Tuesday, 

January 26, 2010 

Part IV 

Department of 

Agriculture 

Animal and Plant Health Inspection 

Service 

7 CFR Parts 301, 305, 318, et al. 

Phytosanitary Treatments; Location of 

and Process for Updating Treatment 

Schedules; Final Rule 

mstockstill on DSKH9S0YB1PROD with RULES2

4228 Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 

1 To view the proposed rule and the comments 

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

fdmspublic/component/main?main=DocketDetail

&d=APHIS–2008–0022). 

2 At (http://www.aphis.usda.gov/import_export/ 

plants/manuals/ports/treatment.shtml). 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

7 CFR Parts 301, 305, 318, 319, 330, 

and 352 

[Docket No. APHIS-2008-0022] 

RIN 0579-AC94 

Phytosanitary Treatments; Location of 

and Process for Updating Treatment 

Schedules 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Final rule. 

SUMMARY: We are amending the 

phytosanitary treatment regulations in 

7 CFR part 305 by removing the lists of 

approved treatments and treatment 

schedules from the regulations, while 

retaining the general requirements for 

performing treatments and certifying or 

approving treatment facilities. We are 

removing treatment schedules from 

other places where they are currently 

found in 7 CFR chapter III as well. 

Approved treatment schedules will 

instead be found in the Plant Protection 

and Quarantine Treatment Manual, 

which is available on the Internet. We 

are also establishing a new process to 

provide the public with notice and the 

opportunity to comment on changes to 

treatment schedules. Finally, we are 

harmonizing and combining the 

requirements for performing irradiation 

treatment for imported articles, articles 

moved interstate from Hawaii and U.S. 

territories, and articles moved interstate 

from an area quarantined for fruit flies. 

These changes will simplify and 

expedite our processes for adding, 

changing, and removing treatment 

schedules while continuing to provide 

for public participation in the process. 

These changes will also simplify our 

presentation of treatments to the public 

by consolidating all treatments into one 

document and eliminating redundant 

text from the regulations. 

EFFECTIVE DATE: February 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 20737-1236; 

(301) 734-0627. 

SUPPLEMENTARY INFORMATION: 

Background 

The regulations in 7 CFR chapter III 

are intended, among other things, to 

prevent the introduction or 

dissemination of plant pests and 

noxious weeds into or within the United 

States. Under the regulations, certain 

plants, fruits, vegetables, and other 

articles must be treated before they may 

be moved into the United States or 

interstate. The phytosanitary treatments 

regulations contained in part 305 of 7 

CFR chapter III (referred to below as the 

regulations) set out standards and 

schedules for treatments required in 

parts 301, 318, and 319 of 7 CFR chapter 

III for fruits, vegetables, and other 

articles. 

On May 12, 2009, we published in the 

Federal Register (74 FR 22318-22345, 

Docket No. APHIS-2008-0022) a 

proposal1 to amend the regulations by 

removing the lists of approved 

treatments and treatment schedules 

from the regulations, while retaining the 

general requirements for performing 

treatments and certifying or approving 

treatment facilities. We proposed to 

remove treatment schedules from other 

places where they are currently found in 

7 CFR chapter III as well, instead listing 

approved treatment schedules in the 

Plant Protection and Quarantine (PPQ) 

Treatment Manual, which is available 

on the Internet.2 We also proposed to 

establish a new process to provide the 

public with notice and the opportunity 

to comment on changes to treatment 

schedules. Finally, we proposed to 

harmonize and combine the 

requirements for performing irradiation 

treatment for imported articles, articles 

moved interstate from Hawaii and U.S. 

territories, and articles moved interstate 

from an area quarantined for fruit flies. 

We solicited comments concerning 

our proposal for 60 days ending July 13, 

2009. We received 14 comments by that 

date. They were from nursery owners, 

academics, treatment facility operators, 

and representatives of State and foreign 

governments. They are discussed below 

by topic. 

General Comments About the 

Treatment Requirements 

As part of proposing to remove 

treatment schedules from 7 CFR chapter 

III, we proposed to move the general 

requirements for each type of treatment 

(chemical treatment, cold treatment, 

etc.) in 7 CFR part 305 to new locations 

within that part. We also proposed to 

make some minor changes to the 

existing treatment requirements. 

One commenter suggested that we 

identify the common requirements for 

all treatments in the remaining 

provisions of 7 CFR part 305 and 

present them in an introductory section, 

setting out specific requirements for the 

individual types of treatments in later 

sections. The commenter also suggested 

that there is a common set of mitigations 

for fruit flies (packaging, product 

movement, and location of treatment 

facilities) that could be contained in a 

separate section and referenced in the 

appropriate treatment requirements. The 

commenter stated that such changes 

would provide more clarity in the 

specific treatment requirements while 

creating more certainty that all 

regulations governing treatment in part 

305 are included without unnecessary 

repetition. 

As we proposed to move the 

treatment requirements but not to make 

any significant changes to them, making 

large-scale revisions to those 

requirements would be outside the 

scope of this final rule. However, we 

appreciate the commenter’s suggestion 

and will consider whether to make such 

changes in a future rulemaking. 

One commenter stated that there are 

inconsistencies in how the terms 

‘‘approve,’’ ‘‘authorize,’’ and ‘‘certify’’ are 

used in the existing treatment 

requirements. The commenter pointed 

out that proposed § 305.5(a), which 

contains requirements for chemical 

treatment facilities, is headed ‘‘Certified 

facility,’’ while proposed § 305.6(a), 

which contains requirements for cold 

treatment facilities, is headed ‘‘Approval 

of treatment facilities.’’ (Paragraph (a) of 

proposed § 305.8(a), which contains 

requirements for heat treatment 

facilities, is also headed ‘‘Certified 

facility.’’) The commenter stated that 

authorization of a quarantine treatment 

facility may be a complex process that 

could include licenses from local, State, 

or Federal regulatory agencies other 

than the Animal and Plant Health 

Inspection Service (APHIS), or a foreign 

national plant protection organization 

(NPPO), in the case of foreign facilities. 

The commenter stated that 

‘‘certification’’ would be a more 

appropriate term for the process 

undertaken by APHIS or a foreign NPPO 

to ensure that a facility can consistently 

perform efficacious phytosanitary 

treatments, including post-treatment 

safeguarding and documentation. 

Another commenter stated that 

proposed § 305.9(b), which referred to 

approval of an irradiation facility by 

APHIS, should instead refer to 

certification of the irradiation facility by 

APHIS. 

We agree with the first commenter’s 

general point that a distinction should 

be drawn between certification of a 

facility as capable of performing 

treatment and approval of that facility to 

mstockstill on DSKH9S0YB1PROD with RULES2

Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 4229 

3 The Glossary of Phytosanitary Terms is 

International Standard for Phytosanitary Measures 

(ISPM) Number 5. To view this and other ISPMs on 

the Internet, go to (http://www.ippc.int/) and click 

on the ‘‘Adopted Standards’’ link under the ‘‘Core 

activities’’ heading. 

perform treatments. In proposed § 305.9, 

which contained our proposed revision 

of the irradiation treatment 

requirements, we referred to 

certification of a facility as part of the 

process for approval of a facility; the 

other part of that process was 

completing the necessary compliance 

agreements or workplans. Our use of the 

term ‘‘certification’’ in proposed §§ 305.5 

and 305.8 was consistent with the use 

in proposed § 305.9. To be consistent, 

this final rule refers to certification, 

rather than approval, of cold treatment 

facilities in § 305.6(a). For reasons 

mentioned earlier, we are not making 

the change suggested by the second 

commenter. 

Definitions 

We proposed to add or change the 

definitions of some terms in § 305.1. 

The definition of irradiation has read: 

‘‘The use of irradiated energy to kill or 

devitalize organisms.’’ We proposed to 

replace the reference to ‘‘irradiated 

energy’’ with a reference to ‘‘ionized 

energy.’’ We also proposed to replace the 

reference to ‘‘devitalize’’ in the 

definition of irradiation with a reference 

to ‘‘neutralize.’’ 

Two commenters suggested that we 

refer instead to ‘‘ionizing energy,’’ as it 

is not the energy itself that is ionized; 

rather, the energy has the effect of 

ionizing atoms that are hit by the 

irradiation. 

We agree with these commenters. 

One commenter suggested that we 

add the word ‘‘pest’’ before the word 

‘‘organisms’’ in the definition of 

irradiation. 

The commenter did not provide any 

specific reason for making this change. 

We believe the suggested change is 

unnecessary, as any organism for which 

treatment is required will be a plant 

pest. 

The International Plant Protection 

Convention’s (IPPC) Glossary of 

Phytosanitary Terms3 defines 

irradiation as ‘‘treatment with any type 

of ionizing radiation.’’ As this definition 

is substantially similar to the proposed 

definition, and adopting the IPPC 

definition would make the regulations 

consistent with international standards, 

we are adopting the IPPC definition of 

irradiation in this final rule. 

We proposed to add a definition of 

neutralize to reflect the fact that an 

effective irradiation treatment does not 

necessarily kill a plant pest. The 

proposed definition of neutralize read: 

‘‘In the case of treatments other than 

irradiation, to kill a plant pest; in the 

case of irradiation, to prevent the 

establishment of the pest by killing it, 

sterilizing it, or preventing its 

development from an immature stage 

into an adult capable of emerging from 

its host, reproducing, or becoming 

established.’’ 

Two commenters recommended that 

the definition of neutralize make no 

distinction between irradiation and 

other treatments. One commenter noted 

that stating that treatments other than 

irradiation must result in the death of a 

plant pest does not provide options for 

other treatments that may be 

demonstrated to achieve a quarantine 

objective without causing mortality. For 

example, the commenter stated, the use 

of juvenile hormones as a treatment 

would prevent the development of larva 

into adults, while not killing the insect 

directly. In this case, the quarantine 

objective would be met, as the pest 

would not be able to reproduce and 

establish. While such treatments are not 

currently approved under the 

regulations or within the PPQ Treatment 

Manual, the commenter stated that, 

should such treatments be approved, it 

would be beneficial to allow for their 

subsequent inclusion within the PPQ 

Treatment Manual without having to 

amend the definition of neutralize. 

We agree with these commenters and 

have removed the distinction between 

methods of treatment in the definition 

of neutralize in this final rule. 

One commenter recommended that 

we remove the phrase ‘‘reproducing or 

becoming established’’ from the 

proposed definition of neutralize and 

instead refer to preventing a pest’s 

development from an immature stage 

into an adult capable of emerging from 

its host or pupal case. As both nonemergence of adults and sterility of any 

life stage would effectively prevent a 

pest from reproducing and thereby 

becoming established, the commenter 

stated that highlighting that both of 

these are potentially acceptable 

outcomes would allow for the different 

biology of the range of pests for which 

a quarantine treatment might be 

applied. 

We agree with the commenter’s 

general point. However, with regard to 

the specific suggested language, ‘‘pupal 

case’’ would be inappropriately limiting, 

as a treatment that prevented 

development of pests in the larval stage 

would also be considered to be effective. 

Referring generally to preventing the 

development of a pest from an immature 

stage will encompass all of the potential 

successful outcomes. We have changed 

the proposed definition of neutralize 

accordingly. 

With these changes, the definition of 

neutralize in this final rule reads: ‘‘To 

prevent the establishment of a plant pest 

by killing it, sterilizing it, preventing its 

development from an immature stage, or 

preventing its emergence from its host.’’ 

One commenter suggested that we 

add a definition of the term monitor, a 

term used in the general treatment 

requirements. The commenter stated 

that readers could be confused regarding 

whether monitor implies constant 

oversight of the treatment process or 

validation of the process at critical 

points in time. 

The tenth edition of MerriamWebster’s Collegiate Dictionary defines 

‘‘monitor’’ as ‘‘to keep watch of, track, or 

check.’’ Other dictionaries provide 

similar definitions. This definition 

indicates that monitoring occurs while 

the treatment is occurring, but does not 

necessarily indicate constant oversight, 

which is consistent with the monitoring 

that officials authorized by APHIS 

perform for treatments. The IPPC 

Glossary of Phytosanitary Terms is 

consistent with the general definition, 

defining monitoring as ‘‘an official 

ongoing process to verify phytosanitary 

situations.’’ We do not see a need to add 

a definition of monitor to the 

regulations, since our use of monitor is 

consistent with common understanding 

of the term and with international 

standards. 

Notice-Based Process for Amending 

Treatments 

Proposed § 305.3 set out a noticebased process for amending approved 

treatments. We received several 

comments supporting the use of such a 

process. One commenter noted that the 

addition, revision, and deletion of 

treatment schedules will directly affect 

the interests of trading partners and 

asked that APHIS provide notification of 

such changes to the World Trade 

Organization (WTO), with a sufficient 

period for comment, so that trading 

partners will be informed of these 

changes in a timely manner. 

We plan to provide WTO notifications 

for notices published under this 

process, as we do for other trade-related 

notices. The notice will provide for a 

public comment period during which 

trading partners, as well as any other 

interested parties, may submit 

comments. 

We are making two minor changes to 

the proposed provisions for the noticebased process. We are changing 

paragraph (b)(1)(iii) to refer to ‘‘articles’’ 

rather than ‘‘commodities,’’ because 

mstockstill on DSKH9S0YB1PROD with RULES2

4230 Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 

‘‘articles’’ is the more commonly used 

general term. 

In addition, proposed paragraph (b)(2) 

stated that treatments added or revised 

through the process we proposed to use 

for immediate changes to treatment 

schedules would be listed in a separate 

section of the PPQ Treatment Manual as 

having been added or revised through 

the immediate process described in 

proposed paragraph (b). However, in the 

current PPQ Treatment Manual, all of 

the treatments are listed by type 

(chemical treatment, cold treatment, 

etc.), which makes it easy for facility 

operators and others to see all the 

treatments that could potentially be 

employed at a specific treatment 

facility. Listing treatments approved 

through the immediate process in a 

separate section would make the PPQ 

Treatment Manual less user-friendly. 

Therefore, we have changed this 

provision in this final rule to indicate 

that treatment schedules that have been 

added to the PPQ Treatment Manual or 

revised under this process will be 

identified in the PPQ Treatment Manual 

as having been added or revised through 

the immediate process. The 

identification will make it clear that 

such treatments may be subject to 

change pending the comments we 

receive on the added or revised 

treatments. 

Monitoring and Certification of 

Treatments 

Section 305.3 has contained 

requirements for monitoring and 

certification of treatments. We proposed 

to move these requirements to § 305.4 

and amend them. 

Paragraph (b) of § 305.3 has required 

any treatment performed outside the 

United States to be monitored and 

certified by an inspector or an official 

from the NPPO of the exporting country. 

In proposed § 305.4(b), we proposed to 

require instead that any treatment 

performed outside the United States 

must be monitored and certified by an 

inspector or an official authorized by 

APHIS. We proposed this change to 

make this requirement consistent with 

the other requirements in part 305, 

which refer to officials authorized by 

APHIS rather than NPPO officials 

specifically. 

Three commenters recommended that 

we not change the language currently in 

the regulations. Two commenters stated 

that the current regulations allow for 

APHIS to require preclearance, in which 

an APHIS inspector is present during 

the treatment and certifies that the 

treated commodity is free of quarantine 

pests, or certification by the NPPO; 

these commenters objected to what they 

perceived as the removal of the latter 

option. 

One of these commenters further 

noted that international agreements 

recognize the NPPO as the official 

service that certifies consignments to 

have been disinfected or disinfested 

when being moved in international 

trade and provides the necessary 

endorsements on phytosanitary 

certificates. This commenter also stated 

that, unless a risk assessment 

demonstrates that preclearance is 

necessary, requiring preclearance 

imposes significant additional costs to 

exporters without increasing the 

quarantine security of consignments. 

This commenter recommended that we 

change the references to ‘‘an official 

authorized by APHIS’’ in other sections 

of the regulations to refer to officials 

from the NPPO of the exporting country, 

to be consistent with the original text of 

§ 305.3. 

The provisions we proposed allow 

everything that is allowed under the 

current regulations; we did not propose 

to remove any options. Officials 

authorized by APHIS would include any 

officials of a foreign NPPO who 

currently certify treatments for articles 

exported to the United States. They 

would also include third parties that 

conduct treatments. Currently, thirdparty officials authorized by APHIS who 

monitor treatments include operators of 

niger seed treatment facilities, operators 

of wood packing material treatment 

facilities, officials who monitor 

precooling treatment temperatures for 

cold treatment, and others. As such, the 

provisions we proposed are more 

inclusive than those currently in the 

regulations and reflect current treatment 

activities; reverting to the original text 

would remove some options for 

exporters. In addition, the provisions we 

proposed continue to allow for 

preclearance or certification of 

treatment by the NPPO, as appropriate. 

We have made no changes in response 

to these comments. 

We also proposed to require treated 

commodities to be accompanied by a 

phytosanitary certificate issued by the 

NPPO of the exporting country 

certifying that treatment was conducted 

in accordance with APHIS regulations 

when monitoring or certification of a 

treatment involves an official authorized 

by APHIS. The current regulations 

require phytosanitary certificates when 

treatment is monitored and certified by 

an official of the exporting country. We 

proposed to retain the requirement that 

the phytosanitary certificate be 

presented to an inspector when the 

commodity is offered for entry into the 

United States. 

One commenter stated that it is 

inappropriate for the NPPO of the 

exporting country to certify that a 

treatment has been conducted in 

accordance with APHIS regulations if 

the treatment is not monitored by an 

NPPO official. This commenter also 

noted that some treated commodities are 

not required to be accompanied by 

phytosanitary certificates. 

When treatments are conducted in a 

foreign country, an NPPO official is 

always involved in monitoring the 

treatment. However, the commenter is 

correct that many articles whose 

importation is authorized only if they 

are treated are not required to be 

accompanied by a phytosanitary 

certificate; for example, regulated wood 

packaging material is required under 

§ 319.40-3(b) to be treated before 

importation, but a stamp on the wood 

packaging indicates that the treatment 

has been conducted. Requirements that 

phytosanitary certificates accompany 

imported articles are typically contained 

in APHIS permits or in the regulations 

in 7 CFR part 319, which contains 

requirements for importing various 

articles; it is not necessary to include a 

separate phytosanitary certificate 

requirement for treated articles in part 

305, especially when there would be 

many exceptions to that requirement. 

Therefore, we will not be finalizing the 

phytosanitary certificate-related 

provisions discussed earlier that we had 

proposed to include in § 305.4(b). 

Chemical Treatment 

We proposed to retain the 

requirements for chemical treatment in 

§ 305.5, with minor changes. Paragraph 

(a) of § 305.5 requires fumigation 

treatment facilities to be certified by 

APHIS and to be inspected and 

recertified annually, or as often as 

APHIS directs, depending upon 

treatments performed, commodities 

handled, and operations conducted at 

the facility. 

One commenter stated that, consistent 

with international agreements, the 

NPPO of the exporting country is 

capable of testing treatment facilities 

and certifying them as being capable of 

delivering the treatments required by 

the importing country. The commenter 

stated that this level of certification is 

not justified and presents a significant 

logistical and cost burden on treatment 

facilities, while not necessarily 

improving the quarantine security of 

consignments being exported to the 

United States. The commenter suggested 

that, at most, the certification be based 

on information submitted by the NPPO 

of the exporting country that is 

sufficient to demonstrate that the 

mstockstill on DSKH9S0YB1PROD with RULES2

Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 4231 

facilities treating consignments are 

capable of meeting the requirements of 

§ 305.5(a). 

We did not propose to change the 

certification requirements for 

fumigation treatment facilities, and we 

would want to allow the public to 

comment on such a change before it was 

implemented. Therefore, we have made 

no changes to these provisions in 

response to this comment. However, we 

will consider the change the commenter 

suggested; if we determine that it is 

warranted, we will publish a proposed 

rule soliciting public comment on the 

change. 

Cold Treatment 

We proposed to move the 

requirements for cold treatment from 

§ 305.15 to § 305.6, with minor changes. 

Paragraph (d)(6) of § 305.15, which is 

identical to proposed § 305.6(d)(6), has 

stated that only the same type of fruit in 

the same type of package may be treated 

together in a container; no mixture of 

fruits in containers may be treated. 

One commenter suggested that we 

define ‘‘type.’’ The commenter stated 

that a ‘‘type’’ of fruit, for the purpose of 

cold treatment, should be those fruits 

that are to be treated under the same 

schedule and that belong to the same 

genus. The commenter stated that 

different types of packaging might affect 

the delivery of cold treatment due to 

issues associated with the circulation of 

cold air, but different varieties of a 

particular species (such as Lisbon and 

Meyer lemons, or Washington Navel 

and Valencia oranges) do not affect 

treatment efficacy. 

