This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

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REGISTER issue of each week.

Rules and Regulations Federal Register

52213 

Vol. 75, No. 164 

Wednesday, August 25, 2010 

1The PPQ Treatment Manual is available at 

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

manuals/ports/treatment.shtml). 

2To view the interim rule, the comments we 

received, and a distribution table listing changes to 

paragraph numbering in the regulations after 

publication of the interim rule, go to (http:// 

www.regulations.gov/fdmspublic/component/ 

main?main=DocketDetail&d=APHIS-2006-0050). 

3Copies of this report are available on 

Regulations.gov at the address in footnote 2. If you 

access the report through Regulations.gov, please be 

aware that the PDF file of the report is 

approximately 17 megabytes in size and may take 

a long time to download. 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

7 CFR Part 305 

[Docket No. APHIS-2006-0050] 

Cold Treatment Regulations 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Final rule. 

SUMMARY: We are adopting as a final 

rule, with changes, an interim rule that 

amended the phytosanitary treatment 

regulations for cold treatment 

enclosures and procedures, including 

regulations for precooling temperatures 

and temperature recording devices. The 

interim rule as amended by this 

document requires articles destined for 

cold treatment to be precooled at or 

below the highest temperature listed in 

the prescribed treatment schedule rather 

than at the intended treatment 

temperature. The amended interim rule 

also requires entities performing cold 

treatment to use measures approved by 

the Animal and Plant Health Inspection 

Service as adequate to ensure the 

security and integrity of cold treatment 

temperature data rather than requiring 

password-protected and tamperproof 

temperature recording devices 

specifically. These actions relieve 

certain requirements that we have 

determined are not necessary while 

continuing to ensure the effectiveness of 

cold treatment and prevent the 

introduction of plant pests into the 

United States. 

EFFECTIVE DATE: August 25, 2010. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Inder P. S. Gadh, Senior Risk Manager– 

Treatments, Regulations, Permits, and 

Manuals, PPQ, APHIS, 4700 River Road 

Unit 133, Riverdale, MD 20737-1231; 

(301) 734-0627. 

SUPPLEMENTARY INFORMATION: 

Background 

The phytosanitary treatments 

regulations in 7 CFR part 305 set out 

general requirements for certifying or 

approving treatment facilities and for 

performing treatments listed in the Plant 

Protection and Quarantine (PPQ) 

Manual1 for fruits, vegetables, and other 

articles to prevent the introduction or 

dissemination of plant pests or noxious 

weeds into or through the United States. 

Within part 305, § 305.6 (referred to 

below as the regulations) sets out 

requirements for treatment procedures, 

monitoring, facilities, and enclosures 

needed for performing cold treatment 

for imported fruits and vegetables and 

for regulated articles moved interstate 

from quarantined areas within the 

United States. 

In an interim rule2 published in the 

Federal Register on July 2, 2007 (72 FR 

35909-35915, Docket No. APHIS-2006- 

0050), and effective on August 31, 2007, 

we amended cold treatment regulations 

by: 

∑ Imposing more stringent 

requirements for precooling fruit prior 

to cold treatment; 

∑ Requiring the use of passwordprotected and tamperproof temperature 

recording devices; 

∑ Adding requirements to increase the 

effectiveness of cold treatment 

conducted in vessel holds and treatment 

enclosures; and 

∑ Providing for officials authorized by 

APHIS to conduct audits of the cold 

treatment process. 

We based these changes on 

recommendations made in an internal 

review of treatment procedures by the 

Center for Plant Health Science and 

Technology (CPHST) of APHIS’ Plant 

Protection and Quarantine (PPQ) 

program and on the findings of an 

APHIS-commissioned study conducted 

by the Cannon Design firm. Their report, 

dated June 30, 2004, and titled 

‘‘Supplementary Guidelines for Cold 

Treatment Application,’’ analyzed cold 

treatment practices described in the 

regulations and the PPQ Treatment 

Manual and offered treatment 

recommendations.3 Both the CPHST 

review and the Cannon Design study 

were initiated in response to concerns 

by industry representatives and other 

interested parties that existing 

procedural requirements were 

inadequate to prevent the development 

of ‘‘hot spots,’’ in which parts of fruit 

consignments undergoing cold 

treatment remain several degrees 

warmer than the temperature prescribed 

in the cold treatment schedule. 

