons ranged from 50 to 100

percent in all lots but 1 (which was 100

percent green lemons), there were no

survivors out of a very conservatively

estimated population of 484,182. The

results of this study, coupled with our

experience with both domestically

produced and imported lemons, has led

us to conclude that the probability of a

Medfly infestation resulting from the

importation of commercial shipments of

smooth-skinned lemons is extremely

low. Thus, because we do not believe

that it is necessary to establish

maximum maturity standards for

smooth-skinned lemons imported under

this rule, we do not believe that it is

necessary to consider the impact of

harvesting lemons at earlier stages on

the ability to detect any citrus black spot

infection.

Comment: APHIS must consider the

effects that fruit fly population pressure

and environmental stress on fruit trees

may have on the nonhost status of

lemons. The existence of a large fruit fly

population in any given year or at any

particular time of year substantially

increases the likelihood that the fruit

flies will infest citrus fruit, especially if

other hosts are not available at that time,

even if the fruit is considered a poor

host for fruit flies. Similarly, the effect

of plant stress on host resistance must

be taken into account. Therefore, APHIS

should integrate on-site field

inspections, trapping programs, and/or

possible field control programs for all

species of fruit flies into the systems

approach for Argentine citrus, and

should require monitoring to ensure that

no conditions arise that overwhelm the

lemons’ resistance to fruit flies. Further,

the effect of citrus tree health on

susceptibility should be included in the

risk assessment.

Response: In the research conducted

by Spitler et al. discussed in the

previous comment, Eureka and Lisbon

variety smooth-skinned lemons were

exposed to a high population pressure

of 7,500 adult medflies per 3.6 m 3 in the

infestation cage, a population level

unlikely to be attained in the field. With

that high population pressure in the

infestation cage, the researchers

estimated that a total of 516,000 eggs

were laid in the 13 lots of lemons used

in the study, with only 5 pupae

surviving, a mortality rate that exceeds

the probit 9 security level of 99.997

percent mortality (i.e., 1 survivor per

33,333). In the last of the 13 lots tested,

a total of 34 yellow lemons were placed

in the infestation cage for 1 day, after

which the eggs in each lemon were

counted (rather than estimated). These

34 lemons yielded a total of 126,997

eggs, an average of 3,735 eggs per

lemon. Despite this exceedingly high

per-fruit egg population, no larvae or

pupae were recovered from the lemons.

The commenter further suggests that we

assess the effect of citrus tree health on

host resistance. Official records

reflecting the host resistance of

commercial smooth-skinned lemons

date back as far as 1914 (Quayle, H.J.,

‘‘Citrus fruit insects in Mediterranean

countries,’’ USDA Bulletin 134, 1914),

yet we have been unable to find any

records or other published material

documenting cases in which plant stress

or other environmental conditions led to

a breakdown in that resistance.

Comment: Fruit flies in many cases

prefer other hosts that are not limited to

subtropical or Mediterranean climates.

For example, the South American fruit

fly and Medfly will lay eggs in stone

fruit, apples, or pears, which are grown

commercially in many areas of the

United States. While it is unlikely that

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37629

the fruit flies would survive during the

winter in northern regions of the United

States and become established

permanently in these regions, their

introduction could still ruin local fruit

crops for one season, and fruit from

temporarily infested regions could be

transported into more hospitable

climates where the fruit flies could

become established. Therefore, APHIS’

risk assessment should consider the full

range of environments in the risk

assessment in which fruit flies, if

introduced, can cause significant

damage to agricultural crops and should

develop confirming data on fruit fly

distributions using insect phenology

models, such as those developed by

plant protection authorities in Australia

(e.g., CLIMEX).

Response: The remote chance of the

occurrence suggested by the commenter

is addressed in the risk assessment’s

node for ‘‘pest finds suitable host.’’ We

believe that it would be exceedingly

unlikely that fruit flies would be

introduced in commercial shipments of

Argentine citrus fruit in such numbers

that their populations would reach

outbreak levels in a matter of a few

months. With regard to the use of

CLIMEX, we have found that this

computerized climate matching system

can be overly conservative and often

does not identify the full range of areas

into which we know a pest could

spread. What we do in most cases, and

did do in the Argentine citrus risk

assessment, is ask what are all the

locations that have both suitable hosts

(not part of CLIMEX) and suitable

habitat (we consider additional factors

not considered by CLIMEX). Our results

typically indicate that a pest could

spread to more areas than indicated by

CLIMEX.

Comment: Having gone through two

Medfly quarantines in the last 10 years

because the USDA considers lemons a

host to the Medfly, we find it difficult

to understand why Argentina is exempt

from the same rules that apply to our

country. Similarly, California spends

hundreds of thousands of dollars per

year on Medfly trapping, survey, and

exclusion activities, yet the proposed

rule does not require any fruit fly

trapping in Argentina.

Response: Smooth-skinned lemons

harvested for packing by commercial

packinghouses are not regulated articles

under our domestic Medfly regulations

in §§ 301.78–2, and it is those varieties

of lemons that are exempted from the

cold treatment requirements of this rule.

Thus, there is no disparity between the

provisions of this rule and our domestic

Medfly regulations in this regard. Any

Medfly-related measures that were

applied to smooth-skinned lemons in

California during Medfly quarantines in

that State were not due to APHIS

regulations, but were applied at the

request of nations to which California

growers sought to export their product.

The Medfly survey and exclusion

activities carried out by California are

designed to maintain that State’s

freedom from Medfly; similar

requirements were not made part of this

rule for the export areas of northwestern

Argentina because that region has not

been represented as a Medfly-free area.

Comment: Lemons have been stated to

be nonhosts of fruit flies, but during the

Medfly eradication program in Ventura

County, CA, and other parts of

California and in Hawaii, lemons have,

in fact, been found that were infested

with Medfly larvae.

Response: Smooth-skinned lemons

harvested for packing by commercial

packinghouses are not regulated articles

under our domestic Medfly regulations

in §§ 301.78–2, and this rule is

consistent with our domestic Medfly

regulations. Neither the risk assessment

nor proposed rule stated that lemons in

general were considered to be nonhosts

of fruit flies. Instead, both documents,

as well as the supporting research such

as that conducted by Spitler et al.

(1984), indicate that it is only smoothskinned varieties of lemons that are

considered nonhosts of fruit flies.

Accordingly, this rule requires all

lemons other than smooth-skinned

varieties to undergo specified cold

treatments to mitigate the risk presented

by fruit flies, a consideration reflected

in the risk assessment. Considerable

research and investigations into

anecdotal reports such as those cited by

the commenter have not uncovered any

documented cases of Medfly attacking

smooth-skinned varieties of lemons.

Comment: No information appears to

be available on what pesticides are used

or registered for use in Argentina. What

assurances can the USDA give that

pesticide residues on imported fruit will

not threaten public health?

Response: The U.S. Food and Drug

Administration (FDA) samples and tests

imported fruits and vegetables for

pesticide residues. If residue of a

pesticide unapproved in the United

States is found in a shipment of

imported fruit or vegetables, the

shipment is denied entry into the

United States by the FDA.

Comment: APHIS has an obligation to

the U.S. citrus grower community to

assess whether Argentine growers

currently use pesticides (for the control

of pests or diseases) that cannot legally

be used in the United States. Further,

APHIS should assess whether there

would be any substance that could be

used in the United States to control a

pest or disease, should such a pest or

disease be brought in that is not

currently present in the United States. If

no substances are registered in the

United States that would replace those

used in Argentina, APHIS should not

allow the citrus to be imported.

Response: As noted in the response to

the previous comment, the FDA samples

and tests imported fruits and vegetables

for pesticide residues. The U.S.

Government does not have any control

over what pesticides are approved for

use in foreign countries. The

Environmental Protection Agency has

regulations that address the exportation

from the United States of pesticides that

are not registered for use in this country

and works with foreign environmental

protection agencies and agricultural

producers to promote safer pesticide use

and food production practices. In

response to the second part of the

commenter’s remarks, there is a variety

of fungicides and other pesticides

available for use in the United States in

the unlikely event that a plant pest is

introduced into this country via citrus

imported from Argentina in accordance

with this rule.

Comment: The proposed rule and risk

assessment do not address the legitimate

concern that a pest that exists in one

U.S. citrus-growing region could be

introduced by imported Argentine citrus

into another U.S. citrus-growing region

that is free of that pest. For example,

brown citrus aphid (Toxoptera

citricidus), a quarantine actionable pest

that is a vector of the tristeza virus, is

listed as existing in Florida in the 1997

Risk Assessment. Currently, Arizona

and California, which have limited

occurrences of tristeza, have measures

in place to prevent the introduction of

brown citrus aphid from Florida; Texas

has not had any serious tristeza

outbreaks due to the lack of good

vectors for the virus. APHIS should

address the possibility that pests

established in one part of the United

States could be introduced into free

areas of this country via imported

Argentine citrus. We suggest that APHIS

should require country-of-origin/lot

number labeling of individual fruit in

order to address this concern and to

allow for the tracking of Argentine fruit

if it becomes necessary. Further, APHIS

should develop an overall policy,

consistent with WTO rules, for dealing

with this situation.

Response: The commenter raises the

concern that pests established in one

part of the United States could be

introduced into free areas of this

country via imported Argentine citrus,

37630 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

and then suggests that country-of-origin/

lot number labeling of individual fruit

to allow for the tracking of Argentine

fruit could be used to address that

concern. To address the commenter’s

first concern, in preparing our risk

assessment, we identified all pests of

citrus known to be present in Argentina,

examined the available information

regarding those pests, then focused our

analysis on any pests that were

identified as quarantine actionable pests

that could reasonably be expected to

follow the pathway, i.e., be included in

commercial shipments of citrus. With

regard to the commenter’s second

concern, this rule, in § 319.56–2f(c)(6),

requires that Argentine fruit be packed

in boxes that bear the SENASA

registration number of the fruit’s grove

of origin, so we will have the ability to

track shipments of imported Argentine

fruit after they enter the United States.

Although the requirement was not

added in response to this commenter’s

suggestion, this final rule does, as

explained earlier in this document

under the heading ‘‘Specific Regulatory

Changes Regarding Limited

Distribution,’’ contain a requirement for

the stickering of individual Argentine

fruit.

The commenter also urged APHIS to

develop an overall policy, consistent

with WTO rules, for dealing with the

issue of pests of limited distribution. We

believe that the new revised text of the

IPPC, which was approved by the FAO

Conference at its 29th Session in

November 1997, provides the kind of

overall policy sought by the commenter.

(The WTO SPS Agreement identifies the

IPPC as the organization providing

international standards for measures

implemented by governments to protect

their plant resources from harmful

pests.) Specifically, Article VI,

‘‘Regulated pests,’’ provides that:

‘‘Contracting parties may require

phytosanitary measures for quarantine

pests and regulated non-quarantine

pests, provided that such measures are:

(a) no more stringent than measures

applied to the same pests, if present

within the territory of the importing

contracting party; and (b) limited to

what is necessary to protect plant health

and/or safeguard the intended use and

can be technically justified by the

contracting party concerned.’’ Under the

Federal Plant Pest Act and the Plant

Quarantine Act, APHIS has the

authority to take action against pests of

limited distribution in the United States

when such pests are found present in

imported plants or plant products. Such

action would be in accord with WTO

rules.

Comment: The risk assessment states

that leprosis is found in Florida, but an

expert states that leprosis has been

eradicated in Florida since the early

1960’s. Leprosis is not present in

California or Arizona. False spider mites

(Brevipalpus spp.) are present in

Argentina and vector the virus for

leprosis; these mites and their eggs are

difficult to detect through visual

inspection, and the usual post-harvest

treatments have no effect on their

presence. Although several Brevipalpus

spp. are present in the United States, the

lack of leprosis has made them less of

a threat to U.S. agriculture. If the

vectoring mites and leprosis occur

together in the northwest region of

Argentina—and there is evidence that

leprosis is a serious disease in Misiones

Province in northern Argentina—then

additional treatments of all the fruit for

the mites is required. APHIS should

consider the risk associated with

Brevipalpus spp. remaining with the

fruit through post-harvest treatment and

shipping and the risk of the mites

carrying the leprosis virus. If a risk is

identified, then measures need to be

taken to prevent the mites from

transmitting leprosis to the United

States via citrus, even if that disease

exists in Florida.

Response: The expert mentioned by

the commenter has not published his

findings regarding leprosis, whereas

Alfieri, et al. (1994) and Brunt, et al.

(1996) both list leprosis as present in the

United States. As both leprosis and

Brevipalpus spp. mites occur in the

United States and are not subject to

official restrictions or regulations (i.e.,

they are not listed as actionable and are

not under an official control program),

these organisms do not meet the

geographical and regulatory definition

of a quarantine pest.

Comment: The risk assessment does

not account for the possibility that a

number of insect and mite species may

be transmitted under the calyx (button)

of citrus fruits, thus allowing for the

possibility of transmission of such pests

into the United States via Argentine

citrus. The calyx of citrus fruit can

harbor a large number of insects and

mites or their eggs. These contaminant

species are not easily visible unless the

button is removed (which leads to more

rapid fruit decay) and are resistant to

cold treatment, surface washes, and

insecticide treatments. APHIS’ risk

assessment should address the issue of

all types of insect pests that may inhabit

the calyx of Argentine citrus, and calyx

inspection should be a routine part of

the inspection of Argentine citrus at the

port of first arrival.

Response: As indicated in an earlier

response, in preparing our risk

assessment, we identified all pests of

citrus known to be present in Argentina,

examined the available information

regarding those pests, then focused our

analysis on any pests that were

identified as quarantine actionable pests

that could reasonably be expected to

follow the pathway, i.e., be included in

commercial shipments of citrus. In

examining the information regarding

citrus pests present in Argentina, we did

not identify any insect or mite species

that could be transmitted under the

calyx of citrus fruit that were quarantine

actionable pests that could reasonably

be expected to follow the pathway.

Thus, we do not believe that it is

necessary to include provisions in this

rule to require the routine calyx

inspection at the port of first arrival.

However, this does not preclude our

inspectors from conducting calyx

inspections, even on a routine basis,

when they believe such a measure might

be necessary.

Disease Detection

Comment: The proposed rule states:

‘‘If, during the course of any inspection

or testing required by this section or

§ 319.56–6 of this subpart, citrus black

spot or sweet orange scab is detected on

any grapefruit, lemons, or oranges, the

grove in which the fruit was grown or

is being grown shall be removed from

the SENASA citrus export program for

the remainder of that year’s growing and

harvest season * * *.’’ It is currently

unclear how much disease detection is

needed to cause SENASA to remove the

grove from the export program. Does a

single infection on a single fruit

disqualify an orchard from the export

program? The presence of the diseases

can be detected in the litter and

occasionally the tree without obvious

fruit infections. Would that be grounds

for the removal of a grove? A much

clearer definition of when a grove must

be removed from the export program,

and an explanation of why that

threshold for removal was chosen,

needs to be established in order to

minimize the risk that latently infected

fruit will reach the United States.

Further, the proposed rule contained no

discussion of whether any special

criteria or measures need to be met for

a grove to re-enter the export program

after it has been disqualified for a

season due to disease incidence.

Response: Paragraph (f) of § 319.56–2f

clearly states that if citrus black spot or

sweet orange scab is detected on any

grapefruit, lemons, or oranges, the grove

will be removed from the export

program. So, in response to the

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37631

commenter’s first question, a single

infection on a single fruit, will result in

a grove’s removal from the export

program. That paragraph does not,

however, call for the removal of a grove

from the export program upon the

detection of either disease in litter or in

the tree if the infection is not detected

in the fruit, since there are no

requirements for the testing of litter or

parts of the tree other than the fruit. The

commenter‘s statement that the

presence of citrus black spot and sweet

orange scab ‘‘can be detected in the

litter and occasionally the tree without

obvious fruit infections’’ is true to a

certain extent; the fungi can be isolated

from leaf litter and leaves on the tree.

However, the presence of these diseases

cannot be reliably detected through the

visual inspection of plants or plant parts

other than the fruit. So, while § 319.56–

2f(b)(6)(i) does provide that a grove’s

freedom from citrus black spot and

sweet orange scab shall be verified

through visual inspection of the grove

and buffer area, that visual inspection

will necessarily be limited to fruit on

the trees. The diseased fruit threshold

was chosen because it will be the fruit

itself, and not any leaves, branches, or

litter, that will be imported into the

United States. We did not include any

special criteria or measures for a

previously disqualified grove to re-enter

the export program because we believe

that the testing, treatment, and

inspection requirements that must be

satisfied by any grove seeking to export

fruit to the United States make such

additional measures unnecessary.

Comment: In the proposed rule,

§ 319.56–2f(f) refers to ‘‘growing,’’

‘‘harvest,’’ and ‘‘shipping’’ seasons, with

no definition of what is meant by such

terms.

Response: We regard the ‘‘growing

season’’ as the period between bloom

and fruit maturity, the ‘‘harvest season’’

as the period during which the mature

fruit are picked, and the ‘‘shipping

season’’ as beginning at roughly the

same time as the harvest season and

continuing until shortly after the harvest

ends. As we are using those terms in

their generally understood sense, we see

no reason to specifically define them in

the regulations.

Comment: In § 319.56–2f(f) of the

proposed rule, it states that fruit must

pass ‘‘any inspection or testing required

by this section or § 319.56–6 of this

subpart.’’ Thus, if fruit is observed to be

infected before fungicide application, or

at some random time (but not during an

inspection), or by non-SENASA

personnel, there is strictly no

requirement to remove the grove from

the export program, since these

inspections are not ‘‘required.’’ There is

no overall catchall requirement that any

detection is sufficient to remove a grove

from the export program.

Response: We believe that the official

inspections and tests called for by this

rule will be sufficient to detect the

diseases of concern should they be

present in a grove or in harvested fruit.

However, in order to address the

concerns raised by this commenter, we

have added the words ‘‘or at any other

time’’ to § 319.56–2f(f).

Comment: While the proposed rule

specifies that any detection of sweet

orange scab or citrus black spot during

required inspections shall result in a

grove’s removal from the export

program, it provides no mechanism by

which this shall happen. For example,

there is no requirement for SENASA to

be notified, and no requirement for

SENASA to notify APHIS.

Response: In response to this

comment, we have amended § 319.56–

2f(f) in this final rule to require that

both SENASA and APHIS be notified in

the event that citrus black spot or sweet

orange scab is detected.

Comment: While the proposed rule

specifies that any detection of sweet

orange scab or citrus black spot during

required inspections shall result in a

grove’s removal from the export

program, it does not state what would

occur if citrus canker was discovered in

a grove or within a particular growing

region.

Response: As stated in the proposed

rule, we believe that Argentina has

demonstrated, in accordance with FAO

guidelines for pest-free areas, that the

citrus production areas in Catamarca,

Jujuy, Salta, and Tucuman are free from

citrus canker. Should citrus canker be

detected in any of those States in the

future, those same FAO guidelines

require that Argentina report that

detection. Because the citrus fruit

regulations in § 319.28 prohibit the

importation of the fruits and

unprocessed peel of all species and

varieties of the genus Citrus from areas

where citrus canker exists, the detection

of citrus canker in an area within the

citrus-canker-free region of

northwestern Argentina would result in

a prohibition on the importation into

the United States of grapefruit, lemons,

and oranges from that area.

Comment: The proposed systems

approach for citrus black spot and sweet

orange scab provides only suppression

of symptoms and reduction of the

inoculum in the area proposed for

export. So the question the risk

assessment must answer is will this

provide the United States with an

appropriate level of protection against

the introduction and establishment of

one or both of these diseases when it is

clear that infected, though symptomless,

fruit will be certified for export to the

United States?

Response: The risk assessment

provides the decisionmaker with the

information he needs to determine

whether certain phytosanitary measures

provide ‘‘an appropriate level of

protection’’ in a particular situation; it

is not the purpose of the risk assessment

itself to answer that question. In this

case, the risk assessment examined the

risk associated with the importation of

Argentine citrus and estimated the

likelihood of pest introduction. In any

event, the systems approach for citrus

black spot and sweet orange scab is not

designed to suppress symptoms. It is

designed to prevent infection. For that

reason, part of the systems approach

includes removal of debris to reduce

inoculum and application of fungicides

to prevent infection. As part of the

entire systems approach, this prevention

portion provides an appropriate level of

protection against the introduction or

establishment of either of these diseases.

It is not ‘‘clear’’ that symptomless,

infected fruit will be certified for export.

In fact, using the systems approach

makes it highly unlikely that

symptomless, infected fruit will be

certified for export.

Risk Assessment

Note: In this section, as well as in the

subsequent section titled ‘‘Risk Assessment—

‘Principles of Good Practice’ some of the

comments state that the proposed rule’s

supporting risk assessment failed to establish

a connection between certain of its

conclusions and the data or information that

was used as the basis for those conclusions.

We have responded to those comments by

explaining the role that expert judgment

played in reaching those conclusions or by

pointing to our use of the sources cited in

section III (‘‘References’’) of the risk

assessment. However, in order to more

thoroughly document the sources of the risk

assessment’s conclusions, we have prepared

an addendum to the risk assessment that

provides, node-by-node, specific references

to the information or data used as the basis

for those conclusions. The addendum may be

obtained from the person listed at the

beginning of this final rule under the heading

FOR FURTHER INFORMATION CONTACT.

Comment: The consequences of

introduction are addressed in the

qualitative portion of the risk

assessment via an estimation of the

economic and/or environmental damage

potential according to ratings applied to

five risk elements. In these estimations,

broad uncharacterized assumptions are

used and the role of uncertainty is never

discussed.

37632 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

Response: The objective criteria we

use to rate the five risk elements are

stated on pages 22 through 25 of the risk

assessment, and our findings regarding

the five risk elements are provided on

page 26. Our findings are not based on

‘‘broad uncharacterized assumptions,’’

but on specific information available in

the scientific literature. The information

used in rating each pest is provided in

the pest data sheets provided for each of

the rated pests (Appendix I–IV for four

species of fruit flies and Appendix V–

VII for the three citrus diseases), which

are supported by the scientific literature

cited and listed in each pest data sheet.

We did not discuss the role of

uncertainty in the assignment of ratings

for the five risk elements because

uncertainty played an insignificant, if

any, role in the assignment of those

ratings. For each risk element, each pest

received a qualitative ranking of high,

medium, or low; the assignment of each

ranking for each pest was dictated by

the responses to specific and objective

criteria. For example, the rankings

assigned for Risk Element #2 (host

range) were assigned as follows:

• High—Pest attacks multiple species

within multiple plant families.

• Medium—Pest attacks multiple

species within a single plant family.

• Low—Pest attacks a single species

or multiple species within a single

genus.

As can be seen in the pest data sheet

included in the risk assessment for each

of the pests examined, the host range of

each pest has been established and

documented, so there was no

uncertainty involved in the assignment

of a qualitative risk rating for each pest

under this risk element. The same may

be said for the other four risk elements

as well, with the possible exception of

Risk Element #5 (environmental

impact), in which three of the five

factors considered involve expected

impacts on the environment or on

threatened/endangered species. Because

those factors involve likely future

impacts as opposed to documented past

impacts, some degree of uncertainty is

inevitable; however, we do not believe

that the level of uncertainty is sufficient

to have had any substantive impact on

the assigned risk ratings.

Comment: Climate-host interaction is

estimated solely on the USDA s Plant

Hardiness Zone Map. This map

provides temperature zones for

specified regions, and risk is calculated

based on a pest’s ability to exist in one

to several temperature zones. Yet,

rainfall and relative humidity play an

equally critical role in the ability of a

disease pathogen to survive and thrive

in a new area. (For example, there is the

added moisture that results from

irrigation and fog, as in the coastal

California growing areas, and the

summer monsoon season that occurs in

both Arizona and southern California.)

The omission is never mentioned, so

neither is the uncertainty this omission

represents.

Response: The plant hardiness zone

map is used in the discussion of Risk

Element #1, ‘‘Climate-Host Interaction,’’

as an objective means of specifying the

extent of the potential range of the pest.

We agree that it may be appropriate, as

suggested by the commenter, to

introduce relative humidity and rainfall

as factors for consideration at this stage.

However, the addition of those factors at

this stage would have the effect of

further limiting the potential range of

the pest under consideration to areas

even smaller than temperature zones, as

the pest would be restricted to areas

with appropriate ranges of multiple

factors (temperature, rainfall, and

relative humidity), rather than just one

factor (temperature). That being said,

the role of moisture is in fact considered

in the risk assessment, contrary to the

commenter’s assertion that it was not.

Specifically, Risk Element #3,

‘‘Dispersal Potential,’’ considers

‘‘whether natural factors (e.g., wind,

water, presence of vectors) facilitate

dispersal’’ as one of the three items

examined when evaluating whether a

pest has the potential to disperse (or, to

use the commenter’s terminology,

‘‘survive and thrive’’) after introduction

into a new area.

Comment: Sweet orange scab is rated

medium for its host range potential yet

it is not known to infect genera of

Rutaceae other than Citrus species.

Citrus black spot is rated high for its

dispersal potential (capable of

movement over 10 km per year), yet the

scientific data, and the data sheet

provided, indicate that this fungus only

spreads short distances under natural

conditions. Long-distance dispersal is

attributed to the artificial movement of

citrus leaves and nursery stock, both of

which are beyond the scope of the risk

assessment. If this assessment is correct,

the 150-meter buffer provision in the

proposed program should be

reexamined.

Response: Our understanding of this

comment is that the commenter is

pointing out that: (1) The rating we

assigned for the host range potential of

sweet orange scab was too high and (2)

the rating we assigned for the dispersal

potential of citrus black spot may have

been too high, and if that is the case, the

150-meter buffer zone may be too large.

We agree that Elsinoe australis (sweet

orange scab) could have received a

rating of ‘‘low’’ for host range potential

and, as a result, sweet orange scab could

have only been rated as ‘‘medium’’—not

‘‘high’’—for its consequences of

introduction. Similarly, Guignardia

citricarpa (citrus black spot) could have

been rated as ‘‘medium’’ for dispersal

potential, and as a result, citrus black

spot could have been rated as

‘‘medium’’—not ‘‘high’’—for its

consequences of introduction. Although

our original rating of ‘‘high’’ for the

dispersal potential of citrus black spot

may have been somewhat conservative,

we believe that the 150-meter buffer

zone provision is still an appropriate

measure to protect production groves

from neighboring properties that are not

participating in the export program.

Comment: Black spot is apparently on

a wide range of other host plants. The

risk of movement of Guignardia

citricarpa on latently infected fruit and

its ability to establish in a new area on

various other hosts (i.e., not citrus) is

underrated.

Response: Guignardia citricarpa is

morphologically identical to another

Guignardia sp. that is latent in citrus

and many other hosts. However, the

identified host range of Guignardia

citricarpa is limited to commercially

grown Citrus spp. except for sour orange

(C. aurantium) and its hybrids. Given

the identified host range of Guignardia

citricarpa, we believe that the risks

presented by Guignardia citricarpa were

appropriately rated in the risk

assessment.

Comment: The likelihood of

introduction is estimated using

probabilistic scenario analysis. Here,

uncertainty is addressed in the

probability distributions, but these

distributions were in turn based upon a

number of assumptions that are not

explained. Among other criteria, pest

risk assessments must contain sufficient

detail and identify all sources of

uncertainty in data extrapolation in

order to be open to evaluation and

review. It is for this reason that the FAO

Guidelines for Pest Risk Analysis

require that the analysis or assessment

clearly state the sources of information

and the rationales used in reaching

decisions regarding the phytosanitary

measures proposed.

Response: Our risk assessment was

conducted with strict adherence to the

FAO guidelines. As explained in the

risk assessment on p. 28, we estimated

model inputs ‘‘using the best available

data and expert judgment as our basis.’’

In those cases where data were

available, we identified those data and

the role they played in the development

of our distributions. When data were not

available, we used additional

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37633

information provided by our experts to

arrive at estimates that reflected what

we considered to be appropriate levels

of uncertainty, and the distributions

were derived to reflect those estimates;

in those cases, the role of expert

judgment or expert information in

arriving at the estimates was

acknowledged. We believe, therefore,

that our risk assessment clearly states

the sources of information and the

rationales used in reaching decisions

regarding the phytosanitary measures

proposed as required by FAO.

Comment: Although some background

information was provided, it would

have been extremely helpful to include

some additional information within or

accompanying the pest risk assessment.

This would include a complete review

of current pest status of citrus black spot

and sweet orange scab in Argentina and

in the four States; the trip reports for

any and all site visits; all survey

methods and results; and a complete

discussion of Argentina s current and

proposed control, harvesting, and

packing procedures.

Response: All of the information cited

by the commenter is either in the public

domain or is part of the rulemaking

record, which was made available to the

commenter. We do not believe that it

would be feasible or even necessary to

reproduce the entire public record in

the risk assessment.

Comment: APHIS has not adequately

considered the risk of infestation and

infection originating in residential areas.

Response: The risk of infestation/

infection in residential areas was

considered in the risk assessment as

part of input probabilities P6 (fruit

transported to suitable habitat), P7 (pest

finds/pathogen reaches suitable host),

and P8 (pest/pathogen able to complete

life cycle). Those input probabilities

considered both commercial production

areas as well as residential areas.

Comment: The mitigation scenarios

for the fruit flies and citrus canker are

estimated against the systems approach

proposed for citrus black spot and sweet

orange scab; there is no analysis

provided for the efficacy of the direct

mitigation measures proposed for these

pests. For the fruit flies, it would be

more relevant to provide the supporting

data evidencing the effectiveness of the

post-harvest cold treatment. For citrus

canker, it would be more appropriate to

show how this program meets the

requirements for designation of a pest

free area.

Response: It is not the case that ‘‘the

mitigation scenarios for the fruit flies

and citrus canker are estimated against

the systems approach proposed for

citrus black spot and sweet orange

scab.’’ The risk presented by each pest

was analyzed individually with respect

to pertinent mitigation measures. In fact,

we state on page 32 of the risk

assessment that the baseline treatments

of washing, waxing, and dipping the

fruit (for diseases) ‘‘are expected to have

only a minor effect on fruit flies.’’ Our

estimates do not include any reduced

fruit fly risk from these treatments. As

shown in Table 7 on p. 35 of the risk

assessment, there are only two

differences between the risk model

inputs for the baseline (no specific

mitigations) and the proposed risk

mitigation program. That is, two of the

nodes were affected by the proposed

program. The first affected node is P5

(pest survives post-harvest treatment).