We agree with the commenter that 

varietal differences within a species do 

not affect the efficacy of cold treatment. 

However, we have determined that 

variations among species are significant 

enough that only fruit of the same 

species should be treated together using 

currently approved cold treatments; 

thus, we currently allow only fruit of 

the same species to be treated together. 

That said, we may determine in the 

future that a cold treatment schedule 

can be applied to fruit of the same 

genus. For that reason, we are not 

adding a definition of ‘‘type’’ to the 

regulations, but we are adding guidance 

on the meaning of ‘‘type’’ to the PPQ 

Treatment Manual. If we determine that 

a schedule could be used for fruit of the 

same genus, we would then be able to 

update the PPQ Treatment Manual to 

reflect that determination through the 

notice-based process we are adding to 

the regulations in this final rule. 

This commenter also stated that, 

where the same treatment is applied and 

the same packaging type is used, the 

inclusion of both lemons and oranges in 

a single treatment container should not 

necessarily be considered to invalidate 

the treatment, provided the more 

stringent of the two available treatments 

is applied. The commenter stated that 

these fruit are closely related, have a 

similar structure, and would be 

predicted to have a similar rate of 

respiration that would influence the 

cold treatment and the development of 

any ‘‘hot spots’’ in the treatment 

enclosure. 

We believe that the commenter’s 

suggestion has some potential merit, but 

operational issues could make such a 

treatment process difficult to 

implement. However, we will consider 

the change the commenter suggested; if 

we determine that it is warranted, and 

that the operational issues associated 

with such a change could be adequately 

resolved, we will publish a proposed 

rule soliciting public comment on the 

change. 

Heat Treatment 

We proposed to move the 

requirements for heat treatment from 

§ 305.20 to § 305.8, with minor changes. 

Paragraph (a)(1) of § 305.20, which is 

identical to proposed § 305.8(a)(1), has 

stated that a certified facility must have 

equipment that is capable of adequately 

circulating air or water (as relevant to 

the treatment). 

One commenter asked whether the 

interpretation of ‘‘air’’ in the regulations 

would include steam or vapor. The 

commenter noted that three main forms 

of heat treatment are generally accepted, 

hot water immersion, high temperature 

forced air, and vapor heat treatment, 

and suggested that the text of this 

section include the term ‘‘air/vapor.’’ 

Steam and vapor are simply phases of 

water and, as used in treatments, are 

thus a mixture of air and water. As the 

regulations include requirements for 

circulation of air and water, we have 

determined that it is not necessary to 

further specify that facilities must be 

able to adequately circulate vapor. 

Irradiation 

The regulations have contained three 

sections that set out requirements for 

performing irradiation treatment: 

§ 305.31, for irradiation treatment of 

imported regulated articles; § 305.32, for 

regulated articles moved interstate from 

areas quarantined for fruit flies; and 

§ 305.34, for regulated articles moved 

interstate from Hawaii, Puerto Rico, and 

the U.S. Virgin Islands. The 

requirements in these sections were 

mostly similar, and some of them were 

identical. We proposed to consolidate 

and harmonize the existing irradiation 

requirements into one section that 

would set out irradiation requirements 

for all articles for which irradiation is an 

authorized treatment. We also proposed 

to make minor changes to the irradiation 

treatment requirements. 

One commenter stated that the 

irradiation treatment regulations 

provide a much greater level of detail 

than the equivalent sections for other 

treatments. The commenter asked 

whether it is necessary to include this 

level of detail in the regulations, or 

whether it would be beneficial to 

include much of this detail in either the 

PPQ Treatment Manual or the other 

documentation specific to the 

irradiation treatment, such as the 

irradiation treatment framework 

equivalency workplan (FEWP). The 

commenter stated that reducing the 

level of detail in the regulations to be 

consistent with the other treatments 

would provide APHIS with more 

flexibility to amend the treatment 

requirements in the future, rather than 

having to complete rulemaking to do so. 

The level of detail we proposed to 

include in the regulations reflects the 

level of detail that has been in the 

regulations. We did not propose to 

change the provisions of the irradiation 

regulations except as necessary to 

harmonize among the three sets of 

regulations and to correct errors and 

inconsistencies. Based on the comments 

we received, we will examine the 

irradiation regulations; if warranted, we 

will publish a separate proposal to 

amend them by removing detail and 

invite public comment on the proposal. 

Two commenters stated that several 

requirements in the irradiation 

treatment regulations are related 

specifically to fruit flies. One of these 

commenters stated that the regulations 

contain requirements related to 

packaging, labeling, movement, and 

facility location that are specific to fruit 

flies and recommended that the 

regulations make it clear that irradiation 

is approved for many pests other than 

fruit flies. 

The other commenter suggested that 

we review the proposed regulations and 

replace references to fruit flies with 

references to ‘‘pests of concern’’ where 

appropriate. This commenter 

specifically suggested that we change 

proposed § 305.9(c)(1)(i), which relates 

to compliance agreements for facilities 

treating imported articles in the United 

States. As proposed, this paragraph 

indicated that, in the facility 

compliance agreement, the facility 

operator must agree to comply with any 

additional requirements found 

necessary by APHIS to prevent the 

escape, prior to irradiation, of any fruit 

mstockstill on DSKH9S0YB1PROD with RULES2

4232 Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 

flies that may be associated with the 

articles to be irradiated. 

We agree with these commenters that 

the regulations should indicate that 

irradiation can be used to treat pests 

other than fruit flies, as irradiation is 

approved as a treatment for all pests of 

the class Insecta, other than pupae and 

adults of the order Lepidoptera. The 

proposed rule included several changes 

to the existing irradiation requirements 

to refer to pests of concern rather than 

to fruit flies specifically. In addition, we 

are taking the second commenter’s 

suggestion to replace the reference to 

fruit flies in proposed § 305.9(c)(1)(i) 

with a reference to ‘‘pests of concern.’’ 

Some of the references to fruit flies in 

the regulations relate to the fact that, for 

articles moved within the continental 

United States, irradiation has only been 

approved as a treatment for articles 

moved interstate from areas quarantined 

for fruit flies. However, under this final 

rule, such facilities can treat any pest for 

which there is an approved dose in the 

PPQ Treatment Manual. We did not 

propose to expand the use of irradiation 

to facilities located in any areas 

quarantined for other pests in the 

proposal, although we may do so in the 

future. 

Of the requirements cited by the first 

commenter, only the facility location 

requirements are specifically related to 

fruit flies. These are discussed in further 

detail in response to the next comment. 

However, the packaging, labeling, and 

movement requirements in the 

regulations all act as general safeguards 

against pests of concern, and the 

regulations as amended by this final 

rule reflect that. 

Paragraph (a) of proposed § 305.9 

contained the facility location 

requirements referred to earlier, which 

were taken from § 305.31(b). Under the 

proposed requirements, for articles that 

are imported or moved interstate from 

Hawaii or U.S. territories, irradiation 

facilities may be located in any State on 

the mainland United States except 

Alabama, Arizona, California, Florida, 

Kentucky, Louisiana, Nevada, New 

Mexico, South Carolina, Tennessee, 

Texas, and Virginia. In the States of 

Georgia, Mississippi, and North 

Carolina, irradiation facilities may only 

be located at the maritime ports of 

Gulfport, MS, or Wilmington, NC, or the 

airport of Atlanta, GA, and only if 

certain special conditions are met. 

Those conditions are designed to 

mitigate the risk of escape of fruit flies 

from the facility. 

One commenter stated that no reason 

for excluding those listed States was 

included in the proposal and suggested 

that information on why these States are 

excluded be added to the rule. The 

commenter suggested that, if it is only 

Federal or State legislation that prevents 

the use of irradiation facilities in those 

States for imported commodities, the 

additional legislation could be 

referenced and the specific list of States 

included only in the PPQ Treatment 

Manual, rather than the regulations. 

This change, the commenter stated, 

would prevent the need for a formal rule 

change should States be added to or 

removed from the list. 

The States listed in the regulations are 

States where fruit flies could become 

established if introduced into the 

United States. We exclude these States 

to safeguard against the possibility that, 

despite the container and movement 

restrictions in the irradiation treatment 

regulations, fruit flies could escape from 

regulated articles in the United States 

prior to treatment. This rationale was 

given in the final rule establishing the 

irradiation treatment regulations for 

imported articles, which was published 

in the Federal Register and effective on 

October 23, 2002 (67 FR 65016-65029, 

Docket No. 98-030-4). As the relevant 

climatic conditions in these States are 

not expected to change, removing this 

list from the regulations to facilitate 

future changes in the list is not 

necessary. 

One commenter noted that the 

regulations provide conditions for the 

placement of a facility in the listed 

States at three specific ports of entry. 

The commenter suggested that these 

provisions should not be in the 

regulations but in the PPQ Treatment 

Manual. The commenter stated that this 

type of detail, which might change 

based on specific approvals, would be 

better handled within the PPQ 

Treatment Manual. Amendments to the 

list could follow the same notice-andcomment process we proposed for 

changes to the PPQ Treatment Manual. 

We are considering rulemaking to 

establish conditions under which 

facilities could be located in the States 

listed in paragraph (a) of proposed 

§ 305.9. Should we decide to 

promulgate rulemaking to establish such 

conditions, we would include the list of 

approved facilities in the Treatment 

Manual, as the commenter suggests. 

However, making such a change in this 

final rule would be beyond the scope of 

the proposed rule. 

The irradiation treatment regulations 

require that an irradiation treatment 

facility be certified by APHIS. The 

proposal included this requirement in 

paragraph (d) of proposed § 305.9. For 

the initial certification of a facility, the 

irradiation treatment regulations require 

that an inspector make a personal 

inspection of the facility to determine 

whether it complies with the irradiation 

treatment facility requirements; the 

proposal included this requirement in 

paragraph (l) of proposed § 305.9. 

One commenter stated that this level 

of certification is not justified and 

presents a significant logistical and cost 

burden on treatment facilities, while not 

necessarily improving the quarantine 

security of consignments being exported 

to the United States. The commenter 

stated that the key parts of the 

irradiation system are the dose mapping 

system and the routine dosimetry 

system. Because the regulations require 

these dosimetry systems to be compliant 

with the International Standards 

Organization/American Society for 

Testing and Materials (ISO/ASTM) 

standard or an equivalent standard 

recognized by APHIS, the commenter 

stated that there should be no need for 

specific certification visits by APHIS 

officials, provided that these standards 

are met. In this case, the commenter 

suggested, APHIS could use audit trails 

and certificates provided by accredited 

testing and certification laboratories to 

determine whether the treatment facility 

meets all the necessary requirements. 

We have determined that, for the 

initial certification of a facility, it is 

necessary to conduct a personal 

inspection to ensure that the facility is 

in compliance with the ISO/ASTM 

standard. Audit trails and certificates 

provided by accredited testing and 

certification laboratories would not 

provide adequate assurance that the 

facility is in compliance with the 

standard. In addition, while we agree 

that the dose mapping and routine 

dosimetry systems are key components 

of irradiation treatment, the regulations 

include many other requirements that 

are necessary to ensure the 

phytosanitary security of treated 

articles, such as provisions to separate 

treated and untreated articles and to 

prevent the infestation of treated articles 

by quarantine pests after treatment. The 

facility’s systems and processes to 

ensure compliance with these 

requirements also need to be verified by 

a personal inspection. We are making no 

changes in response to this comment. 

The irradiation treatment regulations 

have referred to an increase or decrease 

in the amount of radioisotope as an 

event because of which recertification 

would be required. These events are 

found in the introductory text of 

paragraph (d) of proposed § 305.9. We 

proposed to add the word ‘‘significant’’ 

to better characterize the type of 

decrease that would require 

recertification, since radioisotope 

decreases in very small amounts during 

mstockstill on DSKH9S0YB1PROD with RULES2

Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 4233 

treatment; otherwise, we did not 

propose to change this requirement. 

Two commenters stated that increases 

in the amount of isotope should not 

necessitate recertification, and one 

stated that decreases in the amount of 

isotope should not either. Both 

commenters stated that if processes for 

maintaining the isotope have been 

established by the facility and approved 

by APHIS, changes in isotope should 

not require additional review by APHIS, 

except as necessary to confirm that the 

processes are being properly 

implemented. 

As noted, the requirement for 

recertification in the event of a change 

in the amount of radioisotope has been 

found in all three sets of irradiation 

treatment facility provisions; we did not 

propose to change that requirement, 

other than making it more specific and 

thus more clear regarding what events 

require recertification. We have required 

recertification in the event of a change 

in the amount of radioisotope in order 

to verify that the radioisotope is at a 

proper level and treatment is being 

conducted in accordance with the ISO/ 

ASTM standard and the facility’s 

standard operating procedures. As 

discussed in more detail later in this 

document, it is especially important to 

verify that irradiation treatment is being 

properly conducted. We are making no 

changes in response to these comments. 

However, we have determined that 

the proposed text could be more specific 

in describing what decreases warrant 

recertification. This final rule refers to a 

decrease in the amount of radioisotope 

for a reason other than natural decay, 

rather than to a significant decrease in 

the amount of radioisotope, as a reason 

for recertification. This reflects the 

intent of the proposed change more 

specifically and provides helpful 

additional information to the reader. 

The irradiation treatment regulations 

require irradiation treatment to be 

monitored by an inspector. Monitoring 

will include inspection of treatment 

records and unannounced inspections 

of the facility by an inspector, and may 

include inspection of articles prior to or 

after irradiation. The proposal included 

these requirements in paragraph (e) of 

proposed § 305.9. 

One commenter stated that such 

monitoring should not be required. The 

commenter stated that monitoring and 

inspection of treatment records can be 

performed by the NPPO of the exporting 

country. The commenter also stated that 

specific provisions for inspection prior 

to or after irradiation should not be 

included, as these should be performed 

during or after the issuance of a 

phytosanitary certificate by the NPPO of 

the exporting country. 

We have determined that the current 

level of monitoring is appropriate. 

Verifying that irradiation treatment is 

being applied properly is particularly 

important because an inspector looking 

at treated articles themselves after 

treatment would have no practical way 

to determine, based on physical 

evidence from the commodity itself, that 

the articles have been irradiated. 

Irradiation leaves no residue and 

usually causes no discernable change to 

an article’s color or texture. In addition, 

as discussed earlier in this document, 

an effective irradiation treatment may 

not kill all larvae, but instead might 

prevent adult emergence. In cases where 

an inspector at the port of entry 

encounters live larvae of the target pest 

in a shipment that is documented as 

irradiated, it is extremely important that 

the inspector be able to determine with 

full confidence that the article was 

properly treated according to APHIS 

requirements. We are making no 

changes in response to this comment. 

One commenter stated that provisions 

in proposed paragraph (e) imply that an 

inspector need not necessarily be 

present at all times during treatment. 

However, the commenter stated, the 

requirement that treatment ‘‘must be 

monitored by an inspector’’ will lead to 

some confusion. The commenter 

suggested clarifying that an inspector 

may not be required on site during 

treatment. 

The commenter’s interpretation that 

monitoring may or may not be on site 

is correct. Immediately after the 

requirement the commenter cites, the 

regulations go on to explain that 

monitoring will include inspection of 

treatment records and unannounced 

inspections of the facility by an 

inspector, and may include inspection 

of articles prior to or after irradiation. If 

an unannounced visit is not being 

conducted, monitoring would only 

necessarily include a review of 

treatment records, which could be done 

off site. We believe the current language 

is sufficiently clear on this point. 

To ensure the appropriate level of 

monitoring for facilities treating 

imported articles, the regulations in 

§ 305.31(f) have required three 

agreements to be signed before articles 

can be imported in accordance with the 

irradiation treatment requirements: An 

FEWP, a facility preclearance workplan, 

and a trust fund agreement. We 

proposed to move these requirements to 

proposed § 305.9(e)(1). The only change 

we proposed was to limit the 

applicability of these requirements to 

facilities located in foreign countries, 

because ensuring that the irradiation 

treatment requirements are met when 

monitoring irradiation treatment in a 

foreign country involves an additional 

layer of complexity. Such monitoring 

requires us to work with foreign 

governments to ensure that all 

requirements are met, while monitoring 

the irradiation treatment within the 

United States of imported articles does 

not. 

One commenter stated that, as 

specific details regarding the inspection 

of irradiated articles are included in the 

FEWP and the associated operational 

workplans, some of the specific details 

included in proposed paragraph (e) are 

not necessary. Similarly, the commenter 

suggested, as the extent of treatment 

oversight and monitoring would be 

defined in the FEWP, the text of 

proposed paragraph (e)(1)(iii), which 

contains the trust fund agreement 

requirements, could be simplified to 

remove specific references to the duties 

undertaken by APHIS in the exporting 

country. 

The specific details the commenter 

cites are presented in the regulations as 

examples and not as exhaustive lists. 

For example, the requirements for the 

facility preclearance workplan that have 

been found in § 305.31(f)(2) and were 

proposed in § 305.9(e)(1)(ii) cite typical 

activities to be described in the 

workplan. These details provide helpful 

additional detail to the reader. We are 

making no changes in response to this 

comment. 

Two commenters specifically 

addressed the FEWP. The regulations in 

§ 305.31(f)(1), which we included in 

§ 305.9(e)(1)(i) of the proposal, have 

required the NPPO of a country from 

which articles are to be imported into 

the United States in accordance with the 

irradiation treatment regulations to sign 

an FEWP with APHIS. In the FEWP, 

both the NPPO and APHIS will specify 

the following items for their respective 

countries: 

∑ Citations for any requirements that 

apply to the importation of irradiated 

fruits and vegetables; 

∑ The type and amount of inspection, 

monitoring, or other activities that will 

be required in connection with allowing 

the importation of irradiated fruits and 

vegetables into that country; and 

∑ Any other conditions that must be 

met to allow the importation of 

irradiated fruits and vegetables into that 

country. 

One commenter suggested that we 

revise these requirements to simply 

state that APHIS maintains the right to 

either deny the application for, or 

retract the approval of, an operational 

workplan for an irradiation facility if the 

mstockstill on DSKH9S0YB1PROD with RULES2

4234 Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 

NPPO of the exporting country refuses 

to allow the importation of articles 

treated with irradiation. The commenter 

stated that such language would grant 

APHIS the legal right to determine 

equitable reciprocity and take 

appropriate action. The commenter 

stated that, in the case of domestic 

irradiation facilities that do not involve 

operational workplans with foreign 

NPPOs, reciprocity should not be 

required. 

Another commenter requested that 

the requirement for the FEWP be 

removed. This commenter stated that 

the requirement for the FEWP was not 

based on science and thus constituted 

an unjustified barrier to trade. Because 

the requirement for the FEWP is not 

based on science, the commenter stated, 

APHIS is not authorized to impose such 

a requirement under the Plant 

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

which states that decisions affecting 

imports, exports, and interstate 

movement of regulated products shall 

be based on sound science. The 

commenter stated that the requirement 

for the FEWP was causing costly delays 

in attempts by the commenter’s business 

to establish a facility for irradiating 

products for export to the United States, 

as the government of the country in 

which the facility is intended to be 

located is reluctant to take the steps that 

government has determined to be 

necessary to agree to an FEWP. 

The FEWP was originally established 

in the irradiation regulations to support 

the equivalence principle of the WTO 

Agreement on the Application of 

Sanitary and Phytosanitary Measures by 

clearly stating what legislative, 

regulatory, and other requirements must 

be met, and what monitoring and other 

activities must occur, for irradiated 

articles to be imported into the United 

States, or into the foreign country. We 

did not propose to change the 

provisions required to be included in 

the FEWP requirements. 

The FEWP does not obligate the 

government of a country in which an 

irradiation facility is located to agree to 

any specific conditions for the use of 

irradiation as a phytosanitary measure, 

but merely to document the conditions 

under which irradiated articles can be 

imported into that country. We will 

provide clarification regarding this 

point to any country that is 

encountering difficulty in preparing an 

FEWP. 

As noted above, we proposed to 

change the FEWP requirement so that it 

only applied to facilities located outside 

the United States. However, upon 

further considering the purpose of the 

FEWP, we have determined that the 

FEWP should continue to be required 

for all facilities treating imported 

articles, whether located outside or 

inside the United States, as the 

equivalence principle applies regardless 

of where imported articles are treated. 

