28472 Federal Register / Vol. 77, No. 94 / Tuesday, May 15, 2012 / Rules and Regulations 

advising OPM on matters concerning 

the pay of FWS employees, has 

reviewed and recommended these 

changes by consensus. 

Waiver of Notice of Proposed 

Rulemaking and Delay in Effective Date 

Pursuant to 5 U.S.C. 553(b)(3)(B) and 

(d)(3), I find that good cause exists to 

waive the general notice of proposed 

rulemaking. Also pursuant to 5 U.S.C. 

553(d)(3), I find that good cause exists 

for making this rule effective in less 

than 30 days. This notice is being 

waived and the regulation is being made 

effective in less than 30 days because 

the closure of NAS JRB Willow Grove 

left the Montgomery wage area without 

an activity having the capability to 

conduct a local wage survey and the 

remaining NAF FWS employees in 

Chester, Montgomery, and Philadelphia 

Counties must be transferred to a 

continuing wage area as soon as 

possible. 

Regulatory Flexibility Act 

I certify that these regulations will not 

have a significant economic impact on 

a substantial number of small entities 

because they will affect only Federal 

agencies and employees. 

List of Subjects in 5 CFR Part 532 

Administrative practice and 

procedure, Freedom of information, 

Government employees, Reporting and 

recordkeeping requirements, Wages. 

U.S. Office of Personnel Management. 

John Berry, 

Director. 

Accordingly, the U.S. Office of 

Personnel Management is amending 5 

CFR part 532 as follows: 

PART 532—PREVAILING RATE 

SYSTEMS 

■ 1. The authority citation for part 532 

continues to read as follows: 

Authority: 5 U.S.C. 5343, 5346; § 532.707 

also issued under 5 U.S.C. 552. 

Appendix B to Subpart B of Part 532— 

Nationwide Schedule of 

Nonappropriated Fund Regular Wage 

Surveys 

■ 2. Appendix B to subpart B is 

amended by removing, under the State 

of Pennsylvania, the entry for 

‘‘Montgomery.’’ 

Appendix D to Subpart B of Part 532— 

Nonappropriated Fund Wage and 

Survey Areas 

■ 3. Appendix D to subpart B is 

amended for the State of Pennsylvania 

by removing the wage area listing for 

Montgomery, PA, and for the State of 

New Jersey by revising the wage area 

listings for Burlington, NJ, and Morris, 

NJ, to read as follows: 

* * * * * 

NEW JERSEY 

Burlington 

Survey Area 

New Jersey: 

Burlington 

Area of application. Survey area plus: 

Delaware: 

New Castle 

New Jersey: 

Atlantic 

Cape May 

Monmouth 

Ocean 

Salem 

Pennsylvania: 

Chester 

Montgomery 

Philadelphia 

Morris 

Survey Area 

New Jersey: 

Morris 

Area of application. Survey area plus: 

New Jersey: 

Somerset 

Pennsylvania: 

Luzerne 

Monroe 

* * * * * 

[FR Doc. 2012–11763 Filed 5–14–12; 8:45 am] 

BILLING CODE 6325–39–P 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Document Number AMS–NOP–10–0078; 

NOP–09–03FR] 

RIN 0581–AD05 

National Organic Program; 

Amendments to the National List of 

Allowed and Prohibited Substances 

(Livestock) 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Final rule. 

SUMMARY: This final rule amends the 

U.S. Department of Agriculture’s 

(USDA’s) National List of Allowed and 

Prohibited Substances (National List) to 

enact two recommendations submitted 

to the Secretary of Agriculture 

(Secretary) by the National Organic 

Standards Board (NOSB) on June 20, 

2008, and May 30, 2004. This final rule 

establishes exemptions (uses) for two 

substances, fenbendazole and 

moxidectin, along with any restrictive 

annotations, as parasiticides in organic 

livestock production. 

