31720 Federal Register / Vol. 77, No. 104 / Wednesday, May 30, 2012 / Rules and Regulations 

PART 58—[AMENDED] 

■ 1. The authority citation for 7 CFR 

part 58 continues to read as follows: 

Authority: 7 U.S.C. 1621–1627. 

■ 2. Amend § 58.133 by revising 

paragraphs (b)(5) introductory text, 

(b)(5)(ii), and (b)(6) to read as follows: 

§ 58.133 Methods for quality and 

wholesomeness determination. 

* * * * * 

(b) * * * 

(5) Whenever the official test 

indicates the presence of more than 

750,000 somatic cells per ml. (1,500,000 

per ml. for goat milk), the following 

procedures shall be applied: 

* * * * * 

(ii) Whenever two out of the last four 

consecutive somatic cell counts exceed 

750,000 per ml. (1,500,000 per ml. for 

goat milk), the appropriate State 

regulatory authority shall be notified 

and a written notice given to the 

producer. This notice shall be in effect 

as long as two of the last four 

consecutive samples exceed 750,000 per 

ml. (1,500,000 per ml. for goat milk). 

(6) An additional sample shall be 

taken after a lapse of 3 days but within 

21 days of the notice required in 

paragraph (b)(5)(ii) of this section. If this 

sample also exceeds 750,000 per ml. 

(1,500,000 per ml. for goat milk), 

subsequent milkings shall not be 

accepted for market until satisfactory 

compliance is obtained. Shipment may 

be resumed and a temporary status 

assigned to the producer by the 

appropriate State regulatory agency 

when an additional sample of herd milk 

is tested and found satisfactory. The 

producer may be assigned a full 

reinstatement status when three out of 

four consecutive somatic cell count tests 

do not exceed 750,000 per ml. 

(1,500,000 per ml. for goat milk). The 

samples shall be taken at a rate of not 

more than two per week on separate 

days within a 3-week period. 

* * * * * 

■ 3. Amend § 58.134 by revising the 

section heading and paragraphs (b), (c) 

introductory text, (d), and (e) and 

removing paragraphs (c)(1) and (2). 

The revisions read as follows: 

§ 58.134 Sediment content for milk in 

cans. 

(b) Sediment content classification. 

Milk in cans shall be classified for 

sediment content, regardless of the 

results of the appearance and odor 

examination required in § 58.133(a), as 

follows: 

USDA SEDIMENT STANDARD 

No. 1 (acceptable)—not to exceed 0.50 

mg. or equivalent. 

No. 2 (acceptable)—not to exceed 1.50 

mg. or equivalent. 

No. 3 (probational, not over 10 

days)—not to exceed 2.50 mg. or 

equivalent. 

No. 4 (reject)—over 2.50 mg. or 

equivalent. 

(c) Frequency of tests. At least once 

each month, at irregular intervals, one 

or more cans of milk selected at random 

from each producer shall be tested. 

(d) Acceptance or rejection of milk. If 

the sediment disc is classified as No. 1, 

No. 2, or No. 3, the producer’s milk may 

be accepted. If the sediment disc is 

classified No. 4 the milk shall be 

rejected: Provided that, If the shipment 

of milk is commingled with other milk 

in a transport tank the next shipment 

shall not be accepted until its quality 

has been determined before being 

picked up; however, if the person 

making the test is unable to get to the 

farm before the next shipment it may be 

accepted but no further shipments shall 

be accepted unless the milk meets the 

requirements of No. 3 or better. In the 

case of milk classified as No. 3 or No. 

4, all cans shall be tested. Producers of 

No. 3 or No. 4 milk shall be notified 

immediately and shall be furnished 

applicable sediment discs and the next 

shipment shall be tested. 

(e) Retests. On test of the next 

shipment all cans shall be tested. Milk 

classified as No. 1, No. 2, or No. 3 may 

be accepted, but No. 4 milk shall be 

rejected. The producers of No. 3 or No. 

4 milk shall be notified immediately, 

furnished applicable sediment discs and 

the next shipment tested. This 

procedure of retesting successive 

shipments and accepting probational 

(No. 3) milk and rejecting No. 4 milk 

may be continued for not more than 10 

calendar days. If at the end of this time 

all of the producer’s milk does not meet 

the acceptable sediment content 

classification (No. 1 or No. 2), it shall be 

rejected. 

* * * * * 

Dated: May 22, 2012. 

David R. Shipman, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2012–13065 Filed 5–29–12; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

7 CFR Part 301 

[Docket No. APHIS–2012–0003] 

Asian Longhorned Beetle; Quarantined 

Areas in Massachusetts, Ohio, and 

New York 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Interim rule and request for 

comments. 