Therefore, this final rule contains the 

FEWP requirement in a separate 

paragraph (e)(1) that applies to all 

facilities treating imported articles. 

Paragraph (e)(2) contains the remaining 

requirements for facilities located in 

foreign countries, and paragraph (e)(3) 

contains the requirements for facilities 

located in the United States; the latter 

paragraph refers to the FEWP 

requirement in paragraph (e)(1) for 

facilities located in the United States 

that are treating imported articles. 

With regard to the first commenter’s 

suggestion, the current FEWP provisions 

provide helpful additional specificity 

regarding what information about the 

exporting country’s irradiation 

requirements needs to be conveyed in 

order for equivalence to be established. 

We are making no changes in response 

to this comment. 

Two commenters specifically 

addressed the facility preclearance 

workplan. Prior to commencing 

importation into the United States of 

articles treated at a foreign irradiation 

facility, APHIS and the NPPO of the 

country from which articles are to be 

imported must jointly develop a 

preclearance workplan that details the 

activities that APHIS and the foreign 

NPPO will carry out in connection with 

each irradiation facility to verify the 

facility’s compliance with the 

irradiation treatment requirements of 

this section. Typical activities to be 

described in this workplan may include 

frequency of visits to the facility by 

APHIS and foreign plant protection 

inspectors, methods for reviewing 

facility records, and methods for 

verifying that facilities are in 

compliance with the requirements for 

separation of articles, packaging, 

labeling, and other irradiation treatment 

requirements. This facility preclearance 

workplan will be reviewed and renewed 

by APHIS and the foreign NPPO on an 

annual basis. 

Both commenters stated that 

preclearance should not be mandatory 

in all cases and that this specific 

workplan should be renamed. One 

commenter suggested calling it the 

‘‘treatment facility workplan,’’ and the 

other suggested the ‘‘irradiation facility 

workplan.’’ The latter commenter stated 

that making this change would allow 

the flexibility to move from a 

preclearance program to one in which 

treatments are monitored by officials 

authorized by APHIS and the 

commodity is shipped with a 

phytosanitary certificate issued by the 

NPPO of the exporting country, given 

sufficient evidence regarding the 

success of the program. 

We assume that the commenters are 

referring to ‘‘preclearance’’ as the 

activity in which APHIS inspectors are 

present in a foreign country and 

conduct inspections there prior to 

export of the inspected articles. That is 

how APHIS has commonly used the 

term in developing export programs for 

particular articles. However, the 

regulations for irradiation treatment 

facilities use ‘‘preclearance’’ in a 

different sense, to refer to preclearing 

treatments conducted at the facility. 

Because inspectors monitor treatment, 

there is no additional verification of the 

treatment that needs to be done at the 

port of entry, which is important given 

that there is no practical way to verify 

treatment, as discussed earlier. 

However, articles treated in a 

precleared facility are not necessarily 

themselves precleared. Irradiated 

articles may be subject to mitigations 

besides irradiation treatment for certain 

pests. For example, litchi from Thailand 

are required by § 319.56-47 to be treated 

with irradiation for several insect pests 

and also to be inspected by the Thai 

NPPO and found to be free of the fungus 

Peronophythora litchi, which is not 

neutralized by irradiation treatment. 

Thus, litchi from Thailand are not 

precleared for entry into the United 

States, even though the irradiation 

treatment facility in which they are 

treated is precleared. 

As discussed earlier, we need to 

retain the facility preclearance workplan 

in support of our monitoring 

requirements, given the difficulty 

associated with verifying that 

irradiation has been conducted 

properly. As the regulations refer 

specifically to a ‘‘facility preclearance 

workplan’’ and not a general 

preclearance workplan, we do not 

believe any further change is necessary 

to indicate that the preclearance 

discussed applies to treatments 

conducted in the facility and not 

necessarily to any articles treated by the 

facility. 

The regulations have required in 

§§ 305.32(b) and 305.34(b)(3) that 

facilities located within the United 

States that carry out continual 

irradiation operations notify an 

inspector at least 24 hours before the 

date of operations, while facilities that 

carry out periodic irradiation operations 

must notify an inspector of scheduled 

operations at least 24 hours before 

scheduled operations. This requirement 

mstockstill on DSKH9S0YB1PROD with RULES2

Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 4235 

was included in § 305.9(e)(2) of the 

proposal. 

One commenter stated that what is 

meant by ‘‘continual’’ and ‘‘periodic’’ 

operations is not clear. The commenter 

suggested that we either clarify or 

simply change the proposed text from 

‘‘...before the date of operations...’’ to 

‘‘...before the date of initial 

operations....’’. 

Re-examining the current 

requirements, we note that an inspector 

must be notified 24 hours before 

scheduled operations regardless of 

whether operations are continual or 

periodic. Therefore, as the commenter 

suggests, we have simplified this 

requirement in the final rule by 

eliminating distinctions between the 

two types of facilities. 

In order to ensure that inspectors have 

adequate notice, we are also clarifying 

this provision to indicate that the 

notification must come at least 24 hours, 

excluding Saturday, Sunday, and 

Federal holidays, before scheduled 

operations, so that notification for 

irradiation that is scheduled for the next 

Monday does not arrive on a Saturday, 

a Sunday, or a Federal holiday, which 

are not standard business days for 

APHIS inspectors. The provision thus 

reads as follows in this final rule: 

‘‘Facilities located within the United 

States must notify an inspector at least 

24 hours (excluding Saturday, Sunday, 

and Federal holidays) before scheduled 

operations.’’ 

Paragraph (f) of proposed § 305.9 

contained the packaging requirements of 

the irradiation treatment regulations. 

Paragraph (f)(2) contained requirements 

for packaging articles that are irradiated 

prior to arrival in the United States, 

prior to interstate movement from 

Hawaii or U.S. territories, and prior to 

movement from an area quarantined for 

fruit flies. The regulations for irradiation 

treatment of articles moved interstate 

from Hawaii and U.S. territories and 

from quarantined areas only allow 

irradiated articles to be packaged in 

insect-proof cartons. The regulations for 

irradiation treatment of imported 

articles allow either insect-proof cartons 

or noninsect-proof cartons to be used; if 

noninsect-proof cartons are used, the 

cartons must be stored immediately 

after irradiation in a room completely 

enclosed by walls or screening that 

completely precludes access by the 

pests of concern. If stored in noninsectproof cartons in a room that precludes 

access by the pests of concern, prior to 

leaving the room, each pallet of cartons 

must be completely enclosed in 

polyethylene shrink wrap, or another 

solid or netting covering that completely 

precludes access to the cartons by the 

pests of concern. We proposed in 

§ 305.9(f)(2)(i)(B) to allow the use of 

noninsect-proof cartons, subject to these 

conditions, for articles moved interstate 

from areas quarantined for fruit flies and 

from Hawaii and U.S. territories as well. 

One commenter expressed 

uncertainty regarding whether the 

complete enclosure of the pallet in 

polyethylene shrink wrap or other 

covering should include the underside 

of the product and, if so, how one can 

shrink wrap all six sides of a pallet of 

product. 

If the bottom of a pallet was insectproof, we would not require the bottom 

of the pallet to be wrapped in 

polyethylene shrink wrap. The 

requirements for the use of noninsectproof cartons are satisfied if access to 

the pallet is precluded by polyethylene 

shrink wrap or solid or netting covering. 

One commenter stated that the 

requirement to wrap pallets of 

noninsect-proof cartons to prevent 

access by the pests of concern may be 

an appropriate safeguarding measure for 

articles transported by air, since the 

pallets are almost always exposed 

during the loading of the aircraft, but is 

not appropriate for maritime shipments, 

when the pallets of treated articles are 

loaded directly into the maritime 

container at the packing shed under 

adequate safeguards and subsequently 

sealed by the inspector or by another 

official authorized by APHIS. The 

commenter suggested that proposed 

§ 305.9(f)(2)(i)(B) be reworded to make a 

distinction between requirements for air 

and maritime shipment, as is the case in 

other programs such as the program for 

hot water treatment of mango, and 

incorporated into the PPQ Treatment 

Manual rather than remain in the 

regulations. 

The intent of this requirement is to 

prevent the treated articles from being 

reinfested by the pests of concern after 

treatment. As articles are exposed to 

potential pest infestation while they are 

being loaded into maritime containers, 

it is necessary to include a requirement 

to address this risk for maritime 

shipments as well. Although the mango 

hot water treatment program allows for 

such loading to be conducted without 

wrapping the mangoes, as noted earlier, 

it is much more difficult for an 

inspector at a port of entry to verify that 

an article has been treated with 

irradiation; in contrast, an inspector 

could easily determine that live fruit 

flies in mangoes that have been treated 

with hot water represented a failure of 

either the treatment or the posttreatment safeguarding and take 

appropriate action. We will consider 

whether providing for supervision of the 

maritime transloading process might 

adequately mitigate this risk; if we 

determine that it would, we would 

propose rulemaking to provide for such 

supervision, and take public comment 

on the change. 

The regulations in §§ 305.31(g)(3)(ii), 

305.32(c)(2), and 305.34(b)(4)(i)(B) have 

required each pallet-load of cartons 

containing irradiated articles to be 

wrapped before leaving the irradiation 

facility in one of the following ways: 

∑ With polyethylene shrink wrap; 

∑ With net wrapping; or 

∑ With strapping so that each carton 

on an outside row of the pallet load is 

constrained by a metal or plastic strap. 

We included this requirement in 

§ 305.9(f)(2)(ii) of the proposal. 

One commenter stated an assumption 

that the concern of proposed paragraph 

(f)(2)(ii) is to ensure that pallets do not 

topple and that nontreated cartons 

cannot be inserted into pallets of treated 

articles. The commenter suggested that 

we substitute the word ‘‘secured’’ for the 

word ‘‘wrapped,’’ as it more accurately 

describes the process when cornices and 

strapping are used to stabilize the pallet. 

The commenter also stated that 

requiring the strapping to pass and 

constrain each carton on the outside 

row of the pallet load exceeds current 

industry practices and would increase 

operational costs. The commenter 

suggested that the requirement be 

reworded to indicate that pallet loads 

should be secured by shrink wrap, 

netting, or strapping, without specifying 

how the strapping is to be applied. 

We agree with the commenter’s 

suggestions. Accordingly, 

§ 305.9(f)(2)(ii) in this final rule uses the 

word ‘‘secured’’ rather than the word 

‘‘wrapped,’’ and does not include 

specific instructions on how to use 

strapping to secure the pallet. 

In addition, the packaging 

requirements for sweetpotatoes moved 

interstate from Hawaii in § 318.13-25 are 

similar to the packaging requirements 

for irradiated articles, and contain 

identical requirements for wrapping 

pallets; we are also changing those 

requirements in this final rule, to be 

consistent with the changes we are 

making in the irradiation regulations. 

The regulations in §§ 305.31(g)(3)(iii), 

305.32(c)(3), and 305.34(b)(4)(i)(C) have 

required packaging to be labeled with 

treatment lot numbers, packing and 

treatment facility identification and 

location, and dates of packing and 

treatment. We included this 

requirement in § 305.9(f)(2)(ii) of the 

proposal. 

One commenter stated that this level 

of detail does not need to be included 

in the regulations and that it would be 

mstockstill on DSKH9S0YB1PROD with RULES2

4236 Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 

preferable for the regulations to only 

state that the packaging be labeled in 

such a way as to enable the necessary 

level of traceback. The inclusion of any 

identifying mark on the packaging that 

would permit APHIS to correlate the 

specific shipment to a treatment 

certificate, import permit, or other 

system would provide an equivalent 

level of traceback. As this detail already 

exists in the draft operational 

workplans, the commenter suggested 

that the principle of traceback be 

mentioned in paragraph (f)(2)(iii) 

without specifically requiring treatment 

facility codes, dates, or other 

information. As the operational 

workplans will be more easily amended 

than the regulations, the commenter 

stated that this option would allow 

APHIS to more easily take into 

consideration the specific systems in the 

exporting country. 

We agree with the commenter’s 

suggestion. In this final rule, paragraph 

(f)(2)(iii) specifies that packaging must 

be labeled in a manner that allows an 

inspector to determine treatment lot 

numbers, packing and treatment facility 

identification and location, and dates of 

packing and treatment. This ensures 

that the information necessary to 

conduct traceback is available while 

allowing flexibility in providing that 

information. We will approve packaging 

to be used at a specific facility or for a 

specific commodity as part of the 

development of the operational 

workplan for the facility. 

In addition, the labeling requirements 

for sweetpotatoes moved interstate from 

Hawaii in § 318.13-25 contain similar 

requirements for labeling cartons; we 

are also changing those requirements in 

this final rule, to be consistent with the 

changes we are making in the 

irradiation regulations. 

One commenter suggested that APHIS 

change the wording (‘‘Treated by 

irradiation’’ or ‘‘Treated with radiation’’) 

that must be stamped or pre-printed on 

each carton to indicate that the articles 

were irradiated to mitigate pest risks. 

The wording is required by the Food 

and Drug Administration in its 

regulations at 21 CFR 179.26(c). We have 

no authority to make changes to those 

regulations. 

Paragraph § 305.31(h) has required 

containers or vans that will transport 

treated commodities to be free of pests 

prior to loading the treated 

commodities. We proposed to include 

this requirement in § 305.9(g) and to 

make it applicable not only to facilities 

treating imported articles but to 

facilities treating articles moved 

interstate from Hawaii and U.S. 

territories and from areas quarantined 

for fruit flies as well. 

One commenter requested 

clarification on this requirement. The 

commenter asked: 

∑ Whether the intent was to prevent 

infestation by pests of concern or 

hitchhikers; 

∑ Whether the requirement applies to 

product treated in an area where the 

pest(s) of concern are present, other 

areas, or both; 

∑ If articles are treated in a domestic 

facility, why it is important that the 

container or van be pest-free after the 

product has been processed; and 

∑ If the pests are not pests of concern, 

whether freedom would need to be 

established inside the container or 

outside the container. 

The intent of the requirement is to 

prevent infestation by pests of concern. 

The requirement applies regardless of 

whether pests of concern are present in 

the area in which the articles are 

treated. Ensuring that containers are free 

of pests of concern is a basic 

safeguarding principle; for example, 

even if an irradiation facility was 

located in an area free of pests of 

concern, a container could have been 

used to carry infested articles, 

improperly cleaned, and brought to the 

irradiation facility to contain treated 

articles. 

To clarify this requirement, we are 

changing proposed § 305.9(g) to refer 

specifically to pests of concern. We are 

also changing proposed § 305.9(g) to 

refer to ‘‘articles,’’ rather than 

‘‘commodities,’’ as the term ‘‘articles’’ is 

used throughout § 305.9. 

Proposed paragraph (l) of § 305.9 set 

out requirements for requesting 

certification and inspection of a facility. 

These requirements were taken from 

§ 305.31(l); similar requirements are 

contained in §§ 305.32(g) and 305.34(c). 

Each of these paragraphs provides that, 

before the Administrator determines 

whether an irradiation facility is eligible 

for certification, an inspector will make 

a personal inspection of the facility to 

determine whether it complies with the 

regulations. 

One commenter asked whether this 

paragraph also applied to recertification 

and, if so, suggested that we change this 

requirement to indicate that an 

inspector may make a personal 

inspection, rather than that an inspector 

will make a personal inspection. The 

commenter stated that a minor technical 

reason for recertification should not 

obligate APHIS to perform a personal 

inspection of the facility. 

The requirements in proposed 

paragraph (l) apply only to the initial 

certification of a facility, not to 

recertification. We have added 

references to initial certification to 

paragraph (l) to make this more clear. 

We are also changing paragraph (n) of 

proposed § 305.9, which informs the 

reader that the Department is not 

responsible for damage to treated 

articles and is taken from current 

§§ 305.31(n), 305.32(i), and 305.34(e). 

This paragraph refers to ‘‘listed plant 

pests,’’ which we are updating to refer 

to ‘‘plant pests listed in the PPQ 

Treatment Manual.’’ It also refers to 

fruits and vegetables being authorized 

for treatment; however, since articles 

other than fruits and vegetables are 

authorized for treatment, ‘‘articles’’ is a 

more appropriate term, and we are 

changing paragraph (n) accordingly. 

Miscellaneous Changes 

One commenter pointed out two 

typographical errors in the proposed 

rule: 

∑ In proposed § 305.6(b), the text ‘‘and 

located in the area north of 39° 

longitude and east of 104° latitude’’ 

should read ‘‘and located in the area 

north of 39° latitude and east of 104° 

longitude’’. 

∑ The section for quick freeze 

treatments was listed in the regulatory 

text of the proposed rule as being 

§ 305.8. The commenter pointed out that 

the section number should be § 305.7. 

We have corrected both of these errors 

in the final rule. 

We are making two other 

miscellaneous changes to the proposed 

rule. We proposed to remove the 

chemical treatment schedules in the 

appendix to the subpart for imported 

fire ant (§§ 301.81 through 301.81-10), 

retaining only the systems approach for 

ensuring nursery freedom from 

imported fire ant in a new § 301.81-11. 

This systems approach refers to 

treatment at 180-day intervals. However, 

as treatments for the imported fire ant 

are added or changed, different intervals 

may be required for treatment. To add 

flexibility to the systems approach, we 

are changing the references to 180-day 

intervals in proposed § 301.81–11 to 

refer instead to ‘‘the specified number of 

days’’ and ‘‘the specified interval.’’ 

Proposed § 305.6(c) set out the 

requirements for cold treatment 

enclosures that have been found in 

§ 305.15(c). Proposed paragraph (c)(2) 

indicated that such enclosures must 

maintain fruit pulp temperatures 

according to treatment schedules with 

no more than a 0.39 °C (0.7 °F) variation 

in temperature. This is related to a 

requirement for performing cold 

treatment that we proposed to include 

in § 305.6(d)(9), which requires fruit 

pulp temperatures to be maintained at 

mstockstill on DSKH9S0YB1PROD with RULES2

Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 4237 

4 2002 Economic Census. Department of 

Commerce. U.S. Bureau of the Census. North 

American Industry Classification System (NAICS) 

Categories. 424480: Fresh fruit & Vegetable 

merchant wholesalers; 424510: Grain & field bean 

merchant wholesalers; 424930: Flower, nursery 

stock, and florists’ supplies merchant wholesalers. 

5 2002 Census of Agriculture. U.S. Department of 

Agriculture. National Agricultural Statistics 

Service. NAICS Categories. 1111: Oilseed & Grain 

farming; 1112: Vegetable and melon farming; 1113: 

Fruit and tree nut farming; 1114: Greenhouse, 

nursery & Floriculture production; and 1119: Other 

Crop farming. 

the temperature specified in the 

treatment schedule with no more than a 

0.39 °C (0.7 °F) variation in temperature 

between two consecutive hourly 

readings. To make these requirements 

consistent and strengthen the 

connection between them, we are 

changing paragraph (c)(2) in this final 

rule to indicate that the cold treatment 

enclosure must maintain fruit pulp 

temperatures with no more than the 

specified variation between two 

consecutive hourly readings as well. 

Therefore, for the reasons given in the 

proposed rule and in this document, we 

are adopting the proposed rule as a final 

rule, with the changes discussed in this 

document. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This final rule has been determined to 

be not significant for the purposes of 

Executive Order 12866 and, therefore, 

has not been reviewed by the Office of 

Management and Budget. 

In accordance with the Regulatory 

Flexibility Act, we have analyzed the 

potential economic effects of this action 

on small entities. 

APHIS is amending 7 CFR parts 301, 

305, 318, and 319 to streamline the 

process for adding, revising, and 

removing treatment schedules and for 

authorizing the use of existing 

treatments for additional commodities. 

As required by the Regulatory 

Flexibility Act, we have evaluated the 

potential economic effects of this action 

on small businesses, small 

organizations, and small governmental 

jurisdictions 

The regulations in 7 CFR chapter III 

are intended, among other things, to 

prevent the introduction or 

dissemination of plant pests and 

noxious weeds into or within the United 

States. Under the regulations, certain 

plants, fruits, vegetables, and other 

articles must be treated before they may 

be moved into the United States or 

interstate. The phytosanitary treatments 

regulations contained in part 305 set out 

standards and schedules for treatments 

required in parts 301, 318, and 319 for 

fruits, vegetables, and other articles. 