DATES: Effective Date: This rule becomes 

effective May 16, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Bailey, Ph.D., Director, 

Standards Division, National Organic 

Program, (202) 720–3252; Fax: (202) 

205–7808. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On December 21, 2000, the Secretary 

established, within the National Organic 

Program (NOP) (7 CFR part 205), the 

National List regulations sections 

205.600 through 205.607. This National 

List identifies the synthetic substances 

that may be used and the nonsynthetic 

(natural) substances that may not be 

used in organic production. The 

National List also identifies synthetic, 

nonsynthetic nonagricultural and 

nonorganic agricultural substances that 

may be used in organic handling. The 

Organic Foods Production Act of 1990, 

as amended, (7 U.S.C. 6501–6522), 

(OFPA), and NOP regulations, in section 

205.105, specifically prohibit the use of 

any synthetic substance in organic 

production and handling unless the 

synthetic substance is on the National 

List. Section 205.105 also requires that 

any nonorganic agricultural and any 

nonsynthetic nonagricultural substance 

used in organic handling appear on the 

National List. 

Under the authority of the OFPA, the 

National List can be amended by the 

Secretary based on proposed 

amendments developed by the NOSB. 

Since established, the NOP has 

published multiple amendments to the 

National List: October 31, 2003 (68 FR 

61987); November 3, 2003 (68 FR 

62215); October 21, 2005 (70 FR 61217); 

June 7, 2006 (71 FR 32803); September 

11, 2006 (71 FR 53299); June 27, 2007 

(72 FR 35137); October 16, 2007 (72 FR 

58469); December 10, 2007 (72 FR 

69569); December 12, 2007 (72 FR 

70479); September 18, 2008 (73 FR 

54057); October 9, 2008 (73 FR 59479); 

July 6, 2010 (75 FR 38693); August 24, 

2010 (75 FR 51919); December 13, 2010 

(75 FR 77521); March 14, 2011 (76 FR 

13501); August 3, 2011 (76 FR 46595); 

and February 14, 2012 (77 FR 8089). 

Additionally, proposed amendments to 

the National List were published on 

November 8, 2011 (76 FR 69141); 

January 12, 2012 (77 FR 1980; 77 FR 

1996); and February 6, 2012 (77 FR 

5717). 

This final rule amends the National 

List to enact two recommendations 

submitted to the Secretary by the NOSB 

on June 20, 2008, and May 30, 2004. 


wreier-aviles on DSK7SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 94 / Tuesday, May 15, 2012 / Rules and Regulations 28473 

II. Overview of Amendments 

The following provides an overview 

of the amendments made to designated 

sections of the National List regulations: 

Section 205.603 Synthetic Substances 

Allowed for Use in Organic Livestock 

Production 

This final rule amends § 205.603(a) of 

the National List regulations by revising 

paragraph (a)(18) to move ivermectin to 

a new section (ii), adding fenbendazole 

at new section (i), and adding 

moxidectin at new section (iii) as 

follows: (a)(18) Parasiticides. Prohibited 

in slaughter stock, allowed in 

emergency treatment for dairy and 

breeder stock when organic system 

plan-approved preventive management 

does not prevent infestation. Milk or 

milk products from a treated animal 

cannot be labeled as provided for in 

subpart D of this part for 90 days 

following treatment. In breeder stock, 

treatment cannot occur during the last 

third of gestation if the progeny will be 

sold as organic and must not be used 

during the lactation period for breeding 

stock. 

(i) Fenbendazole (CAS #43210–67– 

9)—only for use by or on the lawful 

written order of a licensed veterinarian. 

(ii) Ivermectin (CAS #70288–86–7). 

(iii) Moxidectin (CAS #113507–06– 

5)—for control of internal parasites 

only. 

III. Related Documents 

Two notices were published regarding 

the meetings of the NOSB and 

deliberations on recommendations and 

substances petitioned for amending the 

National List. Substances and 

recommendations included in this final 

rule were announced for NOSB 

deliberation in the following Federal 

Register notices: (1) 73 FR 18491, April 

4, 2008, (Fenbendazole); (2) 69 FR 

18036, April 6, 2004, (Moxidectin). 