[NOTE: On August 31, 2007, we 

published a technical amendment to the 

interim rule in the Federal Register (72 

FR 50201-50204, Docket No. APHIS2006-0050). The technical amendment, 

which was effective upon publication, 

was necessary because another rule (72 

FR 39482-39528, Docket No. APHIS2005-0106, published on July 18, 2007, 

and effective on August 17, 2007) 

reorganized the regulations by moving 

some of the treatment-related provisions 

of the fruits and vegetables regulations 

in 7 CFR part 319 to the cold treatments 

regulations. This reorganization meant 

that the amendatory instructions in the 

interim rule no longer matched up with 

the paragraph numbers that we intended 

to amend in the cold treatment 

regulations. The technical amendment 

corrected this problem by changing the 

paragraph numbers in the interim rule’s 

amendatory instructions to reflect those 

that were changed in the cold 

treatments subpart. The technical 

amendment did not alter the provisions 

of the interim rule, but only presented 

how the changes to the interim rule 

appear in the cold treatments subpart of 

the regulations after the subpart was 

amended by the final rule that became 

effective on August 17, 2007. 

Also, on December 11, 2007, we 

published a correction to the interim 

rule (72 FR 70219-70220, Docket No. 

APHIS-2006-0050) that reinstated 

provisions that were inadvertently 

dropped from the rule during the 

reorganization of the regulations 

described in the August 2007 technical 

amendment. 

Finally, a final rule published in the 

Federal Register on January 26, 2010, 

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52214 Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Rules and Regulations 

and effective on February 25, 2010 (75 

FR 4228-4253, Docket No. APHIS-2008- 

0022), removed treatments and 

treatment schedules from part 305 (and 

elsewhere in 7 CFR chapter III) and 

relocated them to the PPQ Treatment 

Manual. As part of this change, the 

section containing requirements for 

performing cold treatment was 

redesignated from § 305.15 to § 305.6, 

and minor changes were made to the 

section. The amendatory instructions in 

this document reflect that change. 

To help guide the reader through this 

reorganization of the regulations, a 

distribution table laying out the changes 

in paragraph numbers from the interim 

through the final rule can be found on 

the Regulations.gov Web site (see 

footnote 2). 

We solicited comments on the interim 

rule for 60 days ending August 31, 2007, 

and received three comments by that 

date. They were from foreign national 

plant protection organizations (NPPOs) 

and a private citizen. We have carefully 

considered the comments we received. 

One commenter raised no issues related 

to cold treatment or the changes we 

made in the interim rule. The issues 

raised by the other two commenters are 

discussed below. 

General Comments 

One commenter expressed concern 

that, because the rule was published as 

an interim rule, the commenter and 

other interested parties were not given 

an opportunity to contribute to the 

wording of the rule before it became 

effective. 

Immediate action was necessary to 

amend the cold treatment regulations to 

ensure that such treatment continued to 

be effective against quarantine plant 

pests and thus prevent their 

introduction into the United States. 

During the 60 days between publication 

of the rule and its effective date, 

commenters were given the opportunity 

to review the rule and submit 

comments. 

The same commenter also noted that 

the changed regulations would become 

effective during the produce export 

season of the commenter’s country, 

giving exporters insufficient time for 

implementing the changes required for 

conducting cold treatment. 

We made the interim rule effective 60 

days after publication so that affected 

parties would have time to prepare for 

the changes in operations that would 

become necessary on the effective date 

of the rule. 

Precooling Requirements 

The interim rule amended the 

requirements for precooling, a 

procedure that involves cooling fruits or 

other regulated articles to a specified 

temperature before initiating cold 

treatment. To gain a better 

understanding of the precooling 

process, we commissioned Cannon 

Design to conduct a study and report 

their conclusions and 

recommendations. Cannon Design 

focused their investigation on the 

problem of ‘‘hot spots’’ in pallets of fruit 

undergoing cold treatment while in 

transit. Hot spots can occur when fruit 

continues to convert oxygen to carbon 

dioxide, a process that generates heat. 

After 7 days of treatment, fruit 

respiration can raise temperatures and 

create hot spots at the center of large 

fruit consignments several degrees 

warmer than fruit stacked at the 

perimeter. In their study, Cannon 

Design established that, in pallets of 

fruit loaded at 20 °C (68 °F) without 

significant air gaps between them, the 

fruit could maintain temperatures at or 

above the loading temperature during 

cold treatment. They concluded in their 

report that precooling before beginning 

treatment was essential to reducing the 

likelihood of hot spots. 

The cold treatment schedules in the 

PPQ Treatment Manual allow for 

treatment temperatures ranging from 

-17.8 °C to 2.2 °C (0 °F to 36 °F), 

depending on the treatment schedule 

and the article to be treated. The highest 

treatment temperature listed in the 

treatment schedules, 36 °F (2.2 °C), was 

used by Cannon Design as the threshold 

for defining a hot spot. Through their 

modeling, they determined that 

precooling the fruit to 5 °C (41 °F) or 

lower eliminated hot spots (spots where 

the temperature was greater than 2.2 °C). 