APHIS is amending the phytosanitary 

treatment regulations in 7 CFR part 305 

by removing the lists of approved 

treatments and treatment schedules 

from the regulations, while retaining the 

general requirements for performing 

treatments and certifying or approving 

treatment facilities. We are removing 

treatment schedules from other places 

where they are currently found in 7 CFR 

chapter III as well. Approved treatment 

schedules will instead be found in the 

PPQ Treatment Manual, which is 

available on the Internet. We are also 

establishing a new process to provide 

the public with notice and the 

opportunity to comment on changes to 

treatment schedules. Finally, we are 

harmonizing and combining the 

requirements for performing irradiation 

treatment for imported articles, articles 

moved interstate from Hawaii and U.S. 

territories, and articles moved interstate 

from an area quarantined for fruit flies. 

These changes will simplify and 

expedite our processes for adding, 

changing, and removing treatment 

schedules while continuing to provide 

for public participation in the process. 

These changes will also simplify our 

presentation of treatments to the public 

by consolidating all treatments into one 

document and eliminating redundant 

text from the regulations. 

Eliminating the need for specific prior 

rulemaking for approving new 

treatments or treatment schedules or for 

revising existing ones under the noticebased process could result in 

considerable time savings. The 

rulemaking process is an inherently 

longer process than a notice-based 

process. Additionally, establishing a 

notice-based process for approving new 

treatments or treatment schedules will 

facilitate use of the already-established 

notice-based process for authorizing the 

importation of fruits and vegetables set 

out in § 319.56-4. Under § 319.56-4, 

APHIS can authorize the importation of 

fruits and vegetables via a notice-based 

process if APHIS makes the 

determination that the application of 

one or more designated phytosanitary 

measures is sufficient to mitigate the 

risk that plant pests or noxious weeds 

could be introduced into or 

disseminated within the United States 

via the imported fruits or vegetables. 

Currently, however, if one of the 

prescribed designated measures is a 

treatment that requires an amendment 

to part 305, rulemaking is still required 

to amend the lists of approved 

treatments or treatment schedules. 

Establishing a notice-based process to 

amend the lists of approved treatments 

or treatment schedules will streamline 

this process. 

Consumers benefit from the 

opportunity to consume commodities 

from a variety of sources, foreign as well 

as domestic. Consumer expenditures for 

fruit and vegetables are growing faster 

than for any food group other than 

meats. In many cases, fruit and 

vegetable imports can occur only after 

those commodities have been treated to 

prevent the introduction or movement 

of plant pests. This final rule will allow 

treatments to be put in use more quickly 

when treatment changes are necessary 

and when existing treatments are 

applied to new commodities; treated 

products would become available to 

meet consumer demand sooner than at 

present. Treated imports supplement 

domestic supplies, especially of fresh 

products during the winter. Treatments 

also allow for movement of domestically 

produced products to markets around 

the country that otherwise would not 

occur. This movement results in 

increased choices for consumers. Even 

where new imports compete directly 

with domestic production, consumers 

benefit when increased competition 

results in lower prices. 

Those entities most likely to be 

affected by the rule are domestic 

importers and producers of plants and 

plant products. The Small Business 

Administration (SBA) has established 

guidelines for determining which 

establishments are to be considered 

small. Import/export merchants, agents, 

and brokers are identified within the 

broader wholesaling trade sector. A firm 

primarily engaged in wholesaling is 

considered small if it employs not more 

than 100 persons. In 2002, more than 96 

percent of fresh fruit and vegetable 

merchant wholesalers, more than 99 

percent of grain and field bean merchant 

wholesalers, and more than 98 percent 

of flower and nursery stock wholesalers 

were considered small by SBA 

standards.4 All types of farms are 

considered small if they have annual 

receipts of $0.75 million or less. In 

2002, more than 99 percent of oilseed 

and grain farms, more than 99 percent 

of vegetable and melon farms, more than 

99 percent of fruit and tree nut farms, 

more than 99 percent of greenhouse, 

nursery, and floriculture producers, and 

more than 99 percent of other crop 

farms were considered small by SBA 

standards.5

Treatments are applicable to a wide 

variety of products including fruits, 

vegetables, live plants, bulbs, seeds, 

grains, logs, lumber, and other plants 

and plant products in a wide variety of 

circumstances. Vast quantities of treated 

products move into and through the 

United States annually. The United 

States is among the top producers and 

mstockstill on DSKH9S0YB1PROD with RULES2

4238 Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 

consumers of plants and plant products. 

U.S. per-capita use of fruit and tree nuts 

totals nearly 300 pounds each year, 

ranking third in per-capita consumption 

of major food groups, next to dairy and 

vegetables. Oranges, apples, grapes, and 

bananas are the most popular fruit while 

almonds, pecans, and walnuts are the 

most preferred tree nuts. Annual per 

capita use of all vegetables and melons 

averaged 445 pounds during the first 5 

years of the 2000s. 

TABLE 1.—U.S. PRODUCTION VALUE OF SELECTED CROPS, 2004-2006 ($ MILLION) 

Item 2004 2005 2006 

Field and miscellaneous crops: 

Cotton, tobacco, sugar 8,674 8,702 8,648 

Dry beans, peas, lentils 596 650 637 

Grains, hay 47,367 45,225 57,209 

Oilseeds 20,115 19,681 22,412 

Potatoes, misc. 4,054 4,472 4,731 

Fruit and nuts: 

Apples, pears 1,696 1,969 2,567 

Berries 2,082 2,300 2,668 

Citrus 2,485 2,303 2,738 

Grapes 3,010 3,494 3,304 

Nuts, other noncitrus 4,047 4,784 4,132 

Stone fruit 1,243 1,462 1,563 

Fresh vegetables: 

Brassica 1,111 1,118 1,225 

Lettuce, spinach 2,062 2,108 2,635 

Melons 728 873 877 

Onions, peppers 1,300 1,501 1,674 

Tomatoes 2,445 2,609 2,670 

Other vegetables 1,430 1,599 1,619 

In 2006, U.S. production of field and 

miscellaneous crops was valued at more 

than $93 billion, with grains, hay, and 

oilseeds accounting for the majority of 

this value. Fruit and tree nuts 

production was valued at about $17 

billion. More than 63 percent of this 

production was in grapes, apples, 

almonds, oranges, and strawberries. 

Commercial vegetable production for 

the fresh market was valued at almost 

$11 billion, with tomatoes, lettuce, 

onions, broccoli, and sweet corn 

accounting for about 60 percent of this 

value. 

Imports have become increasingly 

important for domestic consumption. 

Imports of plants and plant products 

have expanded rapidly over the past 

two decades, and include many new 

and newly traded commodities. In 2006, 

the United States imported 

approximately $5.8 billion in fresh 

fruits and tree nuts, about $2.5 billion 

in fresh vegetables, and about $1.5 

billion in live plants and other plant 

products. Logs, lumber, and other 

timber product imports were valued at 

nearly $12 billion in 2006. 

TABLE 2.—U.S. IMPORTS OF PLANTS AND PLANT PRODUCTS, 2004-2006 ($ MILLION) 

Item 2004 2005 2006 

Live plants, bulbs, etc.: 

Bulbs, tubers 208 208 208 

Cut flowers, dried 706 709 768 

Foliage 102 114 123 

Other live plants 362 352 358 

mstockstill on DSKH9S0YB1PROD with RULES2

Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 4239 

TABLE 2.—U.S. IMPORTS OF PLANTS AND PLANT PRODUCTS, 2004-2006 ($ MILLION)—Continued 

Item 2004 2005 2006 

Fruit and nuts: 

Bananas 1,102 1,134 1,201 

Citrus, fresh 307 356 407 

Coconuts, Brazil nuts 640 660 602 

Dates, figs, pineapples 570 812 936 

Grapes 743 980 953 

Other fruits and nuts 1,127 1,174 1,297 

Fresh vegetables: 

Cucumbers, gherkins 349 319 421 

Melons 369 393 431 

Onions, shallots 254 308 282 

Tomatoes 1,054 1,075 1,234 

Other vegetables 417 508 543 

Logs, lumber, and other timber products: 

Wood in the rough 246 348 347 

Wood, sawn or chipped 8,799 8,989 8,333 

Other wood 2,894 3,074 3,235 

While treatments are applicable to a 

wide variety of plants and plant 

products in a wide variety of 

circumstances, the changes in this final 

rule will not alter current treatment 

requirements, the manner in which new 

treatments are evaluated, or when and 

how treatments are ultimately used 

other than in emergency situations. The 

final rule will allow treatment changes 

to be implemented more rapidly and 

therefore facilitate the movement of 

treated products to meet consumer 

demand. These changes are not 

expected to significantly impact the 

total supply of plants and plant 

products in the United States. 

Therefore, we expect at most small 

effects on U.S. marketers and 

consumers. 

Under these circumstances, the 

Administrator of the Animal and Plant 

Health Inspection Service has 

determined that this action will not 

have a significant economic impact on 

a substantial number of small entities. 

Executive Order 12372 

This program/activity is listed in the 

Catalog of Federal Domestic Assistance 

under No. 10.025 and is subject to 

Executive Order 12372, which requires 

intergovernmental consultation with 

State and local officials. (See 7 CFR part 

3015, subpart V.) 

Executive Order 12988 

This final rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. This rule: (1) Has no 

retroactive effect and (2) does not 

require administrative proceedings 

before parties may file suit in court 

challenging this rule. 

Paperwork Reduction Act 

This final rule contains no new 

information collection or recordkeeping 

requirements under the Paperwork 

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

seq.). 

List of Subjects 

7 CFR Part 301 

Agricultural commodities, Plant 

diseases and pests, Quarantine, 

Reporting and recordkeeping 

requirements, Transportation. 

7 CFR Part 305 

Agricultural commodities, Chemical 

treatment, Cold treatment, Heat 

treatment, Imports, Irradiation, 

Phytosanitary treatment, Plant diseases 

and pests, Quarantine, Quick freeze, 

Reporting and recordkeeping 

requirements, Transportation. 

7 CFR Part 318 

Cotton, Cottonseeds, Fruits, Guam, 

Hawaii, Plant diseases and pests, Puerto 

Rico, Quarantine, Transportation, 

Vegetables, Virgin Islands. 

7 CFR Part 319 

Coffee, Cotton, Fruits, Imports, Logs, 

Nursery stock, Plant diseases and pests, 

Quarantine, Reporting and 

recordkeeping requirements, Rice, 

Vegetables. 

7 CFR Part 330 

Customs duties and inspection, 

Imports, Plant diseases and pests, 

Quarantine, Reporting and 

recordkeeping requirements, 

Transportation. 

7 CFR Part 352 

Customs duties and inspection, 

Imports, Plant diseases and pests, 

Quarantine, Reporting and 

recordkeeping requirements, 

Transportation. 

■ Accordingly, we are amending 7 CFR 

chapter III as follows: 

mstockstill on DSKH9S0YB1PROD with RULES2

4240 Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 

PART 301—DOMESTIC QUARANTINE 

NOTICES 

■ 1. The authority citation for part 301 

continues to read as follows: 

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

7786; 7 CFR 2.22, 2.80, and 371.3. 

Section 301.75-15 issued under Sec. 204, 

Title II, Public Law 106-113, 113 Stat. 1501A293; sections 301.75-15 and 301.75-16 issued 

under Sec. 203, Title II, Public Law 106-224, 

114 Stat. 400 (7 U.S.C. 1421 note). 

■ 2. In § 301.32-10, in the introductory 

text, the first sentence is revised to read 

as follows: 

§ 301.32-10 Treatments. 

Regulated articles may be treated in 

accordance with part 305 of this chapter 

to neutralize fruit flies. * * * 

* * * * * 

§ 301.50-5 [Amended] 

■ 3. In § 301.50-5, paragraph (a)(1)(i) is 

amended by removing the citation 

‘‘§ 301.50-10(d)’’ and adding the citation 

‘‘§ 301.50-10(b)’’ in its place. 

■ 4. Section 301.50-10 is amended as 

follows: 

■ a. By revising paragraph (a) to read as 

set forth below. 

■ b. By removing paragraphs (b) and (c). 

■ c. By redesignating paragraph (d) as 

paragraph (b). 

§ 301.50-10 Treatments and management 

method. 

(a) Regulated articles may be treated 

in accordance with part 305 of this 

chapter to neutralize the pine shoot 

beetle. 

* * * * * 

§ 301.75-4 [Amended] 

■ 5. In § 301.75-4, paragraph (d)(2)(i)(C) 

is amended by removing the words 

‘‘§ 301-11(d) of this subpart’’ and adding 

the words ‘‘part 305 of this chapter’’ in 

their place; paragraphs (d)(2)(ii)(C), 

(d)(2)(ii)(D), (d)(2)(ii)(E), and (d)(4) are 

amended by removing the words 

‘‘§ 301.75-11(d) of this subpart’’ and 

adding the words ‘‘part 305 of this 

chapter’’ in their place; and paragraph 

(d)(4) is amended by removing the 

words ‘‘§ 301.75-11(c) of this subpart’’ 

and adding the words ‘‘part 305 of this 

chapter’’ in their place. 

§ 301.75-6 [Amended] 

■ 6. In § 301.75-6, paragraphs (b)(5) and 

(b)(6) are amended by removing the 

words ‘‘§ 301.75-11(d)’’ and adding the 

words ‘‘part 305 of this chapter’’ in their 

place; and paragraph (b)(5) is amended 

by removing the words ‘‘§ 301.75-11(c)’’ 

and adding the words ‘‘part 305 of this 

chapter’’ in their place. 

§ 301.75-7 [Amended] 

■ 7. In § 301.75-7, paragraph (a)(2) is 

amended by removing the citation 

‘‘§ 301.75-11(a)’’ and adding the words 

‘‘part 305 of this chapter’’ in its place. 

§ 301.75-8 [Amended] 

■ 8. In § 301.75-8, paragraph (b) is 

amended by removing the words 

‘‘§ 301.75-11(b) of this subpart’’ and 

adding the words ‘‘part 305 of this 

chapter’’ in their place. 

§ 301.75-11 [Removed and Reserved] 

■ 9. Section 301.75-11 is removed and 

reserved. 

§ 301.81-4 [Amended] 

■ 10. Section 301.81-4 is amended as 

follows: 

■ a. In paragraph (a)(2)(iii), by removing 

the words ‘‘the methods and procedures 

prescribed in the Appendix to this 

subpart (‘‘III. Regulatory Procedures’’)’’ 

and adding the words ‘‘part 305 of this 

chapter’’ in their place. 

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

words ‘‘the methods and procedures 

prescribed in the Appendix to this 

subpart (‘‘III. Regulatory Procedures’’), or 

in accordance with the methods and 

procedures prescribed in’’. 

■ 11. Section 301.81-5 is amended as 

follows: 

■ a. In paragraph (a)(3)(ii), at the end of 

the paragraph, by removing the word 

‘‘or’’. 

■ b. In paragraph (a)(3)(iii), by removing 

the words ‘‘methods and procedures 

prescribed in the Appendix to this 

subpart (‘‘III. Regulatory Procedures’’).’’ 

and adding the words ‘‘part 305 of this 

chapter; or’’ in their place. 

■ c. By adding a new paragraph 

(a)(3)(iv) to read as set forth below. 

§ 301.81-5 Issuance of a certificate or 

limited permit. 

(a) * * * 

(3) * * * 

(iv) If the article is containerized 

nursery stock, it has been produced in 

accordance with § 301.81-11. 

* * * * * 

§ 301.81-6 [Amended] 

■ 12. Section 301.81-6 is amended by 

removing the words ‘‘the ‘‘Imported Fire 

Ant Program Manual,’’ as set forth in the 

appendix to this subpart’’ and adding 

the words ‘‘part 305 of this chapter’’ in 

their place. 

■ 13. A new § 301.81-11 is added to read 

as follows: 

§ 301.81-11 Imported fire ant detection, 

control, exclusion, and enforcement 

program for nurseries producing 

containerized plants. 

This detection, control, exclusion, 

and enforcement program is designed to 

keep nurseries free of the imported fire 

ant and provides a basis to certify 

containerized nursery stock for 

interstate movement. Participating 

regulated establishments must be 

operating under a compliance 

agreement in accordance with § 301.81- 

6. Such compliance agreements shall 

state the specific requirements that a 

shipper agrees to follow to move plants 

in accordance with the requirements of 

the program. Certificates and a nursery 

identification number may be issued to 

the nursery for use on shipments of 

regulated articles. 

(a) Detection. (1) Nursery owners are 

required to visually survey their entire 

premises twice monthly for the presence 

of imported fire ants. 

(2) Nurseries participating in this 

program will be inspected by Federal or 

State inspectors at least twice per year. 

More frequent inspections may be 

necessary depending upon imported fire 

ant infestation levels immediately 

surrounding the nursery, the 

thoroughness of nursery management in 

maintaining imported-fire-ant-free 

premises, and the number of previous 

detections of imported fire ants in or 

near containerized plants. Inspections 

by Federal and State inspectors should 

be more frequent just before and during 

the peak shipping season. Any nurseries 

determined during nursery inspections 

to have imported fire ant colonies must 

be immediately treated to the extent 

necessary to eliminate the colonies. 

(b) Control. Nursery plants that are 

shipped under this program must 

originate in a nursery that meets the 

requirements of this section. Nursery 

owners must implement a treatment 

program with registered bait and contact 

insecticides. The premises, including 

growing and holding areas, must be 

maintained free of the imported fire ant. 

As part of this treatment program, all 

exposed soil surfaces (including sod and 

mulched areas) on property where 

plants are grown, potted, stored, 

handled, loaded, unloaded, or sold must 

be treated in accordance with part 305 

of this chapter at least once every 6 

months. The first application must be 

performed early in the spring. Followup 

treatments with a contact insecticide in 

accordance with part 305 of this chapter 

must be applied to eliminate all 

remaining colonies. 

(c) Exclusion. (1) For plants grown on 

the premises, treatment of soil or potting 

media in accordance with part 305 of 

mstockstill on DSKH9S0YB1PROD with RULES2

Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 4241 

this chapter prior to planting is 

required. 

(2) For plants received from outside 

sources, to prevent the spread into a 

nursery free of the imported fire ant by 

newly introduced, infested nursery 

plants, all plants must be: 

(i) Obtained from nurseries that 

comply with the requirements of this 

section and that operate under a 

compliance agreement in accordance 

with § 301.81-6; or 

(ii) Treated upon delivery in 

accordance with part 305 of this 

chapter, and within the specified 

number of days be either: 

(A) Repotted in treated potting soil 

media; 

(B) Retreated in accordance with part 

305 of this chapter at the specified 

interval; or 

(C) Shipped. 

(d) Enforcement. (1) The nursery 

owner must maintain records of the 

nursery’s surveys and treatments for the 

imported fire ant. These records must be 

made available to State and Federal 

inspectors upon request. 

(2) If imported fire ants are detected 

in nursery stock during an inspection by 

a Federal or State inspector, issuance of 

certificates for movement will be 

suspended until necessary treatments 

are applied and the plants and nursery 

premises are determined to be free of 

the imported fire ant. A Federal or State 

inspector may declare a nursery to be 

free of the imported fire ant upon 

reinspection of the premises. This 

inspection must be conducted no sooner 

than 30 days after treatment. During this 

period, certification may be based upon 

treatments for plants in accordance with 

part 305 of this chapter. 

(3) Upon notification by the 

department of agriculture in any State of 

destination that a confirmed imported 

fire ant infestation was found on a 

shipment from a nursery considered free 

of the imported fire ant, the department 

of agriculture in the State of origin must 

cease its certification of shipments from 

that nursery. An investigation by 

Federal or State inspectors will 

commence immediately to determine 

the probable source of the problem and 

to ensure that the problem is resolved. 

If the problem is an infestation, issuance 

of certification for movement on the 

basis of imported-fire-ant-free premises 

will be suspended until treatment and 

elimination of the infestation is 

completed. Reinstatement into the 

program will be granted upon 

determination that the nursery premises 

are free of the imported fire ant, and that 

all other provisions of this subpart are 

being followed. 

(4) In cases where the issuance of 

certificates is suspended through oral 

notification, the suspension and the 

reasons for the suspension will be 

confirmed in writing within 20 days of 

the oral notification of the suspension. 

Any person whose issuance of 

certificates has been suspended may 

appeal the decision, in writing, within 

10 days after receiving the written 

suspension notice. The appeal must 

state all of the facts and reasons that the 

person wants the Administrator to 

consider in deciding the appeal. A 

hearing may be held to resolve any 

conflict as to any material fact. Rules of 

practice for the hearing will be adopted 

by the Administrator. As soon as 

practicable, the Administrator will grant 

or deny the appeal, in writing, stating 

the reasons for the decision. 