As described on p. 32, all of the reduced

likelihood of fruit fly survival with the

proposed program comes directly from

the cold treatment for fruit flies:

USDA has an approved cold treatment

schedule for both Ceratitis capitata,

Treatment T107(a), and Anastrepha fruit flies

other than A. ludens, Treatment T107(c)

(PPQ, 1992). The treatment schedule allows

different temperature/time combinations to

be used. For example, T107(a) allows 32° F

(or below) for 10 days as well as 36° F (or

below) for 16 days. Treatment schedules

were based on demonstrated efficacy of

probit 9 (99.9968 percent) mortality. This

corresponds to a survival rate of 0.00003

(0.003 percent). We represented survival as a

lognormal distribution with a mean of 0.0001

and a standard deviation (sd) of 0.00011. A

sd of 0.00011 was chosen because the

resulting distribution has a mode (peak of the

distribution) at 0.00003.

The other node that is different is P8

(pest able to complete life cycle). As

explained on p. 33 of the risk

assessment, we estimated that this value

would be slightly lower as a result of the

cold treatment for fruit flies. The

reduced risk from fruit flies under the

proposed program results from the cold

treatment for fruit flies, and not from the

treatments applied for the diseases of

concern.

Regarding citrus canker, three main

components are considered in the

establishment and subsequent

maintenance of a pest free area: Systems

to establish freedom, phytosanitary

measures to maintain freedom, and

checks to verify freedom has been

maintained. Argentina established its

freedom from citrus canker, as stated on

page 36 of the pest risk assessment,

through 4 years of comprehensive

specific surveys with negative results as

well as general surveillance for canker

in the field and in published literature.

Argentina continues to maintain area

freedom through phytosanitary

measures outlined on pages 27 and 36

of the pest risk assessment document.

These phytosanitary measures include

restrictions on the movement and

planting of citrus nursery stock in the

free area and domestic quarantine

controls at airports and roads servicing

the area. Continuing canker surveys,

field and packinghouse inspections, and

the requirement for a phytosanitary

certificate help verify that area freedom

is maintained.

Comment: The probability estimate

for ‘‘harvested fruit is infected with

citrus black spot and sweet orange scab’’

is based on limited field survey data

provided by Argentina. For example,

treatment tests for grapefruit were

performed on young trees in 1994 only,

i.e., trees known not to show symptoms

with or without fungicidal treatment.

The 1994–95 treatment data provided

are for oranges only, and the age of the

orchard trees is not provided. There

were no data provided for lemons, the

most susceptible citrus for citrus black

spot infection. No treatment data were

provided for sweet orange scab.

Response: We acknowledged in the

risk assessment that the survey data

provided by Argentina was limited. In

the discussion of node P1, ‘‘Harvested

fruit is infected,’’ we stated that ‘‘our

estimates * * * were based on limited

field survey data provided by Argentina

and expert information provided by

scientists familiar with citrus

production in Argentina and/or the

pathogen.’’ Because the field survey

data were limited, we used additional

information provided by our experts to

arrive at estimates of these probabilities

that reflected what we considered to be

appropriate levels of uncertainty, and

the distributions were derived to reflect

those estimates.

Comment: The probability estimate

for ‘‘pathogen not detected at harvest’’ is

based solely on expert information that

the fruit pickers would be able to find

and cull diseased fruit. It does not

provide any discussion regarding the

latency period of citrus black spot

symptom expression, nor that symptom

expression does not occur at all in fruit

from trees younger than 12 years. Yet,

it does ironically assume in the

mitigation scenario, based on a program

that suppresses symptom expression,

that this activity would result in fewer

citrus black spot infected fruit escaping

detection.

Response: In that latent infections

would not be visible to pickers during

harvest, we do not believe that it is

necessary for the probability estimate

for P2 (pathogen not detected at harvest)

to provide a discussion regarding the

latency period of citrus black spot

symptom expression or the lack of

symptom expression in all fruit from

37634 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

trees less than 12 years old. Rather, the

issues of latency and lack of symptom

expression are considered in, and

factored into, the probability estimates

provided in P3 (pathogen not detected

at packing house inspection) and P4

(pathogens survive post-harvest

treatment). With regard to the last

sentence of the comment, the systems

approach is not, as the commenter

states, a ‘‘program that suppresses

symptom expression.’’ Rather, as we

have stated elsewhere in this document,

the treatments and cultural practices

required by this rule are designed to

prevent fruit from becoming infected in

the first place. Those requirements are

the basis for the risk assessment’s

expectation that ‘‘more rigorous export

standards and reduced frequency of

latent infection would result in fewer

[citrus black spot] diseased fruit

escaping detection.’’

Comment: The probabilistic estimate

for ‘‘pathogens survive post-harvest

treatment’’ predicts that these minimal

treatments would have a deleterious

effect on the survival of both sweet

orange scab and citrus black spot causal

pathogens. What this estimate does not

state is that this node only applies to

pathogen spores that may be found

contaminating the surface of the fruit

and that the fruit at that point is

resistant to infection.

Response: It is correct that mature

fruit is not susceptible to new infection

and that the post-harvest treatment is

intended to render nonviable any spores

contaminating the surface of the fruit.

This is reflected in the risk assessment’s

discussion of node P4, ‘‘Pathogen

survives post-harvest treatment,’’ where

we stated that ‘‘[w]e assumed that the

additional treatments [i.e., the chlorine

dip] included in the proposed export

program would further reduce the

survival rate of the [sweet orange scab]

pathogen’’ and that ‘‘[f]or our mitigated

scenario we assumed that the chlorine

dip would have an additional

deleterious effect on the survival of the

[citrus black spot] fungus.’’ As noted

elsewhere in this document, these postharvest treatments are mainly to prevent

post-harvest decay.

Comment: In section 8.f, ‘‘Inputs,

Sweet orange scab, citrus black spot and

citrus canker,’’ the probabilistic estimate

for ‘‘fruit shipped to a suitable habitat’’

is based solely on the percentage of

geographical area that supports

cultivation of citrus. Yet, in fact, this

node would be more accurate if

estimates were based on population

densities, as fruit is going to be shipped

based upon a target market, not

geography. Then, a comparison should

be made relative to the population

percentage found within the citrus

growing areas. As it is estimated now,

this node is particularly likely to be

grossly underestimated. The

probabilistic estimate for ‘‘pathogen

reach suitable host’’ is based on an

assumption that the initial inoculum

source was introduced into an orchard

setting. In fact, it is much more likely

that the inoculum will initially be

introduced into an urban setting. As a

result, this node is another one that is

particularly likely to be grossly

underestimated. This probability node,

along with the one above, should be

recalculated more appropriately.

Response: We disagree with the

commenter’s statement that the

probabilistic estimate for ‘‘fruit shipped

to a suitable habitat’’ is likely to be

grossly underestimated. With the large

citrus markets throughout the United

States, we have no reason to believe that

our estimate of 5 percent (percentage of

imported fruit that will be shipped to

areas where citrus can survive) is too

low or too high, nor have we received

any specific information from any

commenter that would allow us to

change our estimate. (Note: Tables 8–10

on pp. 44–46 of the risk assessment

correctly list our estimate as 5 percent,

and this is the value used for the

calculations. The text on p. 41

incorrectly states this value as 9

percent). While it is accurate to state

that fruit will be shipped based on

markets rather than geography, one

cannot dispute the link between

geography and suitable habitat. The

ability of an area to support a pest

population is a function of climate and

the availability of host material, and not

population density.

Similarly, the commenter’s statement

that ‘‘the probabilistic estimate for

‘pathogen reach suitable host’ is based

on an assumption that the initial

inoculum source was introduced into an

orchard setting’’ is inaccurate. We can

find no statement in the risk assessment

that could lead the commenter to this

conclusion. We stated in the risk

assessment:

All three pathogens analyzed are

essentially restricted to citrus hosts (or

closely related species). Suitable habitat for

these organisms necessarily corresponds to

the range of their citrus hosts. Consequently,

we considered the citrus growing regions of

the continental United States to be ‘‘suitable

habitat.’’ We estimated the percentage of the

area of the contiguous 48 States that supports

the growth of citrus species.

This percentage of the area of the

contiguous 48 States that supports the

growth of citrus species includes all

areas where citrus fruit can be

produced, including ‘‘backyard trees’’ in

urban, suburban, or rural settings, or

any other areas where citrus plants can

survive and produce fruit, as well as

commercial citrus-production areas.

However, citrus is a subtropical plant

and can only survive and produce fruit

in a small portion of the continental

United States. Accordingly, we do not

agree with the commenter’s statement

that both nodes are grossly

underestimated and need to be

recalculated.

Comment: The probabilistic estimate

for ‘‘pathogen able to complete disease

cycle’’ in particular should evaluate the

effect of the systems approach, i.e., it

should provide a measurement of the

level of infection and an estimation as

to risk from latent or suppressed

symptom expression. It should also

include a discussion of the role of

pycnidiospores in disease establishment

and episode development. Although

citrus black spot epidemics tend to be

caused by the ascospores produced on

dead leaves, the pycnidiospores from

fruit are quite capable of being the

source of introduction of the disease.

The risk assessment should give more

careful consideration to the

pathogenicity of the pycnidiospores and

should consider the possibility that

citrus black spot could become

established in the United States through

pycnidiospores infecting residential

citrus.

Response: Our understanding of the

commenter’s suggestion that ‘‘[t]he

probabilistic estimate for ‘pathogen able

to complete disease cycle’ * * * should

evaluate the effect of the systems

approach, i.e., it should provide a

measurement of the level of infection

and an estimation as to risk from latent

or suppressed symptom expression’’ is

that the commenter believes that the

intended effect of the systems approach

is to suppress the symptoms of citrus

black spot and, on the basis of that

belief, that we should estimate the

percentage of fruit that will be latently

infected and provide an estimate of the

risk presented by that latently infected

fruit. As we have stated elsewhere in

this document, we disagree with the

commenter’s assertion that the goal of

the systems approach is simply to

suppress symptoms; rather, the systems

approach is intended to prevent

infection in the first place, provide for

the detection of infection if it should

occur, and prevent the entry of infected

fruit into the United States. That being

said, this node of the risk assessment

(P8: Pathogen able to complete disease

cycle) is assumed to be an independent

event and, as such, begins with the

assumption that the pest, in some form,

has reached a suitable habitat and a

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37635

suitable host, including residential

citrus. The node then describes ‘‘our

estimate of the likelihood that these

pathogens would, having reached a host

plant, be able to infect that plant and

complete the disease cycle.’’ Thus, we

believe that the risk assessment does in

fact provide the estimation of risk

sought by the commenter in the first

part of her comment.

In the second part of her comment,

the commenter suggests that this node

of the risk assessment ‘‘should also

include a discussion of the role of

pycnidiospores in disease establishment

and episode development.’’ In our

discussion of this node in the risk

assessment, we stated that we ‘‘took into

account the type of infectious propagule

produced by each of the three pathogens

and the environmental and

physiological requirements for host

plant susceptibility and successful

disease progression’’ and later,

specifically with regard to citrus black

spot, that:

The epidemiology of [citrus black spot] is

influenced by the availability of inoculum,

the environmental requirements for infection,

the growth cycle of the host and the age of

the fruit in relation to its susceptibility.

Ascospores formed on dead leaves on the

orchard floor form the main source of

inoculum, however pycnidia on out of season

or late hanging fruit can also serve as sources

of rain splashed inoculum. Spores are

released during rainfall and during irrigation.

Except for lemons, leaf infections seldom

occur. The critical period for infection starts

at fruit set and lasts for 4 to 5 months.

Symptom development is hastened by rising

temperatures, high light intensity, drought

and poor vigor.

Given the above discussion, we

believe that we did give due

consideration in the risk assessment to

the pathogenicity of the pycnidiospores

and the possibility that citrus black spot

could become established in the United

States through pycnidiospores infecting

residential citrus. Our estimates of the

risk presented by pycnidiospores are

supported by the American

Phytopathological Society’s (APS)

Compendium of Citrus Diseases

(Whiteside, J.O., Garnsey, S.M. and

Timmer, L.W., 1988, APS Press,

American Phytopathological Society, St.

Paul, MN. 80 pp.), which is cited

repeatedly in the risk assessment. That

publication states: ‘‘Pycnidiospores

formed on dead leaves on the ground

can reach the susceptible fruit only by

the splashing of raindrops, and they are

not considered an important source of

inoculum.’’ The pycnidiospores play a

role in short distance water-dispersal of

this disease. They may be produced on

symptomatic, late-hanging fruit or on

dead, decaying leaves on the orchard

floor. Pycnidiospores from fallen leaves

are very unlikely to reach fruit because

they are solely waterborne.

Pycnidiospores from late-hanging,

symptomatic fruit can infect fruit that is

in physical contact with the infected

fruit or that is hanging below the

symptomatic fruit, if the fruit are

susceptible and environmental

conditions appropriate. This agrees with

the findings of McOnie (McOnie, K.C.,

1964, ‘‘Speckled blotch of citrus

induced by the citrus black spot

pathogen Guignardia citricarpa,’’

Phytopathology 54: 1488–1489), who

concluded that ascospores are the major

infective bodies and that spores of the

asexual stage (i.e., pycnidiospores) are

unimportant in producing fruit

infections.

Comment: The pest risk assessment

concluded that the pest risk potential,

minus the mitigation measures, is high

for the fruit flies and sweet orange scab

and medium for citrus black spot; citrus

canker is not mentioned. No

conclusions are expressed for the pest

risk potential as mitigated by the

proposed program. In any case,

sufficient information necessary to

assess the efficacy of the proposed

systems approach for sweet orange scab

and citrus black spot is not available

within the proposed rule, the

supporting pest risk assessment, or

other documentation provided.

Response: The pest risk potential of

an organism, which can be viewed as a

constant, is not affected by mitigating

measures, which is why the risk

assessment expressed no conclusions

for the pest risk potential as mitigated

by the proposed program. Rather, it is

the likelihood of introduction that will

be affected by the mitigating measures,

and we did provide our conclusions for

the likelihood of introduction as

mitigated by the proposed program.

Citrus canker is not mentioned because

fruit will be imported only from the

citrus-canker-free area of Argentina.

With regard to the efficacy of those

mitigating measures, we believe that the

data supplied by Argentina and the

reports of APHIS personnel who

conducted the site visits in Argentina,

which are all part of the rulemaking

record and were made available to the

commenter, as well as the information

contained in the scientific literature

cited in the risk assessment, provided

sufficient information to support the

risk assessment and its conclusions

relating to the risk reductions afforded

by the mitigating measures required by

this rule.

Comment: In the risk assessment,

APHIS states that it evaluated only pests

that can ‘‘reasonably be expected to

follow the pathway, i.e., be included in

commercial shipments of citrus.’’ But

the pathway contains more than just

commercial shipment, and much of the

protection estimated in the risk

assessment for the diseases and pests

evaluated comes from other components

of the pathway. What should matter is

not the probability of traversing the

pathway as far as commercial shipment,

but the probability of completing the

whole pathway. The probability

required for ‘‘reasonably be expected’’

appears to be extremely high compared

with the required levels of protection. It

is plausible that for other pests or

diseases, other parts of the pathway are

not of low probability. In that case, the

risk assessment has not included

sufficient pests.

Response: In stating that the pathway

consists of ‘‘more than just commercial

shipment’’ and that protection may be

afforded by ‘‘other components of the

pathway,’’ it appears that the

commenter is confusing the pathway

itself with the mitigation measures

applied to fruit in the pathway. The

only pathway ‘‘opened’’ by this rule,

and thus the only pathway

appropriately considered in a risk

assessment supporting this rule, is the

commercial shipment of citrus fruit

from Argentina to the continental

United States. Other pathways (e.g.,

backyard fruit smuggled by airline

passengers or placed in the mail) would

exist with or without this rule, and thus

did not fall within the scope of the risk

assessment prepared for this rule.

Commercial shipment is the whole

pathway, and not merely a distinct stop

along the pathway as the commenter

suggests when he speaks of ‘‘traversing

the pathway as far as commercial

shipment.’’ In our risk assessment, the

commercial shipment pathway for citrus

fruit begins in the Argentine production

area and ends in the continental United

States in the ultimate consumer’s trash

can or compost pile, and this entire

pathway was considered when assessing

pest risk. The risk assessment lists all

pests of citrus in Argentina, and all

pests that can reasonably be associated

with this pathway were analyzed in

detail.

Comment: The desired result of a

Monte Carlo analysis should be

carefully defined, whereas the risk

assessment has no stated, well-defined,

goal. In our opinion, the goal that would

provide the most useful information

would be an estimate (and its

uncertainty) of the average annual

likelihood that the importation of

Argentine citrus fruit will result in a

pest outbreak in the United States. If

this is the intended goal of the analysis,

37636 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

APHIS must reconsider its use of any

distributions that reflect year-to-year

variability. The distribution for the

number of shipments of fruit that will

be shipped to the United States was

constructed ‘‘to allow for variation in

the frequency of shipments that might

result from variation in production,

frequency of shipments that are cleared

for shipment, and variation in market

demands in the United States.’’ If the

intended goal is to estimate an average

likelihood of a pest outbreak, APHIS

should ignore year-to-year variability in

this value and instead construct a

distribution that accounts only for

uncertainty in the value for the average

number of shipments that will be

shipped to the United States. The same

would apply for any other year-to-year

variabilities included in the probability

estimates, unless they were correlated.

No explicit mention is made of such

variabilities in the discussions of the

other probability estimates, but the

discussion of these estimates is

inadequate. If there are correlations,

such as that explicitly discussed in

section 8.e P8 of the risk assessment,

then such correlations have to be taken

into account. One way to do so would

be to incorporate the year-to-year

variability together with the correlations

in the modeling. Each iteration of the

Monte Carlo assessment would then

require a nested loop that averaged over

multiple years in order to obtain the

long-term average.

Response: We disagree with the

commenter’s statement that the risk

assessment has no stated, well-defined

goal. The overall purpose of our risk

assessment is stated in the first sentence

of that document, i.e. ‘‘* * * to

examine plant pest risks associated with

the importation into the United States of

fresh citrus fruit grown in certain areas

of Argentina.’’ Similarly, with regard to

our use of Monte Carlo simulation

methods to account for uncertainty in

estimating probabilities, we stated the

following in the first paragraph of

section 8, Likelihood of Introduction

(the only section of the risk assessment

in which Monte Carlo simulation

methods were used): ‘‘For the pests

listed in Table 6, we estimate the

likelihood of introduction using a

quantitative method referred to as

‘probabilistic risk assessment’ or

‘probabilistic scenario analysis.’ The

purpose of a probabilistic risk

assessment is to estimate the likelihood

of an undesirable outcome (bad event).

The bad event is represented by the

endpoint of the risk model, i.e.,

introduction of a quarantine pest. Our

method has four basic components:

Scenario analysis, development of a

mathematical model, estimation of

input values for the likelihood model,

and Monte Carlo simulation * * *.’’

Thus, the purpose of the Monte Carlo

portion of the risk assessment is also

stated clearly, i.e., to estimate the

likelihood that quarantine pests will be

introduced.

The goal suggested by the

commenter—to provide ‘‘an estimate

(and its uncertainty) of the average

annual likelihood that the importation

of Argentine citrus fruit will result in a

pest outbreak in the United States’’—is

a reasonable approximation of our

stated goal with a slightly different

endpoint. As explained in the risk

assessment, ‘‘introduction’’ of a pest

means entry and establishment (i.e.,

reproducing, self-sustaining population

of the pest). Pest outbreak is one

possibility for the next step if we were

to continue our scenario. We have used

pest outbreak as our endpoint in

previous risk assessments. However, in

this risk assessment, we chose pest

introduction as our endpoint. Use of

pest introduction as the endpoint is

more conservative (more pest

exclusionary) than using pest outbreak.

Estimates of the likelihood of outbreak

would be lower than estimates of

introduction because additional events

would have to occur before the

introduction would lead to an outbreak.

The commenter also states that

‘‘APHIS should ignore year-to-year

variability in this value and instead

construct a distribution that accounts

only for uncertainty in the value for the

average number of shipments that will

be shipped to the United States.’’ These

remarks are premised on the belief held

by some risk assessors that variability

must be dealt with separately from

uncertainty in all cases; however, the

utility of this approach in all cases has

not been demonstrated. In the case of

our risk assessment, we believe that

separating other forms of uncertainty

from variability (i.e., year-to-year)

would obscure, rather than illuminate,

the issue. Commercial shipments of

citrus from Argentina have never

entered the United States; there are no

data that would allow us to characterize

the expected year-to-year variability in

quantity imported. Although the actual

number of shipments would vary on a

year-to-year basis, the data do not exist

to characterize that variability. There is

considerable uncertainty regarding the

quantity of shipments. That is why we

used a normal distribution that is not

bounded above or below the mean.

Finally, with regard to the

commenter’s suggestion that we

incorporate year-to-year variability

together with correlations in the

modeling, we did consider the

implications of possible correlations

among the nodes, but we determined

that there were not any correlations that

would affect the calculations in the

Monte Carlo simulation.

Comment: APHIS uses a simple

multiplicative mathematical model to

estimate the frequency of pest outbreaks

in the United States. The estimated

number of shipments of citrus fruit is

multiplied by eight probability

distributions to arrive at the final

distribution for the likelihood of a pest

establishing itself in the United States.

If each stage of the process were truly

independent of all preceding stages, and

if it were certain that all fruit would

pass through each stage of the process,

then this would be a simple, accurate

model to describe the likelihood of an

exotic pest establishing itself in the

United States. However, we do not

believe that each stage is independent of

the all preceding stages, nor do we

believe that it is certain that all fruit will

pass through each stage of the process.

The risk assessment’s mathematical

model should take into account the

correlation of the stages and potential

for the failure of fruit to pass through all

those stages.

Response: We believe that the

commenter has misinterpreted the risk

model as a graphical representation of

the risk mitigation process, which it is

not. The steps in our model are

consecutive—for example, fruit must be

harvested before it can be taken to the

packinghouse—which could give the

impression of dependence, but the risks

examined at each step are independent;

the risks examined in one node do not

have a direct impact on the risks

examined in the next. Although certain

of the risk mitigation steps are

represented in the risk model, the model

accounts for other steps (e.g., biological)

that are independent of human

activities. For example, node P7 (figure

2 on page 30) is stated as ‘‘pest locates

suitable host.’’ Clearly, this is not a risk

mitigation step that can be skipped, it is

a representation of the probability that

a pest will find host material should it

enter the United States. This probability

is not correlated with the other nodes.

The scenario should be viewed

according to the description in the risk

assessment:

First, we use the method of scenario

analysis to conceptualize the events (referred

to as nodes) that must occur before the

endpoint or ‘‘bad event’’ (e.g., introduction of

Anastrepha fraterculus or Elsinoe australis)

can occur. Scenario analysis provides a

conceptual framework for assessing and

managing risk. Before the quarantine pest can

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37637

be introduced, all of the events shown in the

model must occur.

Regarding the commenter’s statement

‘‘however, we do not believe that each

stage is independent of the all preceding

stages,’’ we disagree and believe the

nodes are independent; it is not possible

to address this comment more

specifically without further information

from the commenter about which nodes

he believes are correlated with others.

We have discussed the basis for our

belief in the independence of the nodes

elsewhere in this document and address

the issue in the addendum that is

available from the person listed under

FOR FURTHER INFORMATION CONTACT.

Regarding the commenter’s statement

‘‘nor do we believe that it is certain that

all fruit will pass through each stage of

the process,’’ we would point out that

the probabilities assigned to each node

that represents a risk mitigation step

relate directly to a ‘‘failure’’ of that

particular step (e.g., pest not detected,

pest survives treatment), thus the

possibility of failure in each of the

stages was considered in the risk

assessment. Further, this rule requires

that only fruit that passes through each

stage of the process may be approved for

entry into the United States. SENASA

inspectors will be present at each stage

to supervise, confirm, and document the

successful application of each of the

required mitigations, and a

phytosanitary certificate issued by

SENASA confirming that the fruit has

been produced in accordance with the

requirements of this rule must

accompany each shipment of fruit

exported to the United States.

Finally, the commenter states that we

used our model to estimate the

frequency of pest outbreaks, but, as

noted in our response to the previous

comment, that is not the case. As shown

in Figure 2 on page 30 of the risk

assessment, the endpoint of our risk

model for the likelihood of introduction

was ‘‘pest establishes.’’ International

guidelines for pest risk analysis (FAO

1996, as referenced in the risk

assessment) define introduction as pest

entry plus establishment.

Comment: APHIS selected an 18-kg

box of fruit as the ‘‘risk unit’’ for the risk

assessment and bases all estimates of

probability on this unit. This is not

appropriate for all steps, perhaps any

step, in the analysis. For the first four

stages of the pathway defined by the

risk assessment (i.e., until the fruit is

boxed at the packinghouse), the fruit are

acted on independently of the boxes in

which they will be placed. Moreover,

the processes of storage, sorting, and

packing occur in such a way that the

fruit become fairly well randomized.

Thus if p1p2p3p4 are the ‘‘per fruit’’

probabilities designated as P1, P2, P3,

and P4 on a ‘‘per box’’ basis in the risk

assessment, then if p1p2p3p4 are

independent (but see below), the

probability for a box containing n fruit

to be infection-free after the fourth stage

is 1-(1-p1p2p3p4) n. But this cannot in

general be written as the product

P1P2P3P4 (as is done in the risk

assessment) where P1 through P4 are

independent, and it cannot even be so

approximated if the product p1p2p3p4 is

reasonably large, as certainly occurs in

the unmitigated situation. The natural,

indeed the only, unit for consideration

is the individual fruit. Using individual

fruit will also allow straightforward

analysis of the experiments that have

been or can be performed to test efficacy

of various treatments or actions.

Response: As noted elsewhere in this

document, we believe that a box of fruit

is the most appropriate risk unit. No one

unit is perfect for each node; prior to

packing there is mixing of the fruit from

an orchard. Once the fruit are packed,

they are no longer independent of each

other, and it is boxes, and not

individual fruit, that will be shipped

to—and, in all likelihood, remain in—

specific destinations in the United

States. Even though no one unit is

perfect for each node, we decided that

it would be most transparent,

defensible, and correct to use a

consistent risk unit throughout the

model. The primary problem perceived

with using individual fruit as the risk

unit was the different size of the various

fruit being considered (i.e., lemons,

oranges, and grapefruit). Separate

modeling for each type of fruit would

have complicated the assessment

significantly and needlessly; the expert

group did not believe that separate

modeling would improve the accuracy

of the risk estimates, especially given

the inherent uncertainties in the input

parameters.

As explained in the risk assessment

(section 8.e.F1, p. 29), in each step of

the scenario, the probabilities were

estimated for one box of fruit. The

commenter asserts:

Thus if p1p2p3p4 are the ‘‘per fruit’’

probabilities designated as P1, P2, P3 and P4

on a ‘‘per box’’ basis in the risk assessment,

then if p1p2p3p4 are independent (but see

below) the probability for a box containing n

fruit to be infection-free after the fourth stage

is 1-(1-p1p2p3p4) n. But this cannot in general

be written as the product P1P2P3P4 (as is

done in the risk assessment) where P1

through P4 are independent, and it cannot

even be so approximated if the product

p1p2p3p4 is reasonably large, as certainly

occurs in the unmitigated situation.

We believe that assertion is

inappropriate because it mixes units,

first assuming a per-fruit probability,

then a per-box probability. We were

consistent throughout the risk

assessment and used per-box

probabilities for each node.

Comment: To correctly model the

mitigated situation, more information

should be presented about exactly what

happens when citrus black spot or sweet

orange scab is detected on fruit destined

for the United States. Is the entire

shipment prohibited from entering the

United States? What about other

shipments en route from the same

grove? These do not appear to have been

accounted for in the probability

distributions for the risk assessment.

The proposed regulations require that

the grove be removed from the export

program for the duration of the growing

season if citrus black spot or sweet

orange scab is detected upon any

required inspection, including

inspection at the port of first arrival.

Would the removal of such groves from

the export program affect any of the

distributions in the risk assessment? It

certainly affects the structure of the

overall probability model.

Response: As described in the

proposed rule and noted by the

commenter, should any of these

diseases be detected on fruit destined

for the United States, the entire

shipment will be rejected and the grove

will be eliminated from the program for

the remainder of the shipping season.

These events—the rejection of

shipments and the elimination of

groves—can be viewed as successful

applications of the systems approach

and, as such, contribute to the risk

reductions estimated in our risk

assessment. Because the probabilities

assigned to each node that represents a

risk mitigation step relate directly to a

‘‘failure’’ of that particular step (e.g.,

pest not detected, pest survives

treatment), our explicit focus was on

failures rather than on successful

applications of the systems approach.

Those successes were, however,

inherently reflected and accounted for

in the appropriate probability

distributions in the risk assessment.

Comment: APHIS makes no attempt to

account for the number of fruit in a box

that are affected or for the number of

pests affecting each fruit. Certainly, if

several pieces of fruit in a given box

were infested with fruit flies, the

probability of the pest establishing itself

in the United States as a result of the

contaminated box would be much

higher than if only one fruit was

infected, as is explicitly acknowledged

in section 8.e P8 of the risk assessment.

37638 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

Because the ranges for these variables

are large (ranging from zero to the

maximum number of fruit in a box and

from zero to a large number of pests per

box), accounting for variability in the

number of infested or infected fruits per

box and for the number of pests per fruit

(or box) could have a large impact on

the results of the risk assessment.

Response: As stated in the risk

assessment (section 8.e P1, p.29), we

considered the possibility that more

than one fruit in a box might be infested

with fruit flies (‘‘Specifically, this node

represents the probability of one or

more individual fruit in a box being

infested by any of the four species of

fruit flies.’’).

However, because the likelihood that

any individual fruit will be infested is

low (mode of distribution = 0.00009),

and because the fruit are mixed

thoroughly prior to packing, the

likelihood that multiple fruit within a

single box will be infested is

considerably smaller than 0.00009. As

indicated in the quote above, our

estimates accounted for this possibility.

Regarding multiple larvae, the most

likely way (virtually the only way) that

one of these fruit fly species could

become established as a result of the

importation of infested fruit is if there

are multiple larvae in a particular fruit.

A reasonable consideration of this

situation leads to the conclusion that

unless multiple larvae are present, it

would be nearly impossible for a

breeding pair to form. Thus, multiple

larvae infesting a given fruit was the

primary factor in our estimate. In

addition, it should also be remembered

that this rule will require all susceptible

fruit to be treated according to a

treatment schedule with a documented

efficacy of 99.9968 percent.

Comment: APHIS states, ‘‘The nodes

in our scenario (risk model) represent

independent events that must all take

place before an introduction can occur.’’

