Federal Register / Vol. 72, No. 235 / Friday, December 7, 2007 / Rules and Regulations 69139 

then southeast, northeast, southeast, 

southwest, southeast, northeast, 

southeast, northeast, east, southeast, 

southwest, northwest, southwest, 

southeast, southwest, northwest, 

southwest, southeast, southwest, 

northwest, west, southeast, northwest, 

west, and southwest on Alum Rock 

Falls Road to State Highway 130; then 

southeast on State Highway 130 to 

Quimby Road; then southwest, 

northwest, southwest, northwest, 

southwest, and south on Quimby Road 

to Buckeye Ranch; then southeast and 

southwest on Buckeye Ranch to its 

southwesternmost point; then southwest 

from that point along an imaginary line 

to the northeasternmost point of Fowler 

Road; then southwest, southeast, east, 

southeast, northwest, southwest, 

southeast, south, west, northwest, and 

west on Fowler Road to Yerba Buena 

Road; then south and west on Yerba 

Buena Road to San Felipe Road; then 

southeast on San Felipe Road to 

Farnsworth Drive; then southwest, 

northwest, and southwest on 

Farnsworth Drive to Silver Creek Valley 

Road; then southwest, southeast, 

southwest, and west on Silver Creek 

Valley Road to Blossom Hill Road; then 

west and southwest on Blossom Hill 

Road to State Highway 82; then 

northwest on State Highway 82 to 

Southside Drive; then southeast from 

the intersection of State Highway 82 and 

Southside Drive along an imaginary line 

to the northeasternmost point of 

Hillsdale Drive; then southwest on 

Hillsdale Drive to Hillsdale Avenue; 

then west on Hillsdale Avenue to State 

Highway 87; then northwest on State 

Highway 87 to Interstate 880; then 

northeast and north on Interstate 880 to 

the point of beginning. 

Solano County. That portion of 

Solano County in the Dixon area 

bounded by a line as follows: Beginning 

at the intersection of Boyce Road and 

Putah Creek Road; then northeast, 

southeast, and northeast on Putah Creek 

Road to Stevenson Bridge Road; then 

northeast and northwest on Stevenson 

Bridge Road to Putah Creek; then 

southeast along Putah Creek to the south 

fork of Putah Creek; then southeast 

along the south fork of Putah Creek to 

Old Davis Road; then south, west, and 

south on Old Davis Road to Tremont 

Road; then east on Tremont Road to 

Bulkley Road; then south on Bulkley 

Road to Midway Road; then west on 

Midway Road to Sikes Road; then south 

on Sikes Road to Swan Road; then west 

on Swan Road to Bunker Station Road; 

then south on Bunker Station Road to 

Binghamton Road; then west on 

Binghamton Road to State Highway 113; 

then north on State Highway 113 to 

Hawkins Road; then west on Hawkins 

Road to Lewis Road; then north on 

Lewis Road to Weber Road; then west 

and northwest on Weber Road to North 

Meridian Road; then northwest and 

north on North Meridian Road to 

Sweeney Road; then west on Sweeney 

Road to Halley Road; then north, 

southwest, and northwest on Halley 

Road to Wolfskill Road; then southwest 

on Wolfskill Road to Boyce Road; then 

northwest on Boyce Road to the point of 

beginning. 

Done in Washington, DC, this 30th day of 

November 2007. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E7–23770 Filed 12–6–07; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 983 

[Docket No. AMS–FV–07–0082; FV07–983–

1 IFR] 

Pistachios Grown in California; 

Changes in Handling Requirements 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Interim final rule with request 

for comments. 

SUMMARY: This rule changes the 

handling requirements currently 

authorized under the California 

pistachio marketing order (order). The 

order regulates the handling of 

pistachios grown in California and is 

administered locally by the 

Administrative Committee for 

Pistachios (committee). This rule 

suspends the minimum quality 

requirements, including maximum 

defects and minimum sizes, for 

California pistachios. This will reduce 

handler costs and provide handlers 

more flexibility in meeting customer 

needs. 

DATES: Effective December 10, 2007; 

comments received by February 5, 2008 

will be considered prior to issuance of 

a final rule. 