Appendix to Subpart—Imported Fire 

Ant [Removed] 

■ 14. The Appendix to Subpart— 

Imported Fire Ant is removed. 

§ 301.87-5 [Amended] 

■ 15. In § 301.87-5, paragraph (a)(1)(i) is 

amended by removing the words 

‘‘§ 301.87-10 of this subpart’’ and adding 

the words ‘‘part 305 of this chapter’’ in 

their place. 

§ 301.87-10 [Removed and Reserved] 

■ 16. Section 301.87-10 is removed and 

reserved. 

§ 301.89-5 [Amended] 

■ 17. In § 301.89-5, paragraphs (a)(2)(iii) 

and (b) are amended by removing the 

words ‘‘the methods and procedures 

prescribed in § 301.89-13’’ and adding 

the words ‘‘part 305 of this chapter’’ in 

their place. 

§ 301.89-6 [Amended] 

■ 18. In § 301.89-6, paragraph (a)(3)(iii) 

is amended by removing the words 

‘‘methods and procedures prescribed in 

§ 301.89-13’’ and adding the words ‘‘part 

305 of this chapter’’ in their place. 

§ 301.89-7 [Amended] 

■ 19. Section 301.89-7 is amended by 

removing the citation ‘‘§ 301.89-13’’ and 

adding the words ‘‘part 305 of this 

chapter’’ in its place. 

§ 301.89-12 [Amended] 

■ 20. In § 301.89-12, paragraphs (a), (b), 

and (c) are amended by removing the 

citation ‘‘§ 301.89-13’’ and adding the 

words ‘‘part 305 of this chapter’’ in its 

place. 

§ 301.89-13 [Removed and Reserved] 

■ 21. Section 301.89-13 is removed and 

reserved. 

§ 301.92-5 [Amended] 

■ 22. In § 301.92-5, paragraph (a)(1)(i) is 

amended by removing the words 

‘‘§ 301.92-10 or’’. 

§ 301.92-10 [Removed and Reserved] 

■ 23. Section 301.92-10 is removed and 

reserved. 

■ 24. Part 305 is revised to read as 

follows: 

PART 305—PHYTOSANITARY 

TREATMENTS 

Sec. 

305.1 Definitions. 

305.2 Approved treatments. 

305.3 Processes for adding, revising, or 

removing treatment schedules. 

305.4 Monitoring and certification of 

treatments. 

305.5 Chemical treatment requirements. 

305.6 Cold treatment requirements. 

305.7 Quick freeze treatment requirements. 

305.8 Heat treatment requirements. 

305.9 Irradiation treatment requirements. 

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. 

§ 305.1 Definitions. 

Administrator. The Administrator, 

Animal and Plant Health Inspection 

Service, United States Department of 

Agriculture, or any person delegated to 

act for the Administrator in matters 

affecting this part. 

APHIS. The Animal and Plant Health 

Inspection Service, United States 

Department of Agriculture. 

Cold treatment. Exposure of a 

commodity to a specified cold 

temperature that is sustained for a 

specific time period to kill targeted 

pests, especially fruit flies. 

Dose mapping. Measurement of 

absorbed dose within a process load 

using dosimeters placed at specified 

locations to produce a one-, two-, or 

three-dimensional distribution of 

absorbed dose, thus rendering a map of 

absorbed-dose values. 

Dosimeter. A device that, when 

irradiated, exhibits a quantifiable 

change in some property of the device 

that can be related to absorbed dose in 

a given material using appropriate 

analytical instrumentation and 

techniques. 

Dosimetry system. A system used for 

determining absorbed dose, consisting 

of dosimeters, measurement instruments 

and their associated reference standards, 

and procedures for the system’s use. 

Fumigant. A gaseous chemical that 

easily diffuses and disperses in air and 

is toxic to the target organism. 

Fumigation. Releasing and dispersing 

a toxic chemical in the air so that it 

reaches the target organism in a gaseous 

state. 

mstockstill on DSKH9S0YB1PROD with RULES2

4242 Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 

Inspector. Any individual authorized 

by the Administrator of APHIS or the 

Commissioner of Customs and Border 

Protection, Department of Homeland 

Security, to enforce the regulations in 

this part. 

Irradiation. Treatment with any type 

of ionizing radiation. 

Methyl bromide. A colorless, odorless 

biocide used to fumigate a wide range 

of commodities. 

Neutralize. To prevent the 

establishment of a plant pest by killing 

it, sterilizing it, preventing its 

development from an immature stage, or 

preventing its emergence from its host. 

Plant Protection and Quarantine 

(PPQ). The Plant Protection and 

Quarantine program of APHIS. 

PPQ Treatment Manual. The 

document that contains the treatment 

schedules that are approved for use 

under this part. The Treatment Manual 

is available on the Internet at (http:// 

www.aphis.usda.gov/import_export/

plants/manuals/index.shtml) or by 

contacting the Animal and Plant Health 

Inspection Service, Plant Protection and 

Quarantine, Manuals Unit, 92 Thomas 

Johnson Drive, Suite 200, Frederick, MD 

21702. 

Quick freeze. A commercially 

acceptable method of quick freezing at 

subzero temperatures with subsequent 

storage and transportation at not higher 

than 20 °F. Methods that accomplish 

this are known as quick freezing, sharp 

freezing, cold pack, or frozen pack, but 

may be any equivalent commercially 

acceptable freezing method. 

Section 18 of Federal Insecticide, 

Fungicide, and Rodenticide Act 

(FIFRA). An emergency exemption 

granted by the U.S. Environmental 

Protection Agency to Federal or State 

agencies authorizing an unregistered use 

of a pesticide for a limited time. 

Vacuum fumigation. Fumigation 

performed in a gas-tight enclosure. Most 

air in the enclosure is removed and 

replaced with a small amount of 

fumigant. The reduction in pressure 

reduces the required duration of the 

treatment. 

§ 305.2 Approved treatments. 

(a) Certain commodities or articles 

require treatment, or are subject to 

treatment, prior to interstate movement 

within the United States or importation 

or entry into the United States. 

Treatment is required as indicated in 

parts 301, 318, and 319 of this chapter, 

on a permit, or by an inspector. 

(b) Approved treatment schedules are 

set out in the PPQ Treatment Manual. 

Treatments may only be administered in 

accordance with the treatment 

requirements of this part and in 

accordance with treatment schedules 

found in the PPQ Treatment Manual. 

(c) APHIS is not responsible for losses 

or damages incurred during treatment 

and recommends that a sample be 

treated first before deciding whether to 

treat the entire shipment. 

§ 305.3 Processes for adding, revising, or 

removing treatment schedules. 

(a) Normal process for adding, 

revising, or removing treatment 

schedules. Unless there is a need to 

immediately add, revise, or remove a 

treatment schedule, as provided in 

paragraph (b)(1) of this section, a 

treatment schedule may be added to the 

PPQ Treatment Manual, revised, or 

removed from the PPQ Treatment 

Manual as follows: 

(1) Notice of change to treatment 

schedule. APHIS will publish in the 

Federal Register a notice describing the 

reasons we have determined that it is 

necessary to add, revise, or remove a 

treatment schedule and, if necessary, 

making available the new or revised 

treatment schedule as it would be added 

to the PPQ Treatment Manual. In our 

notice, we will provide for a public 

comment period on the new or revised 

treatment schedule or on the removal of 

the treatment schedule from the PPQ 

Treatment Manual. 

(2) Response to comments. (i) APHIS 

will issue a notice after the close of the 

public comment period indicating that 

the treatment schedule specified in the 

initial notice will be added to the PPQ 

Treatment Manual, revised as described 

in the notice, or removed from the PPQ 

Treatment Manual if: 

(A) No comments were received on 

the notice; 

(B) The comments on the notice 

supported our action; or 

(C) The comments on the notice were 

evaluated but did not change our 

determination that it is necessary to 

add, revise, or remove the treatment 

schedule, as described in the notice. 

(ii) If the notice issued after the close 

of the public comment period indicates 

that a change will be made to the PPQ 

Treatment Manual, APHIS will make 

available a new version of the PPQ 

Treatment Manual that reflects the 

addition, revision, or removal of the 

particular treatment schedule. 

(iii) If comments present information 

that causes us to determine that the 

change described in the notice is not 

appropriate, APHIS will issue a notice 

informing the public of this 

determination after the close of the 

comment period. 

(b) Process for immediately adding, 

revising, or removing treatment 

schedules. Treatment schedules may be 

immediately added to the PPQ 

Treatment Manual, revised, or removed 

from the PPQ Treatment Manual under 

the circumstances described in 

paragraph (b)(1) of this section and in 

accordance with the process described 

in paragraphs (b)(2) and (b)(3) of this 

section. 

(1) Circumstances in which the 

immediate process may be used. 

Treatment schedules may be 

immediately added to the PPQ 

Treatment Manual, revised, or removed 

from the PPQ Treatment Manual if any 

of the following circumstances apply: 

(i) PPQ has determined that an 

approved treatment schedule is 

ineffective at neutralizing the targeted 

plant pest(s); 

(ii) PPQ has determined that, in order 

to neutralize the targeted plant pest(s), 

the treatment schedule must be 

administered using a different process 

than was previously used; 

(iii) PPQ has determined that a new 

treatment schedule is effective, based on 

efficacy data, and that ongoing trade in 

an article or articles may be adversely 

impacted unless the new treatment 

schedule is approved for use; or 

(iv) The use of a treatment schedule 

is no longer authorized by the U.S. 

Environmental Protection Agency or by 

any other Federal entity. 

(2) Process for immediate change to 

treatment schedules. If PPQ determines 

that one or more of the circumstances in 

paragraph (b)(1) of this section applies 

and that it is necessary to take 

immediate action, APHIS will publish 

in the Federal Register a notice 

describing the reasons we have 

determined that it is necessary to 

immediately add, revise, or remove a 

treatment schedule and, if necessary, 

making available the new or revised 

treatment schedule as it has been added 

to the PPQ Treatment Manual. 

Treatment schedules that have been 

added to the PPQ Treatment Manual or 

revised under this process will be 

identified in the PPQ Treatment Manual 

as having been added or revised through 

the immediate process described in this 

paragraph (b). The PPQ Treatment 

Manual will indicate that these 

treatment schedules are subject to 

change or removal based on public 

comment. In our notice, we will provide 

for a public comment period on the new 

or revised treatment schedule or on the 

removal of the treatment schedule from 

the PPQ Treatment Manual. 

(3) Response to comments. (i) APHIS 

will issue a notice after the close of the 

public comment period affirming the 

action described in the initial notice if: 

(A) No comments were received on 

the notice; 

mstockstill on DSKH9S0YB1PROD with RULES2

Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 4243 

(B) The comments on the notice 

supported our action; or 

(C) The comments on the notice were 

evaluated but did not change our 

determination that it was necessary to 

add, revise, or remove the treatment 

schedule, as described in the notice. 

(ii) If the notice issued after the close 

of the public comment period indicates 

that the initial change to the PPQ 

Treatment Manual is affirmed, APHIS 

will make available a new version of the 

PPQ Treatment Manual that will reflect 

the addition, revision, or removal of the 

particular treatment schedule in the 

main body of the PPQ Treatment 

Manual. 

(iii) If comments present information 

that causes us to determine that it is 

necessary to change a treatment 

schedule added to the PPQ Treatment 

Manual under this process or to further 

revise a treatment schedule that was 

revised under this process, APHIS will 

publish a notice in the Federal Register 

informing the public of this 

determination after the close of the 

comment period and will revise the 

treatment schedule accordingly. 

(iv) If comments present information 

that causes us to determine that the 

change described in the initial notice 

was not appropriate, APHIS will 

publish a notice in the Federal Register 

informing the public of this 

determination after the close of the 

comment period and will, if necessary, 

remove the new or revised treatment 

schedule from the separate section of 

the PPQ Treatment Manual. 

§ 305.4 Monitoring and certification of 

treatments. 

(a) All treatments approved under 

part 305 are subject to monitoring and 

verification by APHIS. 

(b) Any treatment performed outside 

the United States must be monitored 

and certified by an inspector or an 

official authorized by APHIS. During the 

entire interval between treatment and 

export, the consignment must be stored 

and handled in a manner that prevents 

any infestation by pests and noxious 

weeds. 

§ 305.5 Chemical treatment requirements. 

(a) Certified facility. The fumigation 

treatment facility must be certified by 

APHIS. Facilities are required to be 

inspected and recertified annually, or as 

often as APHIS directs, depending upon 

treatments performed, commodities 

handled, and operations conducted at 

the facility. In order to be certified, a 

fumigation facility must: 

(1) Be capable of administering the 

required dosage range for the required 

duration and at the appropriate 

temperature, as specified in the 

treatment schedules in the PPQ 

Treatment Manual. 

(2) Be adequate to contain the 

fumigant and be constructed from 

material that is not reactive to the 

fumigant. 

(3) For vacuum fumigation facilities, 

be constructed to withstand required 

negative pressure. 

(b) Monitoring. Treatment must be 

monitored by an official authorized by 

APHIS to ensure proper administration 

of the treatment, including that the 

correct amount of gas reaches the target 

organism and that an adequate number 

and placement of blowers, fans, 

sampling tubes, or monitoring lines are 

used in the treatment enclosure. An 

official authorized by APHIS approves, 

adjusts, or rejects the treatment. 

(c) Treatment procedures. (1) To kill 

the pest, all chemical applications must 

be administered in accordance with an 

Environmental Protection Agency (EPA) 

approved pesticide label and the 

APHIS-approved treatment schedule 

prescribed in the PPQ Treatment 

Manual. If EPA cancels approval for the 

use of a pesticide on a commodity, then 

the treatment schedule prescribed in the 

PPQ Treatment Manual is no longer 

authorized for that commodity. If the 

commodity is not listed on the pesticide 

label and/or included in a Federal 

quarantine or crisis exemption in 

accordance with FIFRA section 18, then 

no chemical treatment is available. 

(2) Temperature/concentration 

readings must be taken for items known 

to be sorptive or whose sorptive 

properties are unknown when treatment 

is administered in chambers at normal 

atmospheric pressure. 

(3) Unless otherwise specified in the 

PPQ Treatment Manual, the volume of 

the commodity stacked inside the 

treatment enclosure must not exceed 2/ 

3 of the volume of the enclosure. 

Stacking must be approved by an 

official authorized by APHIS before 

treatment begins. All commodities 

undergoing treatment must be listed on 

the label or authorized under Section 18 

of FIFRA. 

(4) Recording and measuring 

equipment must be adequate to 

accurately monitor the gas 

concentration, to ensure the correct 

amount of gas reaches the pests, and to 

detect any leaks in the enclosure. At 

least three sampling tubes or monitoring 

lines must be used in the treatment 

enclosure. 

(5) An adequate number of blowers or 

fans must be used inside of the 

treatment enclosure to uniformly 

distribute gas throughout the enclosure. 

The circulation system must be able to 

recirculate the entire volume of gas in 

the enclosure in 3 minutes or less. 

(6) The exposure period begins after 

all gas has been introduced. 

(7) For vacuum fumigation: The 

vacuum pump must be able to reduce 

pressure in the treatment enclosure to 1- 

2 inches of mercury in 15 minutes or 

less. 

§ 305.6 Cold treatment requirements. 

(a) Certification of treatment facilities. 

All facilities or locations used for 

refrigerating fruits or vegetables in 

accordance with the cold treatment 

schedules in the PPQ Treatment Manual 

must be certified by APHIS. 

Recertification of the facility or carrier 

is required every 3 years, or as often as 

APHIS directs, depending on treatments 

performed, commodities handled, and 

operations conducted at the facility. In 

order to be certified, facilities and 

carriers must: 

(1) Be capable of keeping treated and 

untreated fruits, vegetables, or other 

articles separate so as to prevent 

reinfestation of articles and spread of 

pests; 

(2) Have equipment that is adequate 

to effectively perform cold treatment. 

(b) Places of treatment; ports of entry. 

Precooling and refrigeration may be 

performed prior to, or upon arrival of 

fruits and vegetables in the United 

States, provided treatments are 

performed in accordance with 

applicable requirements of this section. 

Fruits and vegetables that are not treated 

prior to arrival in the United States must 

be treated after arrival only in cold 

storage warehouses approved by the 

Administrator and located in the area 

north of 39° latitude and east of 104° 

longitude or at one of the following 

ports: The maritime ports of 

Wilmington, NC; Seattle, WA; Corpus 

Christi, TX; and Gulfport, MS; SeattleTacoma International Airport, Seattle, 

WA; and Hartsfield-Atlanta 

International Airport, Atlanta, GA. 

(c) Cold treatment enclosures. All 

enclosures, in which cold treatment is 

performed, including refrigerated 

containers, must: 

(1) Be capable of maintaining the 

treatment temperature specified in the 

PPQ Treatment Manual before the 

treatment begins and holding fruit at or 

below the treatment temperature during 

the treatment. 

(2) Maintain fruit pulp temperatures 

according to treatment schedules with 

no more than a 0.39 °C (0.7 °F) variation 

in temperature between two consecutive 

hourly readings. 

(3) Be structurally sound and 

adequate to maintain required 

temperatures. 

mstockstill on DSKH9S0YB1PROD with RULES2

4244 Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 

(d) Treatment procedures. (1) All 

material, labor, and equipment for cold 

treatment performed on a vessel must be 

provided by the vessel or vessel agent. 

An official authorized by APHIS 

monitors, manages, and advises in order 

to ensure that the treatment procedures 

are followed. 

(2) Refrigeration must be completed in 

the container, compartment, or room in 

which it is begun. 

(3) Fruit that may be cold treated must 

be safeguarded to prevent crosscontamination or mixing with other 

infested fruit. 

(4) Fruit intended for in-transit cold 

treatment must be precooled to the 

temperature at 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 temperature at 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 treatment 

temperature. 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 temperature at which it 

will be treated, as verified by an official 

authorized by APHIS, prior to beginning 

treatment. 

(5) Breaks, damage, etc., in the 

treatment enclosure that preclude 

maintaining correct temperatures must 

be repaired before the enclosure is used. 

An official authorized by APHIS must 

approve loading of compartment, 

number and placement of temperature 

probes or sensors, and initial fruit 

temperature readings before beginning 

the treatment. Hanging decks and hatch 

coamings within vessels may not be 

used as enclosures for in-transit cold 

treatment without prior written 

approval from APHIS. Double-stacking 

of pallets is not allowed. 

(6) Only the same type of fruit in the 

same type of package may be treated 

together in a container; no mixture of 

fruits in containers may be treated. A 

numbered seal must be placed on the 

doors of the loaded container and may 

be removed only at the port of 

destination by an official authorized by 

APHIS. 

(7) Temperature recording devices 

used during treatment must be 

password-protected and tamperproof. 

The devices must be able to record the 

date, time, and sensor number and 

automatic and continuous records of the 

temperature during all calibrations and 

during treatment. Recording devices 

must be capable of generating 

temperature charts for verification by an 

inspector. If records of calibrations or 

treatments are found to have been 

manipulated, the vessel or container in 

which the treatment is performed may 

be suspended from conducting cold 

treatments until proper equipment is 

installed and an official authorized by 

APHIS has recertified it. APHIS’ 

decision to recertify a vessel or 

container will take into account the 

severity of the infraction that led to 

suspension. 

(8) A minimum of four temperature 

probes or sensors is required for vessel 

holds used as treatment enclosures. A 

minimum of three temperature probes 

or sensors is required for other 

treatment enclosures. An official 

authorized by APHIS will have the 

option to require that additional 

temperature probes or sensors be used, 

depending on the size of the treatment 

enclosure. 

(9) Fruit pulp temperatures must be 

maintained at the temperature specified 

in the treatment schedule with no more 

than a 0.39 °C (0.7 °F) variation in 

temperature between two consecutive 

hourly readings. Failure to comply with 

this requirement will result in 

invalidation of the treatment unless an 

official authorized by APHIS can verify 

that the pulp temperature was 

maintained at or below the treatment 

temperature for the duration of the 

treatment. 

(10) The time required to complete 

the treatment begins when all 

temperature probes reach the prescribed 

cold treatment schedule temperature. 

Refrigeration continues until the vessel 

arrives at the port of destination and the 

fruit is released for unloading by an 

inspector even though this may prolong 

the period required for the cold 

treatment. 

(11) Temperatures must be recorded 

at intervals no longer than 1 hour apart. 

Gaps of longer than 1 hour will 

invalidate the treatment or indicate 

treatment failure unless an official 

authorized by APHIS can verify that the 

pulp temperature was maintained at or 

below the treatment temperature for the 

duration of the treatment. 