However, it is not sensible to believe

that the eight stages considered in the

APHIS risk assessment are truly

independent, or that the diagram (Figure

2 of the risk assessment) adequately

represents the process of importation of

citrus fruit. The model used in the

assessment, which consists solely of

independent stages, appears to have

been selected to agree with APHIS’s

‘‘Detailed Description of the PPQ

Pathway-Initiated Qualitative

Commodity Pest Risk Assessment,

Version 4.1’’ for qualitative assessments.

However, these guidelines are incorrect,

even for a qualitative risk assessment. It

may not be possible to construct such a

linear sequence of steps to adequately

represent the movement of a

commodity—a more complex diagram

may be necessary. Moreover, even if it

is possible to construct such a sequence

of such steps, it is incorrect to make

estimates independently for each step.

What is required are the conditional

probabilities for subsequent steps, based

on the prior steps in the sequence.

Response: We consider it completely

reasonable, given the parameters of the

model, that all eight nodes are

independent. Indeed, the model was

constructed with the express purpose of

constructing a model with independent

nodes (events), and an expert review of

the model conducted by the Harvard

Center for Risk Analysis reported in the

journal Risk Analysis (Gray et al., 1998)

has validated our model and its

assumption of independence. Without

specific details from the commenter as

to where and how dependencies might

affect the model and its outcome, it is

not possible to address this comment in

detail except to repeat our statement

that they are independent. Our model

provides a framework for estimating

risk, and we (and others, as noted

above) believe the guidelines are valid.

The model we selected has proven itself

over the years, and for several

commodity/pest combinations, to be an

efficient means of estimating this type of

risk. While we acknowledge that there

are alternative ways of estimating this

type of risk, we do not believe that using

a different model would result in a

substantively different outcome.

The risk model (scenario) was not, as

stated by the commenter, offered to

represent the process of importation of

citrus fruit. The process was explained

in the proposed rule, and details of the

proposed risk mitigation program were

listed in the risk assessment on pp. 26–

28. Nor was our risk scenario offered to

represent each mitigation measure in

the proposed program; rather, it

represents ‘‘independent events that

must all take place before an

introduction can occur.’’ The frequency

of shipments/number of boxes (F1) and

four of the eight nodes (P4, P6–P8) are

not affected by risk mitigation measures.

P1 is affected by standard and special

pest control activities, P2 and P3

represent inspections for pests, and P5

represents a variety of treatments

depending on host and pest.

The commenter asserts that the model

appears to have been selected to agree

with APHIS’ guidance for performing

qualitative risk assessments, when in

fact our baseline scenario (risk model)

for these risk assessments was

developed before our qualitative

process; the qualitative process is based

on the probabilistic scenario. The

commenter continues by stating:

‘‘However, these guidelines are

incorrect, even for a qualitative risk

assessment. It may not be possible to

construct such a linear sequence of

steps to adequately represent the

movement of a commodity—a more

complex diagram may be necessary.

Moreover, even if it is possible to

construct such a sequence of such steps,

it is incorrect to make estimates

independently for each step.’’ As stated

above, the scenario was never intended

to represent movement of a commodity.

As we explained in the risk assessment,

the nodes in our scenario represent

independent events that must all take

place before an introduction can occur.

Regarding the commenter’s statement

that ‘‘a more complex diagram may be

necessary,’’ we disagree. We believe that

the events described in the risk model

are necessary and sufficient for pest

introduction. The commenter also states

that ‘‘What is required are the

conditional probabilities for subsequent

steps, based on the prior steps in the

sequence.’’ Conditional probabilities

would be inappropriate because the

nodes are independent.

Comment: APHIS’ failure to account

for human error and failure modes that

could result in skipping one or more of

the eight stages in its model is the most

significant structural error in the

assessment. It is inconceivable that 1.2

million boxes per year of fruit could all

be treated forever according to the risk

mitigation program without a single

mistake. Some stages of the systems

approach are likely to be omitted at

times through negligence, accident, or

design. Since some of the steps greatly

reduce pest survival (assuming the pest

traverses the step), even small

probabilities for omission of such steps

must be included in the analysis. APHIS

should have used fault tree analysis in

its assessment to evaluate the areas

where failure can occur.

Response: All of the estimates for

model inputs that are affected by human

activities (P1 through P4) are based at

least in part on a consideration of

human error. For example, the most

obvious reason that a pest would not be

detected at harvest (P2) or during

packing (P3) would be an insufficient

inspection (i.e., human error). The

possibility of human error in fungicide

applications is considered in P1 and the

failure of post-harvest treatments is

considered in P4. The other nodes are

based either on marketing decisions (F1,

P6) or pest biology (P5, P7–8). We do

not believe that fault tree analyses are

required in areas where failure can

occur, as all of the nodes in our model

that have a human component represent

a ‘‘failure’’ of the system.

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37639

Comment: APHIS attempts to account

for human error in some stages of the

model, but ignores it in other stages.

When constructing a distribution for

sweet orange scab infection rates,

APHIS claims to account for the nature

of the sweet orange scab fungus and the

possibility of human error in fungicide

applications. However, it is impossible

for us to review the appropriateness of

the distribution constructed by APHIS’

experts because APHIS does not

describe in detail how it accounts for

the possibility of human error.

Response: The direct data we had

available when preparing this

distribution were limited, and we

explicitly acknowledged that in the risk

assessment. As noted by the commenter,

we recognized that human error (e.g.,

the improper or incomplete application

of the fungicidal sprays) would limit the

effectiveness of this aspect of the

program. However, there are no

objective criteria that one can use to

move from recognizing that there is the

possibility of human error in fungicide

application to an estimate of how much

human error there is likely to be. There

is no database that can be used to

predict the frequency or severity of

human error in fungicide applications,

and little or no direct experimental

evidence exists from which one can

derive estimates for the effects of human

error. We recognized, therefore, that

there would necessarily be a large

element of uncertainty in our estimates

of potential human error, which we

considered along with the biology of

sweet orange scab in estimating disease

incidence; that uncertainty is evident in

the fact that the experts agreed that the

disease incidence might range from 0.1

to 30 percent. We believe that the

distribution we constructed

appropriately accounts for the

uncertainty in our estimates of the

effects of human error.

Comment: APHIS takes no account of

the possibility of failure modes

associated with the cold treatment for

fruit flies. Treatment schedules for fruit

flies are based on a demonstrated

survival rate of 0.00003. This survival

rate is the mode of the distribution

selected to characterize the probability

that fruit flies will survive cold

treatment. If any boxes of fruit escape

cold treatment (as will almost certainly

happen for a small fraction of the 1.2

million boxes), the chance of fruit fly

survival increases dramatically (by a

factor of 33,000) for those boxes. Failure

modes could easily be incorporated into

the analysis by adding a Bernoulli

function or a Dirac delta function to

steps that could accidentally be

skipped.

Response: The process of research and

development for establishing

commodity treatments is well

documented in the scientific literature.

Before any treatment is accepted,

confirmatory tests must be completed to

simulate treatments under actual

treatment conditions. When fruit are

treated, monitoring devices are placed

to record the conditions of the

treatment. Before fruit are allowed

entry, the treatment record is verified to

ensure that the fruit were treated

according to the treatment schedule. If

the fruit were not treated according to

the schedule, they would be denied

entry. This requirement directly

addresses the possibility of failures in

the application of the cold treatment.

Comment: The principal failure of the

risk assessment with respect to the

probability distributions is the failure to

cite any credible data underlying their

selection, and the failure to provide any

documentation on their derivation.

Where some studies are cited to provide

a basis for the derivation, APHIS

provides only vague references.

Examination of the rulemaking record

turns up summary data from various

studies in Argentina that may

correspond to those references, but there

is no way a reviewer can be absolutely

certain. No analyses of the studies are

provided or referenced in the risk

assessment or the rulemaking record, so

the basis of the risk assessment

estimates for mean values and

variability or uncertainty cannot be

evaluated. It is clear, however, that the

entire risk assessment fails to

distinguish variability and uncertainty.

Response: The probability density

functions (PDF’s) used by APHIS in the

Argentine citrus and other assessments

are what Hoffman and Kaplan refer to as

‘‘subjective probability distributions’’ in

a recent article in Risk Analysis, An

International Journal (‘‘Beyond the

Domain of Direct Observation: How to

Specify a Probability Distribution that

Represents the ‘State of Knowledge’

about Uncertain Inputs,’’ Vol. 19, No. 1,

1999, pp.131–134). They are subjective

precisely because no direct evidence

existed to allow construction of a

objective probability distribution. As

emphasized by Hoffman and Kaplan,

this is the norm in probabilistic risk

assessment.

In no case were data available that

could be used to directly specify a PDF,

that is, data that represented results of

studies that provided an estimate of the

parameter with associated information

regarding the range of values, variability

or uncertainty in the data, and the shape

of the distribution. ‘‘Risk assessment

does not legitimately focus on filling the

information gaps, but rather on making

a decision in the absence of

information,’’ (Orr, et al., 1994).

Although doing a risk assessment under

these conditions may be considered

unacceptable by non-practitioners, the

only way to complete this type (and

most types) of risk assessment is to

make the best estimate possible based

on whatever indirect information is

available. In most cases, there were no

indirect data either (results of

experiments conducted to test a

particular hypothesis). However, we

relied on the best available scientific

information and, in virtually every case,

reliable data and information existed

that related to the parameter for which

an estimate was needed. For example,

although there may be no data per se

regarding the likelihood that

Xanthomonas axonopodis would be

‘‘. . . able to complete disease cycle’’

(P8) following entry into the United

States on fruit for consumption, there is

a wealth of scientifically valid data and

information, and conclusions in

scientific papers, that demonstrate that

the likelihood is extremely low.

Although we did not, in all cases,

explicitly link sources of information to

the PDF’s in which the information was

used, our knowledge of each of the

insect pests and diseases is summarized

in the pest data sheets contained in the

risk assessment’s appendices and our

sources of information are cited in each

pest data sheet and in section III

(References) of the risk assessment.

Additional information regarding the

construction of each of the distributions

is contained in the addendum to the risk

assessment that is available from the

person listed under FOR FURTHER

INFORMATION CONTACT.

Regarding the statement that ‘‘it is

clear, however, that the entire risk

assessment fails to distinguish

variability and uncertainty,’’ we call the

commenter’s attention to section 8.c

where we stated:

We were uncertain about the input values for

the likelihood model. This is typical for risk

assessments. Uncertainty in the estimated

values may arise from (among other things):

• natural variation over time

• natural variation from place to place

• data gaps or unconfirmed data

• relationships among multiple

components in a node.

This statement documents the fact

that we considered both variability and

uncertainty. While it is true that we did

not model variability or uncertainty

separately, doing so is not a common

practice, and this approach is useful

only in certain circumstances. While

this approach may provide more

detailed information, it is not a given

37640 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

that additional detail can necessarily be

equated with greater accuracy. In the

case of this particular risk assessment—

and virtually any plant pest risk

assessment—separating variability from

other forms of uncertainty would

constitute overinterpretation of

available data.

Comment: The risk assessment states

that all the distributions are based on

the professional judgment of the team of

entomologists who developed the risk

assessment. That professional judgment

appears to have been based on research

or actual data in only a few instances.

APHIS certainly must have access to

data from inspections and from previous

infestations of pests in the United

States. The use of such data would

result in much more credible

distributions than those derived solely

from professional judgment. It is

possible, even likely, that distributions

based solely on professional judgment

(i.e., without reliance on data) are

wildly inaccurate, placing the reliability

of the analysis in serious question.

Response: We did indeed use those

data whenever they were available, and

they were cited in several locations (e.g.,

Alfieri et al., 1994; Brown et al., 1988;

Gould, 1995; etc.). The distributions

were not based solely on professional

judgment, i.e., ‘‘without reliance on

data’’ as suggested by the commenter.

But for many of the nodes, no direct

data existed to provide estimates for the

input distributions, and professional

judgment informed by the ‘‘indirect’’

sources of information available (e.g.,

scientific literature regarding a

particular pest, interception records,

etc.) was used according to international

standards and accepted practice.

Comment: In no case does APHIS

discuss the decision criteria used to

select the type of probability

distribution (normal, lognormal, beta),

let alone why only these three particular

distribution types were used. In most

cases (such as in the construction of

distributions for fruit fly and citrus

canker incidence, the probability that a

pest is detected at harvest, the

probability that the pest is detected in

the packinghouse, the probability that

the pest survives shipment, etc.), no

justification beyond ‘‘expert judgment’’

is given for the parameters selected to

characterize the distributions. While we

recognize that extensive data originally

may not have been available to

characterize, such deficiencies should

have been recognized very early in the

process and further studies carried out

to fill in the gaps in data.

Response: In addition to the three

distribution types identified by the

commenter, we also estimated several

nodes using another type of probability

distribution, truncated lognormal.

Distributions were chosen to reflect the

current state of scientific knowledge.

We explained the nature of each

distribution chosen; in fact, we provide

a separate section for each distribution.

The explanations can be found in

section 8.e., with titled subparts for each

node (probability distribution) used for

the fruit fly simulation, and section 8.f.,

with titled subparts for each probability

distribution used for the three diseases.

We provided justification for our choice

of distribution in many, but not all,

cases. For example, in the discussion of

the choice of distribution to represent

the likelihood that fruit fly larvae will

survive post-harvest treatment (section

8.e P5) we state:

Treatment schedules were based on

demonstrated efficacy of probit 9 (99.9968

percent) mortality. This corresponds to a

survival rate of 0.00003 (0.003 percent). We

represented survival as a lognormal

distribution with a mean of 0.0001 and a

standard deviation (sd) of 0.00011. A sd of

0.00011 was chosen because the resulting

distribution has a mode (peak of the

distribution) at 0.00003.

In this case, although we did not offer

a discussion of why a lognormal

distribution was used, since ‘‘there is a

significant body of work that shows a

particular family of distributions to

match the variability in the type of

variable in question’’ (D. Vose, in press),

insect response to treatments such as

this is distributed lognormally. The

statistical procedure (probit analysis)

that led to the probit 9 estimate (referred

to above and in the risk assessment) is

based on the assumption that response

is distributed lognormally. This

phenomenon and the lognormal

distribution lies at the heart of this

branch of science and is documented in

the scientific references provided in the

risk assessment. Additional information

regarding the selection of distribution

types, including those not discussed in

detail in the risk assessment, is

contained in the addendum to the risk

assessment that is available from the

person listed under FOR FURTHER

INFORMATION CONTACT.

Comment: Some justification needs to

be provided for the estimates in the risk

assessment for situations in which some

data are available. For example, APHIS

acknowledges that field and laboratory

research has been performed on fruit fly

infestations in commercial citrus

production, yet it does not specify how

(or even if) this research was used to

derive the fruit fly infestation

distribution, beyond stating that the

entomologists working on the risk

assessment used their professional

judgment. Neither risk assessment nor

the rulemaking record contains any

documentation of either the evidence

used or the methodology used to codify

that evidence as probability

distributions.

Response: Our knowledge of each of

the insect pests and diseases, which,

given the lack of directly applicable data

in many cases, played an important role

in the formulation of our estimates, is

summarized in the pest data sheets

contained in the risk assessment’s

appendices, and our sources of

information are cited in each pest data

sheet and in section III (References) of

the risk assessment. Where direct

information was available, that

information was identified; the same

holds true for the use of expert

judgment in arriving at our estimates.

The addendum to the risk assessment

that is available from the person listed

under FOR FURTHER INFORMATION

CONTACT identifies, for each node, the

direct information and expert

information that was available and

provides a discussion of how the

available information was used in the

construction of the distribution.

With regard to the commenter’s

specific example, we had no direct

evidence of what the past, present, or

future fruit fly infestation levels may be

in Argentina. But regardless of where

citrus is produced, we are confident that

our distribution, which was based on

expert judgment informed by experience

with fruit flies and by information

gleaned from numerous cited sources,

reflects the entire realm of possibilities.

As stated in section 8.e P1 of the risk

assessment:

The minimum infestation rate used in the

calculations was 0.000535 (e.g., one infested

lemon per 280,400 lemons). The maximum

infestation rate sampled for calculations was

0.495 (e.g., half of all boxes or one infested

grapefruit per every 100 grapefruit).

Thus, because of our uncertainty, we

used a distribution providing values

representing infestation levels from

where the pest is nearly nonexistent

(one lemon out of 280,400) to an

infestation level that would stop

production (half of all boxes infested).

Comment: The number of boxes of

fruit that will be shipped to the United

States from Argentina is estimated as 1.2

million 18-kg boxes of fruit per year.

This information was provided by citrus

industry representatives in Argentina.

From this single piece of data, APHIS

constructed a normal distribution with

a mean of 1.2 million and a standard

deviation of 200,000 to represent the

frequency of citrus shipments each year.

APHIS states that this distribution was

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37641

constructed to allow for variation in the

frequency of shipments that might result

from variations in production, the

frequency of shipments cleared for

export, and market demands in the

United States. Quite apart from the

question as to whether a year-to-year

variability is the correct statistic to

evaluate in this context, APHIS does not

specify how it arrived at a standard

deviation of 200,000—APHIS presents

no evidence whatsoever, nor provides

any methodology. It is certainly possible

to provide a plausible methodology for

obtaining some value for variability; for

example, basing it on distributions for

the U.S. importation of citrus fruit from

other countries, or on distributions for

other exports from Argentina, or even

citrus exports to countries other than

the United States. Moreover, this annual

variability may not be required, and

should certainly not be used in the risk

assessment as APHIS has used it.

Response: While it is true that this

situation could have been analyzed in

greater detail, conducting the suggested

analysis would represent

overinterpretation of available data. We

believe that the suggested analysis

would obscure the situation, provide a

false sense of security, and probably

lead to a less accurate estimate.

In constructing this distribution, the

expert group started with the point

estimate of 1,200,000 boxes per year

supplied by Argentina; the group then

considered whether it was reasonable to

assume central tendency. The group

agreed that the point estimate from

Argentina was the best available

estimate, but that values both above and

below 1,200,000 were possible (i.e., the

distribution should demonstrate central

tendency around 1,200,000). The group

discussed a variety of factors that could

affect the number of boxes imported,

e.g., variation in harvest, variation in

U.S. demand, unanticipated costs of the

export program leading to less interest

by growers, unanticipated success from

the exporters’ point of view leading to

greater interest by growers, etc. There

were, however, no data available that

would allow us to estimate the effects

these factors would have on the number

of boxes shipped. Thus, the standard

deviation of 200,000 chosen by the

expert group represents uncertainty and

not, as the commenter suggests,

variability per se, in the model. (As

noted in a recent paper published in the

journal Risk Analysis (Gray et al., 1998),

‘‘[k]nowledge of variability must be

based on empirical estimates, otherwise

it is another source of uncertainty.’’)

With no information suggesting any

particular distribution type, the group

believed that a normal distribution was

most reasonable (i.e., symmetrical

uncertainty around the mean/mode/

median). They agreed that although the

actual number of boxes imported would

almost certainly be other than exactly

1,200,000 per year, they had no

legitimate reason to believe it would be

higher as opposed to lower or vice

versa, or what the year-to-year

variability would be. Using the software

package Risk View TM (Palisade Corp.,

Newfield, NY) and trial and error, the

group specified the (standard deviation)

value that provided what they

considered to be appropriate positions

for the 5th and 95th percentile values in

the distribution.

Comment: In section 8.f. P1 of the risk

assessment, APHIS identifies data for

sweet orange scab and citrus black spot

infection rates in Argentina. It claims

that limited field surveys indicate that

39 percent of sampled trees in control

plots (untreated) bear fruit with

evidence of sweet orange scab. The

distribution constructed by APHIS for

sweet orange scab infection is a beta

distribution with a mean probability of

0.5 that a box of produce is infected.

How is APHIS’s distribution related to

the infection rates in field surveys? Why

does APHIS select a beta distribution to

characterize this probability? How does

APHIS arrive at the two parameters

necessary to characterize the beta

distribution? There is no information in

the risk assessment or the rulemaking

record to support the constructed

distributions. Similarly, APHIS cites the

results of field surveys for citrus black

spot as finding 14 percent and 82

percent of sampled fruit infected with

citrus black spot in 1994 and 1995, and

56 percent of sampled trees infected in

1996. APHIS goes on to say, ‘‘Our expert

information predicted that the incidence

of citrus black spot, on a per box basis,

in untreated groves would range from a

minimum of 10 percent to a maximum

of 100 percent with a most likely value

of 50 percent.’’ APHIS then proceeds to

construct a beta distribution with a

mean of 60 percent and a mode (most

likely value) of 67 percent. Again, there

is no information in the rulemaking

record or the risk assessment to indicate

how this distribution incorporates either

the results of the field surveys or the

expert information.

Response: As stated in the risk

assessment document, ‘‘our estimates

* * * were based on limited field

survey data provided by Argentina and

expert information provided by

scientists familiar with citrus

production in Argentina and/or the

pathogen.’’ Because the field survey

data were limited, our expert estimates

of these probabilities, which were

informed by the body of scientific

knowledge cited in the references and

summarized in the pest data sheets,

reflected what we considered

appropriate levels of uncertainty, and

the distributions were derived to reflect

those estimates.

The experts relied on professional

judgment to construct probability

density functions that accurately

represented their understanding of the

available information. For both citrus

black spot and sweet orange scab, the

experts, after discussing available

scientific and other information,

identified the general shape of the

distributions that were needed to

account for all identified or assumed

variation and uncertainty. In both cases,

the experts agreed on a beta

distribution, and discussions ensued to

establish the parameters of the chosen

distributions. The experts used an

iterative process in conjunction with the

software program Risk View TM

(Palisade Corp., Newfield, NY) to

provide instant feedback on the shape

and statistics associated with any

particular set of parameters. This was

largely trial and error, and the experts

succeeded in producing beta

distributions that represented the

group’s understanding of the available

information. The experts used a

consensus approach. The distributions

captured the full range of variability and

uncertainty considered essential by all

experts, even though they may have

represented more uncertainty than was

felt necessary by any single expert.

Comment: The rulemaking record

contains some information on the field

surveys performed in Argentina, in the

form of a very short summary of some

results of those field surveys. However,

the record omits crucial information

required to interpret these summary

results, including the protocols used for

the field surveys; complete, written

scientific documents describing the

surveys and their results; and the

contemporaneous field notes that

should have been taken during the

surveys. Despite this lack of

information, we believe that APHIS’

interpretation of the results is incorrect,

as applied in its risk assessment.

Adding up the results of the 1996 field

results, in which 5 fruit per tree were

sampled from each of 300 randomly

selected trees, gives:

37642 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

Number of

infected fruit

per tree

Number of trees (out of 300

in each case)

Sweet orange

scab in

oranges

Citrus black

spot in

lemons

0 181 133

1 95 78

2 22 46

3 2 25

4 0 15

503

(For this analysis, we do not

distinguish Elsinoe australis from

Elsinoe fawcettii.)

The incidence of infection (per fruit)

was 9.67 percent for sweet orange scab

in oranges and 21.3 percent for citrus

black spot in lemons. APHIS apparently

took the fraction of trees infected to be

equal to the number of trees with

observed infected fruit divided by the

total number of trees (119/300=39.7

percent for sweet orange scab in

oranges, 167/300=55.7 percent for citrus

black spot in lemons). This is incorrect,

however, since not all fruit on each tree

were examined. It is clear that not all

fruit are infected even on an infected

tree, so sampling 5 fruit per tree will

likely yield zero fruit infected from

quite a few infected trees. A simple approach to analyzing these

experimental data is to assume some

probability for a tree to be infected, and

then to assume that all the fruit on an

infected tree have an equal probability

for infection (while those on uninfected

trees have zero probability for

infection). For sweet orange scab in

oranges, this leads to a best estimate for

the fraction of trees infected of 97.7

percent, and the observations are

entirely consistent with (and

statistically indistinguishable from) 100

percent infection. In that case, with 9.67

percent fruit infected, we would expect

to see almost exactly the pattern of

detections (per tree) actually observed

(it is just a binomial distribution of

infections). For citrus black spot in

lemons, the best estimate for the fraction

of trees infected is about 64 percent,

with 33 percent of the fruit infected on

an infected tree (note that 0.64 ×

0.33=0.21, the observed fraction of fruit

infected), using the same simple model. The simple model used here leads to

binomial statistics, although it is clear

in the case of citrus black spot that there

is actually more variability than the

binomial distribution would predict. It

is not difficult to postulate a more

plausible model with the higher

variability expected because of

differences between geographic areas,

groves, or field conditions. Accurate

evaluation of the variability requires

more field data, and is required for an

adequate scientific evaluation of the

Argentine situation. Response: We acknowledged that the

information we initially provided to this

commenter did not reflect the entire

body of data that was used to support

the proposed rule. However, as we also

noted, we did forward additional

documentation to the commenter

following the close of the comment

period in response to the commenter’s

FOIA request. We understand that the

commenter is reviewing that additional

documentation, and we have stated our

willingness to thoroughly consider, and

address as appropriate, any new

scientific information that comes to

light as a result of that review that has

a material and significant bearing on

this rulemaking proceeding. With regard to the commenter’s

argument that APHIS’ interpretation of

the results was incorrect, there are

several ways to interpret and use the

data presented by the commenter to

support his argument. However, we

believe that the analysis suggested by

the commenter is based on invalid

assumptions. Specifically, although it

would be inadvisable to ‘‘assume some

probability for a tree to be infected,’’ it

would be a critical error ‘‘to assume that

all the fruit on an infected tree have an

equal probability for infection’’; this is

known to be false. That is why the five

fruit were sampled from the area of the

trees where infected fruit were most

likely. It would also be an error to

assume that on trees where none of the

five sampled fruit were infected, all fruit

were not infected. With a sample of five

fruit, it was known that not all infected

trees were identified. That is one of the

reasons why even though infected fruit

were found on only 39.7 percent of the

sampled trees, the mode and mean of

our estimate (input distribution) was

higher (50 percent). The commenter also

does not account for the fact that our

risk unit was a box of fruit, not an

individual fruit or entire tree. This is

discussed further in the response to the

next comment.

Comment: From the description in

section 8.f P1 of the risk assessment,

APHIS appears to believe that the

fraction of boxes infected is in some

simple way related to the fraction of

trees infected, since the only discussion

of the former immediately follows the

estimate of the latter in such a way as

to suggest such a connection. There is

no other discussion in either the risk

assessment or the rulemaking record,

and the values adopted by APHIS are

very similar. This is incorrect however.

The final shipping boxes are not filled

from individual trees, but in the

packinghouse after processes that will

substantially mix fruit from multiple

trees. To a good approximation, fruit

will be randomized during harvesting,

storage, and the packing process, so that

a given box will be packed with fruit

from a random selection of trees. For

sweet orange scab in oranges, the

probability for no fruit in a box to be

infected would thus be about (1-

0.0967)100 for 100 fruit per box, or 3.8

× 10¥5 if the structure of APHIS’s model

were correct. That is, the probability for

an infected box of oranges (i.e., a box

containing one or more infected fruit) in

the base case for sweet orange scab is

about 99.9962 percent. For citrus black

spot in lemons, a similar calculation

shows that the probability for a box of

lemons (150 per box) to be infected in

the base case is about 1–2.5 × 10–16,

which is 100 percent for all practical

purposes, under the same assumptions.

In fact, the structure of APHIS’s model

is not correct, so these calculations are

somewhat awry. One cannot follow a

‘‘box’’ of fruit through from harvest to

packing, since the box is not

constructed until after many processes

that operate on individual fruit

(independent of which box they finally

end up in) and may affect the

probability of infection. Thus estimating

probabilities ‘‘per box’’ at this stage is

itself a futile exercise. A better approach

is to evaluate on a ‘‘per fruit’’ basis

throughout the risk assessment.

Response: The commenter states that

it is incorrect to believe that the fraction

of boxes infected is in some simple way

related to the fraction of trees infected.

We agree that there is no way to go

directly from a sample of trees (with a

sample of fruit taken from each tree) to

either a per-fruit or per-box estimate.

However, we believe that the sample,

which is indicative of the overall

infection rate in the grove for the year

in which the sample was taken, can be

used as a starting point for an estimate

of the per-box infection rate. That being

said, our estimates were made with the

knowledge that factors existed that

argued for both (1) a lower per-box

infection rate (i.e., not all fruit on a tree

with infected fruit are infected) and (2)

a higher grove infection rate (i.e., not all

sampled trees with infected fruit tested

positive). This is one of the reasons that

even though sweet orange scab-infected

fruit were found on 39.7 percent of the

sampled trees, the mode and mean of

our estimate was higher (50 percent).

As stated in the risk assessment, ‘‘Our

expert information predicted disease

incidence, on a per box basis, to range

from a minimum of 1 percent to a

maximum of 90 percent with a most

likely value of 50 percent.’’ However,

because of the uncertainty in the

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37643

information, and because of the

uncertainty of the experts regarding the

per-box infection rate, we specified a

distribution that allowed values for

infection rates across the entire range of

probabilities from 0 through 1 (100

percent). For sweet orange scab, we

characterized our baseline estimate for

the likelihood harvested fruit was

infected (P1) with a beta (3.5, 3.5)

distribution (see Table 8 of the risk

assessment). With this distribution,

although the most likely value was 50

percent, values up to and including 100

percent were possible. The maximum

value actually used for calculations was

0.9773+, i.e., 97.7 percent. We made our

estimates according to international

guidelines for plant pest risk

assessments, which have been endorsed

by the United States, and are consistent

with common practice in risk

assessment as reported by Hoffman and

Kaplan (1999, see reference above). We

used available data and professional

judgment to represent the data in the

terms needed for the risk assessment.

With regard to our use of ‘‘per-box’’

probabilities, we have stated previously

in this document that we believe that

our selection of the box, rather than

individual fruit, as the risk unit is

appropriate. Once the fruit are packed,

they are no longer independent of each

other, and it is boxes, and not

individual fruit, that will be shipped—

to and, in all likelihood, remain in—

specific destinations in the United

States. Even though no one unit is

perfect for each node, we decided that

it would be most transparent,

defensible, and correct to use a

consistent risk unit throughout the

model. The primary problem perceived

with using individual fruit as the risk

unit was the different size of the various

fruit being considered (i.e., lemons,

oranges, and grapefruit). Separate

modeling for each type of fruit would

have complicated the assessment

significantly and needlessly; the expert

group did not believe that separate

modeling would improve the accuracy

of the risk estimates, especially given

the inherent uncertainties in the input

parameters.

Comment: For citrus black spot, some

additional data are available from the

earlier small field experiments

described in the rulemaking record.