Based on their findings, Cannon Design 

recommended that all fruit in a 

consignment be precooled to at least 

5 °C before initiating cold treatment. 

Prior to the interim rule, the 

regulations allowed precooling 

temperatures up to 4.5 °C (40 °F) for 

articles before undergoing cold 

treatment. However, based on our 

ongoing experience with administering 

cold treatments, we determined that this 

requirement was not sufficient to ensure 

that plant pests would be treated 

successfully. Accordingly, in the 

interim rule we amended the 

regulations to require that fruit intended 

for in-transit cold treatment be 

precooled to the treatment temperature. 

With that change, the required 

precooling temperature will always be 

2.2 °C or lower, because none of the 

treatment options in the cold treatment 

schedules uses a treatment temperature 

above 2.2 °C. As a result of the August 

2007 technical amendment and the 

January 2010 final rule, this requirement 

now appears in § 305.6(d)(4). 

One commenter stated that APHIS has 

not established that precooling to the 

treatment temperature is necessary to 

achieve an effective treatment and that 

the requirements as amended in the 

interim rule are more restrictive than 

necessary. 

The commenter stated that Cannon 

Design’s modeling approach treats 

groups of pallet stacks as a single 

undifferentiated mass, with no gaps 

between stacks for airflow factored into 

the model. Should different pallet 

configurations be modeled, the 

commenter stated, the resulting changes 

in airflow could affect the size, location, 

and duration of any hot spots, which in 

turn could change the minimum 

precooling temperature needed to 

eliminate them. 

The commenter suggested that APHIS 

revisit the modeling and include 

options in the final rule for equivalent 

methods of precooling that consider 

different pallet configurations and 

different precooling temperatures for 

each cold treatment, or range of 

treatments, within a treatment schedule 

and for each type of treatment 

enclosure. The commenter added that 

our requirements do not follow the less 

stringent precooling temperature of 5 °C 

or below recommended in the Cannon 

Design report we commissioned, and 

suggested that, in the case of cold 

treatment performed at temperatures up 

to 3 °C (37.4 °F), precooling to 5 °C is 

likely to be more than adequate. 

We used the Cannon Design report as 

guidance in formulating the precooling 

requirements, but it should not be 

considered the definitive source for our 

decisions. The CPHST internal review 

and our experience in administering 

cold treatment also provided us with 

information for this purpose. 

We acknowledge the commenter’s 

point that further modeling of pallet 

configurations and airflow may yield 

additional information about the 

development of hot spots and optimal 

precooling temperatures. However, 

every consignment of shipped fruit is 

subject to numerous variables, including 

treatment enclosure conditions, pallet 

configurations, and airflow patterns, all 

of which can influence fruit 

temperatures within the consignment. 

Given these variables, we consider it 

infeasible to model scenarios and 

develop separate requirements for each 

different treatment environment. 

As for the commenter’s suggestion to 

raise the required precooling 

temperature to 5 °C, our review 

indicates that doing so would not 

provide adequate protection against 

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Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Rules and Regulations 52215 

plant pests. In fact, we initiated the 

interim rule because we determined that 

the previous required precooling 

temperature of 4.5 °C, a lower 

precooling temperature than that 

recommended by the commenter, was 

not sufficient to eliminate hot spots for 

all treatment schedules at all 

temperatures. 

However, we acknowledge that the 

amended precooling temperature 

requirements in the interim rule, which 

required precooling the entire 

consignment to the prescribed treatment 

temperature, can be made less 

restrictive and yet maintain an effective 

level of phytosanitary security. 

A cold treatment ‘‘passes’’ when an 

official authorized by APHIS verifies 

that the fruit was held at the correct 

temperature for the correct time period 

in accordance with the regulations, and 

no hot spots are observed to have 

developed. Our past experience has 

established that cold treatments 

initiated after the fruit had been 

precooled to the highest temperature 

within the applicable treatment 

schedule can pass at treatment 

temperatures lower than the 

temperature at which the fruit was 

precooled. To cite an example, cold 

treatment schedule T107-a contains 

three treatment options: 36 °F or lower 

for 18 days, 35 °F or lower for 16 days, 

or 34 °F or lower for 14 days. Under 

T107-a, a consignment of fruit might 

first be precooled to the highest 

temperature in the schedule, 36 °F, and 

then begin treatment at 36 °F for 18 

days. Soon after treatment begins, if the 

shipper estimates that the shipping time 

will be shorter than initially expected 

and subsequently decides to treat at 34 

°F for 14 days, the fruit could be cooled 

to 34 °F for at least 14 days, and the 

treatment would pass, with no hot spots 

observed. Based on this experience, we 

have determined that the treatment 

temperature does not necessarily have 

to be equal to the precooling 

temperature to result in an effective 

treatment, although we also established 

that the previous precooling 

temperature of 4.5 °C is too high. 