SUMMARY: We are amending the Asian 

longhorned beetle regulations to make 

changes to the list of quarantined areas 

by adding portions of Worcester County, 

MA, and Clermont County, OH, to the 

list of quarantined areas. We are also 

removing a portion of Suffolk County, 

NY, from the list of quarantined areas 

based on our determination that the area 

meets our criteria for removal. These 

actions are necessary to prevent the 

artificial spread of Asian longhorned 

beetle to noninfested areas of the United 

States and to relieve restrictions on 

certain areas that are no longer 

necessary. 

DATES: This interim rule is effective 

May 30, 2012. We will consider all 

comments that we receive on or before 

July 30, 2012. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/ 

#!documentDetail;D=APHIS-2012-0003- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0003, Regulatory Analysis 

and Development, PPD, APHIS, Station 

3A–03.8, 4700 River Road, Unit 118, 

Riverdale, MD 20737–1238. 

Supporting documents and any 

comments we receive on this docket 

may be viewed at http:// 

www.regulations.gov/ 

#!docketDetail;D=APHIS-2012-0003 or 

in our reading room, which is located in 

room 1141 of the USDA South Building, 

14th Street and Independence Avenue 

SW., Washington, DC. Normal reading 

room hours are 8 a.m. to 4:30 p.m., 

Monday through Friday, except 

holidays. To be sure someone is there to 

help you, please call (202) 799–7039 

before coming. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Claudia Ferguson, Regulatory Policy 

Specialist, Regulations, Permits and 

Manuals, PPQ, APHIS, 4700 River Road, 

Unit 26, Riverdale, MD 20737–1236; 

(301) 851–2352. 


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Federal Register / Vol. 77, No. 104 / Wednesday, May 30, 2012 / Rules and Regulations 31721 

SUPPLEMENTARY INFORMATION: 

Background 

The Asian longhorned beetle (ALB, 

Anoplophora glabripennis), an insect 

native to China, Japan, Korea, and the 

Isle of Hainan, is a destructive pest of 

hardwood trees. The ALB regulations in 

7 CFR 301.51–1 through 301.51–9 

(referred to below as the regulations) 

restrict the interstate movement of 

regulated articles from quarantined 

areas to prevent the artificial spread of 

ALB to noninfested areas of the United 

States. 

On October 25, 2011, an ALB 

infestation was discovered in the central 

portion of Shrewsbury in Worcester 

County, MA. On June 17, 2011, an ALB 

infestation was discovered in the 

townships of Monroe and Tate, and in 

the East Fork State Park in Clermont 

County, OH. These States have 

quarantined the infested areas and are 

restricting the intrastate movement of 

regulated articles from the quarantined 

areas to prevent the further spread of 

ALB within each State. Federal 

regulations are necessary to restrict the 

interstate movement of regulated 

articles from the quarantined areas to 

prevent the interstate spread of ALB. 

The regulations in § 301.51–3(a) 

provide that APHIS will list as a 

quarantined area each State, or each 

portion of a State, where ALB has been 

found by an inspector, where the 

Administrator has reason to believe that 

ALB is present, or where the 

Administrator considers regulation 

necessary because of its inseparability 

for quarantine purposes from localities 

where ALB has been found. 

Less than an entire State will be 

quarantined only if (1) the 

Administrator determines that the State 

has adopted and is enforcing restrictions 

on the intrastate movement of regulated 

articles that are equivalent to those 

imposed by the regulations on the 

interstate movement of regulated 

articles and (2) the designation of less 

than an entire State as a quarantined 

area will be adequate to prevent the 

artificial spread of ALB. 

In accordance with these criteria and 

the recent ALB findings described 

above, we are adding the Town of 

Shrewsbury in Worcester County, MA, 

and a portion of the Township of 

Monroe, the entire Township of Tate, 

and the entire acreage of East Fork State 

Park in Clermont County, OH, to the list 

of quarantined areas in § 301.51–3(c). 

The quarantined areas are described in 

detail in the regulatory text of this 

document. 

In 2000, APHIS established a 

quarantined area in Islip, Suffolk 

County, NY, after ALB was first detected 

in the area in order to prevent the 

artificial spread of ALB. After the 

completion of control and regulatory 

activities, and based on the results of at 

least 3 years of negative surveys of all 

regulated host plants within the 

quarantined area, APHIS determined 

that the villages of Bayshore, East Islip, 

and Islip Terrace in the Town of Islip, 

Suffolk County, NY, have met the 

criteria for removal of the Federal 

quarantine for ALB. 