However, these were not field surveys

as claimed by APHIS in the risk

assessment (for example, the sampled

trees were not selected at random), but

rather the control side of experiments

apparently designed to examine the

effectiveness of fungicides; again no

protocols, scientific documentation,

field notes, or analyses are included in

the rulemaking record. These small

samples showed incidence per fruit of

0/432, 0/432 and 41/216 (19 percent) for

grapefruit, and 36/252 (14 percent) and

207/252 (82 percent) for oranges. The

first and last pairs of these samples were

from the same plot in different years.

The APHIS characterization of these

surveys in the risk assessment omitted

entirely the results in grapefruit. The

results, although not field surveys, do

illustrate the possibility of no observed

infection even without fungicidal

treatments, and the high variability from

place to place and year to year.

Response: As noted by the

commenter, the data we used were

obtained through experiments using

treated and untreated control plots. It is

also the case that the risk assessment

did not explicitly cite the grapefruit data

reviewed by the commenter (which is

available in the additional

documentation that may be obtained

from the person listed under FOR

FURTHER INFORMATION CONTACT). That

being said, it is clear from the available

information that citrus black spot, as is

the case with many diseases, is more

prevalent in some years than in others.

For this reason it is entirely possible

that in some years no infection would

be observed even if fungicides were not

applied. The disease can be variable

from place to place and year to year.

This fact is not relevant to the efficacy

of the systems approach, which is

designed to mitigate the risk during

years in which disease is likely.

Comment: In the risk assessment,

APHIS makes estimates for the

probability of infection when the

mitigation measures are taken. There is

some confusion over the precise

meaning assigned to the various

mitigation measures that may

substantially affect infection

probabilities. Although APHIS does not

provide any indication of its approach

(either citation or methodology) for

estimating post-mitigation infection

probabilities, simple analyses of the

Argentine data on citrus black spot

suppression by copper oxychloride

treatment are possible, as shown in the

following example.

In those experiments, assume that the

probability for a control (untreated) fruit

to be infected is p (different in each

experiment and from season to season),

and that treatment with one application

of copper oxychloride multiplies that

probability by a factor R (different for

each treatment type, and hopefully less

than unity, to have an effective

treatment), with two applications

reducing it by R2 (one could, and

should, test this latter assumption).

Assume binomial responses (e.g.,

because all fruit are equally likely to be

infected, and treatment is equally

effective on all fruit), and use binomial

likelihood methods. We can then

estimate p and R from the available

data, together with the uncertainty on R,

if desired. For grapefruit, two of the

three available experiments show no

responses at all, so they are useless for

estimation of R. For oranges, we could

test whether two applications really

reduced the incidence equally in each

application; inspection of the data

shows that this is certainly plausible.

Applying this simple model to the

single useful experiment on grapefruit

gives a maximum likelihood estimate

(MLE) for R of 1.15 for the 1.8 percent

treatment, and 0.31 for the 3.6 percent

treatment. Thus two applications of 3.6

percent might reduce the rate 10-fold

and three applications 33-fold.

However, the uncertainty is large. This

experiment shows no effect of the 1.8

percent treatment.

For oranges, the MLE for R is 0.22 for

1.8 percent and 0.20 for 3.6 percent, so

that two applications of 3.6 percent

might reduce the infection rate 24-fold,

and three applications 118-fold. Notice

that a 24-fold reduction from the control

group rate of 36/252 is entirely

consistent with the observed 0/252 in

the 93–94 season when two applications

were made.

Such analyses could be extended in

various ways. For example, in this

model the R values for 1.8 percent are

significantly different for grapefruit and

oranges, but for 3.6 percent they are not

significantly different. The MLE for the

combined value (for 3.6 percent) is 0.25,

so that the model prediction for two

applications is a 16-fold reduction in

disease rate, and for three applications

a 128-fold reduction. With so few

experiments, and none available for

analysis with three applications (versus

one and two), one cannot test the model

hypothesis that each application simply

reduces the disease rate by a similar

amount. Apparently, more experiments

were in fact performed, but the

rulemaking record reports only

summary results that cannot be

interpreted without much more

information.

This analysis indicates the paucity of

the data available in the rulemaking

record. For grapefruit, the one available

experiment on the effectiveness on

citrus black spot of 1.8 percent copper

oxychloride treatment shows it to be

ineffective, although it is almost as

effective as 3.6 percent on citrus black

spot on oranges.

Response: The commenter offers an

alternative way to consider the

estimated efficacy of mitigation

37644 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

treatments. However, the approach is

complex and highly speculative, and in

our estimation represents an

overinterpretation of available data,

which, as the commenter notes and we

acknowledged in the risk assessment,

were limited. Copper oxychloride is a

well established treatment for citrus

black spot and sweet orange scab. Our

estimates concerning the efficacy of

these mitigation treatments are based on

expert interpretation of results that have

been obtained in a variety of studies on

the control of these diseases (for

example, as referenced in Whiteside et

al., 1988, as cited in the risk

assessment).

Comment: Only one experiment

reported in the rulemaking record

addresses the effectiveness of copper

oxychloride treatment on citrus black

spot in lemons. While it apparently

showed that the treatment was effective,

there were no details on the protocols

adopted (concentrations, number of

applications, experimental procedures,

and so forth), although a naive

calculation indicates that the incidence

was reduced more than 100-fold

(approximately 95 percent confidence

limit). In another document there are

two figures labeled ‘‘Chemical control

(Santa Clara-Jujuy),’’ apparently for

treatments in the 1993–94 and 1994–95

seasons, that appear to correspond to

suppression of citrus black spot in

Eureka lemons, but there is no

explanation of the origin of the data

used in those two figures. APHIS should

identify which treatments were applied

in the tested groves and describe the

level of disease in the region near the

tested groves. Similarly, the

effectiveness of copper oxychloride

treatment for sweet orange scab is only

demonstrated in one experiment (on

oranges) in the rulemaking record, but

the experimental protocols are not

reported (number of treatments,

concentrations, application rates,

experimental procedures, and so forth).

It is possible that some of this mitigating

effect may be due to other simultaneous

measures, such as cleaning of the

orchard floors; however, in the absence

of experimental protocols, this cannot

be determined. Moreover, the available

evidence is insufficient to adequately

characterize that effect. For a defensible

estimate of the effect of copper

oxychloride treatments on citrus black

spot and sweet orange scab, APHIS must

have experimental data demonstrating

its effectiveness under varying

conditions, in different areas, and for

different fruit. Furthermore, APHIS

must provide details of its analyses

demonstrating effectiveness, and must

show the connection between the

experimental data and the distribution

used in the risk assessment.

Response: As we have recognized in

numerous instances in this document,

there is not always a one-to-one

correlation between the experimental

data, which is limited in some cases,

and the distributions used in the risk

assessment. In this case, our estimates

on the effectiveness of the copper

oxychloride treatment, which is the

treatment that was applied in the tested

groves, are derived not solely from

evidence supplied by Argentina but also

from reports in the scientific literature

(e.g., as reported by Whiteside et al.,

1988, cited in the risk assessment).

These reports represent results that

demonstrate the effectiveness of copper

oxychloride in reducing disease

incidence under varying conditions, in

different areas, and for different fruit,

even in areas where the level of disease

is high.

Comment: The risk assessment (8.f.

P4) states that it is assumed in the

baseline that the fruit ‘‘treatments may

include, but are not limited to, washing

fruit in a detergent bath, waxing and

fungicide dips.’’ It is not clear how

much more extensive the proposed

treatment program is, since the

proposed treatment program could be

described in exactly the same fashion as

the baseline (although washing in

detergent is not prescribed). The risk

assessment (8.f. P4) also states that ‘‘the

only post-harvest treatment for

pathogens that is specifically prescribed

in the proposed export program is a fruit

dip in 200 ppm sodium hypochlorite

(bleach) for 2 minutes.’’ Actually, the

preamble and proposed rule prescribe

other specific treatments (immersion in

orthophenilphenate of sodium, spray

with imidazole, and application of 2–4

thiazalil benzimidazole and wax) that

are specifically for treatment for

pathogens (although this may depend

on one’s definition of ‘‘pathogen’’ in this

context).

Response: The fact that the proposed

treatment program examined in the risk

assessment did not take into account the

other specific treatments (immersion in

orthophenilphenate of sodium, spray

with imidazole, and application of 2–4

thiazalil benzimidazole and wax) that

were described in the proposed rule and

required by this rule can be attributed

to the fact that the risk assessment was

completed before the proposed rule was

fully developed. However, it is clear

that considering those treatments in the

mitigated scenario in section 8.f. P4 of

the risk assessment would have resulted

in a higher risk reduction rating for the

post-harvest mitigations, thus lowering

the overall risk, which we already

considered to be very low.

Comment: APHIS’s assumptions that

sweet orange scab-infected fruit is

removed with 89 percent probability at

harvest (mean value for both baseline

and mitigation program), while citrus

black spot-infected fruit is removed at

harvest with mean 50 percent

probability (baseline) and 89 percent

probability (mitigation program), cannot

be supported by any available evidence.

We see three problems with this

assumption:

• The incidence data used to support

this are largely, if not totally, postharvest incidences for latent disease, not

field-apparent incidence of disease in

unharvested fruit. Any probability for

detection during harvesting is

apparently already incorporated in such

values.

• APHIS has assumed that pickers in

Argentina make an attempt to cull

blemished/diseased fruit, but our

information indicates that pickers in

Argentina do not cull fruit; rather all

picked fruit is sent to the packinghouse

for sorting there.

The entire object of chemical and

other treatment is suppression of

disease. The disease infections in the

export groves should be latent at the

time of picking, as evidenced by the

data provided by the Argentines, so that

there is no visible evidence of disease in

harvested fruit. It should therefore be

physically impossible for the pickers to

detect latent disease.

With a reduced incidence at harvest,

in the case of citrus black spot probably

of entirely latent infections, there is no

evidence that infected fruit is more

likely to be removed by harvesters. At

minimum, APHIS needs to document

harvesting practices and obtain

experimental evidence for removal

probabilities at harvest. Such

experiments would be very

straightforward, since they simply

involve random sampling of

unharvested trees followed by sampling

of fruit harvested in the normal course

of events (and preferably also of the

fruit, if any, that is culled by the

harvesters). These should have been

incorporated in experimental protocols

at an early stage of experiment planning.

Response: The commenter states that

we used incidence data to support our

estimates regarding the removal of

diseased fruit in P2, ‘‘Pathogen not

detected at harvest.’’ This statement is

incorrect. While data on disease

incidence did affect our estimates for

the likelihood that fruit are diseased in

P1, ‘‘Harvested fruit is infected,’’ we

indicated in the risk assessment (section

8.f P2, p.36–38) that our estimates for P2

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37645

were based on a variety of factors,

including ‘‘the nature of the disease

symptoms, the skill of the picker in

recognizing diseased fruit and the

quality standards employed by a given

grove in culling diseased fruit.’’ Because

sweet orange scab symptoms are easily

seen during harvest, our estimates were

based on a higher (compared to citrus

black spot) degree of confidence that

sweet orange scab-infected fruit will be

identified and removed at harvest. The

commenter also states that the ‘‘entire

object of chemical and other treatment

is suppression of disease.’’ This

statement, which we understand to be

referring to citrus black spot, is also

incorrect. As we have stated elsewhere,

the object of the field treatments is the

prevention of the disease, and not

merely the suppression of symptoms.

Latent infections of citrus black spot

would not be observed, which is why

our baseline estimate that this disease

will be missed is higher. However, the

systems approach will reduce the

likelihood of latent infections, thus

decreasing the likelihood that diseased

fruit will be missed.

Comment: APHIS provides estimates

for the probability of detection of sweet

orange scab and citrus black spot at

packinghouse inspection. Again, no

evidence is provided to support its

estimates of 82 percent (mean: baseline)

and 95 percent (mean: mitigation

program) probability of detection of

sweet orange scab, or with 74 percent

(mean: baseline) and 95 percent (mean:

mitigation program) probability of

detection of citrus black spot. Factored

into these estimates, according to

APHIS, was the 20-day preharvest

sampling and incubation of a small

fraction of fruit.

The very existence of the 20-day

preharvest sampling and incubation

program ensures that the detection

probability at this stage is correlated

with the incidence of citrus black spot

or sweet orange scab, since the detection

probability is higher for higher

incidences. Thus, the structure of the

risk assessment model is incorrect. It is

important also to note that the detection

probability is correlated with the actual

incidence, not with the probability of

citrus black spot or sweet orange scab.

The structure of the model has to be

adjusted to account for this. In a Monte

Carlo analysis, for example, the simplest

way is to ensure that the detection

probability at this stage depends

correctly on the incidence in the

particular Monte Carlo sample.

APHIS provides no documented

evidence for the effectiveness of

packinghouse inspections in either the

risk assessment or the rulemaking

record. The Argentines provided

experimental data on the effectiveness

of ‘‘post-harvest treatments’’ or ‘‘postharvest assays’’ that presumably

assessed all events occurring at the

packinghouse, but again, because of the

failure to provide protocols,

experimental details, scientific reports,

and field notes in the risk assessment or

elsewhere, we cannot decipher what

‘‘post-harvest treatments’’ or ‘‘postharvest assays’’ means. We believe that

all the ‘‘post-harvest treatments’’ or

‘‘post-harvest assays,’’ perhaps

including any inspections, have

essentially no effect on the incidence of

latent infections of citrus black spot.

Should it be necessary to evaluate the

effect of packinghouse inspection, as

distinct from further packinghouse

treatment, the experimental procedure

would be straightforward, since all that

is required is sampling of fruit prior to

and after such inspection (and

preferably, also, sampling of rejected

fruit).

Response: The commenter’s statement

that ‘‘The very existence of the 20-day

preharvest sampling and incubation

program ensures that the detection

probability at this stage is correlated

with the incidence of citrus black spot

or sweet orange scab, since the detection

probability is higher for higher

incidences’’ is incorrect. The

packinghouse inspection and our

estimates regarding the likelihood of

detecting pests during this inspection

are independent of both the 20-day

preharvest sampling protocol and the

results of that sampling. If any disease

is detected as a result of the 20-day

preharvest sampling, none of the fruit

from that grove can be shipped to the

United States. The only fruit that will be

inspected and subsequently shipped to

the United States are fruit from groves

where the 20-day preharvest sampling

resulted in a finding of no disease. The

20-day preharvest sampling that would

be conducted to detect the presence of

citrus black spot in the grove was

accounted for in the risk model in P1,

the likelihood that harvested fruit is

infected. This sample must be taken

from all groves that would ship fruit to

the United States.

The commenter’s statement that ‘‘[i]t

is important also to note that the

detection probability is correlated with

the actual incidence, not with the

probability of citrus black spot or sweet

orange scab’’ is likewise incorrect. The

likelihood that diseased fruit will be

detected during packing is not related to

disease incidence. Although the number

of times that diseased fruit are detected

is related to disease incidence (i.e., more

disease, more detections), the likelihood

that diseased fruit will be detected is

not correlated with disease incidence.

In stating ‘‘APHIS provides no

documented evidence for the

effectiveness of packinghouse

inspections in either the risk assessment

or the rulemaking record,’’ the

commenter is correct. These

packinghouse inspections have not yet

been conducted. Our estimates are

based on examinations of citrus

packinghouses in Argentina, experience

with inspections and culling in citrus

packing operations, direct knowledge of

the etiology of these diseases, and

familiarity with the symptoms of these

diseases.

Comment: APHIS estimates the effect

of post-harvest treatments on citrus

black spot survival (on a per-box basis,

which itself may not be appropriate) as

giving a mean survival of 0.64 in the

baseline situation, and a mean of 0.50

under the mitigation program. APHIS

appears to have ignored the results of

experiments apparently designed to test

the effects of post-harvest treatments.

Since APHIS does not document how it

arrived at its estimates, it is impossible

to tell whether it examined these data.

There are no APHIS analyses of the data

in the risk assessment or the rulemaking

record, but the assumptions in the risk

assessment for probability distributions

appear to be contradicted by these data.

Response: The ‘‘results of

experiments’’ referred to by the

commenter are found in Argentine

document Nota S.P. No. 338, which

contains a summary of experiments to

test the efficacy of post-harvest

treatments on citrus black spot. Our

analysis of that document indicates that

the treatment effects were variable;

compared to untreated controls, the

proportion of treated fruit that

developed black spot disease ranged

from 30 to 100 percent. The primary

difference between the treatments

Argentina will use as part of its regular

program (what we refer to as the

baseline risk) and the treatments it will

use as part of the program for exporting

fruit to the United States (the proposed

treatment program) is the sodium

hypochlorite treatment. We did not

ignore the results of the Argentine

experiments, as the commenter asserts;

rather, we believed that it would not be

appropriate to assume that the

difference in efficacy shown in the

experiments, which compared treated to

untreated fruit, would be the same as

the difference in efficacy between the

baseline scenario and the mitigation

scenario examined in the risk

assessment. This is because most of the

treatments applied in the experiments

cited by the commenter were,

37646 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

appropriately, considered in the risk

assessment’s examination of the

baseline risk, as those treatments are

routinely applied by citrus producers in

Argentina as part of their regular

program. Therefore, as documented in

the risk assessment (8.f P4), our

estimates for the mitigated scenario

focused on the degree of additional risk

reduction offered by the sodium

hypochlorite treatment, which we

assumed would have an additional

deleterious effect on the survival of the

citrus black spot fungus. The increased

level of efficacy of the mitigation

program is modest, a probability of 0.50

that the fungus will survive treatment as

opposed to a probability of 0.64 in the

baseline scenario. The primary purpose

of these treatments is to reduce postharvest spoiling, not kill fungus

diseases, and the main effect of the

chlorine dip is to kill spores on the

surface of the fruit.

Comment: Since there is no

information in the rulemaking record on

the protocols for the experiments on the

effectiveness of post-harvest treatments,

nor any scientific documentation, we

have to make some plausible

assumptions in order to perform the

simplest analysis. Assume that each

experiment measures the disease rate in

control and treated fruit, with the

disease rate possibly differing in all the

replicates of all the experiments.

Assume that the post-harvest treatment

alters the disease rate in the

corresponding control by a fixed factor

Q (by inspection, there is little

difference within any set of replicate

experiments; while one could and

should formally test for equality, our

simple analysis will forgo that testing

for the sake of brevity). Assume that the

same factor Q applies to all the

experiments on a given fruit (again, this

could and should be formally tested).

Assume binomial distributions for

infection, as would occur if the fruit

were randomly chosen. Then the

maximum likelihood estimates for Q

are: 0.71 (grapefruit), 1.16 (orange), and

0.92 (lemon).

It should be noted that for this

analysis, we have assumed that the

detailed tables included in the

rulemaking record and largely

corresponding to the summaries

provided by Argentina in Note S.P. 338,

Annex III, are correct, and we have

treated discarded fruit as though they

were diseased. There are significant

differences between those tables and the

summaries presented by Argentina in

Annex III in the descriptions of the

number of fruit examined, and one table

(Orange, Third Replicate) has the

control and T2 groups transposed for all

observations Rl, R2, R3, and R4. Once

again, we are hindered by the absence

of protocols, scientific documentation,

and field notes from the rulemaking

record. For example, whether discarded

fruit should be analyzed as though

infected depends on experimental

details that are not presented within the

rulemaking record, and even the

summary tables in the record are

inconsistent in their treatment of such

discards. There are no comments by

APHIS in either the risk assessment or

the rulemaking record on these

significant discrepancies.

These experimental results indicate

that the post-harvest treatments have

little, if any, effect on latent infections

of citrus black spot. It would be possible

to find confidence limits and test for

equality of effect, but the effort would

be wasted given the tiny number of

experimental conditions, and the

likelihood for variation (beyond the

assumed binomial randomness) with

field conditions, fruit, and possibly

experimental conditions. The results do,

however, throw considerable doubt on

the values used for Q in the risk

assessment for citrus black spot (0.64,

range 0.4 to 0.85).

Response: In this comment, the

commenter states in several places that

there is no information in the

rulemaking record on the protocols for

the experiments on the effectiveness of

post-harvest treatments for citrus black

spot. In fact, the Argentine document to

which the commenter refers, Note S.P.

338, states that ‘‘[t]he results that appear

in Annex III are the results of the assays

that were carried out applying the

methodology informed [sic] to APHIS in

the ‘Protocol of Assays to Evaluate the

Effectiveness of the Post-Harvest

Treatments for the Control of

Guignardia citricarpa in Citrus

Produced in the North-West of

Argentina (NOA)’ * * *.’’ That

document, which is actually titled

‘‘Assays to Test Effectiveness of the

Postharvest Treatment for the Control of

Guignardia citricarpa in Citrus Fresh

Fruit Produced in Argentine Northwest

Region (NOA),’’ was provided to the

commenter following the close of the

comment period and is included in the

material provided in the addendum to

the risk assessment that may be

obtained from the person listed under

FOR FURTHER INFORMATION CONTACT.

In discussing discrepancies that he

believes exist among varies documents

in the record, the commenter first states

that the ‘‘detailed tables,’’ which are not

identified in the comment, ‘‘largely’’

correspond to the summaries in Annex

III of Note S.P. 338, and then states in

the next sentence that there are

‘‘significant differences’’ between those

tables and the summaries in Annex III.

Without specific information as to

where the differences occur, we are

unable to provide the commenter with

any clarification regarding possible

discrepancies.

The commenter concludes, as a result

of the simple analysis set forth in his

comment, ‘‘that the post-harvest

treatments have little, if any, effect on

latent infections of citrus black spot.’’

We acknowledged this in the risk

assessment and recognized that the

primary purpose of these treatments is

to reduce post-harvest spoiling, not kill

fungus diseases, and the main effect of

the chlorine dip is to kill spores on the

surface of the fruit. The expert

information used in the risk assessment

reflected the variability of the treatment

data and the experts’ uncertainty around

those data. While assuming that the

fungicidal and chlorine dips would

have a deleterious effect on the viability

of Guignardia citricarpa propagules, the

experts recognized the latent nature of

black spot infections. The germinating

fungal spore forms an appressorium

from which an infection peg penetrates

the cuticle, and mycelium grows in

between the cuticle and the epidermis

where it may remain quiescent

(Whiteside, 1988) and effectively

protected from fungicidal treatments.

However, the form in which the fungus

remains after treatment (i.e., mycelium)

can hardly be considered infective

(McOnie, 1967). The experts predicted

that between 10 and 90 percent of

infected boxes would survive postharvest treatment with a most likely

value of 50 percent.

In our response to the previous

comment, we discussed the data

provided by Argentina on this subject

and our analysis and interpretation of

those data. As we noted in that

response, we assumed that the addition

of the sodium hypochlorite dip to the

baseline post-harvest treatments would

have an additional deleterious effect on

the survival of the citrus black spot

fungus, but that the increased level of

efficacy would be modest, reducing our

estimate of the probability that the

fungus will survive treatment from 0.64

(baseline) to 0.50 (mitigated).

Comment: For sweet orange scab,

APHIS admits to having no efficacy data

for the post-harvest treatments and

provides no documentation of its

method of reaching the values used in

the risk assessment. Comparison with

the citrus black spot case, where some

data are available, leaves considerable

doubt as to the adequacy of APHIS’s

methodology. In any case, it would be

relatively straightforward to perform

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37647

efficacy studies using methodology

similar to that used on citrus black spot,

and there is no indication of why such

studies have not been performed for

sweet orange scab.

Response: As noted by the commenter

and in the risk assessment, no specific

sweet orange scab efficacy data were

available for the fungicidal activity of

any of the individual post-harvest

treatments that might be employed in

the proposed export program. The

incidence of sweet orange scab in a test

sample of fruit subjected to the entire

preharvest, harvest, and post-harvest

export program was described in

Argentine document 450/96 (September

30, 1996). In this survey, 300 boxes of

fruit were randomly chosen from a

larger lot that had been subjected to the

conditions of the export program. Ten

fruit were collected from each of the 300

boxes and visually inspected for

symptoms of sweet orange scab. None of

the 3,000 total fruit examined expressed

disease symptoms. However, the survey

did not include controls and its design

did not allow for the separation of the

effects of field treatments, inspections,

or post-harvest treatments. The data

provided by this survey were

nonetheless useful in illustrating the

effectiveness of the measures required

by the export program and, when

combined with the considerations

discussed in the next paragraph, led us

to conclude that additional studies such

as those suggested by the commenter

would not be necessary for the purposes

of our risk assessment.

As we have noted elsewhere in this

document and in the risk assessment,

the only additional post-harvest

treatment specifically required by the

proposed export program (compared to

the baseline) is the sodium hypochlorite

dip. We assumed that the sodium

hypochlorite dip—a treatment with

widely recognized antifungal efficacy—

would further reduce the survival rate of

the sweet orange scab pathogen. An

important consideration taken into

account by our experts is the fact that,

unlike citrus black spot, sweet orange

scab lesions are erumpent and exposed

on the surface of the rind. Thus, our

experts believed that the sodium

hypochlorite dip, along with the

fungicidal treatments found in both the

baseline program and the proposed

export program, would be effective in

killing any viable conidia on the surface

of a pustule or contaminating the rind

of fruit and may have some minor effect

on sweet orange scab stomatic tissue.

Comment: For citrus canker, APHIS

cites literature efficacy studies on the

effect of chlorine dips. However, the

method by which probability

distributions were assigned from this

literature is undocumented.

Response: The chlorine dip was only

one factor considered when estimating

the appropriate value for model inputs

for this node (P4). The efficacy data on

chlorine dips were considered along

with other data and information, as

cited on p.39 of the risk assessment:

These treatments may include, but are not

limited to, washing fruit in a detergent bath,

waxing and fungicide dips. The only postharvest treatment for pathogens that is

specifically prescribed in the proposed

export program is a fruit dip in 200 ppm

sodium hypochlorite (bleach) for 2 minutes.

The probability distribution resulted

from the expert judgment of a group of

three plant pathologists familiar with

treatment of commercial fruit for export,

after consideration of all pertinent,

available information. References for

that information were provided in the

risk assessment.

Comment: The proposed rule calls for

testing 320 fruit/200 ha, according to

SENASA’s randomized sampling

protocol, a protocol that is not described

in the proposed rule or the risk

assessment. We believe that the

presence of such a testing procedure

alters the structure of the model that

must be used for the risk assessment. It

also appears that such a testing

procedure is designed to fail—we

believe that fruit with a startlingly high

infection rate could pass through such

a screen.

From the information provided in the

rulemaking record, total citrus

production in northwestern Argentina

appears to have been about 20 tons/ha

in 1989, indicating yields similar to

those in California and Florida (20–40

tons/ha). The tree planting densities

also appear similar (200 to 250 trees/ha).

Thus, for lemons, at 150 fruit per 18-kg

box (as assumed in the risk assessment),

the lemon yield will be about 170,000

to 340,000 per ha, and the total area

required to produce the 1,200,000 boxes

examined in the risk assessment will be

about 600 to 1,000 ha.

For the sake of argument, assume that

Argentina sets up 20 groves each of 100

ha as potential U.S. export groves, and

follows all the procedures of the

proposed rule (and note that this is, at

first sight, about twice the required

area). A 100 ha grove might have a

buffer zone of 69 ha, so that the total

area of the grove plus buffer would be

169 ha, calling for a sample of 270 fruit

per grove+buffer (assuming that the

buffer has to be sampled, but that is

ambiguous in the proposed rule).

Now suppose that all the fruit from all

the proposed U.S. export groves are

infected at a rate of 1 in 400 fruit (0.25

percent), which is fairly high, just 100

to 400 times lower than the unmitigated

rate. The probability for no infected fruit

in a random sample of 270 fruit is (1–

0.0025)270 = 0.5. Thus one could expect

about 10 of the 20 groves to pass this

test, providing the necessary area of

1,000 ha, while the other 10 groves

would be removed from the export

program for this season. The next

season, the same thing might happen,

but with a different (random) set of 10

or so groves excluded, and 10 or so

included. Examination of this scenario

and its extensions shows that with

suitable subdivision of the potential

U.S. export acreage into groves, and

acceptance that some groves each year

will be randomly removed from the

program, almost any infection rate in

the fruit is possible under the sampling

scheme suggested. That is, the sampling

scheme is not effective at controlling the

allowable infection rate.

There is no need to postulate a

deliberate effort to outwit the sampling

scheme. It might prove economically

advantageous for the citrus-producing

region of northwestern Argentina to

adopt all the procedures of the proposed

rule for the entire citrus producing

region, since such procedures may

produce superior yields for many

markets, not just the United States. Only

a very small fraction of groves would

have to meet the testing requirements to

generate the suggested export volumes;

and with the proposed sampling

approach, these are likely to occur

randomly even if the infection rates are

higher than the 1-in-400 fruit of the

preceding example. It would be

straightforward to design statistically

adequate sampling and testing regimes

to ensure that the overall infection rate

of fruit from any grove is below any

required value, and such schemes can

be extended to account for nonuniform

infection rates between groves, and even

infection rates that vary within each

grove, but there is no evidence in the

record of any such attempt.

Response: We disagree with the

commenter’s statement that a testing

procedure that calls for a certain

number of fruit to be collected from a

defined area ‘‘alters the structure of the

model that must be used for the risk

assessment.’’ If the model we used in

the risk assessment was a scenario tree

model with branches that were based in

some way on the outcome of the

sampling, then the sampling protocol

might have an impact on the structure

of that model. In simple terms, the

outcome of the sampling determines

whether the fruit produced in an export

grove will be considered in the export

program, since the detection of disease

37648 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

in a grove or buffer area as a result of

the sampling will result in the

elimination of the grove and the fruit it

produces from the export program.

Thus, the nature of the sampling

protocol used for the export program

does not affect the structure of the

model because the sampling is outside

the scope of the model; the risk model

deals only with fruit from groves that

have been cleared for participation in

the program.

In response to the comments

regarding this sampling protocol, we are

modifying the protocol for the 20-day

preharvest sample and clarifying the

basis and details of the sampling. The

sampling protocol will be based on a

statistically valid hypergeometric

distribution. The ‘‘lot size,’’ or

population size, is equal to the number

of trees in the grove and buffer area. We

will set our desired level of detection as

follows: We will sample enough trees to

have a confidence level of at least 95

percent of detecting an infection rate of

1 percent or more of the trees. In

preparing this protocol, we have

assumed that there will be 250 trees per

hectare, and we have assumed a

maximum grove/buffer area size of 800

hectares based on our available

information. Given those two

assumptions, we will require that 298

trees be sampled from each grove and

buffer area (if an area to be sampled

exceeds 800 hectares, this rule provides

that SENASA will contact APHIS, and

APHIS will determine the number of

trees to be sampled). The 298 trees must

be selected at random. In order to

increase the likelihood of detecting

disease, the fruit must be sampled from

portions of the trees that are mostly

likely to have infected, symptomatic

fruit (i.e. near the outer, upper part of

the canopy on the sides of the tree that

receive the most sunlight). We have set

the number of fruit to be sampled from

each tree (number of replicates) at four

fruit per tree.