Given these considerations, we are 

changing the precooling temperature 

requirement to allow fruit intended for 

in-transit cold treatment to be precooled 

to a temperature no higher than the 

highest temperature of the treatment 

schedule under which the fruit will be 

treated. With the change we are making 

to the precooling temperature 

requirements, the maximum allowable 

precooling temperature will never be 

above 36 °F (2.2 °C), which is 2.3 °C 

lower than the precooling temperature 

required prior to publication of the 

interim rule. 

It should be noted that this change 

does not affect any of the required cold 

treatments themselves; it only slightly 

adjusts the precooling requirements. 

Depending on what treatment option is 

selected from a schedule, some fruit will 

still require precooling at the actual 

treatment temperature. However, our 

experience indicates that as long as a 

consignment of fruit is precooled to the 

highest treatment temperature listed in 

the applicable schedule and treatment is 

performed in accordance with all other 

treatment requirements, any of the 

treatment options within that schedule 

can be administered to provide effective 

phytosanitary security against the plant 

pests of concern. 

The interim rule required that fruit 

precooled outside the treatment 

enclosure be no more than 0.28 °C (0.5 

°F) above the temperature at which the 

fruit will be treated prior to loading for 

treatment. We are amending that 

requirement in this final rule because in 

some cases the difference between the 

treatment temperature and the highest 

temperature in the overall treatment 

schedule is greater than 0.28 °C. As 

amended, § 305.6(d)(4) requires that 

fruit precooled outside the treatment 

enclosure be no more than 0.28 °C above 

the highest treatment temperature in the 

schedule under which the fruit will be 

treated, as listed in the applicable 

treatment schedule. 

Temperature Monitoring Requirements 

In the interim rule, we added a 

requirement that allowed precooling in 

in-transit treatment enclosures only if 

an official authorized by APHIS 

approves the loading of the fruit in the 

treatment enclosure as adequate to 

allow for fruit pulp temperatures to be 

taken prior to beginning treatment. In 

order to manually monitor fruit 

temperatures prior to treatment, an 

official must ensure that there is 

sufficient space within the enclosure to 

gain access to the entire consignment. If 

fruit is precooled outside the treatment 

enclosure, an official authorized by 

APHIS must take pulp temperatures 

manually from a sample of the fruit as 

the fruit is loaded for in-transit cold 

treatment to verify that precooling was 

completed. 

One commenter stated that the 

requirement for manual sampling was 

unnecessary, adding that it fails to 

recognize alternative and equivalent 

options for using remote monitoring to 

measure fruit temperature. As support, 

the commenter cited a test conducted by 

Cannon Design in which a pallet of 

citrus was cooled, followed by pulp 

temperature readings being taken in 

fruit throughout the pallet. While 

readings taken at the bottom of the 

pallet were lower due to direct airflow, 

fruit temperatures throughout the rest of 

the pallet were nearly uniform due to 

thermal conduction. The commenter 

reasoned from this finding that the 

specific fruit sampled, and the carton 

from which it is chosen, are essentially 

unimportant to determining whether 

precooling requirements for a given 

pallet have been met, so there should be 

no requirement for an inspector to have 

the ability to manually monitor fruit 

temperatures prior to beginning 

treatment. The commenter suggested 

that we amend the regulations to 

provide for methods other than the 

manual sampling of pulp temperatures. 

We acknowledge that the Cannon 

Design report found that pallets of fruit 

are cooled primarily by thermal 

conduction, although the report also 

cites airflow through box openings as a 

contributing factor to the cooling 

process. Cooler temperature readings at 

the bottom of the pallet indicate that 

airflow can influence temperature 

variations among individual pallets of 

fruit. Depending on the type of 

enclosure and the configuration of 

pallets, differences in airflow patterns 

can accelerate or impede cooling in 

different parts of a consignment. For 

this reason, an official must be able to 

sample a pallet on all sides to verify that 

precooling has uniformly and 

sufficiently cooled the entire 

consignment. Remote probes will not 

achieve the same result; they remain in 

a fixed position and cannot account for 

container and airflow variables, 

meaning they cannot provide as 

thorough or reliable a level of 

verification. 

Continuation of Current Procedures 

A commenter representing a foreign 

NPPO asked whether that organization 

could continue using its own 

requirements for precooling prior to 

cold treatment instead of following the 

new requirements for precooling in the 

interim rule (which now appear in 

§ 305.6(d)(4)). The commenter’s NPPO 

observes the following requirements: 1) 

Fruit must be precooled to the target 

temperature for 72 hours and must be at 

the target temperature for the last 24 

hours of this period (APHIS imposes no 

time requirement for cooling in the 

regulations); and 2) a variance of 0.3 °C 

is allowed when the temperature is 

checked with a handheld thermometer 

(we allowed a variance of 0.28 °C in the 

interim rule, though it did not specify 

the type of thermometer). 