In a proposed rule published on July 

17, 2006 (71 FR 40624), USDA 

announced its decision that moxidectin 

would not be proposed for inclusion on 

the National List because of its 

macrolide antibiotic classification, 

which was inconsistent with NOP 

policy prohibiting the use of antibiotics 

in organic livestock production. In a 

final rule published on December 12, 

2007 (72 FR 70479), USDA responded to 

comments from the proposed rule and 

affirmed that the NOSB recommended 

use of moxidectin is as a parasiticide, 

not as an antibiotic. 

The proposal to allow the emergency 

use of the two substances in this final 

rule was published as a proposed rule 

on May 5, 2011 (76 FR 25612). 

IV. Statutory and Regulatory Authority 

The OFPA, as amended (7 U.S.C. 

6501–6522), authorizes the Secretary to 

make amendments to the National List 

based on proposed amendments 

developed by the NOSB. Sections 

6518(k) and 6518(n) of the OFPA 

authorize the NOSB to develop 

proposed amendments to the National 

List for submission to the Secretary and 

establish a petition process by which 

persons may petition the NOSB for the 

purpose of having substances evaluated 

for inclusion on or deletion from the 

National List. The National List petition 

process is implemented under section 

205.607 of the NOP regulations. The 

current petition process (72 FR 2167, 

January 18, 2007) can be accessed 

through the NOP Web site at http:// 

www.ams.usda.gov. 

A. Executive Order 12866 

This action has been determined not 

significant for purposes of Executive 

Order 12866, and therefore, has not 

been reviewed by the Office of 

Management and Budget. 

B. Executive Order 12988 

Executive Order 12988 instructs each 

executive agency to adhere to certain 

requirements in the development of new 

and revised regulations in order to avoid 

unduly burdening the court system. 

This final rule is not intended to have 

a retroactive effect. 

States and local jurisdictions are 

preempted under the OFPA from 

creating programs of accreditation for 

private persons or State officials who 

want to become certifying agents of 

organic farms or handling operations. A 

governing State official would have to 

apply to USDA to be accredited as a 

certifying agent, as described in the 

OFPA (7 U.S.C. 6514(b)). States are also 

preempted under the OFPA (7 U.S.C. 

6503 through 6507) from creating 

certification programs to certify organic 

farms or handling operations unless the 

State programs have been submitted to, 

and approved by, the Secretary as 

meeting the requirements of the OFPA. 

Pursuant to the OFPA (7 U.S.C. 

6507(b)(2)), a State organic certification 

program may contain additional 

requirements for the production and 

handling of organically produced 

agricultural products that are produced 

in the State and for the certification of 

organic farm and handling operations 

located within the State under certain 

circumstances. Such additional 

requirements must: (a) Further the 

purposes of the OFPA, (b) not be 

inconsistent with the OFPA, (c) not be 

discriminatory toward agricultural 

commodities organically produced in 

other States, and (d) not be effective 

until approved by the Secretary. 

Pursuant to the OFPA (7 U.S.C. 

6519(f)), this final rule would not alter 

the authority of the Secretary under the 

Federal Meat Inspection Act (21 U.S.C. 

601–624), the Poultry Products 

Inspection Act (21 U.S.C. 451–471), or 

the Egg Products Inspection Act (21 

U.S.C. 1031–1056), concerning meat, 

poultry, and egg products, nor any of 

the authorities of the Secretary of Health 

and Human Services under the Federal 

Food, Drug and Cosmetic Act (21 U.S.C. 

301–399), nor the authority of the 

Administrator of the EPA under the 

Federal Insecticide, Fungicide and 

Rodenticide Act (7 U.S.C. 136–136(y)). 

The OFPA (7 U.S.C. 6520) provides 

for the Secretary to establish an 

expedited administrative appeals 

procedure under which persons may 

appeal an action of the Secretary, the 

applicable governing State official, or a 

certifying agent under this title that 

adversely affects such person or is 

inconsistent with the organic 

certification program established under 

this title. The OFPA also provides that 

the U.S. District Court for the district in 

which a person is located has 

jurisdiction to review the Secretary’s 

decision. 

C. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA) 

(5 U.S.C. 601–612) requires agencies to 

consider the economic impact of each 

rule on small entities and evaluate 

alternatives that would accomplish the 

objectives of the rule without unduly 

burdening small entities or erecting 

barriers that would restrict their ability 

to compete in the market. The purpose 

is to fit regulatory actions to the scale of 

businesses subject to the action. Section 

605 of the RFA allows an agency to 

certify a rule, in lieu of preparing an 

analysis, if the rulemaking is not 

expected to have a significant economic 

impact on a substantial number of small 

entities. 

Pursuant to the requirements set forth 

in the RFA, AMS performed an 

economic impact analysis on small 

entities in the final rule published in the 

Federal Register on December 21, 2000 

(65 FR 80548). AMS has also considered 

the economic impact of this action on 

small entities. The impact on entities 

affected by this final rule would not be 

significant. The effect of this final rule 

is to allow the use of additional 

substances in agricultural production 

and handling. This action would modify 

the regulations published in the final 

rule to provide small entities with more 

tools to use in day-to-day operations. 


wreier-aviles on DSK7SPTVN1PROD with RULES
28474 Federal Register / Vol. 77, No. 94 / Tuesday, May 15, 2012 / Rules and Regulations 

1U.S. Department of Agriculture, Economic 

Research Service. 2009. Data Sets: U.S. Certified 

Organic Farmland Acreage, Livestock Numbers and 

Farm Operations, 1992–2008. http://www.ers.usda.

gov/Data/Organic/. 

2U.S. Department of Agriculture, Economic 

Research Service, 2009. Data Sets: Procurement and 

Contracting by Organic Handlers, http://www.ers.

usda.gov/Data/OrganicHandlers. 

3Organic Trade Association’s 2010 Organic 

Industry Survey, http://www.ota.com. 

4 Ibid. 

AMS concludes that the economic 

impact of this addition of allowed 

substances, if any, would be minimal 

and beneficial to small agricultural 

service firms. Accordingly, AMS 

certifies that this rule will not have a 

significant economic impact on a 

substantial number of small entities. 

Small agricultural service firms, 

which include producers, handlers, and 

accredited certifying agents, have been 

defined by the Small Business 

Administration (SBA) (13 CFR 121.201) 

as those having annual receipts of less 

than $7,000,000 and small agricultural 

producers are defined as those having 

annual receipts of less than $750,000. 

According to USDA Economic 

Research Service (ERS) data based upon 

information from USDA-accredited 

certifying agents, the number of certified 

U.S. organic crop and livestock 

operations totaled nearly 13,000 and 

certified organic acreage exceeded 4.8 

million acres in 2008.1 ERS, based upon 

the list of certified operations 

maintained by the National Organic 

Program, estimated the number of 

certified handling operations was 3,225 

in 2007.2 AMS believes that most of the 

certified production operations would 

be classified as small entities under the 

criteria established by the SBA. 

The U.S. sales of organic food and 

beverages grew from $3.6 billion in 1997 

to nearly $21.1 billion in 2008. Between 

1990 and 2008, organic food sales 

demonstrated a growth rate between 15 

to 24 percent each year. In 2010, organic 

food sales grew 7.7 percent.3 Sales of 

organic dairy products, including milk, 

yogurt and cheese totaled approximately 

$3.6 billion in 2010.4

In addition, USDA has accredited 93 

certifying agents who provide 

certification services to producers and 

handlers under the NOP. A complete 

list of names and addresses of 

accredited certifying agents may be 

found on the AMS NOP web site, at 

http://www.ams.usda.gov/nop. AMS 

believes that most of these accredited 

certifying agents would be considered 

small entities under the criteria 

established by the SBA. 

D. Paperwork Reduction Act 

No additional collection or 

recordkeeping requirements are 

imposed on the public by this final rule. 

Accordingly, OMB clearance is not 

required by the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501, chapter 35). 