Sampling 4 fruit from each of 298

trees will yield a sample size of 1,192

fruit, which is somewhat less than what

would result from sampling 800

hectares at the rate called for in the

proposed rule (320 fruit from each 200

hectares, i.e., 1,280 fruit). However,

given that this new sampling protocol is

based on a statistically valid

hypergeometric distribution, we believe

that it provides the ‘‘statistically

adequate’’ sampling regime called for by

the commenter and, given its random

selection of trees and focus on collecting

fruit from those parts of the tree most

likely to contain infected fruit, will, as

suggested by the commenter, ‘‘account

for nonuniform infection rates between

groves, and even infection rates that

vary within each grove.’’

This sampling protocol will provide

information regarding the disease status

of farms wishing to be included in the

program to export citrus fruit to the

United States. Our risk model focuses

on the risk to the United States of

imported citrus fruit from farms in

Argentina that are part of the official

export program, i.e., farms that have

already been certified for export to the

United States. There are numerous risk

mitigation measures in place, both as

part of the regular risk mitigation

program and the various special

requirements of the U.S. export

program. We believe that the testing and

inspections required by this rule will

ensure that fruit with a startlingly high

infection rate does not enter the United

States.

Comment: The sampling of 320 fruit

per 200 hectares shortly before harvest

is an utterly insufficient sample size to

be assured of detecting the presence of

citrus black spot or sweet orange scab:

• At an 8 m × 5 m planting density,

there would be 50,000 trees/200

hectares; if 320 fruit are sampled, then

0.64 percent of all the trees would be

sampled. If one assumes only 250 fruit

are harvested per tree, then 0.00256

percent of the harvested fruit is

sampled.

• At a 10 m × 5 m planting density,

there would be 40,000 trees/200

hectares; if 320 fruit are sampled, then

0.8 percent of all the trees would be

sampled. If one assumes only 250 fruit

are harvested per tree, then 0.0032

percent of the harvested fruit is

sampled.

This sampling size is especially

inadequate when one considers that

disease incidence will be low due to the

fungicide treatments. Further, the ability

of a sampling program to detect, for

example, citrus black spot, may depend

upon the location of the trees sampled

within the grove, the location of the

samples on those trees, the age of the

trees, etc. Sample size should be based

on biometric principles that consider

the characteristics of the disease, the

incidence, and the level of precision

desired to detect any present infections.

APHIS should explain why the 320

fruit/200 hectares sample size was

chosen and why it is appropriate for the

desired purpose.

Response: As explained in the

response to the previous comment, the

sampling protocol has been modified in

this final rule to provide a statistically

valid hypergeometric distribution that

will provide for the sampling of enough

trees to have a 95 percent confidence

level of detecting an infection rate of 1

percent or more of the trees, and we

have provided for four replicates per

tree. The sampling system described in

the proposed rule was the protocol

offered by Argentina and was designed

to be consistent with Argentina’s

existing monitoring system for citrus

canker, which was based on a transect

design.

Comment: The probabilistic

estimation for ‘‘pathogen not detected at

packinghouse inspection’’ relies here on

the results of the 20-day preharvest

sampling results. But, this sampling

consists of random collection of fruit at

a rate of 320 fruit from each 200

hectares surveyed. No information on

the statistical or biometrical validity of

this sampling protocol is provided in

the pest risk assessment or the proposed

rule. Without this information, it is

impossible to evaluate its impact as a

safeguarding element, particularly as it

relates to the mitigation scenario

estimation.

Response: As discussed in the

responses to the previous comments, we

have modified the sampling protocol

that will be used to collect the fruit that

will be subjected to laboratory analysis.

Also, the commenter inaccurately states

that ‘‘the probabilistic estimation for

‘pathogen not detected at packinghouse

inspection’ relies here on the results of

the 20-day preharvest sampling results.’’

We understand, however, how the

reader could reach that conclusion

based on our statements on p. 38 in

section 8.f P3 of the risk assessment,

which may have given a false

impression. To clarify, the

packinghouse inspection, and our

estimates regarding the likelihood of

detecting pests during this inspection,

are independent of both the 20-day

preharvest sampling protocol and the

results of that sampling. If any disease

is detected as a result of the 20-day

preharvest sampling, none of the fruit

from that grove can be shipped to the

United States. The only fruit that will be

inspected and subsequently shipped to

the United States are fruit from groves

where the 20-day preharvest sampling

resulted in a finding of no disease. The

20-day preharvest sampling, which

would be conducted to detect the

presence of citrus black spot in the

grove and buffer area, was accounted for

in the risk model in P1, the likelihood

that harvested fruit is infected. Upon

reconsideration, our estimates for this

node should probably be considerably

lower, given the rigor of the 20-day

preharvest sample. This sample must be

taken from all groves that ship fruit to

the United States.

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37649

Comment: Because we recognize that

it is not practical to hold all harvested

fruit for up to 3 weeks to detect latent

symptoms, we suggest that the number

of fruit examined in the 20-day

preharvest sample be increased by at

least tenfold to reduce the risk of

disease introduction.

Response: Because the sampling

protocol required by this rule will

provide for the sampling of enough trees

to have a 95 percent confidence level of

detecting an infection rate of 1 percent

or more of the trees, and because the

sampling protocol requires four fruit to

be selected from each tree, with those

fruit being chosen from the portion of

the tree most likely to have infected

fruit, there is almost no chance that

infection could exist in a grove without

infected fruit being included in the

sample subjected to laboratory

examination. Further, during the 20

days that the sampled fruit is in the

laboratory, the fruit will be held under

conditions that are ideal for the

expression of symptoms in any infected

fruit. Given those considerations, and

given that the detection of symptoms in

a single fruit will result in a grove being

removed from the export program, we

do not believe that a tenfold increase in

the sample size is necessary.

Comment: It is possible to design

testing requirements that will reduce the

failure rate below any given value under

normal circumstances, but the risk

assessment ought also to evaluate the

effect of abnormal or unusual events.

For example, the following need to be

explicitly evaluated:

• Failure to apply field control

(copper oxychloride) treatment (e.g.

through inadvertent failure to add the

solution, etc.);

• Failure of the field control

treatment, even if applied;

• Failure to include the chlorine dip

in the treatment schedule;

• Failure of the chlorine dip itself

(e.g. inadvertent neutralization or failure

to refresh or test);

• Temporary or permanent failure of

inspection machinery (e.g. through

operator inattention);

• Reintroduction of culled fruit (from

harvest culling, if any, and/or packing

plant inspection) into the product;

• Infection through the use of the

same packinghouse at different times for

U.S. export and non-U.S. export fruit

(e.g. by accidental inclusion of nonexport fruit still in the packinghouse; or

by infection carried on machinery); and

• Infection through failure to

disinfect tools, clothing etc. used in U.S.

export groves after being used

elsewhere.

Response: Our entire model is a fault

model; thus, it takes into account the

kinds of events suggested by the

commenter, e.g.:

• Failures in the application or

efficacy of field treatments are

considered in the probabilities

constructed for node P1, ‘‘Harvested

fruit is infected’’;

• Failures in the application or

efficacy of the chlorine dips are

considered in the probabilities

constructed for node P4, ‘‘Fungus

survives post-harvest treatment’’;

• Inspection failures are considered

in the probabilities constructed for P2,

‘‘Pathogen not detected during harvest,’’

and node P3, ‘‘Pathogen not detected at

packing house inspection.’’

As discussed in our responses to

earlier comments, measures will be in

place to prevent non-export fruit from

being present in the packinghouses

when any export fruit is present and we

believe that it is unlikely that fruit could

become infected as a result of coming in

contact with packinghouse machinery

or tools, clothing, etc. Finally, the risk

mitigation program has a series of

checks to confirm that the required

steps have been taken.

Comment: From the time the fruit

leaves the packinghouse to the time it

arrives at the U.S. port of entry, the only

control system applied is the labeling on

the boxes. APHIS has not evaluated the

possibility for deliberate introduction of

export-labeled boxes of untreated fruit

in transit, for which there is presumably

considerable economic incentive, nor

for the possibility of misdirected, nonexport-labeled boxes containing infected

fruit that are missed by U.S. port-ofentry inspection.

Response: The commenter states that

there is ‘‘presumably considerable

economic incentive’’ for the deliberate

placement of nonprogram fruit in

export-labeled boxes. We disagree, and

would argue that there are actually

economic disincentives for such actions.

As stated in the proposed rule and in

this final rule, the detection of citrus

black spot or sweet orange scab during

the course of any inspection or testing

required by this rule will result in the

grove in which the fruit was grown or

is being grown being removed from the

SENASA citrus export program for the

remainder of that year’s growing and

harvest season, and the fruit harvested

from that grove may not be imported

into the United States from the time of

detection through the remainder of that

shipping season. Because citrus fruit

from nonparticipating groves is more

likely to be infected with citrus black

spot or sweet orange scab than fruit

grown in registered groves, we believe

that it is unlikely that the growers and

packers participating in the SENASA

citrus export program (and incurring

additional costs of production by doing

so) would allow their entire export

operation to be jeopardized by allowing

potentially infected fruit from

nonparticipating groves to be

commingled with their export-quality

fruit, especially given that Argentina

already has strong domestic demand for

its citrus and numerous well-developed

export markets to which nonprogram

fruit may be exported. In addition to

that purely economic disincentive,

SENASA inspectors will also be present

in the groves and packinghouses during

the growing, harvest, and shipping

seasons to ensure that all requirements

of the regulations are being observed.

Regarding the possibility of

misdirected, non-export-labeled boxes

containing infected fruit being missed

by U.S. port-of-entry inspection, we

believe that it is unlikely that such

misdirection would occur, given that

this rule prohibits non-export fruit from

being in the packinghouse when export

fruit is present. That being said, the

possibility of boxes containing infected

fruit arriving in the United States is

considered throughout the model. The

model is a fault model and estimates the

probability of pests entering the United

States and becoming established. Each

of these nodes are assumed to be

independent events and, as such, begin

with the assumption that pests, in some

form, have infested or infected the fruit

(P1), avoided detection (P2, P3),

survived treatment (P4), survived

shipment (P5), been shipped to a

suitable habitat (P6), found a suitable

host (P7), and will be able to complete

the disease cycle (P8). As such, each of

these nodes represents a ‘‘fault’’ in the

system. One such fault that could lead

to infected or infested fruit being

inserted into the system includes boxes

of fruit that are not part of the system

being inserted into the system.

Comment: Because the proposed rule

does not include any safeguarding

requirements on the fruit as it is moved

from the grove to the packinghouse and

from the packinghouse to the point of

export, the risk assessment needs to

include an evaluation of the

probabilities for infection with citrus

diseases or contamination with infected

material (e.g. blown leaves, ascospores

attaching to fruit or fruit boxes) during

transport within Argentina.

Examination of the transport system

must include staging areas on the road

and in port, and must take account of

simultaneous movement of other fruit

that has not been subject to the same

37650 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

sanitary requirements as the U.S. export

fruit.

Response: Mature fruit is not

susceptible to infection by citrus black

spot or sweet orange scab, so the

possibility of infection during transport

is not relevant and, therefore, did not

need to be considered in the pest risk

assessment.

Comment: APHIS estimates the

fraction of the United States that is

suitable habitat for fruit flies to be 10 to

15 percent, and the fraction of the

United States that is suitable for sweet

orange scab, citrus black spot, and citrus

canker to be approximately 9 percent.

From the text of the risk assessment, it

appears that these values are simply a

fraction of the area of the United States.

A more appropriate value would be the

probability that fruit will actually be

shipped to an area with a suitable

habitat. Such a distribution should take

account of the population of the United

States that lives in suitable habitats or

current (or potential) shipping patterns

for fresh citrus. The distribution should

take account of the seasonal probability

of shipping fruit to a citrus-growing

region, and the correlation of this

probability with the probability for pest

survival.

Response: We have no reason to

believe that the analysis suggested by

the commenter would result in a

different distribution than the ones we

used. As we noted in response to an

earlier comment, with the large citrus

markets throughout the United States,

we have no reason to believe that our

estimate of 5 percent (percentage of

imported fruit that will be shipped to

areas where citrus can survive) is too

low or too high. Nor have we received

any specific information from any

commenter that would allow us to

change our estimate. Further, we do not

believe that human population density

or shipping patterns for citrus fruit are

relevant when one is considering

whether or not an area provides a

suitable habitat for an organism, as that

suitability is more a function of climate

and the availability of host material. The

ability of an area to support a pest

population exists regardless of the

factors raised by the commenter.

Comment: The U.S. segment of the

pathway is identical in the risk

assessment for the baseline and the

mitigation program. The probability

distributions appear to be pure

guesswork by APHIS (so far as can be

evaluated from the documentation in

the risk assessment and proposed rule).

There is no indication of the potential

infection routes that were considered,

nor of the use of any data either on prior

infections elsewhere in the world or

(except to a minor extent for fruit flies)

on the population biology of the pests

themselves.

Response: There is no evidence, nor

any reason to believe, that these

diseases have ever been introduced by

this pathway—i.e., commercial

shipment of citrus fruit—or a similar

pathway anywhere in the world. Every

scientific reference—and the known

biology of these diseases—indicates that

other pathways are responsible for

introductions that have occurred.

Because our risk assessment focused on

the commercial shipment pathway, it

did not consider other pathways such as

the smuggling of plant material and

nursery stock, which is by far

considered the most likely pathway for

introduction in all known introductions

with uncertain cause. Our estimates

resulted from our consideration of a

variety of potential infection routes,

such as consumers discarding rinds or

whole fruit in compost heaps in the

vicinity of citrus trees on their property,

and rinds or fruit discarded in orchards.

The scope of our risk assessment and

consideration of potential infection

routes are discussed in greater detail in

our response to the next comment.

Comment: There are multiple

potential pathways for pests to get into

U.S. citrus areas or other areas of

concern. Without documentation, it is

impossible to evaluate whether APHIS

has considered all of them in the risk

assessment, and it is impossible to

evaluate their relative importance. For

example, citrus groves or backyard trees

could be exposed to pests by a fruit or

peel discarded by workers, trespassers,

or passers-by; by peels placed in

compost piles; by truck accidents

scattering fruit; and by air dispersion of

spores or contaminated material from

ventilated trucks. Indeed, the

probability of discarded fruit will be

higher for sweet orange scab or citrus

black spot infected fruit, since a

consumer is more likely to discard fruit

in which infection has become

apparent. All these examples could

readily be examined using event-tree

modeling, using available data on

consumption of raw fruit, human

activity patterns, accident statistics,

shipping statistics, and so forth. It

should also be noted that most of the

pathways by which infections might

take hold in the United States are based

on single fruit, not on boxes. Thus any

quantitative risk assessment for these

pathways would most readily (and

possibly can only) be conducted on a

‘‘per fruit’’ basis, not on a ‘‘per box’’

basis.

Response: The purpose of the risk

assessment, as stated in the first

sentence of the risk assessment on p. 1,

is ‘‘* * * to examine plant pest risks

associated with the importation into the

United States of fresh citrus fruit grown

in certain areas of Argentina.’’ The

document is a commodity-based risk

assessment conducted to inform the

decision of whether commercial citrus

from Argentina should be enterable

under a specific set of mitigation

measures. It was not the purpose of the

risk assessment to consider all the

various pathways by which citrus pests

could enter the United States. A plant

pest risk assessment that considers all

the different pathways by which a pest

can enter an area, which is referred to

as a pest-initiated risk assessment,

would be the appropriate vehicle for

conducting the types of analyses

suggested by the commenter.

That being said, the possibility that

citrus groves or backyard trees could be

exposed to the pathogen via discarded

fruit or peel was considered in our risk

assessment (P7, Pathogen reaches

suitable host). We concluded that it is

highly unlikely that infected fruit

producing viable pycnidiospores will

ever reach the United States. If this did

occur and the fruit or peel was thrown

in a compost heap, even under a

backyard citrus tree, it would be highly

unlikely that fruit in the tree could

become infected. The pycnidiospores

are only waterborne and, therefore, can

only infect fruit when the inoculum

source is in direct contact with or

physically close to fruit on the tree, or

if there was fruit positioned beneath the

inoculum source so that the spores

could drip onto that lower-hanging fruit.

This also would assume that the

environmental conditions were

favorable for infection and that fruit

were susceptible. Realistically, it would

be difficult to infect U.S. fruit, even if

infected fruit was purposely placed in

the tree canopy. In greenhouse

inoculation studies conducted by an

APHIS scientist, it was necessary to

place fungal cultures of citrus black spot

directly on susceptible fruit and to keep

the inoculum and fruit moist for nearly

7 days. Even under these highly

favorable conditions, not all inoculated

fruit became infected. Thus, the

likelihood of infection in the field, even

by symptomatic fruit, is very low.

Finally, we believe that our use of the

box as the risk unit, as opposed to the

individual fruit as the commenter

suggests, is an appropriate choice. Retail

boxes stay intact from the packinghouse

until their point of final sale (e.g., a

supermarket), and it is reasonable to

assume that most or all of the fruit in

a box would be used, and the remains

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37651

discarded, in the same general vicinity

(e.g., town, neighborhood) as the point

of final sale.

Comment: For the U.S. segment of the

pathway considered (including

shipping), APHIS estimates the

probability for citrus black spot

outbreak to be about 10¥9 per infected

18-kg box (0.83 0.05 × 0.005 ×

0.000005), using the mean values for the

distributions given in Table 9 of the risk

assessment. The total U.S. consumption

of fresh citrus fruit is about 25 lbs/

person/yr, or 2.8 × 109 kg/yr, or 1.6 × 108

boxes/yr at 18 kg/box. Thus, APHIS is

effectively suggesting that if the entire

U.S. fresh citrus fruit supply were

imported, and it was all infected at

source (100 percent), the probability for

a citrus black spot outbreak in the

United States would be on the order of

0.16 per year. This is an unreasonable

prediction, given the experiences

elsewhere with citrus black spot

infection. Note that the APHIS approach

(on a ‘‘per box’’ basis) cannot apparently

distinguish between 1 infected fruit per

box, and 100 percent infected fruit in a

box, whereas these clearly pose different

risks.

Response: First, as explained in the

response to the previous comment and

elsewhere in this document, we believe

that a box of fruit is an appropriate risk

unit. Second, given the preponderance

of evidence and expert opinion that long

distance spread of Guignardia citricarpa

via infected fruit is unlikely, and the

dearth of documented cases of such

spread, we believe that the probability

calculated by the commenter is not

unreasonable and our distributions,

therefore, are appropriate. We offer the

following citations from the scientific

literature to support our conclusions:

• ‘‘Ascocarps of the pathogen have

never been found on fruit and the

pycnidiospores are not airborne.

Therefore, disease spread is unlikely

through the movement of infected

fruit.’’ (Whiteside, J.O.; Garnsey, S.M.;

Timmer, L.W. 1988. St. Paul, MN:

American Phytopathological Society. 80

p.).

• ‘‘The fungus can readily be carried

on imported citrus fruits, but the risk of

spread from these is relatively low.’’

(Smith, I.M.; McNamara, D.G.; Scott,

P.R.; Holderness, M.; Burger, B. 1997.

Quarantine Pests for Europe. New York:

CAB International. 1,425 p.).

• ‘‘Fruit cannot rate high as an

effective source of inoculum (pathway)

in international trade. Ascospores have

never been found on fruit, but

pycnidiospores are produced that are

not airborne.’’ (Santacroce, N.G. 1982.

‘‘Guignardia citricarpa Kiely.’’

Hyattsville, MD: USDA, APHIS, BASS.

7 p.)

Comment: To provide a reliable risk

assessment, APHIS must provide

documentation according to the

procedure of Kaplan (1992), which

APHIS claims to have followed in

preparing the risk assessment. First, this

documentation must explicitly lay out

the evidence upon which the

probability distributions are based,

including any disagreements between

the experts. Second, it must show the

reasoning leading from the evidence to

the distributions. Third, APHIS should

state the names of the experts involved,

and the risk assessors involved. In

several places throughout the risk

assessment, there is confusion between

the experts and the authors—or are they

the same, and does this violate the spirit

of Kaplan’s approach? We suggest that

if the experts and the risk assessors are

the same people, then the spirit of

Kaplan’s approach requires a

substantially larger effort to separately

document the evidence and the line of

reasoning taken in obtaining

distributions from such evidence.

Response: The reliability of a risk

assessment depends on the extent to

which it accurately represents the actual

risk. We agree, however, that it is

important to document the basis of a

risk assessment so that readers can make

judgments about the validity of the

information in the risk assessment. That

is why we provided extensive

information and references concerning

the scientific information that formed

the basis of our risk assessment. The

information, scientific data, and

evidence used to estimate the

appropriate input values (distributions)

was cited in the 162 scientific

references, 13 regulatory references, and

supporting documents cited in the risk

assessment. Specifics about how this

information was interpreted and used is

provided in the discussions for each of

the nodes in our model (sections 8.e.

and 8.f.) and in the pest data sheets

prepared for, and presented in, the risk

assessment (Appendices I through VII).

The three authors of the document are

listed on the cover sheet. Tables 7

through 10 list the 72 node estimates

used to conduct the Monte Carlo portion

of the risk assessment. Each estimate

consists of a distribution type and

estimates for the distribution

parameters. The exact list of experts

used to estimate each of the 72

distributions varied from node to node.

However, section IV of the risk

assessment (‘‘Preparation, Consultation

and Review,’’ pp. 58–59) lists the 21

experts (including the three authors)

within and outside USDA who were

consulted during production of the risk

assessment. While the three authors did,

in some cases, double as both risk

assessors and experts, we believe that

the review provided by the remaining

18 listed experts who were consulted, as

well as the State regulatory personnel

and others who reviewed the risk

assessment in its draft form, preclude

the lending of any undue weight to the

opinions of the authors when it was

necessary for them to act in both

capacities.

Comment: The FAO ‘‘Guidelines for

Pest Risk Analysis’’ provide that risk

assessments must be well documented:

‘‘A risk assessment [pest risk analysis]

should be sufficiently documented so

that when a review or a dispute arises,

the risk assessment will clearly state the

sources of information and the

rationales used in reaching a

management decision regarding

phytosanitary measures taken or to be

taken’’ (FAO, International Standards

for Phytosanitary Measures, adopted

November 1995 by the 28th Session of

the FAO Conference, p. 20). In contrast

to the FAO requirements, however, the

1997 risk assessment does not disclose

the sources of much of the data relied

upon, the basis for a number of

assumptions relied upon, nor the names

of particular experts who were looked to

for estimates that are used in the risk

assessment.

Response: The commenter states that

we did not disclose the sources of much

of the data relied upon, but we believe

that we thoroughly documented our

sources of information in section III of

the risk assessment (References) and in

the references listed at the end of each

of the pest data sheets provided as

appendices.

The commenter states that we did not

disclose the basis for a number of

assumptions relied upon, but we did

provide a narrative discussion of how

we arrived at probabilities used in each

of the nodes for each of the pests of

concern (fruit flies and diseases). While

the information we provided for each

node may not have contained the level

of detail that the commenter appears to

believe would have been appropriate,

we did attempt to describe how we

arrived at each of our estimates in those

discussions rather than simply reporting

our estimates in table form. Additional

information regarding the construction

of our distributions is provided in the

addendum to the risk assessment that

may be obtained from the person listed

under FOR FURTHER INFORMATION

CONTACT.

The commenter states that we did not

disclose the names of particular experts

who were looked to for estimates that

37652 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

are used in the risk assessment, but

section IV of the risk assessment

(Preparation, Consultation, and Review)

lists the names of each of the

entomologists, botanists, plant

pathologists, agriculturalists, plant

virologists, and information specialists

who participated in the preparation of

the assessment, as well as the names of

the APHIS and State personnel who

were consulted during the preparation

of the assessment and who reviewed

drafts of the assessment. As can be seen

by the Argentine citrus risk assessment

and our previous risk assessments, it

has not been our normal practice to

explicitly tie individual experts to the

estimates provided for specific nodes;

we will, however, consider doing so in

future risk assessments.

Comment: Variability represents

known heterogeneity of a quantity.

Uncertainty represents lack of

knowledge about that quantity that

could be better characterized with

further research and/or measurement.

Variability and uncertainty should be

considered separately in a Monte Carlo

risk assessment, so that one can identify

the sources of the spread in the resulting

distribution. A final risk distribution

might be interpreted very differently if

the source of most of the spread were

uncertainty than if the source were true

variability in the input parameters. The

APHIS risk assessment focuses

primarily on uncertainty, with a smaller

emphasis on variability, but APHIS

makes no distinction between the two in

its risk assessment calculations.

Moreover, APHIS seems to confuse the

two when it states, ‘‘Uncertainty in the

estimated values may arise from natural

variation over time, natural variation

from place to place, data gaps or

unconfirmed data, [and] relationships

among multiple components in a node.’’

Many of the distributions presented in

the risk assessment are claimed to be

uncertainty distributions for

probabilities, but since the methods

used to elicit these distributions are not

specified, we cannot evaluate whether

the distinctions between variability and

uncertainty were maintained during the

elicitation. The object of the risk

assessment is not adequately specified

with respect to variability and

uncertainty, but the most logical

interpretation would exclude year-toyear variability as being of great interest.

However, such year-to-year variability is

explicitly included in at least one

distribution incorporated in the

assessment.

Response: As noted in a recent paper

published in the journal Risk Analysis

(Gray et al., 1998) and cited in response

to a previous comment, [k]nowledge of

variability must be based on empirical

estimates, otherwise it is another source

of uncertainty. With the exception of

one or two nodes, data providing an

estimate of ‘‘variability (as it) represents

known heterogeneity of a quantity’’ do

not exist for these parameters.

Accounting separately for variability

and other forms of uncertainty in this

risk assessment would constitute

overinterpretation of available data.

Overinterpretation of available data

would most likely lead to risk estimates

that are less, rather than more, accurate.

Comment: APHIS states that the risk

analysis computer software package

@Risk for Excel (Palisade Corp.,

Newfield, NY) is used to run the Monte

Carlo Analysis. However, APHIS does

not state which version of this software

was used, in what spreadsheet package,

nor where to find technical details of

the software that are necessary to

critically evaluate the adequacy of this

software for the assessment. The

spreadsheet itself is not included in the

risk assessment or in the rulemaking

record. To ensure reproducibility of the

analysis, APHIS should at least

document which version of @Risk was

used, and should provide a copy of the

spreadsheet used for the analysis. We

have reservations that even this is

sufficient, since required technical

details of @Risk are not publicly

available. These include such important

details as the algorithm used to generate

(pseudo) random numbers. Other

software packages with similar

capabilities make technical details

available.

Response: We used @Risk for Excel,

version 3.5c, to run the analysis. We did

not supply the ‘‘required technical

details of @Risk’’ because we believed

that sufficient information—i.e., all the

technical information the software

company has chosen to make publicly

available was provided in the @Risk

documentation. We concluded that

including the spreadsheets would

provide no new information; the risk

model (i.e., the calculations used) is

completely described and adequately

represented in Figure 2 (p. 30) and

section 8.b. (p. 28) of the risk

assessment, and all input values used in

all spreadsheets are completely

specified in Tables 7 through 10. The

spreadsheets themselves may be

obtained from the person listed under

FOR FURTHER INFORMATION CONTACT.

Comment: Although the primary

focus of the risk assessment is, as it

should be, on pests that affect or are

present on Argentine citrus crops, the

citrus fruit itself is not the only item

that will be imported. The fruit will be

packed in crates or boxes and shipped

on pallets. The North American Plant

Protection Organization (NAPPO) has

recognized that a large percentage of

wood dunnage or packing materials

moving in international trade is

composed of low quality, inexpensive

wood products that may contain

quarantine pests. The structure of the

model used by APHIS does not allow

problems such as this to be addressed in

the risk assessment.

Response: APHIS recognizes the plant

pest risk presented by solid wood

packing materials and has separate

regulations in 7 CFR 319.40–3(b) that

address these risks. Further, on January

20, 1999, we published in the Federal

Register (64 FR 3049–3052, Docket No.

98–057–1) an advance notice of

proposed rulemaking soliciting public

comment on how to amend our

regulations on the importation of logs,

lumber, and other unmanufactured

wood articles to decrease the risk of

solid wood packing material (e.g.,

crates, dunnage, wooden spools, pallets,

packing blocks) introducing exotic plant

pests into the United States. We are

currently reviewing the information

received in response to that notice and

are preparing a risk assessment and

other documentation regarding the

issue.

Comment: The eighth step in the risk

assessment (pest able to complete its life

cycle) is likely to be the most uncertain

of all, certainly for the diseases, since so

little is known of the population biology

of these diseases. For fruit flies, APHIS

clearly recognizes that a problem exists,

but its attempt to take account of it

(section 8.e. P8) is unfortunately

incorrect and inadequate. It seems likely

that a better incorporation of concepts

from population biology would almost

certainly change the model used in the

risk assessment, at least for the final

step(s).

Response: Much is known about the

population biology of the diseases and

fruit flies, and we believe that we took

into account all the pertinent aspects of

the known biology of these plant pests

in our estimates for P8 for both the

diseases and fruit flies. For the diseases,

we considered the type of infective

propagules produced by the pathogens

and the environmental and

physiological requirements for host

plant susceptibility and successful

disease progression. For fruit flies, we

estimated the probability of an outbreak,

per infested lot of fruit fly host material,

for infested lots delivered to suitable

habitats using data on the known

number of Anastrepha outbreaks from

1990 through 1996 and estimates of the

number of infested lots entering

favorable habitats in the United States.

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37653

The paper that forms the basis of those

estimates (Miller et al. 1996, cited in the

risk assessment) was subjected to

international review by scientists

conducting research on the population

biology of fruit flies. Thus, we believe

that we did incorporate concepts from

population biology in our estimates for

P8 for each of the diseases and fruit

flies, and do not believe that there are

any pertinent aspects of the known

biology of these plant pests that were

not considered in the risk assessment.

Comment: The most difficult and least

certain parts of the pathway (the U.S.

segment) are common to the mitigated

and unmitigated scenarios. It seems

unlikely that incorporation of details of

population biology would make as large

a difference for diseases as it might for

fruit flies, since it is unlikely that

interactions between fungal spores or

colonies are as substantial as between

individual fruit flies. In such

circumstances, it may be useful to

perform a differential analysis of the

risks for diseases that will isolate just

the effects of the mitigation measures. In

this case, a differential analysis would

stop at the calculation of the probability

for infected fruit to enter the United

States, and so emphasize the relative

effect of the mitigation measures. This

procedure has the effect of removing the

substantial uncertainties in the rest of

the pathway from consideration, since

such uncertainties would be common to

both mitigated and unmitigated

scenarios (unless, for some reason, there

were correlations connecting the

Argentine and U.S. segments of the

pathways).