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52216 Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Rules and Regulations 

We have determined that the 

precooling requirements observed by 

the commenting NPPO are consistent 

with the new requirements established 

in the interim rule, as the NPPO already 

requires precooling to the treatment 

temperature. However, for fruit 

precooled outside the treatment 

enclosure, we require that fruit pulp 

temperature samples be taken prior to 

loading the fruit, and that these sample 

temperatures not vary more than 0.28 °C 

above the highest temperature of the 

prescribed treatment schedule. 

Sampling Location 

The interim rule provided that an 

official authorized by APHIS must take 

pulp temperatures manually from a 

sample of the fruit as the fruit is loaded 

for in-transit cold treatment to verify 

that precooling was completed. One 

commenter asked whether sampling can 

be conducted after removing the fruit 

from the precooling space and before 

loading it into the treatment enclosure. 

Temperature sampling should be 

conducted immediately before the fruit 

is loaded into the treatment enclosure. 

If the fruit sits outside the precooling 

space for any length of time before 

loading into the treatment enclosure, 

this location should be where the 

temperature sampling is conducted. 

Officials Authorized by APHIS 

The interim rule also included 

requirements that only officials 

authorized by APHIS may oversee 

proper administration of cold treatment, 

which includes approving the loading of 

fruit in the treatment enclosure and 

sampling fruit pulp temperatures. One 

commenter, a foreign NPPO, sought 

confirmation that an official authorized 

by APHIS can be an NPPO official from 

the commenter’s country. Likewise, a 

commenter from another foreign NPPO 

requested that inspectors from that 

country be allowed to act as an official 

authorized by APHIS as defined in the 

interim rule. 

The NPPOs of both these countries are 

signatories to the International Plant 

Protection Convention (IPPC) and 

therefore observe phytosanitary 

treatment standards that are recognized 

by other signatories, including the 

United States. Officials from any IPPC 

member country who are trained and 

authorized by APHIS can verify 

compliance with precooling 

requirements, approve the loading of 

fruit into treatment enclosures, initiate 

in-transit cold treatment, and exercise 

other responsibilities specified in the 

regulations. 

Pallet Stacking 

In the interim rule, we added 

requirements regarding vessel 

enclosures used for in-transit cold 

treatment of fruit. One specific change 

we made was to prohibit doublestacking of pallets, because doing so can 

constrict airflow to the fruit and allow 

hot spots to form. 

A commenter requested that we 

define the term double-stacking with 

regard to pallets of fruit. 

We define the term to mean one 

loaded pallet physically resting atop 

another loaded pallet. 

Another commenter disagreed with 

our prohibition on double-stacking of 

pallets. They noted that the Cannon 

Design report recommended placing 

spacers between pallets to maintain 

adequate cooling airflow. 

The Cannon Design study examined 

the effects of airflow on temperature in 

pallets of fruit. Through computer 

modeling and real-world simulations, 

Cannon Design determined that airflow 

patterns around pallet stacks influence 

the rate of cooling. To speed the rate of 

cooling in fruit, they recommended that 

air gaps be maintained by placing 

spacers between pallet stacks. 

We concur with Cannon Design’s 

conclusion that air gaps between and 

around pallets can affect the rate of 

cooling, but the report does not discuss 

using spacers as part of the physical 

testing that was conducted. We 

therefore lack sufficient data to 

determine the actual implications of 

using spacers between double-stacked 

pallets of fruit. For this reason, we are 

not changing the regulations established 

by the interim rule regarding doublestacking of pallets. 

Security of Temperature Recorders 

In the interim rule, we added 

requirements to the treatment 

procedures to help ensure the integrity 

of temperature recording. We required 

the temperature recording devices used 

during treatment to be passwordprotected and tamperproof. In addition, 

we required the devices to be capable of 

recording the date, time, and sensor 

number and automatic and continuous 

records of the temperature during all 

calibrations and during treatment. 

One commenter stated that the 

requirement for password-protected and 

tamperproof temperature recording 

devices does not allow for equivalent 

measures for recording fruit 

temperatures. The commenter added 

that the security and integrity of cold 

treatment data could be achieved by 

other methods, such as proprietary 

software for interfacing with 

temperature recorders, encrypted data, 

limited distribution of necessary 

software, or locking doors to rooms 

containing recording equipment. The 

commenter requested that APHIS 

recognize equivalent temperature 

recording methods that can provide an 

effective level of security. 