(12) Cold treatment is not completed 

until so declared by an official 

authorized by APHIS or the certifying 

official of the foreign country; 

consignments of treated commodities 

may not be discharged until APHIS 

clearance has been fully completed, 

including review and approval of 

treatment record charts. 

(13) Cold treatment of fruits in break 

bulk vessels or containers must be 

initiated by an official authorized by 

APHIS if there is not a treatment 

technician who has been trained to 

initiate cold treatments for either break 

bulk vessels or containers. 

(14) An official authorized by APHIS 

may perform audits to ensure that the 

treatment procedures comply with the 

regulations in this section and that the 

treatment is administered in accordance 

with the treatment schedules in the PPQ 

Treatment Manual. The official 

authorized by APHIS must be given the 

appropriate materials and access to the 

facility, container, or vessel necessary to 

perform the audits. 

(15) An inspector will sample and cut 

fruit from each consignment cold 

treated for Mediterranean fruit fly 

(Medfly) to monitor treatment 

effectiveness. If a single live Medfly in 

any stage of development is found, the 

consignment will be held until an 

investigation is completed and 

appropriate remedial actions have been 

implemented. If APHIS determines at 

any time that the safeguards contained 

in this section do not appear to be 

effective against the Medfly, APHIS may 

suspend the importation of fruits from 

the originating country and conduct an 

investigation into the cause of the 

deficiency. 

(16) The cold treatments required for 

the entry of fruit are considered 

necessary for the elimination of plant 

pests, and no liability shall attach to the 

U.S. Department of Agriculture or to any 

officer or representative of that 

Department in the event injury results to 

fruit offered for entry in accordance 

with these instructions. In prescribing 

cold treatments of certain fruits, it 

should be emphasized that inexactness 

and carelessness in applying the 

treatments may result in injury to the 

fruit or its rejection for entry. 

(e) Monitoring. Treatment must be 

monitored by an inspector to ensure 

proper administration of the treatment. 

An inspector must also approve the 

recording devices and sensors used to 

monitor temperatures and conduct an 

operational check of the equipment 

before each use and ensure sensors are 

calibrated. An inspector may approve, 

adjust, or reject the treatment. 

(f) Compliance agreements. Facilities 

located in the United States must 

operate under a compliance agreement 

mstockstill on DSKH9S0YB1PROD with RULES2

Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 4245 

with APHIS. The compliance agreement 

must be signed by a representative of 

the cold treatment facility and APHIS. 

The compliance agreement must contain 

requirements for equipment, 

temperature, circulation, and other 

operational requirements for performing 

cold treatment to ensure that treatments 

are administered properly. Compliance 

agreements must allow officials of 

APHIS to inspect the facility to monitor 

compliance with the regulations. 

(g) Workplans. Facilities located 

outside the United States may operate in 

accordance with a bilateral workplan. 

The workplan, if and when required, 

must be signed by a representative of 

the cold treatment facility, the national 

plant protection organization (NPPO) of 

the country of origin, and APHIS. The 

workplans must contain requirements 

for equipment, temperature, circulation, 

and other operational requirements for 

performing cold treatment to ensure that 

cold treatments are administered 

properly. Workplans for facilities 

outside the United States may also 

include trust fund agreement 

information regarding payment of the 

salaries and expenses of APHIS 

employees on site. Workplans must 

allow officials of the NPPO and APHIS 

to inspect the facility to monitor 

compliance with APHIS regulations. 

(h) Additional requirements for 

treatments performed after arrival in the 

United States. 

(1) Maritime port of Wilmington, NC. 

Consignments of fruit arriving at the 

maritime port of Wilmington, NC, for 

cold treatment, in addition to meeting 

all other applicable requirements of this 

section, must meet the following special 

conditions: 

(i) Bulk consignments (those 

consignments which are stowed and 

unloaded by the case or bin) of fruit 

must arrive in fruit fly-proof packaging 

that prevents the escape of adult, larval, 

or pupal fruit flies. 

(ii) Bulk and containerized 

consignments of fruit must be coldtreated within the area over which the 

U.S. Department of Homeland Security 

is assigned the authority to accept 

entries of merchandise, to collect duties, 

and to enforce the various provisions of 

the customs and navigation laws in 

force. 

(iii) Advance reservations for cold 

treatment space must be made prior to 

the departure of a consignment from its 

port of origin. 

(iv) The cold treatment facility must 

remain locked during non-working 

hours. 

(2) Maritime port of Seattle, WA. 

Consignments of fruit arriving at the 

maritime port of Seattle, WA, for cold 

treatment, in addition to meeting all 

other applicable requirements of this 

section, must meet the following special 

conditions: 

(i) Bulk consignments (those 

consignments which are stowed and 

unloaded by the case or bin) of fruit 

must arrive in fruit fly-proof packaging 

that prevents the escape of adult, larval, 

or pupal fruit flies. 

(ii) Bulk and containerized 

consignments of fruit must be cold 

treated within the area over which the 

U.S. Department of Homeland Security 

is assigned the authority to accept 

entries of merchandise, to collect duties, 

and to enforce the various provisions of 

the customs and navigation laws in 

force. 

(iii) Advance reservations for cold 

treatment space must be made prior to 

the departure of a consignment from its 

port of origin. 

(iv) The cold treatment facility must 

remain locked during non-working 

hours. 

(v) Black light or sticky paper must be 

used within the cold treatment facility, 

and other trapping methods, including 

APHIS-approved fruit fly traps, must be 

used within the 4 square miles 

surrounding the cold treatment facility. 

(vi) The cold treatment facility must 

have contingency plans, approved by 

the Administrator, for safely destroying 

or disposing of fruit. 

(3) Airports of Atlanta, GA, and 

Seattle, WA. Consignments of fruit 

arriving at the airports of Atlanta, GA, 

and Seattle, WA, for cold treatment, in 

addition to meeting all other applicable 

requirements of this section, must meet 

the following special conditions: 

(i) Bulk and containerized 

consignments of fruit must arrive in 

fruit fly-proof packaging that prevents 

the escape of adult, larval, or pupal fruit 

flies. 

(ii) Bulk and containerized 

consignments of fruit arriving for cold 

treatment must be cold treated within 

the area over which the U.S. Department 

of Homeland Security is assigned the 

authority to accept entries of 

merchandise, to collect duties, and to 

enforce the various provisions of the 

customs and navigation laws in force. 

(iii) The cold treatment facility and 

APHIS must agree in advance on the 

route by which consignments are 

allowed to move between the aircraft on 

which they arrived at the airport and the 

cold treatment facility. The movement 

of consignments from aircraft to a cold 

treatment facility will not be allowed 

until an acceptable route has been 

agreed upon. 

(iv) Advance reservations for cold 

treatment space must be made prior to 

the departure of a consignment from its 

port of origin. 

(v) The cold treatment facility must 

remain locked during non-working 

hours. 

(vi) Black light or sticky paper must 

be used within the cold treatment 

facility, and other trapping methods, 

including APHIS-approved fruit fly 

traps, must be used within the 4 square 

miles surrounding the cold treatment 

facility. 

(vii) The cold treatment facility must 

have contingency plans, approved by 

the Administrator, for safely destroying 

or disposing of fruit. 

(4) Maritime ports of Gulfport, MS, 

and Corpus Christi, TX. Consignments 

of fruit arriving at the ports of Gulfport, 

MS, and Corpus Christi, TX, for cold 

treatment, in addition to meeting all 

other applicable requirements of this 

section, must meet the following special 

conditions: 

(i) All fruit entering the port for cold 

treatment must move in maritime 

containers. No bulk consignments (those 

consignments which are stowed and 

unloaded by the case or bin) are 

permitted. 

(ii) Within the container, the fruit 

intended for cold treatment must be 

enclosed in fruit fly-proof packaging 

that prevents the escape of adult, larval, 

or pupal fruit flies. 

(iii) All consignments of fruit arriving 

at the port for cold treatment must be 

cold treated within the area over which 

the U.S. Department of Homeland 

Security is assigned the authority to 

accept entries of merchandise, to collect 

duties, and to enforce the various 

provisions of the customs and 

navigation laws in force. 

(iv) The cold treatment facility and 

APHIS must agree in advance on the 

route by which consignments are 

allowed to move between the vessel on 

which they arrived at the port and the 

cold treatment facility. The movement 

of consignments from vessel to cold 

treatment facility will not be allowed 

until an acceptable route has been 

agreed upon. 

(v) Advance reservations for cold 

treatment space at the port must be 

made prior to the departure of a 

consignment from its port of origin. 

(vi) Devanning, the unloading of fruit 

from containers into the cold treatment 

facility, must adhere to the following 

requirements: 

(A) All containers must be unloaded 

within the cold treatment facility; and 

(B) Untreated fruit may not be 

exposed to the outdoors under any 

circumstances. 

mstockstill on DSKH9S0YB1PROD with RULES2

4246 Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 

(vii) The cold treatment facility must 

remain locked during non-working 

hours. 

(viii) Black lights or sticky paper must 

be used within the cold treatment 

facility, and other trapping methods, 

including APHIS-approved fruit fly 

traps, must be used within the 4 square 

miles surrounding the cold treatment 

facility at the maritime port of Gulfport, 

MS, and within the 5 square miles 

surrounding the cold treatment facility 

at the maritime port of Corpus Christi, 

TX. 

(ix) During cold treatment, a backup 

system must be available to cold treat 

the consignments of fruit should the 

primary system malfunction. The 

facility must also have one or more 

reefers (cold holding rooms) and 

methods of identifying lots of treated 

and untreated fruits. 

(x) The cold treatment facility must 

have the ability to conduct methyl 

bromide fumigations on site. 

(xi) The cold treatment facility must 

have contingency plans, approved by 

the Administrator, for safely destroying 

or disposing of fruit. 

§ 305.7 Quick freeze treatment 

requirements. 

Quick freeze treatment for fruits and 

vegetables imported into the United 

States or moved interstate from Hawaii 

or Puerto Rico must be conducted in 

accordance with §§ 319.56-12 or 318.13- 

13, respectively, of this chapter. The 

PPQ Treatment Manual indicates the 

fruits and vegetables for which quick 

freeze is an authorized treatment. 

§ 305.8 Heat treatment requirements. 

(a) Certified facility. The treatment 

facility must be certified by APHIS. 

Recertification is required annually, or 

as often as APHIS directs, depending 

upon treatments performed, 

commodities handled, and operations 

conducted at the facility. In order to be 

certified, a heat treatment facility must: 

(1) Have equipment that is capable of 

adequately circulating air or water (as 

relevant to the treatment), changing the 

temperature, and maintaining the 

changed temperature sufficient to meet 

the treatment schedule parameters in 

the PPQ Treatment Manual. 

(2) Have equipment used to record, 

monitor, or sense temperature, 

maintained in proper working order. 

(3) Keep treated and untreated fruits, 

vegetables, or articles separate so as to 

prevent reinfestation and spread of 

pests. 

(b) Monitoring. Treatment must be 

monitored by an official authorized by 

APHIS to ensure proper administration 

of the treatment. An official authorized 

by APHIS approves, adjusts, or rejects 

the treatment. 

(c) Compliance agreements. Facilities 

located in the United States must 

operate under a compliance agreement 

with APHIS. The compliance agreement 

must be signed by a representative of 

the heat treatment facilities located in 

the United States and APHIS. The 

compliance agreement must contain 

requirements for equipment, 

temperature, water quality, circulation, 

and other measures for performing heat 

treatments to ensure that treatments are 

administered properly. Compliance 

agreements must allow officials of 

APHIS to inspect the facility to monitor 

compliance with the regulations. 

(d) Workplans. Facilities located 

outside the United States must operate 

in accordance with a workplan. The 

workplan must be signed by a 

representative of the heat treatment 

facilities located outside the United 

States, the national plant protection 

organization of the country of origin 

(NPPO), and APHIS. The workplan must 

contain requirements for equipment, 

temperature, water quality, circulation, 

and other measures to ensure that heat 

treatments are administered properly. 

Workplans for facilities outside the 

United States must include trust fund 

agreement information regarding 

payment of the salaries and expenses of 

APHIS employees on site. Workplans 

must allow officials of the NPPO and 

APHIS to inspect the facility to monitor 

compliance with APHIS regulations. 

(e) Treatment procedures. (1) Before 

each treatment can begin, an official 

authorized by APHIS must approve the 

loading of the commodity in the 

treatment container. 

(2) Sensor equipment must be 

adequate to monitor the treatment, its 

type and placement must be approved 

by an official authorized by APHIS, and 

the equipment must be tested by an 

official authorized by APHIS prior to 

beginning the treatment. Sensor 

equipment must be locked before each 

treatment to prevent tampering. 

(3) Fruits, vegetables, or articles of 

substantially different sizes must be 

treated separately; oversized fruit may 

be rejected by an official authorized by 

APHIS. 

(4) The treatment period begins when 

the temperature specified by the 

treatment schedule has been reached. 

An official authorized by APHIS may 

abort the treatment if the facility 

requires an unreasonably long time to 

achieve the required temperature. 

§ 305.9 Irradiation treatment requirements. 

Irradiation, carried out in accordance 

with the provisions of this section, is 

approved as a treatment for any 

imported regulated article (i.e., fruits, 

vegetables, cut flowers, and foliage); for 

any regulated article moved interstate 

from Hawaii, Puerto Rico, the U.S. 

Virgin Islands, Guam, and the 

Commonwealth of the Northern 

Marianas Islands (referred to 

collectively, in this section, as Hawaii 

and U.S. territories); and for any berry, 

fruit, nut, or vegetable listed as a 

regulated article in § 301.32-2(a) of this 

chapter. 

(a) Location of facilities. (1) Where 

certified irradiation facilities are 

available, an approved irradiation 

treatment may be conducted for any 

imported regulated article either prior to 

shipment to the United States or in the 

United States. For any regulated article 

moved interstate from Hawaii or U.S. 

territories, irradiation treatment may be 

conducted either prior to movement to 

the mainland United States or in the 

mainland United States. For articles that 

are imported or moved interstate from 

Hawaii or U.S. territories, irradiation 

facilities may be located in any State on 

the mainland United States except 

Alabama, Arizona, California, Florida, 

Kentucky, Louisiana, Nevada, New 

Mexico, South Carolina, Tennessee, 

Texas, and Virginia. In the States of 

Georgia, Mississippi, and North 

Carolina, irradiation facilities may only 

be located at the maritime ports of 

Gulfport, MS, or Wilmington, NC, or the 

airport of Atlanta, GA, and only if the 

following special conditions are met: 

The articles to be irradiated must be 

imported or moved interstate packaged 

in accordance with paragraph (f)(3) of 

this section; the irradiation facility and 

APHIS must agree in advance on the 

route by which shipments are allowed 

to move between the vessel on which 

they arrive and the irradiation facility; 

untreated articles may not be removed 

from their packaging prior to treatment 

under any circumstances; blacklight or 

sticky paper must be used within the 

irradiation facility, and other trapping 

methods, including APHIS-approved 

fruit fly traps, must be used within the 

4 square miles surrounding the facility; 

and the facility must have contingency 

plans, approved by APHIS, for safely 

destroying or disposing of regulated 

articles. Prior to treatment, the fruits 

and vegetables to be irradiated may not 

move into or through any of the States 

listed in this paragraph, except that 

movement is allowed through Dallas/ 

Fort Worth, TX, as an authorized stop 

for air cargo, or as a transloading 

location for shipments that arrive by air 

but that are subsequently transloaded 

into trucks for overland movement from 

mstockstill on DSKH9S0YB1PROD with RULES2

Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 4247 

1 The maximum absorbed ionizing radiation dose 

and the irradiation of food is regulated by the Food 

and Drug Administration under 21 CFR part 179. 

Dallas/Fort Worth into an authorized 

State by the shortest route. 

(2) For articles that are moved 

interstate from areas quarantined for 

fruit flies, irradiation facilities may be 

located either within or outside of the 

quarantined area. If the articles are 

treated outside the quarantined area, 

they must be accompanied to the facility 

by a limited permit issued in 

accordance with § 301.32-5(b) of this 

chapter and must be moved in 

accordance with any safeguards 

determined to be appropriate by APHIS. 

(b) Approved facilities. The 

irradiation treatment facility must be 

approved by APHIS. In order to be 

approved, a facility must fulfill the 

requirements in paragraphs (c) and (d) 

of this section. 

(c) Compliance agreements. (1) 

Irradiation facilities treating imported 

articles. (i) Compliance agreements with 

importers and facility operators for 

irradiation in the United States. If 

irradiation of imported articles is 

conducted in the United States, both the 

importer and the operator of the 

irradiation facility must sign 

compliance agreements with APHIS. In 

the facility compliance agreement, the 

facility operator must agree to comply 

with any additional requirements found 

necessary by APHIS to prevent the 

escape, prior to irradiation, of any pests 

of concern that may be associated with 

the articles to be irradiated. In the 

importer compliance agreement, the 

importer must agree to comply with any 

additional requirements found 

necessary by APHIS to ensure the 

shipment is not diverted to a destination 

other than an approved treatment 

facility and to prevent escape of plant 

pests from the articles to be irradiated 

during their transit from the port of first 

arrival to the irradiation facility in the 

United States. 

(ii) Compliance agreement with 

irradiation facilities outside the United 

States. If irradiation of imported articles 

is conducted outside the United States, 

the operator of the irradiation facility 

must sign a compliance agreement with 

APHIS and the national plant protection 

organization (NPPO) of the country in 

which the facility is located. In this 

agreement, the facility operator must 

agree to comply with the requirements 

of this section, and the NPPO of the 

country in which the facility is located 

must agree to monitor that compliance 

and to inform the Administrator of any 

noncompliance. 

(2) Irradiation facilities treating 

articles moved interstate from Hawaii 

and U.S. territories. Irradiation facilities 

treating articles moved interstate from 

Hawaii and U.S. territories must 

complete a compliance agreement with 

APHIS as provided in § 318.13-3(d) of 

this chapter. 

(3) Irradiation facilities treating 

articles moved interstate from areas 

quarantined for fruit flies. Irradiation 

facilities treating articles moved 

interstate from areas quarantined for 

fruit flies must complete a compliance 

agreement with APHIS as provided in 

§ 301.32-6 of this chapter. 

(d) Certified facility. The irradiation 

treatment facility must be certified by 

APHIS. Recertification is required in the 

event of an increase in the amount of 

radioisotope, a decrease in the amount 

of radioisotope for a reason other than 

natural decay, a major modification to 

equipment that affects the delivered 

dose, or a change in the owner or 

managing entity of the facility. 

Recertification also may be required in 

cases where a significant variance in 

dose delivery has been measured by the 

dosimetry system. In order to be 

certified, a facility must: 

(1) Be capable of administering the 

minimum absorbed ionizing radiation 

doses specified in the PPQ Treatment 

Manual to the regulated articles;1

(2) Be constructed so as to provide 

physically separate locations for treated 

and untreated articles, except that 

articles traveling by conveyor directly 

into the irradiation chamber may pass 

through an area that would otherwise be 

separated. The locations must be 

separated by a permanent physical 

barrier such as a wall or chain link fence 

6 or more feet high to prevent transfer 

of cartons, or some other means 

approved during certification to prevent 

reinfestation of articles and spread of 

pests. 

(3) If the facility is to be used to treat 

imported articles and is located in the 

United States, the facility will only be 

certified if APHIS determines that 

regulated articles will be safely 

transported to the facility from the port 

of arrival without significant risk that 

plant pests will escape in transit or 

while the regulated articles are at the 

facility. 

(e) Monitoring and interagency 

agreements. Treatment must be 

monitored by an inspector. This 

monitoring will include inspection of 

treatment records and unannounced 

inspections of the facility by an 

inspector, and may include inspection 

of articles prior to or after irradiation. 

(1) Irradiation facilities treating 

imported articles; irradiation treatment 

framework equivalency workplan. The 

NPPO of a country from which articles 

are to be imported into the United States 

in accordance with this section must 

sign a framework equivalency workplan 

with APHIS. In this plan, both the 

NPPO and APHIS will specify the 

following items for their respective 

countries: 

(A) Citations for any requirements 

that apply to the importation of 

irradiated fruits and vegetables; 

(B) The type and amount of 

inspection, monitoring, or other 

activities that will be required in 

connection with allowing the 

importation of irradiated fruits and 

vegetables into that country; and 

(C) Any other conditions that must be 

met to allow the importation of 

irradiated fruits and vegetables into that 

country. 