Response: Separate analyses were

performed for the fruit flies and the

diseases. International guidelines, and

APHIS interests, dictate that the

likelihood estimate of primary interest

is the likelihood of introduction, not the

likelihood of entry. Nonetheless, it is

possible to calculate our estimates for

the likelihood of entry using the

information provided in the risk

assessment. Estimates for the likelihood

of entry could be obtained by using P5

as the endpoint of the simulation and

the values provided in Tables 7 through

10. Regarding the issue of a differential

analysis, it is not clear how conducting

a differential analysis to emphasize the

relative effect of the mitigation measures

would aid APHIS’ decisionmaking

process. We must consider the risk

posed by the entire pathway. The

decision of whether to proceed with the

rulemaking process is based on the risk

presented by the entire pathway.

Comment: In the current assessment,

the known total mitigation effect for

citrus black spot (ratio of infection rates

for fruit at the U.S. in the unmitigated

versus mitigated scenarios) is controlled

solely by the effect of the copper

oxychloride treatment, and might

amount to a factor of 50 to 200-fold

under the conditions of the experiments

available in the record. No evidence has

been presented in the record for any

mitigating effect of the other proposed

steps, and there is evidence indicating

a lack of effect for the post-harvest

treatments. The full system tests are

entirely consistent with such minimal

effects, given the detection limits of

those tests. Moreover, there is no

evidence that good results could be

achieved consistently over time, with

fruit from different areas, with

grapefruit, or with different varieties of

lemons and oranges. This minimal and

relatively unproved mitigation effect

might be compared with the much

higher and well-proved 30,000-fold

(probit 9) mitigation effect afforded

against fruit flies by cold treatment,

although the absolute probability for

subsequent infection in the United

States must also be taken into account.

Response: It is not true, as stated by

the commenter that ‘‘the known total

mitigation effect for citrus black spot

(ratio of infection rates for fruit at the

U.S. in the unmitigated versus mitigated

scenarios) is controlled solely by the

effect of the copper oxychloride

treatment.’’ Although the copper

oxychloride treatment is the primary

risk mitigation measure against citrus

black spot, other measures that will

have a mitigating effect on citrus black

spot were identified and discussed in

the risk assessment; these measures are

required by this rule and thus will be

applied consistently over time.

Specifically, the removal of debris prior

to bloom is also an effective mitigation

measure in that it reduces inoculum

present in the grove. Additionally, the

harvest and packinghouse culling

reduces the likelihood that diseased,

symptomatic fruit will be shipped. It is

correct that the post-harvest treatments

have little effect on citrus black spot.

With the inclusion of the 20-day

preharvest incubation to detect latent

infection, whereby observation of a

single infected fruit will remove the

entire grove from the export program for

the entire year, the overall systems

approach results in a substantial risk

reduction. Our estimates of the risk

reduction afforded by all these

measures, and our use of supporting

data and expert judgment in arriving at

those estimates, are set forth in the risk

assessment.

The commenter concludes by

contrasting the 30,000-fold mitigating

effect of cold treatment for fruit flies

with the smaller (50- to 200-fold) effect

of the mitigating measures for citrus

black spot. Taken on its face, this

comparison would seem to indicate that

the mitigating measures for citrus black

spot leave something to be desired in

terms of their ability to reduce the risk

presented by that disease. However, as

is clearly presented in table 11 of the

risk assessment, the baseline

(unmitigated) risk presented by citrus

black spot is far lower than that

presented by fruit flies (in the mean, 1

chance in 28,653 for citrus black spot

versus 1 chance in 7.4 for fruit flies).

Thus, even with the comparatively more

modest mitigating effect of the citrus

black spot measures, the risk estimated

for citrus black spot in the mitigated

scenario is still lower than that

estimated for fruit flies (in the mean, 1

chance in 3.2 million for citrus black

spot versus 1 chance in 350,000 for fruit

flies).

Comment: APHIS does not have

guidelines for performing quantitative

pest risk assessments. While such

guidelines can, in many cases, be

restrictive and prevent development of

better approaches, they can also serve a

useful purpose by preventing common

errors. In view of the myriad problems

with the risk assessment, APHIS should

consider developing quantitative

guidelines, in consultation with experts

in probabilistic risk assessment, to

prevent similar problems in future

quantitative assessments.

Response: APHIS has published very

specific guidelines for qualitative plant

pest risk assessments (USDA 1995,

‘‘Pathway-Initiated Pest Risk

Assessment: Guidelines for Qualitative

Assessments, version 4.0,’’ USDA–

APHIS–PPQ, Riverdale, MD). The only

difference between the methods

described in that document and our

probabilistic assessments is section 8,

where we estimate the likelihood of

introduction. APHIS has not published

a separate document describing the

methods it uses to estimate the

likelihood of introduction when using

probabilistic methods. Although our

methods have evolved slightly with

each probabilistic assessment as we

obtain comments, our methods have

remained fairly consistent and clearly

illustrated. Additionally, the methods

we used in the present risk assessment

are clear. Our process was created in

consultation with world leaders in the

field of probabilistic risk assessment,

and our process has indeed been

subjected to extensive peer review by

experts in probabilistic risk assessment.

Subsequent reviews by experts have

been very favorable and have led to

several improvements in our process.

37654 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

Although improvements will be made

following the present risk assessment,

we have not been made aware of any

significant errors that require significant

changes in our methods.

Risk Assessment—‘‘Principles of Good

Practice’’

The following comments were

generated by a commenter who

evaluated the risk assessment against 14

principles of good practice for Monte

Carlo risk assessment outlined by

Burmaster and Anderson (1944). APHIS

is familiar with this publication, has

referred to it often, and has used it along

with other similar works as a guide

when conducting probabilistic risk

assessments. However, this particular

work represents only one set of

suggestions and does not represent an

‘‘industry standard.’’ Despite that, as

indicated in the individual responses

below, our methods are consistent with

many of the suggestions listed by the

commenter. Below, we have presented

each principle and the accompanying

critique provided by the commenter,

and each is followed by APHIS’

response. Further, as discussed in the

introductory note to the previous

section of this document (‘‘Risk

Analysis’’), additional documentation

regarding the information or data used

as the basis for the risk assessment’s

conclusions is contained in an

addendum to the risk assessment that

may be obtained from the person listed

under FOR FURTHER INFORMATION

CONTACT.

Show all formulas used in the risk

assessment. We do not agree with the

structure of the model used in the risk

assessment. However, the only formula

used in the APHIS risk assessment is the

simple multiplicative formula used to

calculate the likelihood of pest

establishment. This formula is simple

and, while not presented algebraically,

is presented in Figure 2 and adequately

described in the text. However, Figure 2

is illegible, even in the electronic

version of the report available on the

Internet, due to the extremely low

resolution of the image file. No better

copy is available anywhere in the risk

assessment or in the rulemaking record.

Response: As indicated by the

commenter, our risk assessment is quite

transparent. We explained in extensive

detail how we conducted our risk

assessment, and we and our peer

reviewers have found the structure of

our model to be appropriate and correct.

We apologize if the commenter had

difficulty downloading material from

our web site and we would be happy to

provide additional copies of our model.

APHIS regularly supplies paper copies

of the risk assessment to anyone

requesting a copy.

Calculate and present point estimates

of risk. APHIS does not calculate a point

estimate of the risk of infestation;

however, this principle is not

necessarily applicable to a plant pest

risk assessment. In a human health risk

assessment, such a point estimate

provides a point of comparison for the

results of the Monte Carlo analysis with

standard analyses that are familiar. In a

plant pest risk assessment, a point

estimate would be somewhat less useful

since quantitative point estimates are as

unfamiliar as probabilistic estimates,

and so may not be necessary.

Response: We agree with the

commenter’s sense that point estimates

are not a necessary element of a plant

pest risk assessment, which is why we

did not calculate a point estimate of the

risk of infestation.

Present the results from sensitivity

analyses to identify inputs suitable for

probabilistic treatment. APHIS does not

perform sensitivity analyses or analyze

inputs to determine how given variables

affect the predicted risk. As mentioned

previously, many of the distributions

used in the risk assessment are not

based on measured data. A sensitivity

analysis could be used to help focus

data collection on the most important

variables. Additionally, such an analysis

could identify variables that drive the

risk assessment in two senses: (1)

Variables that account for the magnitude

of the predicted risks and (2) variables

that account for the range of the

predicted risks. Understanding which

variables drive the resulting risk

distribution in these two senses is key

to interpreting the results of the risk

assessment and focusing future

research.

Response: We did perform sensitivity

analyses as part of the final step of the

probabilistic analysis of the proposed

mitigation program; as the earlier steps

in the risk assessment were not

probabilistic, sensitivity analyses were

not performed on those earlier steps.

Further, because sensitivity analyses are

not particularly useful with a simple,

linear, multiplicative model of the type

used in the risk assessment, they were

not discussed in the risk assessment. If

the commenter is interested, our

sensitivity analyses are part of the

documentation contained in the

supplemental information that is

available from the person listed under

FOR FURTHER INFORMATION CONTACT.

The commenter suggests that

sensitivity analysis could be used to

help focus data collection on the most

important variables, but that was not the

purpose of the risk assessment. Rather,

the purpose of the risk assessment was

to estimate the risk associated with a

particular proposed program, and not to

aid in the design of a new program.

The commenter also suggests that:

‘‘Additionally, such an analysis could

identify variables that drive the risk

assessment in two senses: (1) Variables

that account for the magnitude of the

predicted risks and (2) variables that

account for the range of the predicted

risks. Understanding which variables

drive the resulting risk distribution in

these two senses is key to interpreting

the results of the risk assessment and

focusing future research.’’ Regarding

item (1), the risk assessment discusses

mitigations that reduce risk, and it

provides estimates of the likelihood of

pest introduction with and without the

system of risk mitigations. The various

input parameters do not represent

sources of risk per se, they represent

events that must occur before a pest can

be introduced; some of them represent

specific risk mitigations (e.g., P5, cold

treatment for fruit flies), not sources of

risk, while others reflect the biology of

the organism and are not sources of risk

(e.g., P7, pest locates suitable host). The

sources of risk are identified in the

hazard identification section of the

assessment (Sections 4–6).

Regarding item (2), the sensitivity

analyses we conducted do in a sense

identify ‘‘variables that account for the

range of the predicted risks,’’ but the

commenter’s wording does not reflect

the purpose, outcome, or use of the risk

assessment. The risk assessment does

not deal with a ‘‘range of predicted

risks.’’ The probabilistic portion of the

risk assessment estimates, for four

separate pests, the likelihood of

introduction given importations with no

specific risk mitigations (the baseline

scenario) and with a specific set of

mitigations (the proposed program).

However, our sensitivity analyses do

indeed identify those variables that

account for the largest amount of

uncertainty in the output (the estimated

likelihood of pest introduction). As

noted earlier, with the type of model

used in the risk assessment (i.e., simple,

linear, and multiplicative), that

information can be obtained by

examination of the input parameters

(Tables 7–10).

Restrict the use of probabilistic

techniques to issues of regulatory

importance. The APHIS risk assessment

is restricted to the issue of regulatory

importance, i.e., the likelihood that

exotic pests imported with Argentine

produce will establish themselves in the

United States. There are few enough

parameters in the model that

probabilistic techniques can be used on

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37655

all. A more realistic model (e.g.

including failure modes and

correlations) might, however, be too

complex for such an approach

(particularly using the chosen software).

Response: We agree that our model is

appropriate to the task at hand. We

disagree that a more complex model

would necessarily be more realistic;

thus, we see no reason to needlessly

complicate our model.

Provide detailed information on the

input distributions selected. APHIS

presents the parameters necessary to

characterize the distributions used in

the risk assessment. It also, and

unnecessarily, presents the mean, mode,

standard deviation, 5th percentile, and

95th percentile of most distributions, at

great length and repetitively in the text.

This allows an informed reader to

reproduce the calculations. APHIS,

however, provides very little additional

information about the distributions it

selected. It presents no graphs of the

distributions used in the assessment.

Very little justification is provided for

the choice of distributions in the report

beyond ‘‘expert judgment,’’ so that even

knowledgeable persons cannot

reproduce the full analysis. For some

distributions, APHIS identifies data that

can be used to support the distribution

(such as for sweet orange scab

incidence), but offers no justification for

the type of distribution selected and no

description of how the data are used to

construct the distribution.

Response: We agree that the

information we provided was sufficient

to allow an informed reader to

reproduce our calculations. We did not

present graphs for a variety of reasons,

not the least of which is that graphs

would be redundant. However, an

informed reader could produce graphs

of our distributions using the

information provided in the risk

assessment. We believe we included

sufficient information about the

generation of our input distributions in

the narrative descriptions that are

provided in the risk assessment for each

of the input values (F1, P1 through P8)

used in our likelihood model. If the

commenter is interested, expanded

explanations regarding our selection of

input distributions are part of the

documentation contained in the

supplemental information that is

available from the person listed under

FOR FURTHER INFORMATION CONTACT.

Show how the input distributions

capture and represent both the

variability and the uncertainty in input

variables. APHIS makes no effort to

distinguish between variability and

uncertainty, and offers no discussion of

their separate contributions to the

results of the analysis. The roles played

by uncertainty and variability in the risk

assessment depend on the goal of the

analysis. If the goal of the analysis is to

estimate a distribution for the average

annual likelihood that an infestation

will occur in the United States,

uncertainty will play a larger role in the

analysis than variability. Year-to-year

variability may be intentionally ignored

in the analysis because the analysis

would not be focusing on variations in

the likelihood of an infestation from

year to year. If, instead, the goal of the

analysis is to generate a distribution of

the likelihood that each box of fruit will

cause an infestation, year-to-year

variability may play a much larger role.

The goal of the analysis should be more

clearly defined, and APHIS should

include a discussion of the roles of

uncertainty and variability in the

analysis.

Response: The approach suggested

here is relatively new and is appropriate

only in certain situations. In other

situations, such as the present risk

assessment, it is not clear that better

results would be obtained. In fact, using

this approach would require a

significant overinterpretation of

available data and would most likely

lead to risk estimates that are less, rather

than more, accurate. When making a

decision about whether to allow

importation of a particular commodity,

whether uncertainty in the estimate

results from variability or other forms of

uncertainty may not matter. The

primary consideration is the value of the

risk, not the shape of the output

distribution.

The purpose of our analysis is closer

to the first of the possible goals

suggested by the commenter (‘‘to

estimate a distribution for the average

annual likelihood that an infestation in

the United States’’) than it is to the

second (‘‘to generate a distribution of

the likelihood that each box of fruit will

cause an infestation’’). Specifically, in

section 8 of the risk assessment, we

state: ‘‘The purpose of a probabilistic

risk assessment is to estimate the

likelihood of an undesirable outcome

(bad event). The bad event is

represented by the endpoint of the risk

model, i.e., introduction of a quarantine

pest.’’

Use measured data to inform the

choice of input distributions whenever

possible. As noted above, most of

APHIS’s distributions are based on

expert judgment. The risk assessment

includes little discussion of the

reasoning behind the selection of

distribution type and the parameters

used to characterize the distributions. In

some cases, APHIS identifies available

data, but it is not clear how these data

are used in the construction of the

distribution.

Response: We did, in fact, use

measured data whenever possible to

inform our choice of input distributions

when preparing the risk assessment.

Ideally, existing data would provide the

basis for direct estimation of model

inputs; however, when conducting

probabilistic assessments to inform

decisions regarding importation of

agricultural commodities, scientific

experiments have not, except in rare

cases, been conducted that provide data

that represent ‘‘direct evidence’’ for risk

assessments. In fact, results are seldom

provided that can even be used as

indirect model inputs. As we made clear

in the risk assessment, all available data

were reviewed and professional

judgment then used to represent the

available information. Because most of

our commodity risk assessments are

conducted to support decisions that

must be made within relatively narrow

time frames, research programs can

seldom be designed and conducted to

provide data specifically for the

assessments (although in the present

case, the United States required

Argentina to design and conduct

additional experiments that were

completed before completion of the risk

assessment). Beyond directly applicable

measured data, USDA bases the

estimates needed for its probabilistic

commodity risk assessments on pest

interception records, the known biology

of the organism being assessed (or the

known biology of related taxa) as

represented in the scientific literature,

expert judgment based on laboratory

experience with the pest or related

organisms, expert judgment based on

field experience with the pest or related

organisms, expert judgment based on

experience conducting commodity

inspections at ports of entry or in the

exporting country, and experience

working with export programs and

export-quality commodities.

Discuss the methods and report the

goodness-of-fit statistics for any

parametric distributions that were fit

quantitatively to measured data. It is

not clear from the text of the report

whether APHIS actually fits

distributions to any real data. No

goodness-of-fit statistics are reported in

the assessment. There is no discussion

of any relation between the cited

experts’ estimates of minimum,

maximum, and mode, and the

parameters of the distributions, nor is

such a relation self-evident. If the data

fitting algorithms in @Risk were used to

fit distributions to data, the procedure

should be clearly described in the text.

37656 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

Response: The only situation where

goodness-of-fit statistics are appropriate

was for the distribution used to

characterize fruit fly survival with the

cold treatment. We did not conduct

goodness-of-fit tests because they were

completed as part of the scientific

research conducted during

establishment of the treatment protocol.

Discuss the presence or absence of

moderate to strong correlations between

input variables. The APHIS report

assumes that each of the eight steps in

the model is independent from all other

steps. It is unlikely that the eight steps

are truly independent. Whether or not

strong correlations exist, APHIS should

discuss the possibility that correlations

exist and estimate the effects of such

correlations on the results of the

analysis.

Response: We did consider the

possibility of correlations among the

various nodes. As we reported in the

risk assessment, we are confident that

the nodes are independent, given the

model and values used. Our analyses

detected no correlations. Our

conclusion that the nodes are

independent resulted from both prior

and ad hoc considerations, as well as

model outputs.

Provide detailed information and a

graph for each output distribution.

APHIS presents the mode, median,

mean, and 95th percentile of the output

distributions for each pest under the

baseline import program and assuming

the presence of a pest mitigation

program. APHIS does not provide a

graph for any of the output

distributions.

Response: We have frequently

considered whether we should include

graphical representations of our output

distributions. We have repeatedly

reached the conclusion that it is neither

necessary nor important to do so. In

fact, we believe it could serve to obscure

our findings.

Perform probabilistic sensitivity

analyses for all key inputs to distinguish

the effects of variability from the effects

of uncertainty in the inputs. APHIS does

not perform any sensitivity analyses to

identify the inputs with the greatest

contributions to the output distribution.

As discussed previously, APHIS makes

no attempt to distinguish the effects of

variability from those of uncertainty.

Response: We always conduct

sensitivity analyses as part of our

probabilistic risk modeling, and did so

for the Argentine citrus risk assessment;

contrary to the commenter’s assertion,

those analyses did indeed indicate those

inputs that contributed the greatest

amount of uncertainty to the output.

(Those analyses are part of the

documentation contained in the

supplemental information that is

available from the person listed under

FOR FURTHER INFORMATION CONTACT.) A

sensitivity analysis addresses the

relationship between variation in the

input parameters and variation in the

output. Specifically, the analysis

quantifies the degree of correlation

between variation in individual input

parameters and the output parameter.

The value of these coefficients does not,

however, indicate the amount of

uncertainty in an input parameter.

Because of the type of model we used

(i.e., simple, linear, and multiplicative),

the values represent the magnitude of

the uncertainty (as represented by the

standard deviation of the input

distribution) relative to the mean of the

input distribution.

The commenter suggest that

sensitivity analysis can be used to

distinguish the effects of variability

from the effects of uncertainty in the

inputs, but we do not believe that is

possible. When data are available to

allow analysts to distinguish variability

from other sources of uncertainty,

variability and other forms of

uncertainty can be accounted for, and

modeled, separately. This is

accomplished by having separate inputs

for variability and other forms of

uncertainty in the input parameters.

However, in this particular case (as in

the majority of probabilistic risk

assessments), the available information

did not allow us to model variability

separately from other sources of

uncertainty. A sensitivity analysis

cannot change this fact and cannot

provide us with the ability to

distinguish the effects of variability

from the effects of other sources of

uncertainty.

In a simple, linear, multiplicative

model of the type used in the Argentine

citrus assessment, the sensitivity

analysis reflects little more than the

‘‘coefficient of variation’’ of the input

parameters. The coefficient of variation

is obtained by dividing the standard

deviation of the distribution by the

mean. Parameters with relatively large

amounts of variation relative to their

mean will have a relatively high

‘‘sensitivity coefficient’’ and will have a

‘‘larger impact’’ on the output. Another

way of stating this is that the output is

most sensitive to those input parameters

about which the experts were most

uncertain. Thus, with this type of

model, the sensitivity analysis reflects

uncertainty in the input parameters.

Tables 7 through 10 reveal those

parameters about which the experts

were most uncertain (P1, P5, P6, P7, P8,

depending on pest and scenario); thus

these are the parameters that had the

‘‘biggest impact’’ on the output. The

values for both the standard deviation

and the mean were provided in the

tables of input values (Tables 7 through

10), so the information necessary to

obtain the coefficient of variation was

available in the risk assessment. As the

sensitivity analysis provides

information that is already available in

Tables 7 through 10, we believed that

little if any additional information

would have been provided by reporting

the sensitivity analysis in the risk

assessment.

Regarding distinguishing the effects of

variability and uncertainty, as stated

above, we have not encountered many

situations where we had sufficient,

directly applicable data to provide

separate estimates for variability and

other forms of uncertainty. Thus, to

conduct such an analysis would

constitute overinterpretation of

available data.

Investigate the numerical stability of

the output distribution. APHIS does not

investigate the numerical stability of

either the central moments of the output

distribution (such as the mean and

standard deviation) or the tails of the

output distribution. Additionally,

APHIS provides no discussion of the

sensitivity of the upper tails of the

output distribution to the tails of the

input distributions. One option for

investigating the numerical stability of

the output distribution is to calculate

the uncertainty for the mean and the 5th

and 95th percentiles of the distribution.

A second option would be to perform a

larger run (e.g., 50,000 iterations instead

of 10,000) and to compare the

distributions.

Response: The @Risk software we

used automatically monitors

convergence ‘‘to help monitor the

stability of the output distributions

created during a simulation’’ (@Risk

software documentation: @Risk

Advanced Risk Analysis for

Spreadsheets, 1997, Palisade

Corporation, Newfield, NY). That

documentation states that the statistics

monitored on each output distribution

are the average percent change in

percentile values (0 to 100 percent, in 5

percent steps), the mean, and the

standard deviation. Thus, we monitored

the stability during all simulations.

Although @Risk simulations can be run

with an ‘‘automatic shutoff’’ option that

is triggered when the output

distribution has reached stability, and

despite the fact that the distributions

reached stability before completing all

10,000 iterations, we completed 10,000

iterations on each simulation. Prior to

conducting the Argentine citrus

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37657

assessment, APHIS conducted informal

investigations of the number of

simulations needed to reach stability

with our simple, linear, multiplicative

models. We found that in some cases

that running 1,000 iterations was not

sufficient to reach stability, so we

increased the number of iterations in

our simulations to 10,000. In the

Argentine citrus risk assessment, 10,000

iterations was found to be sufficient to

reach stability.

While considering out response to

this comment, we re-ran our simulations

with 10,000 iterations (as done in the

assessment) and then with 50,000

iterations as suggested by the

commenter. We used the same random

number generator seed. Results were the

same with 10,000 iterations and not

significantly different with 50,000

iterations. For example, with the fruit

fly program (as opposed to baseline)

simulation, the 95th percentile value

with 10,000 iterations was 1.07 × 10¥5

(0.0000107) and with 50,000 iterations

the 95th percentile value was 1.08 ×

10¥5 (0.0000108). Another example

with the same simulation is for the 90th

percentile value, the value with 10,000

iterations was 5.80 × 10¥6 (0.00000580)

and with 50,000 iterations was 5.61 ×

10¥6 (0.00000561); thus, the 90th

percentile value (part of the upper tail)

was lower (less risk) with more

iterations. Because the 90th and 95th

percentile values can be considered

representative of the upper tail (upper

estimate for the likelihood of pest

introduction), we offer this as an

indication of the stability of the upper

tail. The purpose of conducting a

probabilistic assessment is to try a range

of values to see how the output changes.

When the experts constructed the input

distributions, all necessary uncertainty

regarding the inputs was captured and

the simulations included calculations

based on the upper tails of all nine

distributions.

Present the name and statistical

quality of the random number generator

used. APHIS does not present any

information about the random number

generator used for the risk assessment.

We assume that the random number

generator provided with @Risk was used

in the assessment, but as mentioned

previously, the version of @Risk that

was used in the assessment is not

specified. Even if this was the random

number generator used, more

information should be provided, such

that a reader of the risk assessment

could determine the quality of the

random number generator without

purchasing @Risk.

Response: In section 8.d of the risk

assessment, we stated that ‘‘a computer

program randomly selects a value from

each of the input probability

distributions. * * * We use the risk

analysis computer software package

@Risk for Excel (Palisade Corp.,

Newfield, NY, USA) to run our

simulations.’’ As noted previously, we

used version 3.5c of that program. We

did not supply additional information

regarding @Risk’s random number

generator because we concluded that

sufficient information was provided in

the @Risk documentation.

Discuss the limitations of the methods

and the interpretation of the results.

APHIS offers neither a discussion of the

limitations of the methods used in the

risk assessment nor an interpretation of

the results. APHIS does not

acknowledge any sources of bias in the

risk assessment and does not discuss

how additional research or

measurements might be able to improve

the analysis.

Response: The purpose of our risk

assessment was to inform a decision

regarding the enterability of commercial

citrus from Argentina under a specific

risk mitigation program. We improve

our risk assessment process as needed,

and it was not our purpose to discuss

the evolution of our risk assessment

process as part of this or any other plant

pest risk assessment. An interpretation

of our results and specific

recommendations are provided on p. 48

in the section titled ‘‘Conclusion: Pest

Risk Potential and Phytosanitary

Measures.’’ In that section we stated that

without mitigations, there is a high

likelihood that one or more of the

analyzed pests will be introduced.

Regarding the proposed risk mitigation

measures, we state that ‘‘an appropriate

level of protection from introduction of

plant pests with shipments of

commercial citrus from Argentina

requires strict adherence to risk

mitigation measures such as those

analyzed in this assessment,’’ i.e., the

proposed risk mitigation measures

provide an appropriate level of

protection. With regard to the

commenter’s statement regarding a

discussion of the ability of additional

research or measurement to improve the

risk assessment, it is the very nature of

risk assessment to deal with incomplete

information—otherwise, the risk

assessment would be rendered

unnecessary. We believe that the

available information is sufficient to

support the efficacy of the measures

required by this rule and our analysis of

the risks associated with Argentine

citrus.

Economic and Other Analyses

Comment: The proposed rule’s

economic analysis states that Argentine

citrus would enter the U.S. market at a

time when few lemons are produced by

U.S. growers. This is not true. The

California lemon industry has invested

heavily in developing specialized lemon

trees that are harvested year round.

Moreover, although the peak of the

California harvest comes from March to

June, the fruit is capable of being stored

for 90 to 120 days without loss of color,

flavor, or quality. Hence, the great

majority of California lemons are sold

into the summer marketplace at the very

time Argentina intends to export fruit.

Response: The proposed rule’s

economic analysis was not focused on

lemon production alone, as the

commenter suggests. Rather, our

consideration of the domestic citrus

market was more general. Specifically,

we stated in the proposed rule that

‘‘* * * domestic shipments of citrus

fruit are at their lowest during the

months of July, August, and September,

dropping to approximately 3.5 to 5

percent of average annual shipments

* * *. Since the peak production

period for citrus in Argentina is from

May to October, the entry of Argentine

fresh citrus fruits would likely peak

during these months, which represent

the most likely window of opportunity

for Argentine imports to enter the U.S.

market * * *. Importers and brokers

would likely benefit from the entry of

Argentine citrus fruit into the U.S.

market because they would be able to

provide quality fruits during the months

when domestic production is lowest.’’

That discussion in the proposed rule

was intended to illustrate the

complementary nature of production in

the northern and southern hemispheres,

and not to discount the potential

presence of domestically produced fruit

in the marketplace.

Comment: The economic analysis

prepared for the proposed rule provides

an inaccurate representation of the

potential economic effects of imported

Argentine citrus by: (1) Assuming that

oranges, grapefruit and lemons are in

the same product market, i.e., that they

are perfect substitutes in both

production and consumption and that a

pound of imported oranges has the same

impact on lemon prices as does a pound

of imported lemons; (2) asserting that

there is very little U.S. citrus production

during the summer months when most

Argentine exports occur and that few

U.S. citrus producers would, therefore,

be affected; (3) assuming that the

composition of citrus imports (oranges,

grapefruit, or lemons) does not alter the

37658 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

impact of imports; (4) ignoring the

multiplier effects of fresh citrus sales;

and (5) assuming that marketing

margins are constant and that price

changes at the producer and wholesale

levels are transmitted immediately to

the retail level.

Response: The commenter’s

statements numbered 1, 3, 4, and 5 are

addressed in our final economic

analysis set forth in this final rule under

the heading ‘‘Executive Order 12866

and Regulatory Flexibility Act.’’ With

regard to point number 2, we noted in

the response to the previous comment

that our economic analysis did not

discount the presence of domestically

grown fruit in the marketplace during

the summer months. Rather, we stated

that because Argentina exports most of

its fresh fruit during the summer

months, those imports would not

compete with the peak production

season in the United States (late fall,

winter, and early spring), which would

limit—not eliminate—the impact on

U.S. producers, exporters, and importers

of citrus. In several places, including

both the introduction and conclusion of

our analysis, we explicitly recognized

that the magnitude of the economic

effect of Argentine citrus would depend

on the additional Argentine supply, the

U.S. supply and demand for citrus, and

price conditions in the rest of the world,

and concluded that the larger the share

of Argentine imports, relative to U.S.

domestic supply, the larger the U.S.

producer losses and the larger the U.S.

consumer gains. We did not, as the

commenter suggests, assert that only a

few U.S. producers would be affected by

Argentine citrus imports.

Comment: The economic analysis

prepared for the proposed rule fails to

recognize that the growth in Argentine

citrus exports has been and will

continue to be concentrated in fresh

lemons and that there are significant

amounts of lemons now being processed

that could be diverted to the fresh

export market, since the price paid for

lemons for processing is usually much

lower than for fresh use. There is,

therefore, the potential that fresh lemon

imports from Argentina during the

summer months could likely range from

40 to 100 million pounds, and not the

10 to 50 million pounds examined in

the analysis.