We agree that the security and 

integrity of cold treatment data is 

achievable through equivalent 

measures, as long as the recording 

devices and methods used conform to 

all applicable requirements. For this 

reason, we are revising the sentence 

‘‘Temperature recording devices used 

during treatment must be passwordprotected and tamperproof’’ in 

§ 305.6(d)(7) to read ‘‘Temperature 

recording devices used during treatment 

must be secured using measures 

approved by APHIS as adequate to 

ensure the security and integrity of cold 

treatment data.’’ Regardless of which 

measures are employed to ensure the 

security and integrity of temperature 

recording devices, officials authorized 

by APHIS are required to identify 

instances of recording device 

manipulation or malfunction and make 

decisions about certifying consignments 

as necessary. 

One commenter asked APHIS which 

organization was responsible for 

ensuring that shippers comply with the 

requirements for password-protected 

and tamperproof temperature recording 

devices. The commenter, a foreign 

NPPO, also asked whether officials of its 

organization with access to temperature 

recording devices and passwords would 

be liable for any problems involving the 

equipment, and expressed concerns 

about the availability and cost to 

exporters of such devices. 

As noted above, we are amending the 

regulations established by the interim 

rule so that they no longer specifically 

require that temperature recording 

devices be password-protected and 

tamperproof. As a result, exporters will 

have the flexibility to use other 

measures to ensure adequate data 

security and integrity. APHIS and other 

NPPOs work in cooperation to ensure 

compliance with treatment 

requirements, including data security 

and integrity. 

Placement of Temperature Probes or 

Sensors 

In the interim rule, we added 

provisions specifying that a minimum of 

four temperature probes or sensors is 

required for vessel holds used as 

treatment enclosures, and a minimum of 

three temperature probes or sensors is 

required for other treatment enclosures. 

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Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Rules and Regulations 52217 

4See Chapter 6 of the PPQ Treatment Manual for 

practices regarding sensor placement on vessels: 

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

manuals/ports/downloads/treatment.pdf). 

One commenter stated that it is 

standard practice for APHIS to require 

a minimum of four pulp temperature 

sensors and two air sensors in an 

independent deck; six pulp sensors 

(three per deck) and three air sensors 

(one in the bottom deck and two in the 

upper deck) for a common deck; and 

two pulp sensors in a small lower bow 

deck. The commenter noted the interim 

rule requires a minimum of four 

temperature probes or sensors for vessel 

holds used as treatment enclosures and 

three sensors for other types of 

treatment enclosures and asked where 

the additional temperature sensors are 

to be placed in the vessel hold. 

The requirements established in the 

interim rule set the minimum number of 

probes or sensors required for an 

approved vessel hold regardless of deck 

size or type, and provide that an official 

authorized by APHIS will have the 

option to require that additional 

temperature probes or sensors be used 

depending on variables such as 

treatment enclosure conditions, pallet 

configurations, and airflow patterns.4

Therefore, for the reasons given in the 

interim rule and this document, we are 

adopting the interim rule as a final rule 

with the changes discussed in this 

document. 

This final rule also affirms the 

information contained in the interim 

rule concerning Executive Orders 12372 

and 12988 and the Paperwork 

Reduction Act. 

Further, for this action, the Office of 

Management and Budget has waived its 

review under Executive Order 12866. 

Effective Date 

Pursuant to the administrative 

procedure provisions in 5 U.S.C. 553, 

we find good cause for making this rule 

effective less than 30 days after 

publication in the Federal Register. 

This rule revises the precooling 

temperature and temperature recording 

device requirements included in the 

interim rule to make them less 

restrictive. Therefore, the Administrator 

of the Animal and Plant Health 

Inspection Service has determined that 

this rule should be effective upon 

publication in the Federal Register. 

Regulatory Flexibility Act 

This final rule follows an interim rule 

that amended the regulations for cold 

treatment enclosures and procedures, 

including regulations for precooling 

temperatures and temperature recording 

devices. 

We have prepared an economic 

analysis for this final rule. The analysis, 

which considers the number and types 

of entities that are likely to be affected 

by this action and the potential 

economic effects on those entities, 

provides the basis for the 

Administrator’s determination that the 

rule will not have a significant 

economic impact on a substantial 

number of small entities. The full 

economic analysis may be viewed on 

the Regulations.gov Web site (see 

footnote 2 for instructions for accessing 

Regulations.gov). Copies of the 

economic analysis are also available 

from the person listed under FOR

FURTHER INFORMATION CONTACT. 