ADDRESSES: Interested persons are 

invited to submit written comments 

concerning this rule. Comments must be 

sent to the Docket Clerk, Marketing 

Order Administration Branch, Fruit and 

Vegetable Programs, AMS, USDA, 1400 

Independence Avenue, SW., STOP 

0237, Washington, DC 20250–0237; Fax: 

(202) 720–8938; or Internet: http:// 

www.regulations.gov. All comments 

should reference the docket number and 

the date and page number of this issue 

of the Federal Register and will be 

made available for public inspection in 

the Office of the Docket Clerk during 

regular business hours, or can be viewed 

at: http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Terry Vawter, Senior Marketing 

Specialist, or Kurt J. Kimmel, Regional 

Manager, California Marketing Field 

Office, Marketing Order Administration 

Branch, Fruit and Vegetable Programs, 

AMS, USDA; Telephone: (559) 487–

5901, Fax: (559) 487–5906, or Email: 

Terry.Vawter@usda.gov or 

Kurt.Kimmel@usda.gov. 

Small businesses may request 

information on complying with this 

regulation by contacting Jay Guerber, 

Marketing Order Administration 

Branch, Fruit and Vegetable Programs, 

AMS, USDA, 1400 Independence 

Avenue, SW., STOP 0237, Washington, 

DC 20250–0237; Telephone: (202) 720–

2491, Fax: (202) 720–8938, or E-mail: 

Jay.Guerber@usda.gov. 

SUPPLEMENTARY INFORMATION: This rule 

is issued under Marketing Order No. 

983 (7 CFR part 983), regulating the 

handling of pistachios grown in 

California, hereinafter referred to as the 

‘‘order.’’ The order is effective under the 

Agricultural Marketing Agreement Act 

of 1937, as amended (7 U.S.C. 601–674), 

hereinafter referred to as the ‘‘Act.’’

The Department of Agriculture 

(USDA) is issuing this rule in 

conformance with Executive Order 

12866. 

This rule has been reviewed under 

Executive Order 12988, Civil Justice 

Reform. This rule is not intended to 

have retroactive effect. This rule will 

not preempt any State or local laws, 

regulations, or policies, unless they 

present an irreconcilable conflict with 

this rule. 

The Act provides that administrative 

proceedings must be exhausted before 

parties may file suit in court. Under 

section 608c(15)(A) of the Act, any 

handler subject to an order may file 

with USDA a petition stating that the 

order, any provision of the order, or any 

obligation imposed in connection with 

the order is not in accordance with law 

and request a modification of the order 

or to be exempted therefrom. A handler 

is afforded the opportunity for a hearing 

on the petition. After the hearing, USDA 

would rule on the petition. The Act 

provides that the district court of the 

United States in any district in which 

the handler is an inhabitant, or has his 

or her principal place of business, has 

jurisdiction to review USDA’s ruling on 


rfrederick on PROD1PC67 with RULES
69140 Federal Register / Vol. 72, No. 235 / Friday, December 7, 2007 / Rules and Regulations 

1 Doster, M.A., T.J. Michailides, L.D. Boeckler, 

and D.P. Morgan, 2006. Development of expert 

systems and predictive models for aflatoxin 

contamination in pistachios. In California Pistachio 

Industry Annual Report Crop Year 2005–2006, pg. 

101–102. 

2 Doster, M.A., T.J. Michailides, L.D. Boeckler, 

and D.P. Morgan, 2007. Prediction of aflatoxin 

contamination and a survey of fungi producing 

Ochratoxin A in California pistachios. In California 

Pistachio Industry Annual Report Crop Year 2006–

2007, pg. 109–110. 

the petition, provided an action is filed 

not later than 20 days after the date of 

the entry of the ruling. 

This rule changes the handling 

requirements for pistachios currently 

authorized under the order. This rule 

suspends the minimum quality 

requirements, including maximum 

defects and minimum sizes, for 

California pistachios. This will reduce 

handler costs and provide handlers 

more flexibility in meeting customer 

needs. This action was recommended by 

the committee. 

Section 983.39 establishes minimum 

quality levels for pistachios, including 

maximum defects and minimum sizes 

permitted under the order. Under 

§ 983.46, the Secretary may modify, 

suspend, or make rules and regulations 

to implement §§ 983.38 through 983.45 

based upon a recommendation by seven 

concurring committee members or other 

available information. 