Therefore, in this interim rule, we are 

amending the list of quarantined areas 

in § 301.51–3(c) by removing the 

villages of Bayshore, East Islip, and Islip 

Terrace in the Town of Islip, Suffolk 

County, NY. This action relieves 

restrictions on the movement of 

regulated articles from those areas that 

are no longer warranted. 

Immediate Action 

Immediate action is necessary to help 

prevent ALB from spreading to 

noninfested areas of the United States. 

In addition, this rule also relieves 

restrictions on certain areas that are no 

longer warranted. Under these 

circumstances, the Administrator has 

determined that prior notice and 

opportunity for public comment are 

contrary to the public interest and that 

there is good cause under 5 U.S.C. 553 

for making this action effective less than 

30 days after publication in the Federal 

Register. 

We will consider comments we 

receive during the comment period for 

this interim rule (see DATES above). 

After the comment period closes, we 

will publish another document in the 

Federal Register. The document will 

include a discussion of any comments 

we receive and any amendments we are 

making to the rule. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This interim rule is subject to under 

Executive Order 12866. However, for 

this action, the Office of Management 

and Budget has waived its review under 

Executive Order 12866. 

In accordance with 5 U.S.C. 603, we 

have performed an initial regulatory 

flexibility analysis, which is 

summarized below, regarding the 

economic effects of this rule on small 

entities. The full analysis may be 

viewed on the Regulations.gov Web site 

(see ADDRESSES above for instructions 

for accessing Regulations.gov) or 

obtained from the person listed under 

FOR FURTHER INFORMATION CONTACT. 

This rule amends the ALB regulations 

by adding certain areas in 

Massachusetts and Ohio to the list of 

quarantined areas. This rule also 

removes certain areas in New York from 

quarantine based on surveys that 

indicate these areas have met the 

criteria for release from regulation. 

Potentially, about 30 entities may be 

affected in the expanded quarantine 

area in Massachusetts, and about 80 

entities may be affected in Ohio. These 

businesses include landscape 

companies, tree service companies, 

firewood dealers, construction 

companies, waste haulers, and other 

operations that move regulated articles 

from the quarantined areas. Additional 

costs of operating such businesses under 

ALB quarantine are small, and 

principally derive from self-inspection 

and certification of regulated material 

under compliance agreements. In Islip, 

New York, the approximately 90 entities 

that have been affected by the 

quarantine will benefit from its removal 

by no longer having to satisfy movement 

restrictions. Most if not all of the 

businesses that will be affected by this 

rule in the three States are 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 rule has been reviewed under 

Executive Order 12988, Civil Justice 

Reform. This rule: (1) Preempts all State 

and local laws and regulations that are 

in conflict with this rule; (2) has no 

retroactive effect; and (3) does not 

require administrative proceedings 

before parties may file suit in court 

challenging this rule. 

Paperwork Reduction Act 

This interim rule contains no 

information collection or recordkeeping 

requirements under the Paperwork 

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

et seq.). 

List of Subjects in 7 CFR Part 301 

Agricultural commodities, Plant 

diseases and pests, Quarantine, 

Reporting and recordkeeping 

requirements, Transportation. 

Accordingly, we are amending 7 CFR 

part 301 as follows: 

PART 301—DOMESTIC QUARANTINE 

NOTICES 

■ 1. The authority citation for part 301 

continues to read as follows: 


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31722 Federal Register / Vol. 77, No. 104 / Wednesday, May 30, 2012 / Rules and Regulations 

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, Pub. L. 106–113, 113 Stat. 1501 

A–293; sections 301.75–15 and 301.75–16 

issued under Sec. 203, Title II, Pub. L. 106– 

224, 114 Stat. 400 (7 U.S.C. 1421 note). 

■ 2. In § 301.51–3, paragraph (c) is 

amended as follows: 

■ a. Under the heading 

‘‘Massachusetts,’’ by revising the entry 

for Worcester County; 

■ b. Under the entry for ‘‘New York,’’ by 

removing the second paragraph under 

the entry for Nassau and Suffolk 

Counties. 

■ c. By adding, in alphabetical order, an 

entry for ‘‘Ohio.’’ 

The revision and addition read as 

follows: 

§ 301.51–3 Quarantined areas. 