This final rule follows an interim rule 

that amended the phytosanitary 

treatment regulations for cold treatment 

enclosures and procedures, including 

regulations for precooling. As described 

in the economic analysis, it is unlikely 

that U.S. entities will be directly 

affected by the new cold treatment 

requirements; compliance will be the 

responsibility of the exporting entity. 

Any reporting or recordkeeping 

requirements for U.S. entities will be 

those normally associated with 

importing fruit from abroad. In theory, 

if foreign exporters do experience a cost 

increase because of this amendment, the 

quantity of fruit supplied may decrease. 

This decrease could result in an 

increase in the price of fruit, costing 

U.S. consumers and benefiting U.S. 

producers and suppliers. However, 

these impacts, if they occur, are 

expected to be negligible. Any 

additional costs because of this 

amendment will represent only a small 

fraction of the price of the fruit. 

The number of U.S. industries that 

could be potentially affected by this 

amendment are small, and any impacts 

on these industries due to these changes 

in the cold treatment regulations will be 

insignificant. 

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. 

List of Subjects in 7 CFR Part 305 

Irradiation, Phytosanitary treatment, 

Plant diseases and pests, Quarantine, 

Reporting and recordkeeping 

requirements. 

■ Accordingly, the interim rule 

amending 7 CFR part 305 that was 

published at 72 FR 35909-35915 on July 

2, 2007, and amended in documents 

published at 72 FR 50201-50204 on 

August 31, 2007, and 72 FR 70219- 

70220 on December 11, 2007, is adopted 

as a final rule with the following 

changes: 

PART 305—PHYTOSANITARY 

TREATMENTS 

■ 1. The authority citation for part 305 

continues to read as follows: 

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

7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 

2.80, and 371.3. 

■ 2. Section 305.6 is amended as 

follows: 

■ a. In paragraph (c)(1), by removing the 

words ‘‘treatment temperature’’ the first 

time they occur and adding the words 

‘‘highest temperature of the treatment 

schedule under which the fruit will be 

treated’’ in their place. 

■ b. By revising paragraph (d)(4) to read 

as set forth below. 

■ c. In paragraph (d)(7), by removing the 

words ‘‘password-protected and 

tamperproof’’ and adding the words 

‘‘secured using measures approved by 

APHIS as adequate to ensure the 

security and integrity of cold treatment 

data’’ in their place. 

§ 305.6 Cold treatment requirements. 

* * * * * 

(d) * * * 

(4) Fruit intended for in-transit cold 

treatment must be precooled to no more 

than the highest temperature of the 

treatment schedule under which the 

fruit will be treated prior to beginning 

treatment. The in-transit treatment 

enclosure may not be used for 

precooling unless an official authorized 

by APHIS approves the loading of the 

fruit in the treatment enclosure as 

adequate to allow for fruit pulp 

temperatures to be taken prior to 

beginning treatment. If the fruit is 

precooled outside the treatment 

enclosure, an official authorized by 

APHIS will take pulp temperatures 

manually from a sample of the fruit as 

the fruit is loaded for in-transit cold 

treatment to verify that precooling was 

completed. If the pulp temperatures for 

the sample are 0.28 °C (0.5 °F) or more 

above the highest temperature of the 

treatment schedule under which the 

fruit will be treated, the pallet from 

which the sample was taken will be 

rejected and returned for additional 

precooling until the fruit reaches the 

highest temperature of the treatment 

schedule under which the fruit will be 

treated. If fruit is precooled in the 

treatment enclosure, or if treatment is 

conducted at a cold treatment facility in 

the United States, the fruit must be 

precooled to the highest temperature of 

the treatment schedule under which the 

fruit will be treated, as verified by an 

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52218 Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Rules and Regulations 

official authorized by APHIS, prior to 

beginning treatment. 

* * * * * 

Done in Washington, DC, this 18th day 

of August 2010. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2010–21134 Filed 8–24–10; 8:45 am] 

BILLING CODE 3410–34–S 

DEPARTMENT OF AGRICULTURE 

Federal Crop Insurance Corporation 

7 CFR Part 457 

RIN 0563–AC10 

Common Crop Insurance Regulations; 

Apple Crop Insurance Provisions 

AGENCY: Federal Crop Insurance 

Corporation, USDA. 

ACTION: Final rule. 

SUMMARY: The Federal Crop Insurance 

Corporation (FCIC) finalizes the 

Common Crop Insurance Regulations, 

Apple Crop Insurance Provisions. The 

intended effect of this action is to 

provide policy changes and clarify 

existing policy provisions to better meet 

the needs of insured producers, and to 

reduce vulnerability to program fraud, 

waste, and abuse. The changes will 

apply for the 2011 and succeeding crop 

years. 

DATES: This rule is effective August 25, 

2010. 