E. Executive Order 13175 

This final rule has been reviewed in 

accordance with the requirements of 

Executive Order 13175, Consultation 

and Coordination with Indian Tribal 

Governments. The review reveals that 

this regulation will not have substantial 

and direct effects on Tribal governments 

and will not have significant Tribal 

implications. 

F. Comments Received on Proposed 

Rule NOP–09–03 

AMS received 15 comments on the 

proposed rule AMS–NOP–10–0078; 

NOP–09–03. Comments were received 

from large animal veterinarians, organic 

dairy producers and handlers, a 

livestock parasitologist, agricultural 

consultants, a trade association, an 

accredited certifying agent, a nonorganic 

beef operation, and a private citizen. 

Some of the comments supported the 

additions of fenbendazole and 

moxidectin to the National List as 

proposed. Many comments stated that 

fenbendazole and moxidectin were 

preferable to ivermectin, which is the 

only parasiticide currently approved for 

internal use in organic dairy or breeder 

livestock. Several comments supporting 

the use of fenbendazole and moxidectin 

asserted that under the access to pasture 

requirements for organic ruminants, 

which were fully implemented in June 

2010, these livestock face an increased 

risk of parasite infestations which 

warrants greater access to synthetic 

parasiticides. Some comments 

emphasized that the restrictive 

annotations as proposed would ensure 

that use of fenbendazole and moxidectin 

would be used infrequently as a last 

resort emergency treatment when 

preventive practices and veterinary 

biologics are not effective. Two 

comments which opposed the use of 

both fenbendazole and moxidectin 

either disputed their necessity in 

organic livestock production or broadly 

opposed the use of animal drugs in 

organic production. 

A number of comments expressed 

support for fenbendazole by comparing 

that substance to the parasiticide 

ivermectin, with respect to ecological 

impacts, effectiveness and parasite 

resistance. Some comments 

characterized fenbendazole as more 

benign towards earthworms and dung 

beetles than ivermectin. Commenters 

described ivermectin as harmful to 

aquatic and soil plants, microorganisms, earthworms, and dung 

beetles. Several comments indicated 

that ivermectin has limited 

effectiveness. One comment specifically 

noted that this parasiticide does not 

cover all life stages of all gastrointestinal parasites. Another comment 

remarked that the development of 

resistance to ivermectin can be 

attributed to the frequency of treatment 

in organic production due to the lack of 

other approved treatments for internal 

parasites. Finally, one comment noted 

that there are no ivermectin products 

labeled for use in female cattle of 

breeding age, while fenbendazole is not 

subject to such restriction. Support for 

the use of moxidectin was also framed 

in comparison to ivermectin. Several 

comments stated that moxidectin is less 

toxic to important soil organisms and a 

more effective treatment for long-term 

control of certain fecal parasitic eggs. 

The Food and Drug Administration 

(FDA) regulations permit the use of 

topical and injectable solutions of 

moxidetin for both internal and external 

parasites, however, only the topical 

form is permitted in dairy cattle. In the 

proposed rule, AMS specifically 

requested comments on the moxidectin 

annotation which limits use for internal 

parasites only. One comment stated that 

moxidectin could be useful to treat 

external parasiticides, but the 

availability of fenbendazole would make 

moxidectin unnecessary for internal 

parasites. Some comments, however, 

suggested that a producer’s ability to 

alternate parasiticides would help 

prevent resistance. As comments did 

not substantively object to the proposed 

use of moxidectin, the listing of 

moxidectin for internal parasites only 

has not been altered. As of this final 

rule, three parasiticides will be 

permitted for internal parasites in 

organic livestock production: 

ivermectin, fenbendazole, and 

moxidectin. 

Changes Requested But Not Made 

Reduce the Length of the Milk 

Withdrawal Period. A number of 

comments which supported the use of 

fenbendazole objected to the proposed 

90-day milk withholding period 

following treatment with fenbendazole. 