(2) Irradiation facilities located in 

foreign countries. Facilities in foreign 

countries that carry out irradiation 

operations must notify the Director of 

Preclearance, PPQ, APHIS, 4700 River 

Road Unit 140, Riverdale, MD 20737- 

1236, of scheduled operations at least 30 

days before operations commence, 

except where otherwise provided in the 

facility preclearance workplan. To 

ensure the appropriate level of 

monitoring, before articles may be 

imported in accordance with this 

section, the following agreements must 

be signed, in addition to the irradiation 

treatment framework equivalency 

workplan required in paragraph (e)(1) of 

this section: 

(i) Facility preclearance workplan. 

Prior to commencing importation into 

the United States of articles treated at a 

foreign irradiation facility, APHIS and 

the NPPO of the country from which 

articles are to be imported must jointly 

develop a preclearance workplan that 

details the activities that APHIS and the 

foreign NPPO will carry out in 

connection with each irradiation facility 

to verify the facility’s compliance with 

the requirements of this section. Typical 

activities to be described in this 

workplan may include frequency of 

visits to the facility by APHIS and 

foreign plant protection inspectors, 

methods for reviewing facility records, 

and methods for verifying that facilities 

are in compliance with the requirements 

for separation of articles, packaging, 

labeling, and other requirements of this 

section. This facility preclearance 

workplan will be reviewed and renewed 

by APHIS and the foreign NPPO on an 

annual basis. 

(ii) Trust fund agreement. Irradiated 

articles may be imported into the United 

States in accordance with this section 

only if the NPPO of the country in 

which the irradiation facility is located 

mstockstill on DSKH9S0YB1PROD with RULES2

4248 Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 

2 Inspectors are assigned to local offices of the 

Animal and Plant Health Inspection Service, which 

are listed in telephone directories. 

3 If there is a question as to the adequacy of a 

carton, send a request for approval of the carton, 

together with a sample carton, to the Animal and 

Plant Health Inspection Service, Plant Protection 

and Quarantine, Center for Plant Health Inspection 

and Technology, 1730 Varsity Drive, Suite 400, 

Raleigh, NC 27606-5202. 

or a private export group has entered 

into a trust fund agreement with APHIS. 

That agreement requires the NPPO or 

the private export group to pay, in 

advance of each shipping season, all 

costs that APHIS estimates it will incur 

in providing inspection and treatment 

monitoring services at the irradiation 

facility during that shipping season. 

Those costs include administrative 

expenses and all salaries (including 

overtime and the Federal share of 

employee benefits), travel expenses 

(including per diem expenses), and 

other incidental expenses incurred by 

APHIS in performing these services. The 

agreement will describe the general 

nature and scope of APHIS services 

provided at irradiation facilities covered 

by the agreement, such as whether 

APHIS inspectors will monitor 

operations continuously or 

intermittently, and will generally 

describe the extent of inspections 

APHIS will perform on articles prior to 

and after irradiation. The agreement 

requires the NPPO or private export 

group to deposit a certified or cashier’s 

check with APHIS for the amount of 

those costs, as estimated by APHIS. If 

the deposit is not sufficient to meet all 

costs incurred by APHIS, the agreement 

further requires the NPPO or the private 

export group to deposit with APHIS a 

certified or cashier’s check for the 

amount of the remaining costs, as 

determined by APHIS, before any more 

articles irradiated in that country may 

be imported into the United States. 

After a final audit at the conclusion of 

each shipping season, any overpayment 

of funds would be returned to the NPPO 

or the private export group or held on 

account until needed, at the option of 

the NPPO or the private export group. 

(3) Irradiation facilities located within 

the United States. Facilities located 

within the United States must notify an 

inspector at least 24 hours (excluding 

Saturday, Sunday, and Federal 

holidays) before scheduled operations.2

If the facility will be used to treat 

imported articles, the NPPO of the 

country from which the articles are to be 

imported into the United States in 

accordance with this section must also 

sign the irradiation treatment framework 

equivalency workplan required in 

paragraph (e)(1) of this section. 

(f) Packaging. Articles that are 

irradiated in accordance with this 

section must be packaged in cartons in 

the following manner: 

(1) Irradiated articles may not be 

packaged for shipment in a carton with 

nonirradiated articles. 

(2) For all imported articles irradiated 

prior to arrival in the United States, all 

articles moved interstate from Hawaii or 

U.S. territories and irradiated prior to 

arrival in the mainland United States, 

and all regulated articles to be moved 

interstate from an area quarantined for 

fruit flies that are treated within the 

quarantined area: 

(i) The fruits and vegetables must be 

packaged either: 

(A) In insect-proof cartons that have 

no openings that will allow the entry of 

the pests of concern. The cartons must 

be sealed with seals that will visually 

indicate if the cartons have been 

opened. The cartons may be constructed 

of any material that prevents entry or 

oviposition (if applicable) by the pests 

of concern into the articles in the 

carton;3 or 

(B) In noninsect-proof cartons that are 

stored immediately after irradiation in a 

room completely enclosed by walls or 

screening that completely precludes 

access by the pests of concern. If stored 

in noninsect-proof cartons in a room 

that precludes access by the pests of 

concern, prior to leaving the room, each 

pallet of cartons must be completely 

enclosed in polyethylene shrink wrap, 

or another solid or netting covering that 

completely precludes access to the 

cartons by the pests of concern. 

(ii) To preserve the integrity of treated 

lots, each pallet-load of cartons 

containing the fruits and vegetables 

must be secured before leaving the 

irradiation facility in one of the 

following ways: 

(A) With polyethylene shrink wrap; 

(B) With net wrapping; or 

(C) With strapping. 

(iii) Packaging must be labeled in a 

manner that allows an inspector to 

determine treatment lot numbers, 

packing and treatment facility 

identification and location, and dates of 

packing and treatment. 

(A) For imported articles that are 

treated prior to arrival in the United 

States, pallets that remain intact as one 

unit until entry into the United States 

may have one such label per pallet. 

Pallets that are broken apart into smaller 

units prior to or during entry into the 

United States, or that will be broken 

apart into smaller units after entry into 

the United States, must have the 

required label information on each 

individual carton. 

(B) For articles moved interstate from 

Hawaii or U.S. territories that are treated 

prior to arrival in the mainland United 

States, pallets that remain intact as one 

unit until entry into the mainland 

United States may have one such label 

per pallet. Pallets that are broken apart 

into smaller units prior to or during 

entry into the mainland United States, 

or that will be broken apart into smaller 

units after entry into the mainland 

United States, must have the required 

label information on each individual 

carton. 

(3) For all articles imported to be 

irradiated upon arrival in the United 

States, moved interstate from Hawaii or 

U.S. territories to be irradiated upon 

arrival in the mainland United States, or 

moved interstate from areas quarantined 

for fruit flies to be irradiated outside the 

quarantined area, the articles must be 

packed in cartons that have no openings 

that will allow the exit of the pests of 

concern and that are sealed with seals 

that will visually indicate if the cartons 

have been opened. They may be 

constructed of any material that 

prevents the pests of concern from 

exiting the carton. Cartons of untreated 

articles must be shipped in shipping 

containers sealed prior to their 

shipment with seals that will visually 

indicate if the shipping containers have 

been opened. 

(g) Containers or vans. Containers or 

vans that will transport treated articles 

must be free of pests of concern prior to 

loading the treated articles. 

(h) Certification of treatment for 

articles treated outside the United 

States. For each consignment treated in 

an irradiation facility outside the United 

States, a phytosanitary certificate, with 

the treatment section completed and 

issued by the NPPO, must accompany 

the consignment. 

(i) Dosage. The regulated articles must 

receive the minimum absorbed ionizing 

radiation dose specified in the PPQ 

Treatment Manual. 

(j) Dosimetry systems at the 

irradiation facility. (1) Dosimetry must 

indicate the doses needed to ensure that 

all the articles will receive the 

minimum dose prescribed. 

(2) The absorbed dose, as measured 

using an accurate dosimetry system, 

must meet or exceed the absorbed dose 

for the pest(s) of concern required by the 

PPQ Treatment Manual. 

(3) When designing the facility’s 

dosimetry system and procedures for its 

operation, the facility operator must 

address guidance and principles from 

the International Standards 

Organization/American Society for 

mstockstill on DSKH9S0YB1PROD with RULES2

Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 4249 

4 Designation ISO/ASTM 51261-2002(E), 

‘‘Standard Guide for Selection and Calibration of 

Dosimetry Systems for Radiation Processing,’’ American Society for Testing and Materials, Annual 

Book of ASTM Standards. 

Testing and Materials standard4 or an 

equivalent standard recognized by 

APHIS. 

(k) Records. An irradiation processor 

must maintain records of each treated 

lot for 1 year following the treatment 

date, and must make these records 

available for inspection by an inspector 

during normal business hours (8 a.m. to 

4:30 p.m., Monday through Friday, 

except holidays). These records must 

include the lot identification, scheduled 

process, evidence of compliance with 

the scheduled process, ionizing energy 

source, source calibration, dosimetry, 

dose distribution in the product, and the 

date of irradiation. 

(l) Request for initial certification and 

inspection of facility. Persons requesting 

initial certification of an irradiation 

treatment facility must submit the 

request for approval in writing to the 

Animal and Plant Health Inspection 

Service, Plant Protection and 

Quarantine, Center for Plant Health 

Inspection and Technology, 1730 

Varsity Drive, Suite 400, Raleigh, NC 

27606-5202. The initial request must 

identify the owner, location, and 

radiation source of the facility, and the 

applicant must supply additional 

information about the facility 

construction, treatment protocols, and 

operations upon request by APHIS if 

APHIS requires additional information 

to evaluate the request. Before the 

Administrator determines whether an 

irradiation facility is eligible for 

certification, an inspector will make a 

personal inspection of the facility to 

determine whether it complies with the 

standards of this section. 

(m) Denial and withdrawal of 

certification. (1) The Administrator will 

withdraw the certification of any 

irradiation treatment facility upon 

written request from the irradiation 

processor. 

(2) The Administrator will deny or 

withdraw certification of an irradiation 

treatment facility when any provision of 

this section is not met. Before 

withdrawing or denying certification, 

the Administrator will inform the 

irradiation processor in writing of the 

reasons for the proposed action and 

provide the irradiation processor with 

an opportunity to respond. The 

Administrator will give the irradiation 

processor an opportunity for a hearing 

regarding any dispute of a material fact, 

in accordance with rules of practice that 

will be adopted for the proceeding. 

However, the Administrator will 

suspend certification pending final 

determination in the proceeding if he or 

she determines that suspension is 

necessary to prevent the spread of any 

dangerous insect. The suspension will 

be effective upon oral or written 

notification, whichever is earlier, to the 

irradiation processor. In the event of 

oral notification, written confirmation 

will be given to the irradiation processor 

within 10 days of the oral notification. 

The suspension will continue in effect 

pending completion of the proceeding 

and any judicial review of the 

proceeding. 

(n) Department not responsible for 

damage. This treatment is approved to 

assure quarantine security against the 

plant pests listed in the PPQ Treatment 

Manual. From the literature available, 

the articles authorized for treatment 

under this section are believed tolerant 

to the treatment; however, the facility 

operator and shipper are responsible for 

determination of tolerance. The 

Department of Agriculture and its 

inspectors assume no responsibility for 

any loss or damage resulting from any 

treatment prescribed or monitored. 

Additionally, the Nuclear Regulatory 

Commission is responsible for ensuring 

that irradiation facilities are constructed 

and operated in a safe manner. Further, 

the Food and Drug Administration is 

responsible for ensuring that irradiated 

foods are safe and wholesome for 

human consumption. 

(Approved by the Office of Management 

and Budget under control numbers 

0579-0155, 0579-0215, and 0579-0198) 

PART 318—STATE OF HAWAII AND 

TERRITORIES QUARANTINE NOTICES 

■ 25. The authority citation for part 318 

continues to read as follows: 

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

7786; 7 CFR 2.22, 2.80, and 371.3. 

§ 318.13-3 [Amended] 

■ 26. In § 318.13-3, paragraph (b)(2) is 

amended by removing the words 

‘‘approved in’’ and adding the words 

‘‘approved under’’ in their place. 

■ 27. Section 318.13-16 is amended as 

follows: 

■ a. In the table in paragraph (a), by 

adding, under Hawaii, new entries for 

litchi and longan in alphabetical order 

to read as set forth below. 

■ b. By adding a new paragraph (b)(1)(ii) 

to read as set forth below. 

§ 318.13-16 Regulated articles allowed 

interstate movement subject to specified 

conditions. 

(a) * * * 

State, territory, or district of 

origin Common name Botanical name Plant part(s) Additional requirements 

Hawaii 

* * * * * * * 

Litchi Litchi chinensis Fruit (b)(1)(ii), (b)(3)(ii) 

Longan Dimocarpus longan Fruit (b)(1)(ii), (b)(3)(ii) 

* * * * * * * 

(b) * * * 

(1) * * * 

(ii) May not be moved interstate into 

Florida. Cartons must be stamped ‘‘Not 

for movement into or distribution in 

FL.’’ 

* * * * * 

■ 28. Section 318.13-22 is amended by 

revising paragraphs (b)(1) and (b)(2) to 

read as follows: 

§ 318.13-22 Bananas from Hawaii. 

* * * * * 

(b) * * * 

(1) The bananas are irradiated in 

accordance with part 305 of this chapter 

for the Mediterranean fruit fly (Ceratitis 

capitata), the melon fruit fly (Bactrocera 

curcurbitae), the Oriental fruit fly 

(Bactrocera dorsalis), and the green 

scale (Coccus viridis) and are inspected, 

mstockstill on DSKH9S0YB1PROD with RULES2

4250 Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 

5 If there is a question as to the adequacy of a 

carton, send a request for approval of the carton, 

together with a sample carton, to the Animal and 

Plant Health Inspection Service, Plant Protection 

and Quarantine, Center for Plant Health Science 

and Technology, 1730 Varsity Drive, Suite 400, 

Raleigh, NC 27606. 

after removal from the stalk, in Hawaii 

and found to be free of the banana moth 

(Opogona sacchari (Bojen)) by an 

inspector before or after undergoing 

irradiation treatment; or 

(2) The bananas are irradiated in 

accordance with part 305 of this chapter 

for the Mediterranean fruit fly (Ceratitis 

capitata), the melon fruit fly (Bactrocera 

curcurbitae), and the Oriental fruit fly 

(Bactrocera dorsalis) and are inspected, 

after removal from the stalk, in Hawaii 

and found to be free of the green scale 

(Coccus viridis) and the banana moth 

(Opogona sacchari (Bojen)) before or 

after undergoing irradiation treatment. 

* * * * * 

■ 29. Section 318.13-25 is revised to 

read as follows: 

§ 318.13-25 Sweetpotatoes from Hawaii. 

Sweetpotatoes may be moved 

interstate from Hawaii in accordance 

with this section only if the 

sweetpotatoes meet the conditions in 

paragraph (a) or paragraph (b) of this 

section or if the sweetpotatoes are 

fumigated with methyl bromide in 

accordance with part 305 of this 

chapter. 

(a) Vapor heat treatment and 

inspection. (1) The sweetpotatoes must 

be treated with vapor heat in accordance 

with part 305 of this chapter. 

(2) The sweetpotatoes must be 

sampled, cut, and inspected and found 

to be free of the ginger weevil 

(Elytrotreinus subtruncatus). Sampling, 

cutting, and inspection must be 

performed under conditions that will 

prevent any pests that may emerge from 

the sampled sweetpotatoes from 

infesting any other sweetpotatoes 

intended for interstate movement in 

accordance with this section. 

(3) The sweetpotatoes must be 

inspected and found to be free of the 

gray pineapple mealybug (Dysmicoccus 

neobrevipes) and the Kona coffee-root 

knot nematode (Meloidogyne 

konaensis). 

(4)(i) Sweetpotatoes that are treated in 

Hawaii must be packaged in the 

following manner: 

(A) The cartons must have no 

openings that will allow the entry of the 

pests of concern and must be sealed 

with seals that will visually indicate if 

the cartons have been opened. They 

may be constructed of any material that 

prevents the entry of the pests of 

concern.5

(B) The pallet-load of cartons must be 

secured before it leaves the treatment 

facility in one of the following ways: 

(1) With polyethylene sheet wrap; 

(2) With net wrapping; or 

(3) With strapping. 

(C) Packaging must be labeled in a 

manner that allows an inspector to 

determine treatment lot numbers, 

packing and treatment facility 

identification and location, and dates of 

packing and treatment. 

(ii) Cartons of untreated sweetpotatoes 

that are moving to the mainland United 

States for treatment must be shipped in 

shipping containers sealed prior to 

interstate movement with seals that will 

visually indicate if the shipping 

containers have been opened. 

(5)(i) Certification on basis of 

treatment. Certification shall be issued 

by an inspector for the movement of 

sweetpotatoes from Hawaii that have 

been treated in accordance with part 

305 of this chapter and handled in 

Hawaii in accordance with this section. 

(ii) Limited permit. A limited permit 

shall be issued by an inspector for the 

interstate movement of untreated 

sweetpotato from Hawaii for treatment 

on the mainland United States in 

accordance with this section. 

(b) Irradiation treatment and 

inspection. (1) The sweetpotatoes must 

be treated with irradiation in 

accordance with part 305 of this 

chapter. 

(2) Sweetpotatoes that are not treated 

with an irradiation dose approved to 

neutralize the ginger weevil 

(Elytrotreinus subtruncatus) must be 

sampled, cut, and inspected and found 

to be free of the ginger weevil by an 

inspector in Hawaii. Sampling, cutting, 

and inspection must be performed 

under conditions that will prevent any 

pests that may emerge from the sampled 

sweetpotatoes from infesting any other 

sweetpotatoes intended for interstate 

movement in accordance with this 

section. 

(3)(i) To be certified for interstate 

movement under this paragraph, 

sweetpotato from Hawaii must be 

inspected in Hawaii and found free of 

the gray pineapple mealybug 

(Dysmicoccus neobrevipes) and the 

Kona coffee-root knot nematode 

(Meloidogyne konaensis) by an 

inspector before undergoing irradiation 

treatment in Hawaii. 

(ii) To be eligible for a limited permit 

under this section, untreated 

sweetpotato from Hawaii must be 

inspected in Hawaii and found free of 

the gray pineapple mealybug 

(Dysmicoccus neobrevipes) and the 

Kona coffee-root knot nematode 

(Meloidogyne konaensis) by an 

inspector. 

(Approved by the Office of Management 

and Budget under control number 0579– 

0281) 

■ 30. A new § 318.13-26 is added to read 

as follows: 

§ 318.13-26 Breadfruit, jackfruit, fresh 

pods of cowpea, dragon fruit, mangosteen, 

and moringa pods from Hawaii. 

(a) Breadfruit and jackfruit. (1) To be 

eligible for interstate movement, 

breadfruit and jackfruit from Hawaii 

must be treated with irradiation in 

accordance with part 305 of this 

chapter. 

(2) To be certified for interstate 

movement, breadfruit and jackfruit from 

Hawaii must be inspected in Hawaii and 

found free of spiraling whitefly 

(Aleurodicus dispersus), inornate scale 

(Aonidiella inornata), red wax scale 

(Ceroplastes rubens), green scale 

(Coccus viridis), gray pineapple 

mealybug (Dysmicoccus neobrevipes), 

pink hibiscus mealybug 

(Maconellicoccus hirsutus), spherical 

mealybug (Nipaecoccus viridis), citrus 

mealybug (Pseudococcus cryptus), 

melon thrips (Thrips palmi), and signs 

of thrip damage before undergoing 

irradiation treatment in Hawaii at a dose 

approved to neutralize fruit flies. Fruit 

treated for fruit flies also must either 

receive a post-harvest dip in accordance 

with part 305 of this chapter to treat 

external feeders or originate from an 

orchard or growing area that was 

previously treated with a broadspectrum insecticide during the growing 

season and a pre-harvest inspection of 

the orchard or growing area found the 

fruit free of any surface pests as 

prescribed in a compliance agreement. 

Post-treatment inspection in Hawaii is 

not required if the fruit undergoes 

irradiation treatment at a dose approved 

to neutralize all plant pests of the class 

Insecta, except pupae and adults of the 

order Lepidoptera. Regardless of 

irradiation dose, the fruit must be free 

of stems and leaves and must originate 

from an orchard that was previously 

treated with a fungicide appropriate for 

the fungus Phytophthora tropicalis 

during the growing season and the fruit 

must be inspected prior to harvest and 

found free of the fungus or, after 

irradiation treatment, must receive a 

post-harvest fungicidal dip appropriate 

for Phytophthora tropicalis. 