FOR FURTHER INFORMATION CONTACT: Erin 

Albright, Risk Management Specialist, 

Product Management, Product 

Administration and Standards Division, 

Risk Management Agency, United States 

Department of Agriculture, Beacon 

Facility—Mail Stop 0812, PO Box 

419205, Kansas City, MO 64141–6205, 

telephone (816) 926–7730. 

SUPPLEMENTARY INFORMATION: 

Executive Order 12866 

The Office of Management and Budget 

(OMB) has determined that this rule is 

non-significant for the purposes of 

Executive Order 12866 and, therefore, it 

has not been reviewed by OMB. 

Paperwork Reduction Act of 1995 

Pursuant to the provisions of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. chapter 35), the collections of 

information in this rule have been 

approved by OMB under control 

number 0563–0053 through March 31, 

2012. 

E-Government Act Compliance 

FCIC is committed to complying with 

the E-Government Act of 2002, to 

promote the use of the Internet and 

other information technologies to 

provide increased opportunities for 

citizen access to Government 

information and services, and for other 

purposes. 

Unfunded Mandates Reform Act of 

1995 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) establishes 

requirements for Federal agencies to 

assess the effects of their regulatory 

actions on State, local, and tribal 

governments and the private sector. 

This rule contains no Federal mandates 

(under the regulatory provisions of title 

II of the UMRA) for State, local, and 

tribal governments or the private sector. 

Therefore, this rule is not subject to the 

requirements of sections 202 and 205 of 

UMRA. 

Executive Order 13132 

It has been determined under section 

1(a) of Executive Order 13132, 

Federalism, that this rule does not have 

sufficient implications to warrant 

consultation with the States. The 

provisions contained in this rule will 

not have a substantial direct effect on 

States, or on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government. 

Regulatory Flexibility Act 

FCIC certifies that this regulation will 

not have a significant economic impact 

on a substantial number of small 

entities. Program requirements for the 

Federal crop insurance program are the 

same for all producers regardless of the 

size of their farming operation. For 

instance, all producers are required to 

submit an application and acreage 

report to establish their insurance 

guarantees and compute premium 

amounts, and all producers are required 

to submit a notice of loss and 

production information to determine the 

amount of an indemnity payment in the 

event of an insured cause of crop loss. 

Whether a producer has 10 acres or 

1000 acres, there is no difference in the 

kind of information collected. To ensure 

crop insurance is available to small 

entities, the Federal Crop Insurance Act 

authorizes FCIC to waive collection of 

administrative fees from limited 

resource farmers. FCIC believes this 

waiver helps to ensure that small 

entities are given the same opportunities 

as large entities to manage their risks 

through the use of crop insurance. A 

Regulatory Flexibility Analysis has not 

been prepared since this regulation does 

not have an impact on small entities, 

and, therefore, this regulation is exempt 

from the provisions of the Regulatory 

Flexibility Act (5 U.S.C. 605). 

Federal Assistance Program 

This program is listed in the Catalog 

of Federal Domestic Assistance under 

No. 10.450. 

Executive Order 12372 

This program is not subject to the 

provisions of Executive Order 12372, 

which require intergovernmental 

consultation with State and local 

officials. See the Notice related to 7 CFR 

part 3015, subpart V, published at 48 FR 

29115, June 24, 1983. 

Executive Order 12988 

This final rule has been reviewed in 

accordance with Executive Order 12988 

on civil justice reform. The provisions 

of this rule will not have a retroactive 

effect. The provisions of this rule will 

preempt State and local laws to the 

extent such State and local laws are 

inconsistent herewith. With respect to 

any direct action taken by FCIC or to 

require the insurance provider to take 

specific action under the terms of the 

crop insurance policy, the 

administrative appeal provisions 

published at 7 CFR part 11 must be 

exhausted before any action against 

FCIC for judicial review may be brought. 

Environmental Evaluation 

This action is not expected to have a 

significant economic impact on the 

quality of the human environment, 

health, or safety. Therefore, neither an 

Environmental Assessment nor an 

Environmental Impact Statement is 

needed. 

Background 

This rule finalizes changes to the 

Common Crop Insurance Regulations, 

Apple Crop Insurance Provisions that 

were published by FCIC on September 

8, 2009, as a notice of proposed 

rulemaking in the Federal Register at 74 

FR 46023—46026. The public was 

afforded 60 days to submit written 

comments after the regulation was 

published in the Federal Register. 

Based on comments received and 

specific requests to extend the comment 

period, FCIC published a notice in the 

Federal Register at 74 FR 59108 on 

November 17, 2009, extending the 

initial 60-day comment period for an 

additional 30 days, until December 17, 

2009. 

A total of 193 comments were 

received from 39 commenters. The 

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