The quality and size requirements 

have been in effect for California 

pistachios since the order’s inception in 

2004. Evidence provided at the 

promulgation hearing suggested that 

there was a direct link between lowerquality pistachios and the incidence of 

aflatoxin contamination (see 68 FR 

45990). Aflatoxin is one of a group of 

mycotoxins produced by the molds 

Aspergillus flavus and Aspergillus 

parasiticus. Aflatoxins are naturallyoccurring in the field and can be further 

spread in improperly processed and 

stored nuts, dried fruits, and grains. The 

data presented at the hearing was based 

on aflatoxin analyses of pistachios with 

different defects. Although the data also 

indicated that the levels of aflatoxin 

associated with each defect varied 

widely, researchers attributed this to 

variability among the samples. 

As further data was collected in 2005 

and 2006, University of California 

researchers concluded that variability in 

aflatoxin levels seen in previous studies 

may have been due to geographic 

variability 1 2. Aflatoxin contamination 

is more prevalent in pistachios 

produced in the northern San Joaquin 

Valley, while quality defects, largely 

due to insect damage, are less prevalent. 

The opposite is true for the southern 

San Joaquin Valley. It is now believed 

that these differences in aflatoxin 

contamination between the growing 

areas are due to differences in climate. 

The northern San Joaquin Valley has 

more aflatoxin contamination because 

its cooler temperatures and greater 

moisture are more conducive to 

Aspergillus and aflatoxin development, 

but less conducive to insect population 

and damage. However, in the southern 

San Joaquin Valley, there is a higher 

incidence of insect damage and a much 

lower incidence of aflatoxin 

contamination because of the drier 

environment and higher temperatures. 

Thus, recent research suggests that 

aflatoxin occurrence in pistachios may 

be attributable to climatic factors. 

Additionally, growers and handlers 

are reporting unexpected problems with 

the size of pistachios this season, as 

well as with staining of the nut shell 

from the hull. Pistachios are smaller 

than usual, and the large crop has 

resulted in a large percentage of 

pistachios which may not meet the 

requirements of the order because the 

sizes are smaller than currently 

authorized, which is 30/64ths of an 

inch. Staining is a problem this season 

due to unseasonable humidity and 

spotty rains on August 26th and 30th. 

The moisture wet the outer hull, and the 

hull then stained the pistachio shell. 

Dark stains are an external defect, which 

affects overall pistachio quality. 

Thus, the committee recommended 

suspending the minimum quality 

requirements, which include maximum 

defects and minimum sizes, under the 

order. This will reduce handler costs 

and provide handlers more flexibility in 

meeting customer needs. Suspending 

these requirements also necessitates 

modifications to other sections of the 

order and regulations that reference 

minimum quality and size 

requirements. Accordingly, this rule 

partially suspends or amends language 

in §§ 983.6, 983.7, 983.31, 983.38, 

983.40, 983.41, 983.42, 983.45, 983.138, 

983.143, and 983.147 of the order; and 

suspends §§ 983.19, 983.20, 983.39, and 

983.141 in their entirety. 

Additionally, the third sentence in 

§ 983.11(b), and all of § 983.71 are 

removed because the committee’s State 

counterpart, the California Pistachio 

Commission, has been terminated and 

there is currently no relationship 

between the two organizations. 

Initial Regulatory Flexibility Analysis 

Pursuant to requirements set forth in 

the Regulatory Flexibility Act (RFA), 

Agricultural Marketing Service (AMS) 

has considered the economic impact of 

this action on small entities. 

Accordingly, AMS has prepared this 

initial regulatory flexibility analysis. 

The purpose of the RFA is to fit 

regulatory actions to the scale of 

business subject to such actions in order 

that small businesses would not be 

unduly or disproportionately burdened. 

Marketing orders issued pursuant to the 

Act, and the rules issued thereunder, are 

unique in that they are brought about 

through group action of essentially 

small entities acting on their own 

behalf. 

There are approximately 740 

producers in the production area, and 

50 handlers of California pistachios 

subject to regulation. The Small 

Business Administration (SBA) (13 CFR 

121.201) defines small agricultural 

producers as those having annual 

receipts less than $750,000, and defines 

small agricultural service firms those 

whose annual receipts are less than 

$6,500,000. Of the 740 producers, 

approximately 722 have annual receipts 

of less than $750,000. Forty-two of the 

50 handlers subject to regulation have 

annual pistachio receipts of less than 

$6,500,000. Thus, the majority of 

producers and handlers of California 

pistachios may be classified as small 

entities. 