Response: The economic analysis did

recognize the growth in Argentine citrus

production and, since that growth is

predominantly in the lemon sector,

implicitly recognized the concentration

on fresh lemons noted by the

commenter. Indeed, it was the growth in

Argentine citrus production levels that

served as the basis for our estimates of

potential imports of Argentine citrus

into the United States, as we expect that

Argentina will maintain its wellestablished export markets in Europe,

given the substantial investment that

they have made to cultivate those

markets and the inadvisability of

developing a heavy dependence on a

single market such as the United States.

With regard to the diversion of lemons

from the processing market to the fresh

market, we acknowledge that fresh

lemons bring higher prices than lemons

for processing, but one must also

consider that the costs of production

will be higher for those groves

producing fresh lemons for the U.S.

export market in light of this rule’s

requirements for additional

phytosanitary measures during the

growing and packing process and the

costs of transporting fresh lemons

versus the costs of transporting

concentrated lemon juice and essential

oils. With these considerations in mind,

we do not believe that a significant

diversion of lemons from the processing

market to the fresh market is likely.

Comment: Section 603 of the

Regulatory Flexibility Act requires

agencies to prepare and make available

for comment an initial regulatory

flexibility analysis in connection with

any proposed rule. The purpose of the

analysis is to assess the impact of the

proposed rule on small entities. While

APHIS correctly recognizes that 96

percent of U.S. citrus fruit farms are

small entities, it nonetheless states that

‘‘this action would not have a

significant economic impact on a

substantial number of small entities.’’

We do not understand how APHIS

could conclude that the approval of

citrus imports, some of which will be in

direct competition with domestic

growers, would not have a significant

economic impact on a significant

number of those small growers. Thus,

APHIS must prepare the analysis

required by 5 U.S.C. 603, including the

preparation of an analysis of significant

alternatives. Even if APHIS concludes

that no significant alternative exists

which can accomplish the stated

objectives and minimize the impact on

small growers, this discussion must still

be set forth in the proposed rule.

Response: In the economic analysis

provided in the proposed rule, we

identified 17,898 farms producing citrus

in the United States and stated that 96

percent (17,182) of those farms were

small entities with gross sales of less

than $500,000. The remaining 4 percent

(716) of those farms had gross sales of

more than $500,000 and thus were not

considered small entities under the

applicable Small Business

Administration criteria. In the scenario

we examined in which 50 million

pounds of Argentine citrus entered the

United States (the largest import volume

of the five scenarios considered), we

stated that the expected loss to

producers would be $36.674 million.

When spread evenly across the 17,898

producers identified, that would

amount to a loss of $2,049 per farm.

However, we also noted in our analysis

that the 4 percent of producers who are

not small entities owned 66 percent of

the total citrus-growing acreage. If the

expected losses are weighted to the

relative shares of citrus-producing

acreage, the 17,182 small entities could

expect to bear a collective loss of

$12,469,160 (i.e., $36.674 million

multiplied by 0.34), which amounts to

$726 per small farm. Under section

605(b) of the Regulatory Flexibility Act,

the requirements of section 603 do not

apply to any proposed or final rule if the

head of the agency certifies that the rule

will not, if promulgated, have a

significant economic impact on a

substantial number of small entities.

Thus, our statement in the proposed

rule that ‘‘this action would not have a

significant economic impact on a

substantial number of small entities’’

was the Administrator’s certification of

this minimal effect, as required by

section 605(b).

Comment: There is no evidence in the

proposed rule that APHIS prepared an

environmental impact assessment of the

rule, which should have been prepared

in order for APHIS to comply with the

requirements of the National

Environmental Policy Act (NEPA).

APHIS’ NEPA implementing regulations

in 7 CFR 372.5(b)(1) require the

preparation of such a report. If either the

Medfly, various species of Anastrepha,

or possibly other pests were to enter the

United States via Argentine fruit and

become established, a significant, and

perhaps widespread spraying program

would be required. We submit that

APHIS is obligated to consider this

possibility, and prepare, at a minimum,

an environmental impact assessment if

such an event were to occur.

Response: For the proposed rule,

those issues were considered in the risk

assessment in section 7 (Consequences

of Introduction: Economic/

Environmental Importance) of chapter II

(Risk Assessment). An environmental

assessment was not prepared for the

proposed rule because APHIS

previously decided, in accordance with

our NEPA implementing regulations in

7 CFR 372.5(c), to classify future

amendments to 7 CFR part 319 as

categorically excluded actions not

requiring the preparation of an

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37659

environmental assessment. However, in

December 1998, following the

publication of the proposed rule, our

review and consideration of the

comments that had been received by

that time led us to prepare an

environmental assessment that

addresses the concerns raised by the

commenter. That environmental

assessment, as well as a finding of no

significant impact based on the

information presented in the

environmental assessment, may be

obtained by contacting the person listed

under FOR FURTHER INFORMATION

CONTACT.

Comment: APHIS has failed to

prepare a civil rights impact analysis to

analyze the impact of the proposed rule,

if adopted, on various minority groups.

The potential for the rule to lead to a

significant loss of jobs for one or more

ethnic groups must be considered.

Response: We did in fact prepare a

civil rights impact assessment for the

proposed rule. It may be obtained by

contacting the person listed under FOR

FURTHER INFORMATION CONTACT.

Miscellaneous

In addition to the changes discussed

previously in this document, we are also

amending two other sections of the

fruits and vegetables regulations to

correct outdated and erroneous

references to several sections of the

regulations, including § 319.56–2f,

which will be the location of this rule’s

provisions regarding the importation of

grapefruit, lemons, and oranges from

Argentina.

Specifically, paragraph (e) of

§ 319.56a, ‘‘Administrative instructions

and interpretation relating to entry into

Guam of fruits and vegetables under

§ 319.56,’’ refers to ‘‘the provisions of

§§ 319.56–2d and 319.56–2f to 319.56–

2m, inclusive,’’ but all of those sections,

with the exception of § 319.56–2d, have

been removed or redesignated since the

time the regulations in § 319.56a became

effective in 1959. Therefore, we are

amending § 319.56a(e) so that it

accurately reflects the locations of those

remaining sections of the regulations to

which it originally referred.

Similarly, we are amending § 319.56–

2i to remove a reference to § 319.56–2f

that dates back to when that section

contained provisions regarding the

importation of Manila mangoes from

Mexico. In 1995, § 319.56–2f was

removed and reserved and its provisions

regarding the importation of oranges,

grapefruit, and mangoes from Mexico

were integrated into the table contained

in § 319.56–2x. Section 319.56–2i

should have been amended at that time

to reflect the removal of § 319.56–2f, but

was not. Further, the inclusion of

mangoes from Mexico on the list of

commodities in § 319.56–2x that may be

imported subject to treatment in

accordance with the PPQ Treatment

Manual means that it is no longer

necessary to include provisions

regarding Mexican mangoes in § 319.56–

2i. Therefore, we are amending

§ 319.56–2i by removing the reference to

Mexico from the title of the section,

eliminating paragraph (a)(2), and

removing the reference to § 319.56–2f

from paragraph (b).

Therefore, for the reasons set forth in

the proposed rule and in this document,

we are adopting the provisions of the

proposal as a final rule with the changes

discussed in this document.

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.

Argentina has demonstrated in

accordance with international standards

that the citrus-growing areas of the

States of Catamarca, Jujuy, Salta, and

Tucuman are free from citrus canker.

Further, we believe that the

phytosanitary requirements contained

in this rule to prevent the introduction

of other plant pests will reduce the risks

posed by the importation of grapefruit,

lemons, and oranges to a negligible

level. Given these considerations, we

believe that it is no longer necessary to

prohibit the importation of grapefruit,

lemons, and oranges from Argentina.

Immediate implementation of this

rule is necessary to provide relief to

those persons who are adversely

affected by restrictions we no longer

find warranted. This rule requires that

certain measures be taken in order for

grapefruit, lemons, and oranges to be

imported into the continental United

States, including measures that must be

applied early in the growing season.

Making this rule effective immediately

will allow plant health authorities and

interested producers in Argentina to

initiate the required measures as the

growing season begins in order for their

fruit to be eligible for export to the

continental United States during the

2000 shipping season. Therefore, the

Administrator of the Animal and Plant

Health Inspection Service has

determined that this rule should be

effective less than 30 days after

publication.

Executive Order 12866 and Regulatory

Flexibility Act

This rule has been reviewed under

Executive Order 12866. The rule has

been determined to be significant for the

purposes of Executive Order 12866 and,

therefore, has been reviewed by the

Office of Management and Budget.

This rule amends the citrus fruit

regulations by recognizing a citrusgrowing area within Argentina as being

free from citrus canker. This rule also

amends the fruits and vegetables

regulations to allow the importation of

grapefruit, lemons, and oranges from the

citrus canker-free area of Argentina

under conditions designed to prevent

the introduction into the United States

of two other diseases of citrus, sweet

orange scab and citrus black spot, and

other plant pests. These changes will

allow grapefruit, lemons, and oranges to

be imported into the continental United

States from Argentina subject to certain

conditions.

The entry of Argentine fresh citrus

fruits into the continental United States

can be expected to place additional

competitive pressure on domestic

producers and on exporters from other

countries who currently market fresh

citrus fruits in the United States. The

net benefits of this rule are likely to be

positive, where consumers would

benefit from lower prices while

producers would likely bear the primary

losses.

Analysis

This analysis, which also serves as

our cost-benefit analysis, considers the

potential economic effects on domestic

producers and consumers of citrus of

allowing the importation of fresh citrus

fruits from Argentina into the

continental United States. Since entry of

Argentine citrus to the continental

United States will take place in three

stages, the study focuses on citrus

production, price and potential

economic effects of this rule on

consumers and producers during each

stage. The major effects considered are

losses to domestic producers and gains

to consumers due to decreased prices

resulting from increased volume. The

magnitude of the impact will depend on

the size of additional Argentine supply,

the U.S. supply and demand for citrus,

and price conditions in the rest of the

world. Because Argentina already has

well-established international markets,

particularly in Europe, potential

additional Argentine supply to the

United States would likely be limited.

After brief overviews of U.S. and

Argentine production and import/export

status and a discussion of prices, we

evaluate the impact of increased imports

from Argentina on the U.S. lemon,

orange, and grapefruit markets.

The data sources used for the analysis

include: USDA, National Agricultural

37660 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

Statistics Service (NASS) production

statistics; the 1997 Census of

Agriculture; USDA, Economic Research

Service, ‘‘Foreign Agricultural Trade of

the United States’’; USDA, Agricultural

Marketing Service, marketing

information; USDA, Foreign

Agricultural Service, ‘‘Annual Citrus

Report’’; and United Nations, Food and

Agricultural Organization, production

and trade statistics. A complete

bibliography of the sources used in this

analysis is available from the person

listed under FOR FURTHER INFORMATION

CONTACT.

U.S. Citrus Industry

Citrus production

The United States produced 30,270

million pounds of grapefruit, lemons,

and oranges (citrus henceforth) in 1996,

with a value of $2.4 billion. Four

States—Arizona, California, Florida and

Texas—accounted for about 98 percent

of the grapefruit, lemon, and orange

farms and more than 99 percent of the

acreage in 1997 (the latest census year).

As shown in Table 1, in 1997 there

were 4,410 farms in the four main

citrus-producing States that produced

grapefruit, 1,978 that produced lemons,

and 13,133 that produced oranges.

Approximately 97 percent of these fruit

farms (Standard Industrial Classification

0272) had gross sales of less than

$500,000 and thus are considered to be

small entities according to the Small

Business Administration size standards

(13 CFR 121.601). These small citrus

farms accounted for less than 34 percent

of the total citrus growing acreage, while

the remaining 3 percent of citrus farms

(i.e., those with annual gross sales of

$500,000 or more) accounted for about

66 percent of the acreage.

TABLE 1.—FARMS BY STATE AND TYPE OF CITRUS, 1997

State

Grapefruit Lemons Oranges

Number

of farms

Small

entities

(%)

Number

of farms

Small

entities

(%)

Number

of farms

Small

entities

(%)

Arizona ..................................................................................................... 159 100 154 95 266 98

California .................................................................................................. 1,279 97 1,824 93 5,640 98.5

Florida ...................................................................................................... 2,549 97 ................ ................ 6,893 96.2

Texas ....................................................................................................... 423 97 ................ ................ 334 99

Total farms ........................................................................................ 4,410 ................ 1,978 ................ 13,133 ................

Source: USDA/NASS, Census of Agriculture 1997. Note the United States Summary includes farms that may be producing more than one type

of citrus and thus reports fewer farms than when farms are added up by States.

Oranges, grapefruit, and lemons

account for about 95 percent of the total

U.S. citrus production. The 1996 value

of U.S.-produced oranges was $1.82

billion; grapefruit, $289 million; and

lemons, $261 million. Table 2 below

shows the end use of grapefruit, lemons,

and oranges for the United States (1993/

94 to 1997/98 average). As the table

shows, the share of processed fruit is

greater than that diverted to the fresh

export market or fresh domestic market.

TABLE 2.—END USE OF CITRUS IN THE UNITED STATES: AVERAGE OF 1993/94 TO 1997/98

Fruit

Percentage to:

Export Fresh fruit

market Processing

Grapefruit ................................................................................................................................................. 18.6 28.7 52.7

Lemons .................................................................................................................................................... 14.4 36.8 48.8

Oranges ................................................................................................................................................... 5.4 14.7 79.9

Source: USDA/ERS, Fruit and Tree Nuts: Situation Outlook Yearbook, FTS–287, October 1999.

Production for the fresh orange,

grapefruit, and lemon markets

accounted for about 25.2 percent of total

citrus production or approximately

8,662 million pounds in 1997/98. The

share of citrus fruits destined for the

fresh market varied by State and by

fruit. Table 3 below shows fresh utilized

production, fresh fruit share, and

distribution by State.

TABLE 3.—FRESH PRODUCTION AND SHARE BY STATE AND TYPE OF CITRUS, 1993/94 TO 1997/98

State

Grapefruit Lemons Oranges

Fresh

utilized

production*

Fresh

fruit share

(%)

Fresh

utilized

production *

Fresh

fruit share

(%)

Fresh

utilized

production *

Fresh

fruit share

(%)

Arizona .................................................................................................. 56 68 168 59 84 87

California ............................................................................................... 400 68 807 50 3,700 78

Florida ................................................................................................... 1,904 42 ................ ................ 940 5

Texas .................................................................................................... 250 70 ................ ................ 69 77

* Fresh utilized production is in millions of pounds.

Source: USDA/ERS, Fruit and Tree Nuts: Situation Outlook Yearbook, FTS–287, October 1999.

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37661

As can be seen from Table 3, the fresh

market accounted for about 87 percent

of the oranges, 68 percent of the

grapefruit, and 59 percent of the lemons

produced in Arizona; about 78 percent

of the oranges, 68 percent of the

grapefruit, and 50 percent of the lemons

produced in California; about 5 percent

of the oranges and 42 percent of the

grapefruit produced in Florida; and 77

percent of the oranges and 70 percent of

the grapefruit produced in Texas.

The annual average consumption of

oranges, grapefruit, and lemons in the

United States has stayed at around 21.7

pounds per person (12.6 pounds of

oranges, 6.5 pounds of grapefruit, and

2.4 pounds of lemons), 1977 to 1997,

with a variability of about 10 percent.

Fresh citrus fruits are marketed

throughout the year, most heavily

between October and May. Table 4

shows the marketing seasons for the

fruits, by State.

TABLE 4.—MARKETING SEASONS BY FRUIT AND STATE, 1999

Fruit State Marketing season

Grapefruit .............................................................. Arizona ................................................................. November 1 to July 31.

California .............................................................. November 15 to October 30.

Florida ................................................................... September 10 to July 31.

Texas .................................................................... October 1 to May 30.

Lemons .................................................................. Arizona ................................................................. August 15 to March 1.

California .............................................................. August 1 to July 31.

Oranges ................................................................. Arizona ................................................................. November 1 to August 31.

California (Navels) ................................................ November 1 to June 15.

California (Valencias) ........................................... March 15 to December 20.

Florida (Early and midseason) ............................. October 1 to April 15.

Florida (Valencia) ................................................. February 1 to July 31.

Texas .................................................................... September 25 to May 15.

Source: USDA, NASS, Citrus Fruits 1999 Summary, September 1999.

Domestic shipments of citrus fruit are

at their lowest during the months of

July, August, and September (the

distribution of oranges drops to

approximately 6.4 percent of average

annual shipments, grapefruit to 0.7

percent, and lemons to 16.3 percent).

U.S. citrus exports are also at their

lowest during these months. Citrus

imports are also widely distributed

throughout the year, but with aboveaverage imports during July, August,

and September (about 29 percent).

Wholesale prices follow the same

seasonal supply patterns, as they are

lower during peak production months—

October to May—and higher during

summer months from June to

September. Since the peak production

period for citrus in Argentina is from

May to October, the entry of Argentine

fresh citrus fruits will likely peak during

these months, which represent the most

likely window of opportunity for

Argentine imports to enter the U.S.

market. The annual average terminal

market wholesale price in 1996 in major

U.S. cities was approximately 40 cents

per pound for oranges, 29 cents per

pound for grapefruit, and 43 cents per

pound for lemons. (The average

monthly wholesale prices were

estimated from Terminal Market Prices

by cities for January to December 1996;

USDA/AMS, Fruit and Vegetable Market

News.)

Importers and brokers will likely

benefit from the entry of Argentine

citrus fruit into the U.S. market because

they will be able to provide quality

fruits during the months when domestic

production is lowest. Consumers will be

able to obtain a wide choice of fresh

citrus throughout the year and will not

need to wait for the peak domestic

production season or switch to noncitrus fruits.

Citrus Trade

Foreign markets play an increasingly

important role for U.S. producers,

accounting for approximately 29 percent

of the 1996 annual fresh citrus fruit

sales. The total value of the U.S. fresh

grapefruit, lemon, and orange exports

was approximately $659 million in

1996. In terms of value, oranges

accounted for 43.9 percent of citrus

exports, grapefruit for 38.1 percent; and

lemons for 18 percent. The United

States is a net exporter of citrus fruits.

Imports of fresh grapefruit, lemons, and

oranges were valued at about $26.7

million in 1996; by value, about 5.4

percent of imports were grapefruit, 10.1

percent were lemons, and 84.5 percent

were oranges.

A few countries accounted for the

bulk of the U.S. fresh citrus export

market. In Asia, Japan (46 percent),

Hong Kong (10.4 percent), the Republic

of Korea (3 percent), and Taiwan (3

percent) together accounted for

approximately 62.4 percent of total U.S.

exports. Next, exports to Canada were

about 25 percent. In Europe, France (3.3

percent), The Netherlands (2.9 percent),

and the United Kingdom (1 percent) are

the major importers. The United States,

as noted above, is not a major importer

of fresh citrus fruits. Major suppliers are

Australia (67 percent), Mexico (13

percent), and Chile (6.2 percent); these

countries together supplied about 86

percent of U.S. fresh citrus imports in

1996.

U.S. fresh orange exports increased at

an average growth rate of 4.2 percent

between 1985 and 1996; fresh grapefruit

exports increased by 3.7 percent during

that same period. In contrast, exports of

lemons declined by an average rate of

1.1 percent between 1985 and 1996.

Citrus imports to the United States

increased at an average annual growth

rate of 10 percent between 1985 and

1996. Imports are heaviest during the

months when U.S. production and

shipments are lowest. There is also a

reciprocal window of opportunity for

U.S. producers to step in during the

months when production is low in

countries of southern hemisphere. At

present, the United States is exporting

approximately $100,000 worth of citrus

fruit to Argentina and importing none.

Argentine Citrus Industry

Production

Argentina produced an annual

average of 3,104 million pounds of

grapefruit, lemons, and oranges between

1985 and 1996. Of this, about 1,632

million pounds is from three States:

Jujuy, Salta, and Tucuman. (The fourth

State affected by this rule—Catamarca—

has little to no commercial citrus

production.) Table 5 shows the end use

of the three fruits in Argentina.

37662 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

1Producers and exporters in Argentina would not

have the flexibility to make adjustments from

domestic sales to exports or from processing to

fresh, at least not within a single season. The rule

essentially requires growers to commit their groves

to the U.S. export market before a tree ever blooms,

given that they must register with SENASA prior to

the start of the growing season and begin applying

specific phytosanitary measure (e.g., grove cleaning,

field treatments) very early in the season. A nonregistered grove that normally produces fruit for the

Argentine domestic fresh or processing market

could not, in response to high U.S. prices, simply

decide to begin shipping fruit to the United States.

It is possible that a profitable shipping season in the

U.S. market for Argentine export could lead

additional Argentine growers to enter into the

export program for the following year. Historical

export growth is a good indicator of what could

happen. The recent growth in lemon exports is used

to estimate Argintina’s fresh lemon exports to the

United States.

TABLE 5.—END USE OF CITRUS IN ARGENTINA, 1996–1998 AVERAGE

Fruit

Percentage to:

Export Fresh fruit

market Processing

Grapefruit ....................................................................................................................................................... 13 69 18

Lemons .......................................................................................................................................................... 18 15 67

Oranges ......................................................................................................................................................... 11 71 18

Source: USDA/FAS, Argentina Citrus Annual Report 1999, No. AR9034.

A greater proportion of grapefruit and

oranges is consumed domestically as

fresh fruit, while a larger proportion of

lemon is industrially processed.

The annual rate of increase in

Argentine citrus production between

1985 and 1996 is attributable mostly to

a 4.7 percent increase in lemon

production. For the other citrus

varieties, the growth rate was much less

(0.7 percent for oranges and 0.4 percent

for grapefruit). Export growth rates

during this period were 15.4 percent for

lemons, 4.1 percent for oranges, and 0.7

percent for grapefruit.

Citrus Trade

Argentina is one of South America’s

major exporters of grapefruit, lemons,

and oranges. It exported 638 million

pounds of those varieties in 1996 and an

average of 470 million pounds per year

between 1992 and 1996 (433, 334, 445,

500, and 638 million pounds per year,

respectively). Most of that fruit went to

Europe, which accounted for nearly 87

percent of exports. Major destinations

included The Netherlands (52 percent),

France (14 percent), Spain (8 percent),

the United Kingdom (10 percent), and

Russia (8 percent). Smaller importers of

Argentine citrus include Portugal,

Belgium, Germany, Hong Kong, and

Saudi Arabia. Since the majority of the

U.S. fresh citrus exports went to the Far

East, the United States and Argentina

appear to be serving distinct markets.

Imports of fresh citrus accounted for

only about 0.06 percent of the utilized

total Argentine citrus supply.

Argentina can be expected to

maintain its well-established export

markets, which, as noted in the previous

paragraph, are mainly in Europe.

Exports to the United States would

provide another potential outlet for the

Argentine citrus industry.

Wholesale Terminal Market Prices

Fresh citrus fruit wholesale prices are

lower in Argentina than in the United

States. Average wholesale prices in

Argentina for fresh grapefruit, oranges,

and lemons were 17, 18, and 17 cents

per pound, respectively, in 1996. These

are lower than the average U.S.

wholesale price of 29, 40, and 43 cents

per pound of the respective fresh fruits

for the same period. However, the

Argentine wholesale prices do not

reflect the additional costs that

exporting these fruits to the United

States would entail; i.e., overland

transport cost from northwestern

Argentina to the south-central coast, the

sea freight rate, cold treatment, and the

tariff rates, which add about 15 to 20

cents per pound to the average

Argentine wholesale price. In addition,

even before their fruit is exported to the

United States, participating groves will

incur added production costs in meeting

the requirements of this rule. These

requirements include grove cleaning,

grove treatment, visual survey of groves

20 days prior to harvest, sampling and

laboratory examination of fruit from the

grove and buffer area, registered

technicians at each packinghouse to

verify the origin of fruit coming in, and

sodium hypochlorite dipping prior to

packing. These additional requirements

are expected to add about 3 to 5 cents

per pound to costs. Thus, by the time

the fresh citrus from Argentina arrives at

U.S. ports, the gap in prices will be

narrower.

Effects on Producers and Consumers

This section of the analysis examines

the potential economic effects on U.S.

producers and consumers of allowing

fresh lemons, oranges, and grapefruit

from Argentina to enter the U.S. market.

Because of our conclusion that the

importation of Argentine citrus poses a

negligible pest risk, we do not believe

that it is necessary to evaluate the costs

of pest introduction in this analysis.

This analysis is based on expected

additional exports of these fruits by

Argentina.1 As noted previously, the

entry of Argentine citrus fruit into the

continental United States will be phased

in over three stages. In the first stage

(the 2000 and 2001 shipping seasons),

the fruit will be authorized entry into 34

non-citrus-producing, non-buffer States;

in the second stage (the 2002 and 2003

shipping seasons), the fruit may enter

the original 34 States plus an additional

10 buffer States; and in the final stage

(beginning with the 2004 shipping

season), the fruit may enter all areas of

the continental United States.

A partial equilibrium economic

surplus framework is used in this

analysis to consider the benefits and the

costs of this rule. Potential producer

losses and gains to consumers are

quantified for each citrus product in

terms of changes in producer and

consumer surplus resulting from

increased imports from Argentina. This

analysis measures the direct effects of

this rule on domestic producers of

oranges, grapefruit, and lemons. Indirect

and induced effects on income, output,

and employment are not considered.

To simplify the analysis, supply and

demand curves are assumed to be linear

and the supply shift is assumed to be

parallel. We use point estimates for the

elasticities of supply and demand,

average annual prices, and estimates of

annual U.S. production and annual

Argentine exports in the analysis. We

assume U.S. and Argentine citrus are

substitutes for one another. Seasonality

in their production, consumption, and

distribution are ignored.

To estimate the total exports of

oranges, lemons, and grapefruit that

could be expected to result from this

rule, we use State- and fruit-specific

1995 production data from three of the

four eligible Argentine States—Jujuy,

Salta, and Tucuman. Because export

levels for Argentine citrus fruit have

been subject to marked fluctuations over

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37663

time, a simple semi-log model is used to

estimate the growth rate of exports of

each of the three fresh fruits. Exports to

the United States are then calculated by

assuming that Argentina would

maintain its current exports to the rest

of the world and divert its incremental

export to the United States.

Exports from Argentina will depend

to a large extent on whether Argentine

citrus will be price competitive with

U.S. citrus. Table 6 shows the average

annual prices in Argentina, plus

shipping and additional costs imposed

by the rule, and U.S. prices. While

seasonal prices can vary substantially

from the average, we believe that the

averages provide some sense of the

incentives for Argentine citrus exports

to the United States. Price differentials

for the three citrus commodities

indicate that Argentine lemons will be

able to compete effectively with U.S.

lemons. It is less likely that oranges and

grapefruit from Argentina will have the

same competitive advantage and,

therefore, it is less likely that they will

be exported to the United States.

TABLE 6.—ESTIMATES OF PRICE DIFFERENTIALS FOR CITRUS

Fruit

Per-pound price

(dollars)

Argentina

wholesale

price

Transport

cost

Additional

costs due to

rule

Price of Argentine fruit

in U.S.

Price of

U.S. fruit

Grapefruit ................................................................................................. .17 .15–.20 .03–.05 .35–.42 .29

Oranges ................................................................................................... .18 .15–.20 .03–.05 .36–.43 .40

Lemons .................................................................................................... .17 .15–.20 .03–.05 .35–.42 .43

Lemons

Using a 5-year average (1992/93

through 1996/97) of U.S. consumption,

production plus imports minus exports,

we estimated U.S. domestic

consumption of lemons to be 728

million pounds. The average price is

$0.43 per pound. There are very few

published elasticity estimates available.

Published estimates from quantitydependent models for lemon demand

elasticity are not available, but Ferguson

and Carman find an elasticity of

demand for lemon of ¥0.44 in an

unpublished study. Another study

yielded an elasticity of supply for

lemons greater than zero (Kinney et al.,

1987, p.9, equation 6). Estimation by

various data points, using acreage and

per-acre revenue data in Tables 9 and 6,

respectively, of Kinney et al. yields

elasticities of supply for lemons

between 0.04 and 0.17. In our analysis

we use the ¥0.44 estimate for the

elasticity of demand and assume an

elasticity of supply equal to 0.09.

Because export levels for Argentine

lemons have been subject to marked

fluctuations over time (e.g., increases of

73 percent in 1994, 17 percent in 1995,

49 percent in 1996, and almost 10

percent in 1997 and decreases of 55

percent in 1986, 15 percent in 1989, and

25 percent in 1993), the quantities of

fruit considered in this analysis are

based on growth rates in Argentina’s

fresh lemon exports to the rest of the

world. As discussed above, a simple

semi-log model was used to estimate the

growth rate of lemon exports between

1985 and 1998. The results show that

lemon exports increased at the rate of 15

percent during that period. Using 1994–

1998 average exports from the eligible

Argentine States, 293.6 million pounds,

as a baseline number, the total expected

increase in exports would be 44.04

(293.6 × 0.15) or, rounding, 44 million

pounds.

We assume that the elasticities, the

quantity of the domestic lemons

produced and consumed, and the

quantity of Argentine lemons imported

would not change over the 3-stage

phase-in period.

Estimated results of introducing

imported fresh lemons from the

Argentine States of Jujuy, Salta, and

Tucuman into the U.S. market are as

shown in Tables 7, 8, and 9. Because the

price differential between Argentine

lemons and U.S.-produced lemons

shown in Table 6 appears to be

sufficient to make export of lemons

profitable to Argentine exporters, we

estimate the impacts on consumers and

producers considering three scenarios

for each phase of the rule’s

implementation. The three scenarios

examine the impact of 60 percent, 80

percent, and 100 percent of the 44-

million-pound increase in lemon

exports being shipped to U.S. markets.

We assume that the elasticities and

the quantity of Argentine lemons

imported would not change over the 3-

stage phase-in. Our point of comparison

in each stage is the absence of lemon

imports from Argentina. In other words,

the analysis at each stage assumes the

same level of domestic production and

consumption and the same price prior

to importation of Argentine lemons. We

have made no attempt to assess the

incremental effects of the rule over the

3-stage phase-in period and,

furthermore, it is not appropriate to

compare the impacts of the various

stages or to sum across the stages to

obtain a total effect.

Table 7 provides an analysis of

expected impacts during Stage 1,

including percent change in price,

percent change in quantity, resultant

producer losses, consumer benefits, and

net benefits, for each diversion scenario.