(3) To be eligible for a limited permit, 

breadfruit and jackfruit from Hawaii 

must be free of stems and leaves and 

must originate from an orchard that was 

previously treated with a fungicide 

appropriate for the fungus Phytophthora 

tropicalis during the growing season 

mstockstill on DSKH9S0YB1PROD with RULES2

Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 4251 

and the fruit must be inspected prior to 

harvest and found free of the fungus or, 

after irradiation treatment, must receive 

a post-harvest fungicidal dip 

appropriate for Phytophthora tropicalis. 

(b) Fresh pods of cowpea. (1) To be 

eligible for interstate movement, fresh 

pods of cowpea and its relatives from 

Hawaii must be treated with irradiation 

in accordance with part 305 of this 

chapter. 

(2) To be certified for interstate 

movement, fresh pods of cowpea and its 

relatives from Hawaii must be inspected 

in Hawaii and found free of the cassava 

red mite (Oligonychus biharensis) and 

adults and pupae of the order 

Lepidoptera before undergoing 

irradiation treatment. The pods must be 

free of stems and leaves. 

(3) To be eligible for a limited permit, 

fresh pods of cowpea and its relatives 

from Hawaii must be free of stems and 

leaves and must be inspected in Hawaii 

and found free of the cassava red mite 

(Oligonychus biharensis) and adults and 

pupae of the order Lepidoptera. 

(c) Dragon fruit. To be certified for 

interstate movement, dragon fruit from 

Hawaii presented for inspection must 

have the sepals removed and must be 

inspected in Hawaii and found free of 

gray pineapple mealybug (Dysmicoccus 

neobrevipes), pink hibiscus mealybug 

(Maconellicoccus hirsutus), and citrus 

mealybug (Pseudococcus cryptus) before 

undergoing irradiation treatment in 

Hawaii at a dose approved to neutralize 

fruit flies. Fruit treated for fruit flies also 

must either receive a post-harvest dip in 

accordance with part 305 of this chapter 

to treat external feeders or originate 

from an orchard or growing area that 

was previously treated with a broadspectrum insecticide during the growing 

season and a pre-harvest inspection of 

the orchard or growing area found the 

fruit free of any surface pests as 

prescribed in a compliance agreement. 

Post-treatment inspection in Hawaii is 

not required if the fruit undergoes 

irradiation treatment at a dose approved 

to neutralize all plant pests of the class 

Insecta, except pupae and adults of the 

order Lepidoptera. Regardless of 

irradiation dose, the fruit must be free 

of stems and leaves. 

(d) Mangosteen. To be certified for 

interstate movement, mangosteen from 

Hawaii must have the sepals removed 

and must be inspected in Hawaii and 

found free of gray pineapple mealybug 

(Dysmicoccus neobrevipes), pink 

hibiscus mealybug (Maconellicoccus 

hirsutus), citrus mealybug 

(Pseudococcus cryptus), and Thrips 

florum before undergoing irradiation 

treatment in Hawaii at a dose approved 

to neutralize fruit flies. Fruit treated for 

fruit flies also must either receive a 

post-harvest dip in accordance with part 

305 of this chapter to treat external 

feeders or originate from an orchard or 

growing area that was previously treated 

with a broad-spectrum insecticide 

during the growing season and a preharvest inspection of the orchard or 

growing area found the fruit free of any 

surface pests as prescribed in a 

compliance agreement. Post-treatment 

inspection in Hawaii is not required if 

the fruit undergoes irradiation treatment 

at a dose approved to neutralize all 

plant pests of the class Insecta, except 

pupae and adults of the order 

Lepidoptera. Regardless of irradiation 

dose, the fruit must be free of stems and 

leaves. 

(e) Melon. To be certified for interstate 

movement, melon from Hawaii must be 

inspected in Hawaii and found free of 

spiraling whitefly (Aleurodicus 

dispersus) before undergoing irradiation 

treatment in Hawaii at a dose approved 

to neutralize fruit flies. Fruit treated for 

fruit flies also must either receive a 

post-harvest dip in accordance with part 

305 of this chapter to treat external 

feeders or originate from an orchard or 

growing area that was previously treated 

with a broad-spectrum insecticide 

during the growing season and a preharvest inspection of the orchard or 

growing area found the fruit free of any 

surface pests as prescribed in a 

compliance agreement. Post-treatment 

inspection in Hawaii is not required if 

the fruit undergoes irradiation treatment 

at a dose approved to neutralize all 

plant pests of the class Insecta, except 

pupae and adults of the order 

Lepidoptera. Regardless of irradiation 

dose, melons must be washed to remove 

dirt and must be free of stems and 

leaves. 

(f) Moringa pods. To be certified for 

interstate movement, moringa pods from 

Hawaii must be inspected in Hawaii and 

found free of spiraling whitefly 

(Aleurodicus dispersus), inornate scale 

(Aonidiella inornata), green scale 

(Coccus viridis), and citrus mealybug 

(Pseudococcus cryptus) before 

undergoing irradiation treatment in 

Hawaii at a dose approved to neutralize 

fruit flies. Fruit treated for fruit flies also 

must either receive a post-harvest dip in 

accordance with part 305 of this chapter 

to treat external feeders or originate 

from an orchard or growing area that 

was previously treated with a broadspectrum insecticide during the growing 

season and a pre-harvest inspection of 

the orchard or growing area found the 

fruit free of any surface pests as 

prescribed in a compliance agreement. 

Post-treatment inspection in Hawaii is 

not required if the fruit undergoes 

irradiation treatment at a dose approved 

to neutralize all plant pests of the class 

Insecta, except pupae and adults of the 

order Lepidoptera. 

§ 318.47-3 [Amended] 

■ 31. In § 318.47-3, paragraph (a) is 

amended by adding the words ‘‘in 

accordance with part 305 of this 

chapter’’ after the word ‘‘origin’’. 

PART 319—FOREIGN QUARANTINE 

NOTICES 

■ 32. The authority citation for part 319 

continues to read as follows: 

Authority: 7 U.S.C. 450, 7701-7772, and 

7781-7786; 21 U.S.C. 136 and 136a; 7 CFR 

2.22, 2.80, and 371.3. 

■ 33. In § 319.8-23, paragraph (a)(1) is 

revised to read as follows: 

§ 319.8-23 Treatment. 

(a)(1) Vacuum fumigation as required 

in this subpart must be conducted in 

accordance with part 305 of this 

chapter. 

* * * * * 

§ 319.28 [Amended] 

■ 34. Section 319.28 is amended as 

follows: 

■ a. In paragraph (b)(5), by adding the 

words ‘‘treated in accordance with part 

305 of this chapter’’ after the words 

‘‘fumigated with methyl bromide’’; and 

by removing the second sentence. 

■ b. In paragraphs (b)(7)(i) and (b)(7)(ii), 

by removing the words ‘‘paragraph (b)(5) 

of this section’’ and adding the words 

‘‘part 305 of this chapter’’ in their place. 

§ 319.37-13 [Amended] 

■ 35. In § 319.37-13, paragraph (c) is 

amended by removing the words ‘‘the 

Plant Protection and Quarantine 

Treatment Manual’’ and adding the 

words ‘‘7 CFR part 305’’ in their place. 

■ 36. In § 319.40-3, paragraph (b)(1) is 

revised to read as follows: 

§ 319.40-3 General permits; articles that 

may be imported without a specific permit; 

articles that may be imported without either 

a specific permit or an importer document. 

* * * * * 

(b) * * * 

(1) The wood packaging material must 

have been treated in accordance with 

part 305 of this chapter. 

* * * * * 

■ 37. Section 319.40-5 is amended as 

follows: 

■ a. In paragraph (b)(1)(i)(C), by 

removing the citation ‘‘§ 319.40-7(f)(1)’’ 

and adding the words ‘‘part 305 of this 

chapter’’ in its place. 

■ b. In paragraph (b)(1)(i)(D), by 

removing the citation ‘‘§ 319.40-7(d)’’ 

mstockstill on DSKH9S0YB1PROD with RULES2

4252 Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 

and adding the words ‘‘part 305 of this 

chapter’’ in its place. 

■ c. In paragraph (b)(1)(iii)(A), by 

removing the citations ‘‘§ 319.40-7(c)’’ 

and ‘‘§ 319.40-7(d)’’ and adding the 

words ‘‘part 305 of this chapter’’ in their 

place. 

■ d. In paragraph (b)(1)(iii)(C), by 

removing the citations ‘‘§ 319.40-7(c)’’, 

‘‘§ 319.40-7(d)’’, and ‘‘§ 319.40-7(f)(3)’’ 

each time they occur and adding the 

words ‘‘part 305 of this chapter’’ in their 

place. 

■ e. In paragraph (b)(2)(i), by removing 

the citation ‘‘§ 319.40-7(f)(2)’’ and adding 

the words ‘‘part 305 of this chapter’’ in 

its place. 

■ f. In paragraph (b)(2)(ii), by removing 

the citations ‘‘§ 319.40-7(c)’’ and 

‘‘§ 319.40-7(d)’’ and adding the words 

‘‘part 305 of this chapter’’ in their place. 

■ g. In paragraph (c)(2), by removing the 

citation ‘‘§ 319.40-7(f)(1)’’ and adding the 

words ‘‘part 305 of this chapter’’ in its 

place. 

■ h. In paragraph (d), by removing the 

citation ‘‘§ 319.40-7(f)’’ and adding the 

words ‘‘part 305 of this chapter’’ in its 

place. 

■ i. In paragraph (f), by removing the 

citation ‘‘§ 319.40-7(c)’’ and adding the 

words ‘‘part 305 of this chapter’’ in its 

place. 

■ j. By revising paragraph (l)(3) to read 

as set forth below. 

■ k. In paragraph (m)(2)(iv)(A)(1), by 

removing the citation ‘‘319.40-7(f)’’ and 

adding the words ‘‘part 305’’ in its place. 

■ l. In paragraph (m)(2)(iv)(A)(4), by 

removing the citation ‘‘§ 319.40-6’’ and 

adding the words ‘‘7 CFR part 305’’ in its 

place. 

■ m. In paragraph (n)(1)(ii), by removing 

the citation ‘‘§ 319.40-7(c)’’ and adding 

the words ‘‘part 305 of this chapter’’ in 

its place. 

§ 319.40-5 Importation and entry 

requirements for specific articles. 

* * * * * 

(l) * * * 

(3) Are fumigated in accordance with 

part 305 of this chapter prior to arrival 

in the United States. 

* * * * * 

§ 319.40-6 [Amended] 

■ 38. Section 319.40-6 is amended as 

follows: 

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

citation ‘‘§ 319.40-7(c)’’ and adding the 

words ‘‘part 305 of this chapter’’ in their 

place. 

■ b. In paragraphs (b)(1) introductory 

text, (b)(1)(i), (b)(1)(ii), (b)(2)(ii), 

(c)(2)(i)(B), (c)(2)(iii), (c)(2)(iv), and (d), 

by removing the citation ‘‘§ 319.40-7(c)’’ 

each time it occurs and adding the 

words ‘‘part 305 of this chapter’’ in its 

place; and by removing the citation 

‘‘§ 319.40-7(d)’’ each time it occurs and 

adding the words ‘‘part 305 of this 

chapter’’ in its place. 

■ c. In paragraph (c)(1)(i)(A), by 

removing the citation ‘‘§ 319.40-7(e)’’ 

each time it occurs and adding the 

words ‘‘part 305 of this chapter’’ in its 

place. 

■ d. In paragraphs (c)(2)(i)(B), (c)(2)(iii), 

(c)(2)(iv), and (d), by removing the 

citation ‘‘§ 319.40-7(f)(3)’’ each time it 

occurs and adding the words ‘‘part 305 

of this chapter’’ in its place. 

■ 39. Section 319.40-7 is amended as 

follows: 

■ a. By removing paragraphs (c) through 

(f). 

■ b. By adding a new paragraph (c) to 

read as set forth below. 

■ c. By redesignating paragraph (g) as 

paragraph (d). 

§ 319.40-7 Treatments and safeguards. 

* * * * * 

(c) Treatments. Treatment of regulated 

articles under this subpart must be 

conducted in accordance with part 305 

of this chapter. 

* * * * * 

§ 319.41-5 [Amended] 

■ 40. Section 319.41-5 is amended as 

follows: 

■ a. In paragraph (a), second sentence, 

by removing the words ‘‘other 

necessary’’; and by adding the words ‘‘in 

accordance with part 305 of this 

chapter,’’ after the word ‘‘treatment’’. 

■ b. In paragraph (a), third sentence, by 

adding the words ‘‘in accordance with 

part 305 of this chapter’’ after the word 

‘‘treatment’’. 

■ c. In paragraphs (b), (c), (d)(1), and 

(d)(3), by adding the words ‘‘in 

accordance with part 305 of this 

chapter’’ after the words ‘‘other 

treatment’’ each time they occur. 

§ 319.41-5a [Removed] 

■ 41. Section 319.41-5a is removed. 

§ 319.55-6 [Amended] 

■ 42. Section 319.55-6 is amended as 

follows: 

■ a. In paragraph (a), in the first 

sentence, by adding the words ‘‘in 

accordance with part 305 of this 

chapter’’ after the word ‘‘disinfection’’; 

and in the second sentence, by adding 

the words ‘‘in accordance with part 305 

of this chapter’’ after the word 

‘‘treatment’’. 

■ b. In paragraph (b)(1), in the first 

sentence, by adding the words ‘‘in 

accordance with part 305 of this 

chapter’’ after the word ‘‘treatment.’’ 

§ 319.56-3 [Amended] 

■ 43. In § 319.56-3, paragraph (c)(2) is 

amended by removing the citation 

‘‘§ 305.15’’ and adding the words ‘‘part 

305’’ in its place. 

§ 319.56-7 [Amended] 

■ 44. In § 319.56-7, paragraph (b)(1)(ii) 

is amended by removing the words 

‘‘with an approved treatment listed in’’ 

and adding the words ‘‘in accordance 

with’’ in their place. 

§ 319.56-11 [Amended] 

■ 45. In § 319.56-11, paragraph (b)(1) is 

amended by removing the words ‘‘with 

an approved treatment listed in’’ and 

adding the words ‘‘in accordance with’’ 

in their place. 

§ 319.56-12 [Amended] 

■ 46. Section 319.56-12 is amended by 

removing in the second sentence the 

words ‘‘at a temperature not higher than 

20 °F during shipping and upon arrival 

in the United States, and’’; and by 

removing the third sentence. 

§ 319.56-13 [Amended] 

■ 47. Section 319.56-13 is amended as 

follows: 

■ a. In paragraph (b)(1)(ii), by removing 

the words ‘‘an approved treatment listed 

in’’. 

■ b. In paragraphs (b)(5)(xiii) and 

(b)(5)(xv), by removing the words ‘‘with 

an approved treatment listed in 7 CFR’’ 

and adding the words ‘‘in accordance 

with’’ in their place; and by adding the 

words ‘‘of this chapter’’ after the words 

‘‘part 305’’. 

§ 319.56-21 [Amended] 

■ 48. In § 319.56-21, paragraphs (b)(2) 

and (d)(2) are amended by removing the 

words ‘‘an approved treatment listed in’’. 

■ 49. In § 319.56-22, paragraph (g)(2) is 

revised to read as follows: 

§ 319.56-22 Apples and pears from certain 

countries in Europe. 

* * * * * 

(g) * * * 

(2) Treatments must be conducted in 

accordance with part 305 of this 

chapter. 

* * * * * 

■ 50. Section 319.56-23 is amended as 

follows: 

■ a. In footnote 3, by removing the 

words ‘‘a treatment listed in’’. 

■ b. By revising paragraph (f)(2) to read 

as set forth below. 

§ 319.56-23 Apricots, nectarines, peaches, 

plumcot, and plums from Chile. 

* * * * * 

(f) * * * 

mstockstill on DSKH9S0YB1PROD with RULES2

Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Rules and Regulations 4253 

(2) Treatments must be conducted in 

accordance with part 305 of this 

chapter. 

* * * * * 

§ 319.56-38 [Amended] 

■ 51. In § 319.56-38, paragraph 

(d)(4)(ii)(B) is amended by removing the 

words ‘‘an authorized treatment for the 

pest is available in’’ and adding the 

words ‘‘a treatment for the pest is 

authorized by’’ in their place. 

§ 319.56-46 [Amended] 

■ 52. In § 319.56-46, paragraph (a) is 

amended by removing the words ‘‘by 

receiving a minimum absorbed dose of 

400 Gy’’ and adding the words ‘‘for plant 

pests of the class Insecta, except pupae 

and adults of the order Lepidoptera’’ in 

their place; and by removing the citation 

‘‘§ 305.31’’ and adding the words ‘‘part 

305’’ in its place. 

§ 319.56-47 [Amended] 

■ 53. Section 319.56-47 is amended as 

follows: 

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

citation ‘‘§ 305.31’’ and adding the words 

‘‘part 305’’ in its place. 

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

citation ‘‘§ 305.31’’ and adding the words 

‘‘part 305 of this chapter’’ in its place. 

■ 54. In § 319.59-4, paragraph (d)(3) is 

revised to read as follows: 

§ 319.59-4 Karnal bunt. 

* * * * * 

(d) * * * 

(3) Items that require disinfection 

prior to entry into the United States 

must be disinfected in accordance with 

part 305 of this chapter. 

* * * * * 

■ 55. Section 319.74-2 is amended as 

follows: 

■ a. By redesignating the introductory 

text to paragraph (c)(1) as the 

introductory text to paragraph (c); 

removing paragraph (c)(2); and 

redesignating paragraphs (c)(1)(i) and 

(c)(1)(ii) as paragraphs (c)(1) and (c)(2), 

respectively. 

■ b. In the newly redesignated 

introductory text of paragraph (c), by 

removing the words ‘‘paragraph (c)(2) of 

this section’’ and adding the words ‘‘part 

305 of this chapter’’ in their place. 

■ c. By revising the first two sentences 

of paragraph (e) to read as set forth 

below. 

§ 319.74-2 Conditions governing the entry 

of cut flowers. 

* * * * * 

(e) Irradiation. Cut flowers and foliage 

that are required under this part to be 

treated or subjected to inspection to 

control one or more of the plant pests 

for which irradiation is an approved 

treatment under part 305 of this chapter 

may instead be treated with irradiation. 

Irradiation treatment must be conducted 

in accordance with the requirements of 

part 305 of this chapter. * * * 

* * * * * 

PART 330—FEDERAL PLANT PEST 

REGULATIONS; GENERAL; PLANT 

PESTS; SOIL, STONE, AND QUARRY 

PRODUCTS; GARBAGE 

■ 56. The authority citation for part 330 

continues to read as follows: 

Authority: 7 U.S.C. 450, 7701-7772, 7781- 

7786, and 8301-8317; 21 U.S.C. 136 and 136a; 

31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3. 

§ 330.106 [Amended] 

■ 57. In § 330.106, paragraph (a) is 

amended by adding in the fourth 

sentence the words ‘‘in accordance with 

part 305 of this chapter’’ after the word 

‘‘treatment.’’ 

§ 330.300 [Amended] 

■ 58. In § 330.300, paragraph (a) is 

amended by removing the words 

‘‘methods of’’ and by adding the words 

‘‘in accordance with part 305 of this 

chapter’’ after the word ‘‘treatment.’’ 

PART 352—PLANT QUARANTINE 

SAFEGUARD REGULATIONS 

■ 59. The authority citation for part 352 

continues to read as follows: 

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

7786; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 

7 CFR 2.22, 2.80, and 371.3. 

§ 352.10 [Amended] 

■ 60. In § 352.10, paragraph (b)(2)(viii) 

is amended by adding the words ‘‘in 

accordance with part 305 of this 

chapter’’ after the word ‘‘treatment.’’ 

§ 352.30 [Amended] 

■ 61. In § 352.30, paragraph (a)(4)(iii) is 

amended by removing the word ‘‘such’’ 

and by adding the word ‘‘any’’ in its 

place; and by adding the words ‘‘in 

accordance with part 305 of this 

chapter’’ after the word ‘‘treatment.’’ 

Done in Washington, DC, January 19, 

2010. 

Kevin Shea 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2010–1375 Filed 1–25–10: 8:45 am] 

BILLING CODE 3410–34–S 

mstockstill on DSKH9S0YB1PROD with RULES2