This rule changes the handling 

requirements authorized under the 

order. This rule suspends the minimum 

quality requirements, including 

maximum defects and minimum sizes, 

for California pistachios. Authority for 

this action is provided in § 983.46. 

Regarding the impact on affected 

entities, suspending the minimum 

quality requirements will decrease 

handler inspection costs. The committee 

currently estimates that the direct costs 

to obtain inspection average 

approximately $50.00 per lot. The 

average lot is approximately 44,000 

pounds. With over 100,000,000 pounds 

shipped domestically, the direct costs 

for inspection for approximately 2,300 

lots could total $115,000 for the 

industry. The direct costs do not 

include handler staff time in preparing 

samples, and handler storage and 

recordkeeping costs associated with 

inspected pistachios. 

The committee considered 

alternatives to suspending the minimum 

quality requirements. Some producers 

were concerned that this could give 

handlers too much latitude in their 

operations. Other producers commented 

that handlers’ customers would likely 

dictate product quality and prevent 

shipment of substandard pistachios into 

the market. Ultimately, the majority of 

committee members supported the 

changes. 


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Federal Register / Vol. 72, No. 235 / Friday, December 7, 2007 / Rules and Regulations 69141 

In accordance with the Paperwork 

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

Chapter 35), the form ACP–5, ‘‘Minimal 

Testing’’ being suspended by this rule 

was previously approved by the Office 

of Management and Budget and 

assigned OMB No. 0581–0215, 

Pistachios Grown in California, for 1 

burden hour. As with all Federal 

marketing order programs, reports and 

forms are periodically reviewed to 

reduce information requirements and 

duplication by industry and public 

sector agencies. 

AMS is committed to complying with 

the E-Government Act, to promote the 

use of the Internet and other 

information technologies to provide 

increased opportunities for citizen 

access to Government information and 

services, and for other purposes. 

USDA has not identified any relevant 

Federal rules that duplicate, overlap, or 

conflict with this rule. 

Further, the committee meetings 

where this action was discussed were 

widely publicized throughout the 

pistachio industry and all interested 

persons were encouraged to attend the 

meetings and participate in the 

committee’s deliberations. Like all 

committee meetings, these were public 

meetings, and entities of all sizes were 

encouraged to express their views on 

these issues. Finally, interested persons 

are invited to submit comments on this 

interim final rule, including the 

regulatory and informational impacts of 

this action on small businesses. 

A small business guide on complying 

with fruit, vegetable, and specialty crop 

marketing agreements and orders may 

be viewed at: http://www.ams.usda.gov/ 

fv/moab/html. Any questions about the 

compliance guide should be sent to Jay 

Guerber at the previously mentioned 

address in the FOR FURTHER INFORMATION

CONTACT section. 

This rule invites comments on 

changes to the handling requirements 

currently prescribed under the order. 

Any comments received will be 

considered prior to finalization of this 

rule. 

The order provisions suspended by 

this action no longer tend to effectuate 

the declared policy of the Act. 

Accordingly, after consideration of all 

relevant material presented, including 

the committee’s recommendation, and 

other information, it is found that this 

interim final rule, as hereinafter set 

forth, will effectuate the declared policy 

of the Act. 

Pursuant to 5 U.S.C. 553, it is also 

found and determined upon good cause 

that it is impracticable, unnecessary, 

and contrary to the public interest to 

give preliminary notice prior to putting 

this rule into effect and that good cause 

exists for not postponing the effective 

date of this rule until 30 days after 

publication in the Federal Register 

because: (1) It relaxes quality 

requirements currently in effect; (2) 

handlers are already receiving 2007–08 

crop pistachios, and this rule should 

apply to as much of the 2007–08 crop 

as possible; (3) handlers are aware of 

these changes, which were discussed at 

two public meetings; and (4) this rule 

has a 60-day comment period and any 

comments received will be considered 

prior to finalization of this rule. 

List of Subjects in 7 CFR Part 983 

Pistachios, Marketing agreements and 

orders, Reporting and recordkeeping 

requirements. 