* * * * * 

(c) * * * 

Massachusetts 

* * * * * 

Worcester County. The portion of 

Worcester County, including portions or 

all of the municipalities of Worcester, 

Holden, West Boylston, Boylston, 

Auburn, and Shrewsbury that is 

bounded by a line starting at the 

intersection of Route 9 (Belmont Street) 

and the eastern boundary of the town of 

Shrewsbury; then follow the 

Shrewsbury town boundary northerly 

until the Boylston town boundary; then 

follow the entirety of the Boylston town 

boundary until it comes to the West 

Boylston town boundary on the 

Massachusetts Department of 

Conservation and Recreation Watershed 

property; then along the West Boylston 

town boundary until it intersects 

Manning Street; then southwest on 

Manning Street in Holden to Wachusett 

Street (Route 31); then south on 

Wachusett Street to Highland Street 

(still Route 31); then southwest on 

Highland Street to Main Street; then 

southeast on Main Street to Bailey Road; 

then south on Bailey Road to Chapin 

Road; then south on Chapin Road to its 

end; then continuing in a southeasterly 

direction to Fisher Road; then southwest 

on Fisher Road to Stonehouse Hill Road; 

then south on Stonehouse Hill Road to 

Reservoir Street; then southeast on 

Reservoir Street until it intersects the 

Worcester city boundary; turn south on 

Oxford Street to Auburn Street; then 

southeast on Auburn Street crossing 

under the Massachusetts Turnpike 

(I–90) and continuing southeast on 

Millbury Street; at the intersection of 

Washington Street, turn northeast and 

continue along Washington Street to the 

northern boundary of the Massachusetts 

Turnpike (I–90); then east along the 

northern boundary of the Massachusetts 

Turnpike (I–90) to the Auburn town 

boundary; then follow the Auburn town 

boundary northerly to the Worcester 

city boundary; continue along the 

Worcester city boundary until the 

Shrewsbury town boundary; then follow 

the entirety of the Shrewsbury town 

boundary until the point of beginning. 

* * * * * 

Ohio 

Clermont County. The portion of 

Clermont County, including all of the 

municipalities of Tate and East Fork 

State Park, and the portions of the 

Township of Monroe that include the 

following land parcels: 232609C094, 

232609C113, 232609C215, 232609C085, 

232609C128, 232609B224, 232609B188, 

232609E223, 232609B215, 32609B193, 

232609E075, 232609B161, 232609E156, 

232609E245, 232609E037, 232609E074, 

232609E230, 232609E031, 232609E220, 

232609E232, 232609E240, 232609E239, 

232609E241, 232609E175, 232609E228, 

232609E250, 232609E235, 232609E238, 

232609E227, 232609E242, 32609E226, 

232609E249, 232609E236, 232609E234, 

232609C217, 232609C040, 234715.008, 

232609C227, 232609C222, 232609C092, 

232609C093, 232609C129, 232609C098, 

232609C195, 232609C100, 232609C169, 

232609C136, 232609C097, 232609C139, 

232609C148, 232609C042, 232609C150, 

232609C182, 234715.009, 234715.005, 

234715.006, 234715.001, 232609E246, 

232609E247, 234715.004, 234715.003, 

232609E222, 232609C228, 234425.001, 

232609E233, 232609C170, 232609C216, 

232609C196, 232609C105, 232609E237, 

232609C225, 232609C091, 232609C197, 

232609C218, 232609C198, 232609C041, 

232609C212, 232609C194, 232609C214, 

232609E224, 232609E231, 232609E248, 

234715.007, 234715.002, 232609C120, 

232609C226, 232609C229, and 

232609C043. 

Done in Washington, DC, this 23rd day of 

May 2012. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2012–13111 Filed 5–29–12; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510, 522, and 558 

[Docket No. FDA–2012–N–0002] 

New Animal Drugs; Change of 

Sponsor; Estradiol; Estradiol Benzoate 

and Testosterone Propionate; 

Progesterone and Estradiol Benzoate; 

Trenbolone Acetate; Trenbolone 

Acetate and Estradiol; Melengestrol; 

Ractopamine; Zilpaterol 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect a 

change of sponsor for 17 new animal 

drug applications (NADAs) and 

abbreviated new animal drug 

applications (ANADAs) for various 

steroid ear implants for cattle and for 

melengestrol acetate liquid Type A 

medicated article and use in 

combination medicated feeds for heifers 

fed in confinement for slaughter from 

Ivy Laboratories, Division of Ivy Animal 

Health, Inc., to Elanco Animal Health, 

Division of Eli Lilly & Co. 

DATES: This rule is effective May 30, 

2012. 

FOR FURTHER INFORMATION CONTACT: 

Steven D. Vaughn, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7520 Standish Pl., 

Rockville, MD 20855, 240–276–8300, 

email: steven.vaughn@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Ivy 

Laboratories, Division of Ivy Animal 

Health, Inc., 8857 Bond St., Overland 

Park, KS 66214, has informed FDA that 

it has transferred ownership of, and all 

rights and interest in, the NADAs and 

ANADAs in this table to Elanco Animal 

Health, Division of Eli Lilly & Co., Lilly 

Corporate Center, Indianapolis, IN 

46285. 


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