Stage 1 allows for importation of citrus

into 34 States. These States account for

approximately 60 percent of fresh lemon

consumption in the United States, about

437 million pounds.

TABLE 7.—THE IMPORTATION OF FRESH LEMONS FROM ARGENTINA TO APPROVED STATES (STAGE 1)

Percentage of average Argentine lemon

export growth diverted to the U.S.

market:

60 80 100

Imports (millions of pounds) .................................................................................................................... 26.4 35.2 44

Percent change in price ........................................................................................................................... ¥11.4 ¥15.2 ¥19

Percent change in quantity ...................................................................................................................... ¥1.03 ¥1.37 ¥1.71

37664 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

TABLE 7.—THE IMPORTATION OF FRESH LEMONS FROM ARGENTINA TO APPROVED STATES (STAGE 1)—Continued

Percentage of average Argentine lemon

export growth diverted to the U.S.

market:

60 80 100

Decrease in producer surplus (millions of dollars) .................................................................................. ¥22.251 ¥29.616 ¥36.957

Increase in consumer surplus (millions of dollars) .................................................................................. 22.926 30.817 38.833

Net benefit (millions of dollars) ................................................................................................................ 0.675 1.201 1.876

As Table 7 shows, during the first

stage producer losses could potentially

range between $22.251 million and

about $36.957 million, while consumer

gains could range between $22.926

million and $38.33 million. The net

benefits, therefore, would be between

$675,000 and about $1.876 million.

In Stage 2, Argentine imports will be

shipped to 44 States, which account for

72.4 percent of lemon consumption,

approximately 527 million pounds.

Table 8 shows that the expansion in

Stage 2 will yield about the same results

as Stage 1.

TABLE 8.—THE IMPORTATION OF FRESH LEMONS FROM ARGENTINA TO APPROVED STATES (STAGE 2)

Percentage of average Argentine lemon

export growth diverted to the U.S.

market:

60 80 100

Imports (millions of pounds) .................................................................................................................... 26.4 35.2 44

Percent change in price ........................................................................................................................... ¥9.452 ¥12.602 ¥15.753

Percent change in quantity ...................................................................................................................... ¥0.851 ¥1.134 ¥1.418

Decrease in producer surplus (millions of dollars) .................................................................................. ¥22.270 ¥29.651 ¥37.011

Increase in consumer surplus (millions of dollars) .................................................................................. 22.830 30.647 38.567

Net benefit (millions of dollars) ................................................................................................................ 0.560 0.996 1.556

Table 9 presents the results for the third stage, when fresh lemons imported from Argentina are allowed in all

areas of the continental United States.

TABLE 9.—THE IMPORTATION OF FRESH LEMONS FROM ARGENTINA (STAGE 3)

Percentage of average Argentine lemon

export growth diverted to the U.S.

market:

60 80 100

Imports (millions of pounds) .................................................................................................................... 26.4 35.2 44

Percent change in price ........................................................................................................................... ¥6.84 ¥9.12 ¥11.4

Percent change in quantity ...................................................................................................................... ¥0.62 ¥0.82 ¥1.03

Decrease in producer surplus (millions of dollars) .................................................................................. ¥21.35 ¥28.44 ¥35.52

Increase in consumer surplus (millions of dollars) .................................................................................. 21.74 29.13 36.59

Net benefit (millions of dollars) ................................................................................................................ 0.39 0.69 1.07

As shown in Table 9, both producer

losses and consumer gains during this

final period would be slightly less than

during the previous two stages, as

Argentine imports would compete with

the entire domestic fresh supply.

Producer losses in this scenario range

between $21.35 million and $35.52

million, while consumer gains are

between $21.74 million and $36.59

million. The net benefits would thus be

between $390,000 and $1.07 million.

One of the commenters who

responded to our proposed rule stated

that in Argentina, 30 percent of lemon

acreage is due to begin bearing during

the next 5 years, thus annual production

of lemons will increase significantly.

This commenter reported that estimated

lemon production increased 240 million

pounds from 1996 to 1997 and

concluded that within 5 years,

Argentine citrus exporters, with an

established distribution network, could

very easily export 100 to 200 million

pounds or more of fresh lemons to the

United States during the summer

months, a much larger export level than

was considered in the proposed rule’s

economic analysis.

With regard to current increases and

potential suitable land for future

expansion of lemon groves in Argentina,

both planted acres and harvested acres

have increased from their 1996 levels.

Planted acreage increased from 76,763

acres to 102,698 acres in 1998, while

harvested acreage increased from 69,854

acres to 95,095 acres. As can be seen,

harvested acres accounted for about 92.6

percent of the planted acreage in 1998.

For 1999, acres planted are forecasted to

increase to 106,210 acres, while

harvested acres are forecasted to decline

to 93,860 acres as older groves are

replaced by younger, non-fruit-bearing

trees. Over 90 percent of the planted

acreage is being harvested, and about 5

percent of new plantings are

replacement plantings. If these

expansions continue and if weather

conditions are favorable, Argentina will

have a much larger potential to export

more fresh lemons to all countries,

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37665

including the United States. (USDA/

FAS, Argentina Citrus Annual Reports

for 1997 [AR7043], 1998 [AR8032], and

1999 [AR9034], U.S. Embassy, Buenos

Aires, Argentina; Randall J. Hager,

Agricultural Attache ́, Office of

Agricultural Affairs, U.S. Embassy,

Buenos Aires, August 1999, personal

communication; and Mariano Ripari,

Agricultural Attache ́, Embassy of

Argentina, Washington DC, August

1999, personal communication).

Whether this expansion will continue,

and how it will affect the United States,

depends not only on the availability of

suitable land in Argentina and the

capital to convert that land to lemon

groves, but also on many other factors

such as production costs, relative world

prices for fresh lemons, U.S. prices, the

exchange rates for major currencies,

changes in consumer taste for fresh

lemons, growth in the demand for fresh

lemons in other countries that are

already importing from Argentina, the

opening of other potential markets (e.g.,

new markets for Argentine lemons are

opening in the Far East), and the

profitability of alternative land use.

Since inclement weather can affect both

the quantity and quality of fresh lemons,

there is added uncertainty in predicting

Argentina’s fresh lemon export capacity.

For example, although production

increased from about 1,905 million

pounds in 1997 to 2,260 million pounds

in 1998, this did not translate to large

export levels for fresh lemons. Instead,

exports declined from 388 million

pounds to 344 million pounds, as fresh

lemons were diverted for processing due

to rainy weather that caused poor

quality.

Table 10 shows an import of 100

million pounds of fresh lemon to the

United States would result in price

decline of about 26 percent and

producer loss of about $80 million.

However, consumer benefit would be

about $86 million dollars, yielding a net

benefit of about $5.57 million. We do

not expect this level of lemon imports

from Argentina to be realized.

TABLE 10.—IMPACT IN THE UNITED

STATES OF LARGER ARGENTINE

LEMON EXPORTS TO THE UNITED

STATES

[Price elasticity of demand is ¥0.44 and price

elasticity of supply is 0.09]

Potential exports to the United

States (millions of pounds) ... *100

Percent change in price ........... ¥25.92

TABLE 10.—IMPACT IN THE UNITED

STATES OF LARGER ARGENTINE

LEMON EXPORTS TO THE UNITED

STATES—Continued

[Price elasticity of demand is ¥0.44 and price

elasticity of supply is 0.09]

Percent change in quantity** .... ¥2.33

Decrease in producer surplus

(millions of dollars) ................ ¥80.19

Increase in consumer surplus

(millions of dollars) ................ 85.76

Total surplus (millions of

dollars) ........................... 5.57

*Less than perfectly inelastic supply.

**This decrease in quantity may be due to

diversion of fresh lemons to the processing

sector as the price of fresh lemons declines.

Increased ability to export will

translate to sales only if there is a

comparable market demand for fresh

lemons. Over the last several years, per

capita consumption (between 2.54 and

2.90 pounds per person) has remained

stable, with very small variability (a

mean of 2.7 pounds per person and a

standard deviation of 0.12 pounds per

person). U.S. consumption of fresh

lemons over the last 3 years has

declined from 766.3 million pounds

(peak amount in 1995/96) to 747.9

million and 675.8 million pounds in

1996/97 and 1997/98, respectively

(USDA/ERS, ‘‘Fruit and Tree Nuts:

Situation and Outlook Report,’’ October

1999, p.74). Most available estimates for

the price elasticity of demand for fresh

lemon are below -0.5, implying that the

demand for fresh lemons is price

inelastic. This means that for every 1

percent decrease in their price, the

demand for fresh lemons would

increase by less than 0.5 percent. Given

an estimated price elasticity of -0.44, a

100-million-pound increase in supply of

fresh lemons would require a price

decrease of about 26 percent. In other

words, for a large quantity of fresh

lemons to be absorbed, the price of fresh

lemons has to decrease substantially. If

100 million or more pounds of fresh

lemons were to be imported from

Argentina, the negative effect on

domestic producers would be much

larger than predicted under the

importation scenario of 44 million

pounds. Consumer benefits would still

outweigh producer losses. Since such a

large influx of fresh lemons would

require a large price decline to be

absorbed, it would not be profitable for

Argentina to export fresh lemons in

such large quantities to the United

States.

Oranges

Using a 5-year average (1992/93

through 1996/97) of U.S. consumption,

production plus imports minus exports,

we estimated U.S. domestic

consumption of oranges to be 3,479

million pounds. The average price is

$0.40 per pound. As with lemons, there

are very few published elasticity

estimates available. The two studies

most often referred to are by Huang

(1993) and Thompson et al. (1990) and

relate to oranges and grapefruit. Huang

provides estimates both for Marshallian

and Hicksian demand systems. The

results of the Marshallian demand

system are reported and used here—a

demand elasticity of -0.849 for oranges.

Thompson, et al. estimate -0.719 for the

demand elasticity for oranges. A recent

study showed that the elasticity of

supply for California oranges was 0.149

(Villezca-Becerra and Shumway 1992).

In our analysis, we use the -.849

estimate made by Huang for the

elasticity of demand and assume an

elasticity of supply equal to 0.149.

Similar to lemons, our estimate for

Argentine orange exports to the United

States are based on growth rates in

Argentina’s fresh orange exports to the

rest of the world. As above, a simple

semi-log model was used to estimate the

growth rate of orange exports between

1985 and 1996. The results show that

orange exports increased at the rate of

4.1 percent during that period. Using

1992–1996 average exports from the

Argentina, 171 million pounds, as a

baseline number and assuming the share

of exports from the eligible Argentine

States would continue to be 26.59

percent, the total expected increase in

exports would be 1.86 million pounds

(171 × 0.2659 × .041) or, rounding, 2

million pounds.

Table 11 reports the potential effects

of orange imports from Argentina during

the first, second, and third stages of the

import program. We believe the price

differential between U.S. and Argentine

oranges illustrated in Table 6 suggests

that a lower proportion of Argentine

orange exports will be diverted to the

United States. Therefore, we assume a

20 percent diversion of the 2 million

pounds of the expected increase in

Argentine exports, or 400,000 pounds.

Table 11 shows that price decreases as

the volume of imported oranges

increases, given domestic supply in the

approved States during every stage.

37666 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

TABLE 11.—THE IMPORTATION OF FRESH ORANGES FROM ARGENTINA TO APPROVED STATES FOR STAGES 1 THROUGH 3,

ASSUMING 20 PERCENT OF AVERAGE ARGENTINE ORANGE EXPORT DIVERTED TO THE U.S. MARKET

Stage

123

Imports (millions of pounds) .................................................................................................................... 0.4 0.4 0.4

Percent change in price ........................................................................................................................... ¥0.04 ¥0.03 ¥0.012

Percent change in quantity ...................................................................................................................... ¥0.003 ¥0.003 ¥0.002

Decrease in producer surplus (millions of dollars) .................................................................................. ¥0.3019 ¥0.3019 ¥0.16032

Increase in consumer surplus (millions of dollars) .................................................................................. 0.3019 0.3019 0.16033

Net benefit (millions of dollars) ................................................................................................................ 0.0000 0.0000 0.00001

Note: The utilized supply for Stage 1 is 2,089 million pounds for approved States; for Stage 2 it is 2,518 million pounds.

Consumer gains in every stage are

approximately equal to producer losses.

Grapefruit

Using a 5-year average (1992/93

through 1996/97) of U.S. consumption,

production plus imports minus exports,

we estimated U.S. domestic

consumption of grapefruit to be 1,602

million pounds. The average price is

$0.29 per pound. As with lemons, there

are very few published elasticity

estimates available. The two studies

most often referred to are by Huang

(1993) and Thompson et al. (1990) and

relate to oranges and grapefruit. Huang

provides estimates both for Marshallian

and Hicksian demand systems. The

results of the Marshallian demand

system are reported and used here—a

demand elasticity of -0.455 for

grapefruit.

Thompson, et al. estimate -0.523 for

the demand elasticity for grapefruit. A

recent study showed that the elasticity

of supply for California grapefruit was

0.409 (Villezca-Becerra and Shumway

1992). In our analysis we use the -0.455

estimate made by Huang for the

elasticity of demand and assume an

elasticity of supply equal to 0.409.

Similar to lemons and oranges, our

estimate for Argentine grapefruit exports

to the United States are based on growth

rates in Argentina’s fresh grapefruit

exports to the rest of the world. As

above, a simple semi-log model was

used to estimate the growth rate of

grapefruit exports between 1985 and

1996. The results show that grapefruit

exports increased at the rate of 1 percent

during that period. Using 1992–1996

average exports from the Argentina,

79.72 million pounds, as a baseline

number and assuming the share of

exports from the eligible Argentine

States would continue to be 51.22

percent, the total expected increase in

exports would be 0.41 million pounds

(79.72 × 0.5122 × 0.01).

Given the price advantage possessed

by U.S. producers of grapefruit (see

Table 6), we believe that it is highly

unlikely that Argentine grapefruit will

be marketed in the United States.

However, if we perform an analysis of

the impact of grapefruit imports similar

to the analysis done for oranges and

lemons, we find that there is not a

significant effect on either U.S.

producers or consumers. On the basis of

the growth rate of grapefruit production

in Argentina, which was less than 1

percent, the maximum that could be

diverted would be about 410,000

pounds. This amount, when compared

to about 1,603 million pounds of

domestic supply of fresh grapefruit in

the United States, is very small. As a

result, price would decrease by only

about 0.03 percent with 100-percent

diversion in Stage 3. Producers losses

and consumer gains both would be

around $137,600, yielding a net benefit

of zero.

Conclusion

Overall, the estimated net economic

effects of this rule are positive. There is

a direct relationship between producer

losses and consumer gains on the one

hand and the quantity of imports on the

other hand. Therefore, the larger the

share of imports from Argentina,

relative to U.S. domestic supply, the

larger the U.S. producer losses and the

larger the U.S. consumer gains. In all

cases, consumer gains are equal to or

slightly outweigh grower losses.

As seen in Tables 7 through 11, the

entry of fresh citrus fruits from

Argentina into U.S. markets would

induce producer losses and consumer

gains. The greatest effect would be due

to importation of lemons because the

price differential between domestic

fresh lemons and Argentine lemons may

be largest. The expected lemon imports

from Argentina would represent a larger

proportion of the U.S. domestically

available fresh lemon volume compared

to that for fresh oranges and grapefruit.

Overall, considering all three stages of

the import program, fresh lemon prices

could potentially decrease between 6.84

percent and 19 percent. Producers

would possibly lose between $21.35

million and $36.96 million, while

consumers would potentially gain

between $21.74 million and $38.83

million annually as the result of

importing fresh lemons from Argentina,

yielding a net benefit of between

$390,000 and $1.876 million. In all

cases, consumer gains slightly outweigh

grower losses.

The extent of any actual decrease in

prices would depend to a great degree

upon the size of the price elasticity of

demand, the magnitude of the change in

supply, and the size of the baseline

price. For lower price elasticities, both

losses and gains would be higher. Since

fresh fruit exports from Argentina,

especially of oranges and grapefruit, are

not expected to be large, they are not

expected to change citrus fruit

production and consumption patterns in

the United States.

Because Argentina’s peak season of

production complements the U.S. low

season of production (particularly for

oranges and grapefruit) and vice versa,

this rule should have a positive effect

for consumers. U.S. prices during the

months of June through September are

higher than the annual average. The

effect would vary by commodity, with

the largest effect on lemon prices. As a

result of the highest expected additional

fresh lemon supply, the average lemon

price in the United States would

decrease by as much as 19 percent (in

Stage 1), from 43 cents per pound to

about 34.83 cents per pound. Orange

prices would decline by as much as 0.04

percent (in Stage 1), from 40 cents per

pound to 39.98 cents per pound. The

effect on grapefruit prices is even more

insignificant.

In addition, it is important to note

that the analysis implicitly assumes the

worst-case scenario because the partial

equilibrium analysis does not allow for

substitution among producers. If the

price of fresh citrus fruits decreases

significantly, then the producers may

choose to channel their products to

overseas markets or to processing

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37667

markets. Under those scenarios, the

decrease in prices expected to result

from this rule would be less than that

estimated in this analysis, resulting in

less of a decrease in producer surplus.

This rule would have a net positive

effect on the overall economy, since

consumer benefits would be slightly

higher than producer losses. The

increased potential for trade and

facilitation of flow of goods will benefit

the welfare of both countries. These

trading relationships benefit numerous

sectors in the U.S. national economy.

Increased trade in these sectors have

dual benefits. Those employed are also

consumers of fresh citrus fruit. Since

fresh citrus fruits are normal goods,

with positive income elasticities,

increased jobs, outputs, and income in

those sectors can also mean increased

consumption of citrus products.

The only significant alternative to this

rule would be to make no changes in the

regulations; i.e., to continue to prohibit

the importation of grapefruit, lemons,

and oranges from Argentina. We have

rejected that alternative because we

believe that Argentina has demonstrated

that the citrus-growing areas of the

States of Catamarca, Jujuy, Salta, and

Tucuman are free from citrus canker

and because we believe that the systems

approach offered by Argentina to

prevent the introduction of other plant

pests reduces the risks posed by the

importation of grapefruit, lemons, and

oranges to a negligible level.

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 12988

This final rule allows the importation

of grapefruit, lemons, and oranges from

Argentina under certain conditions.

State and local laws and regulations

regarding grapefruit, lemons, and

oranges imported under this rule are

preempted while the fruit is in foreign

commerce. Grapefruit, lemons, and

oranges are generally imported for

immediate distribution and sale to the

consuming public and will remain in

foreign commerce until sold to the

ultimate consumer. The question of

when foreign commerce ceases in other

cases must be addressed on a case-bycase basis. No retroactive effect will be

given to this rule, and this rule 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 rule. The

assessment provides a basis for the

conclusion that the importation of

grapefruit, lemons, and oranges under

the conditions specified in this rule will

not present a risk of introducing or

disseminating plant pests and would

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).

Copies of the environmental

assessment and finding of no significant

impact are 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

In accordance with section 3507(d) of

the Paperwork Reduction Act of 1995

(44 U.S.C. 3501 et seq.), the information

collection or recordkeeping

requirements included in this final rule

have been approved by the Office of

Management and Budget (OMB). The

assigned OMB control number is 0579–

0134.

List of Subjects

7 CFR Part 300

Incorporation by reference, Plant

diseases and pests, Quarantine.

7 CFR Part 319

Bees, Coffee, Cotton, Fruits, Honey,

Imports, Incorporation by reference,

Nursery Stock, Plant diseases and pests,

Quarantine, Reporting and

recordkeeping requirements, Rice,

Vegetables.

Accordingly, we are amending title 7,

chapter III, of the Code of Federal

Regulations as follows:

PART 300—INCORPORATION BY

REFERENCE

1. The authority citation for part 300

continues to read as follows:

Authority: 7 U.S.C. 150ee, 154, 161, 162

and 167; 7 CFR 2.22, 2.80, and 371.2(c).

2. In § 300.1, paragraph (a), the

introductory text is revised to read as

follows:

§ 300.1 Materials incorporated by

reference.

(a) Plant Protection and Quarantine

Treatment Manual. The Plant Protection

and Quarantine Treatment Manual,

which was reprinted November 30,

1992, and includes all revisions through

May 2000, has been approved for

incorporation by reference in 7 CFR

chapter III by the Director of the Office

of the Federal Register in accordance

with 5 U.S.C. 552(a) and 1 CFR part 51.

* * * * *

PART 319—FOREIGN QUARANTINE

NOTICES

3. The authority citation for part 319

continues to read as follows:

Authority: 7 U.S.C. 150dd, 150ee, 150ff,

151–167, 450, 2803, and 2809; 21 U.S.C. 136

and 136a; 7 CFR 2.22, 2.80, and 371.2(c).

§ 319.28 [Amended]

4. In Subpart—Citrus Fruit, § 319.28 is

amended as follows:

a. In paragraph (a)(1), by adding the

words ‘‘Argentina (except for the States

of Catamarca, Jujuy, Salta, and

Tucuman, which are considered free of

citrus canker),’’ immediately after the

word ‘‘Seychelles,’’.

b. In paragraph (a)(2), by adding the

words ‘‘(except as provided by § 319.56–

2f of this part)’’ immediately after the

word ‘‘Argentina’’.

c. In paragraph (a)(3), by adding the

words ‘‘(except for the States of

Catamarca, Jujuy, Salta, and Tucuman,

which are considered free of Cancrosis

B)’’ immediately after the word

‘‘Argentina’’.

§ 319.56a [Amended]

5. In § 319.56a, paragraph (e), the first

sentence is amended by removing the

words ‘‘and 319.56–2f to 319.56–2m,

inclusive,’’ and adding the words ‘‘,

319.56–2e, 319.56–2g, 319.56–2k,

319.56–2l, and 319.56–2p’’ in their

place.

6. In Subpart Fruits and Vegetables, a

new § 319.56–2f is added to read as

follows:

37668 Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations

§ 319.56–2f Administrative instructions

governing importation of grapefruit,

lemons, and oranges from Argentina.

Fresh grapefruit, lemons, and oranges

may be imported from Argentina into

the continental United States (the

contiguous 48 States, Alaska, and the

District of Columbia) only under permit

and only in accordance with this section

and all other applicable requirements of

this subpart.

(a) Origin requirement. The grapefruit,

lemons, or oranges must have been

grown in a grove located in a region of

Argentina that has been determined to

be free from citrus canker. The

following regions in Argentina have

been determined to be free from citrus

canker: The States of Catamarca, Jujuy,

Salta, and Tucuman.

(b) Grove requirements. The

grapefruit, lemons, or oranges must have

been grown in a grove that meets the

following conditions:

(1) The grove must be registered with

the citrus fruit export program of the

Servicio Nacional de Sanidad y Calidad

Agroalimentaria (SENASA).

(2) The grove must be surrounded by

a 150-meter-wide buffer area. No citrus

fruit grown in the buffer area may be

offered for importation into the United

States.

(3) Any new citrus planting stock

used in the grove must meet one of the

following requirements:

(i) The citrus planting stock originated

from within a State listed in paragraph

(a) of this section; or

(ii) The citrus planting stock was

obtained from a SENASA-approved

citrus stock propagation center.

(4) All fallen fruit, leaves, and

branches must be removed from the

ground in the grove and the buffer area

before the trees in the grove blossom.

The grove and buffer area must be

inspected by SENASA before blossom to

verify that these sanitation measures

have been accomplished.

(5) The grove and buffer area must be

treated at least twice during the growing

season with an oil-copper oxychloride

spray. The timing of each treatment

shall be determined by SENASA’s

expert system based on its monitoring of

climatic data, fruit susceptibility, and

the presence of disease inoculum. The

application of treatments shall be

monitored by SENASA to verify proper

application.

(6) The grove and buffer area must be

surveyed by SENASA 20 days before the

grapefruit, lemons, or oranges are

harvested to verify the grove’s freedom

from citrus black spot (Guignardia

citricarpa) and sweet orange scab

(Elsinoe australis). The grove’s freedom

from citrus black spot and sweet orange

scab shall be verified through:

(i) Visual inspection of the grove and

buffer area; and

(ii) The sampling of 4 fruit from each

of 298 randomly selected trees from

each grove and buffer area covering a

maximum area of 800 hectares. If the

area to be sampled exceeds 800

hectares, SENASA must contact APHIS

for APHIS’ determination as to the

number of trees to be sampled. The

sampled fruit must be taken from those

portions of the trees that are mostly

likely to have infected, symptomatic

fruit (i.e. near the outer, upper part of

the canopy on the sides of the tree that

receive the most sunlight). The sampled

fruit must be held in the laboratory for

20 days at 27 °C, 80 percent relative

humidity, and in permanent light to

promote the expression of symptoms in

any fruit infected with citrus black spot.

(c) After harvest. After harvest, the

grapefruit, oranges, or lemons must be

handled in accordance with the

following conditions:

(1) The fruit must be moved from the

grove to the packinghouse in field boxes

or containers of field boxes that are

marked to show the SENASA

registration number of the grove in

which the fruit was grown. The identity

of the origin of the fruit must be

maintained.

(2) During the time that any

grapefruit, lemons, or oranges from

groves meeting the requirements of

paragraph (b) of this section are in the

packinghouse, no fruit from groves that

do not meet the requirements of

paragraph (b) of this section may enter

the packinghouse. A packinghouse

technician registered with SENASA

must verify the origin of all fruit

entering the packinghouse.

(3) After arriving at the packinghouse,

the fruit must be held at room

temperature for 4 days to allow bruises

or other fruit damage to become

apparent.

(4) After the 4-day holding period,

bruised or damaged fruit must be culled

and the fruit must be inspected by

SENASA to verify its freedom from

citrus black spot and sweet orange scab.

The fruit must then be chemically

treated as follows:

(i) Immersion in sodium hypochlorite

(chlorine) at a concentration of 200 parts

per million for 2 minutes;

(ii) Immersion in orthophenilphenate

of sodium;

(iii) Spraying with imidazole; and

(iv) Application of 2–4 thiazalil

benzimidazole and wax.

(5) Before packing, the treated fruit

must be individually labeled with a

sticker that identifies the packinghouse

in which they were packed and must be

inspected by SENASA to verify its

freedom from citrus black spot and

sweet orange scab and to ensure that all

stems, leaves, and other portions of

plants have been removed from the

fruit.

(6) The fruit must be packed in clean,

new boxes that are marked with the

SENASA registration number of the

grove in which the fruit was grown and

a statement indicating that the fruit may

not be distributed in Hawaii, Guam, the

Northern Mariana Islands, Puerto Rico,

the U.S. Virgin Islands, or in any State

(each of which must be individually

listed) into which the distribution of the

fruit is prohibited pursuant to paragraph

(g)(1) or (g)(2) of this section.

(d) Phytosanitary certificate.

Grapefruit, lemons, and oranges offered

for entry into the United States from

Argentina must be accompanied by a

phytosanitary certificate issued by

SENASA that states the grapefruit,

lemons, or oranges were produced and

handled in accordance with the

requirements of paragraphs (a), (b), and

(c) of this section and that the

grapefruit, lemons, or oranges are

apparently free from citrus black spot

and sweet orange scab.

(e) Cold treatment. Due to the

presence in Argentina of Mediterranean

fruit fly (Medfly) (Ceratitis capitata) and

fruit flies of the genus Anastrepha,

grapefruit, lemons (except smoothskinned lemons), and oranges offered

for entry from Argentina must be treated

with an authorized cold treatment listed

in the Plant Protection and Quarantine

Treatment Manual, which is

incorporated by reference at § 300.1 of

this chapter. The cold treatment must be

conducted in accordance with the

requirements of § 319.56–2d of this

subpart.

(f) Disease detection. If, during the

course of any inspection or testing

required by this section or § 319.56–6 of

this subpart, or at any other time, citrus

black spot or sweet orange scab is

detected on any grapefruit, lemons, or

oranges, APHIS and SENASA must be

notified and the grove in which the fruit

was grown or is being grown shall be

removed from the SENASA citrus

export program for the remainder of that

year’s growing and harvest season, and

the fruit harvested from that grove may

not be imported into the United States

from the time of detection through the

remainder of that shipping season.

(g) Limitations on distribution. The

distribution of the grapefruit, lemons,

and oranges is limited to the continental

United States (the 48 contiguous States,

Alaska, and the District of Columbia.).

In addition, during the 2000 through

Federal Register / Vol. 65, No. 116 / Thursday, June 15, 2000 / Rules and Regulations 37669

2003 shipping seasons, the distribution

of the grapefruit, lemons, and oranges is

further limited as follows:

(1) During the 2000 and 2001

shipping seasons, the fruit may be

distributed in all areas of the

continental United States except

Alabama, Arizona, Arkansas, California,

Colorado, Florida, Georgia, Louisiana,

Mississippi, Nevada, New Mexico,

Oklahoma, Oregon, Texas, and Utah.

(2) During the 2002 and 2003

shipping seasons, the fruit may be

distributed in all areas of the

continental United States except

Arizona, California, Florida, Louisiana,

and Texas.

(3) For the 2004 shipping season and

beyond, the fruit may be distributed in

all areas of the continental United

States.

(h) Ports of entry. The grapefruit,

lemons, and oranges may enter the

United States only through a port of

entry located in a State where the

distribution of the fruit is authorized

pursuant to paragraph (g) of this section.

(i) Repackaging. If any grapefruit,

lemons, or oranges are removed from

their original shipping boxes and

repackaged, the stickers required by

paragraph (c)(5) of this section may not

be removed or obscured and the new

boxes must be clearly marked with all

the information required by paragraph

(c)(6) of this section.

(Approved by the Office of Management and

Budget under control number 0579–0134)

7. Section 319.56–2i, including the

section heading, is revised to read as

follows:

§ 319.56–2i Administrative instructions

prescribing treatments for mangoes from

Central America, South America, and the

West Indies.

(a) Authorized treatments. Treatment

with an authorized treatment listed in

the Plant Protection and Quarantine

Treatment Manual will meet the

treatment requirements imposed under

§ 319.56–2 as a condition for the

importation into the United States of

mangoes from Central America, South

America, and the West Indies. The Plant

Protection and Quarantine Treatment

Manual is incorporated by reference.

For the full identification of this

standard, see § 300.1 of this chapter,

‘‘Materials incorporated by reference.’’

(b) Department not responsible for

damage. The treatments for mangoes

prescribed in the Plant Protection and

Quarantine Treatment Manual are

judged from experimental tests to be

safe. However, the Department assumes

no responsibility for any damage

sustained through or in the course of

such treatment.

Done in Washington, DC, this 8th day of

June 2000.

Bobby R. Acord,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 00–14851 Filed 6–9–00; 10:00 am]

BILLING CODE 3410–34–U