■ For the reasons set forth in the 

preamble, 7 CFR part 983 is amended as 

follows: 

PART 983—PISTACHIOS GROWN IN 

CALIFORNIA 

■ 1. The authority citation for 7 CFR 

part 983 continues to read as follows: 

Authority: 7 U.S.C. 601–674. 

§§ 983.19, 983.20, 983.39, 983.141 

[Amended] 

■ 2. In part 983, §§ 983.19, 983.20, 

983.39, and 983.141 are suspended 

indefinitely. 

§ 983.6 [Amended] 

■ 3. In § 983.6, the words ‘‘free of 

internal defects as defined in 

§ 983.39(b)(4) and (5)’’ are suspended 

indefinitely. 

§ 983.7 [Amended] 

■ 4. In § 983.7, the words ‘‘and 

minimum quality’’ are suspended 

indefinitely. 

§ 983.11 [Amended] 

■ 5. In § 983.11, paragraph (b), the third 

sentence is removed. 

§ 983.31 [Amended] 

■ 6. In § 983.31, the words ‘‘and/or 

minimum quality’’ are suspended 

indefinitely. 

§ 983.38 [Amended] 

■ 7. In § 983.38, paragraph (d)(1), the 

words ‘‘and divided between those 

pistachios for aflatoxin testing and those 

for minimum quality testing’’ are 

suspended indefinitely. 

■ 8. In § 983.38, paragraph (d)(4), the 

word ‘‘, grade’’ is suspended from the 

penultimate sentence indefinitely. 

§ 983.40 [Amended] 

■ 9. Paragraph (a) of § 983.40 is 

suspended indefinitely. 

■ 10. In § 983.40, paragraph (b), the 

words ‘‘and/or the minimum quality’’

are suspended from the first sentence 

indefinitely, the words ‘‘either’’ and ‘‘or 

the minimum quality’’ are suspended 

from the second sentence indefinitely, 

and the words ‘‘, and the handler, under 

the supervision of an inspector, shall 

send the failed lot notification reports 

for the lots that do not meet the 

minimum quality requirements to the 

committee’’ are suspended from the 

third sentence indefinitely. 

■ 11. In § 983.40, paragraph (c), the fifth 

sentence is suspended indefinitely. 

■ 12. Paragraph (e) of § 983.40 is 

suspended indefinitely. 

§ 983.41 [Amended] 

■ 13. Paragraph (b) of § 983.41 is 

suspended indefinitely. 

§ 983.42 [Amended] 

■ 14. In § 983.42, the words ‘‘and 

minimum quality certificate’’ are 

suspended indefinitely. 

§ 983.45 [Amended] 

■ 15. In § 983.45, the words ‘‘and 

minimum quality requirements,’’ the 

first ‘‘§ ,’’ and ‘‘and 983.39’’ are 

suspended indefinitely. 

§ 983.71 [Removed] 

■ 16. Section 983.71 is removed. 

■ 17. Section 983.138 is revised to read 

as follows: 

§ 983.138 Samples for testing. 

Prior to testing, a sample shall be 

drawn from each lot to be used to test 

pistachios for aflatoxin. The lot sample 

shall be of sufficient weight to comply 

with Tables 1 and 2 of § 983.38. 

§ 983.143 [Amended] 

■ 18. Section 983.143 is amended by 

revising paragraph (b) to read as follows: 

§ 983.143 Reinspection. 

(a) * * * 

(b) Each handler who handles 

pistachios shall cause any lot or portion 

of a lot initially certified for aflatoxin, 

and subsequently materially changed, to 

be reinspected for aflatoxin and certified 

as a new lot or new lots: Provided, That, 

handlers exempted from order 

requirements under § 983.170 are 

exempt from all reinspection 

requirements. 

■ 19. In § 983.147, paragraph (a) is 

revised to read as follows: 


rfrederick on PROD1PC67 with RULES
69142 Federal Register / Vol. 72, No. 235 / Friday, December 7, 2007 / Rules and Regulations 

§ 983.147 Reports. 

(a) ACP–2, Failed Lot Notification. 

Each handler shall notify the 

Administrative Committee for 

Pistachios (committee) of all lots that 

fail to meet the order’s maximum 

aflatoxin requirements by completing 

section A of this form. Handlers shall 

furnish this report to the committee no 

later than 10 days after completion of 

the aflatoxin test. Each USDA-approved 

aflatoxin testing laboratory shall 

complete section C of this report, and 

forward this report and the failing 

aflatoxin test results to the committee 

and to the handler within 10 days of the 

test failure. 

* * * * * 

§ 983.147 [Amended] 

■ 20. Paragraph (d) of § 983.147 is 

suspended indefinitely. 

Dated: December 4, 2007. 

Lloyd C. Day, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. 07–5989 Filed 12–5–07; 10:02 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

Implantation or Injectable Dosage 

Form New Animal Drugs; Erythromycin 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of a supplemental new animal 

drug application (NADA) filed by Cross 

Vetpharm Group Ltd. The supplemental 

NADA provides for use of a 100 

milligram per milliliter (mg/mL) 

strength erythromycin injectable 

solution in cattle for the treatment of 

bovine respiratory disease. 

DATES: This rule is effective December 7, 

2007. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–104), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Cross 

Vetpharm Group Ltd., Broomhill Rd., 

Tallaght, Dublin 24, Ireland, filed a 

supplement to NADA 12–123 for 

GALLIMYCIN–100 (erythromycin) 

Injection. The supplemental NADA 

provides for use of a 100 mg/mL 

strength erythromycin injectable 

solution in cattle for the treatment of 

bovine respiratory disease. The 

supplemental NADA is approved as of 

November 15, 2007, and the regulations 

in 21 CFR 522.820 are amended to 

reflect the approval and a current 

format. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

may be seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852, between 9 

a.m. and 4 p.m., Monday through 

Friday. 

The agency has determined under 21 

CFR 25.33(a)(1) that this action is of a 

type that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subject in 21 CFR Part 522 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 522 is amended as follows: 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 522 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 2. Revise § 522.820 to read as follows: 

§ 522.820 Erythromycin. 

(a) Sponsor. See No. 061623 in 

§ 510.600(c) of this chapter. 

(b) Specifications—(1) Each milliliter 

(mL) of solution contains 100 

milligrams (mg) erythromycin base. 

(2) Each mL of solution contains 200 

mg erythromycin base. 

(c) Related tolerances. See § 556.230 

of this chapter. 

(d) Conditions of use—(1) Dog. 

Administer product described in 

paragraph (b)(1) of this section as 

follows: 

(i) Amount. 3 to 5 mg per pound (/lb) 

body weight, intramuscularly, two to 

three times daily, for up to 5 days. 

(ii) Indications for use. For the 

treatment of bacterial pneumonia, upper 

respiratory infections (tonsillitis, 

bronchitis, tracheitis, pharyngitis, 

pleurisy), endometritis and metritis, and 

bacterial wound infections caused by 

Staphylococcus spp., Streptococcus 

spp., and Corynebacterium spp., 

sensitive to erythromycin. 

(iii) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

(2) Cats. Administer product 

described in paragraph (b)(1) of this 

section as follows: 

(i) Amount. 3 to 5 mg/lb body weight, 

intramuscularly, two to three times 

daily, for up to 5 days. 

(ii) Indications for use. For the 

treatment of bacterial pneumonia, upper 

respiratory infections (rhinitis, 

bronchitis), secondary infections 

associated with panleukopenia, and 

bacterial wound infections caused by 

Staphylococcus spp. and Streptococcus 

spp., susceptible to erythromycin. 

(iii) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

(3) Cattle. Administer products 

described in paragraph (b) of this 

section as follows: 

(i) Amount. 4 mg/lb body weight by 

deep intramuscular injection once daily 

for up to 5 days. 

(ii) Indications for use. For the 

treatment of bovine respiratory disease 

(shipping fever complex and bacterial 

pneumonia) associated with Pasteurella 

multocida susceptible to erythromycin. 

(iii) Limitations. Do not use in female 

dairy cattle over 20 months of age. Do 

not slaughter treated animals within 6 

days of last treatment. A withdrawal 

period has not been established for this 

product in pre-ruminating calves. Do 

not use in calves to be processed for 

veal. To avoid excess trim, do not 

slaughter within 21 days of last 

injection. 

Dated: November 30, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. E7–23763 Filed 12–6–07; 8:45 am] 

BILLING CODE 4160–01–S 


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