They indicated that the use of 

fenbendazole would not be feasible in 

organic production if milk cannot be 

marketed as organic for 90 days 

following treatment. The alternatives 

suggested by commenters were a 30-day 

withholding period or no withholding 

period. The commenters proposed that 


wreier-aviles on DSK7SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 94 / Tuesday, May 15, 2012 / Rules and Regulations 28475 

5Commenters were referencing amendments 

codified through the NOP Access to Pasture final 

rule. This rule was published in the Federal 

Register on February 17, 2010 (75 FR 7154). 

a 30-day withholding period would be 

a disincentive to routine use, but would 

not be excessively punitive. Other 

commenters argued for no withholding 

period to be consistent with FDA 

approved fenbendazole labels for use in 

dairy cattle. 

Several commenters who supported 

the use of fenbendazole cited economic 

factors for opposing the 90-day 

withholding period for milk. They 

explained that recent amendments to 

the NOP regulations at section 205.239, 

which requires pasturing of ruminants 

during the grazing season, will increase 

livestock exposure to parasites.5 The 

comments also explained that cows are 

at the greatest risk of parasite infection 

during the first 100 days of lactation 

which can decrease milk production, 

and consequently, financial returns. 

Other commenters argued that the risk 

of parasite infestation is greatest during 

the first year of any animal’s life, when 

the animal is not sufficiently mature to 

have developed the immune responses 

that protect mature animals from 

parasites. One of these comments 

explained that lactating mature animals 

do not normally need parasiticides due 

to fully developed immune 

mechanisms, and that administration of 

parasiticides in early lactation could be 

used to increase milk production. 

A number of comments cited research 

to assert that fenbandazole is rapidly 

metabolized and does not leave residues 

in milk. The studies cited indicated that 

fenbendazole degrades quickly after 48 

hours and residues were undetectable 

after 72 hours to six days. 

Under the existing NOP regulations at 

§ 205.238(b), a 90-day milk withholding 

period is required after use of any 

synthetic parasiticide treatment 

approved for organic dairy animals. 

This has been a requirement since the 

NOP regulations were established in 

2000. Despite objections at that time, 

which asserted that the provision 

ignored animal welfare and farm 

economics, the 90-day withholding 

period was retained in the NOP final 

rule. The preamble to the NOP final rule 

explained that the 90-day timeframe 

was based on a NOSB recommendation 

and the NOSB has the authority to 

reconsider this requirement (65 FR 

80573). 

The NOSB has the authority to 

recommend a change to the 90-day milk 

withholding period. The OFPA restricts 

the Secretary from adding an exemption 

for the use of a synthetic substance 

unless this has been proposed by the 

NOSB. A reduction in the withholding 

period would relax the use restrictions 

on a synthetic substance and would, 

therefore, require NOSB consideration. 

Any NOSB recommendation to change a 

withholding period for parasiticides 

would need to address section 

205.238(b) in the Livestock Health Care 

practice standards as well as the listing 

for parasiticides at section 

205.603(a)(18). AMS understands that 

producers may occasionally need to 

withhold milk from the organic market 

when fenbendazole is administered to 

lactating dairy animals that are suffering 

from parasite infestation. However, the 

routine use of parasiticides is prohibited 

under the NOP regulations and therefore 

AMS does not expect that use of 

fenbendazole will be widespread or 

frequent. Furthermore, rotating pastures 

and maintaining suitable stocking rates 

are preventative practices that can 

interrupt the host-parasite cycle and 

reduce susceptibility of livestock to 

infection. 

Requirement for the Written Order 

from a Veterinarian for Fenbendazole. A 

comment speculated that the 

requirement to obtain a written 

veterinarian’s order to administer 

fenbendazole may encourage the use of 

ivermectin and moxidectin because 

these do not require a veterinarian’s 

written order in organic production. 

FDA requires the order of a licensed 

veterinarian only for the administration 

of 10 mg. fenbendazole suspension to 

beef cattle, per 21 CFR Section 

520.905(2)(iii). FDA regulations do not 

stipulate that requirement for other 

fenbendazole dosage forms. The 

annotation requiring a veterinarian’s 

written order for any administration of 

fenbendazole was recommended by 

NOSB to prevent non-emergency use 

and is only applicable to the use of the 

fenbendazole in organic production. 

AMS concurs with the NOSB’s intent 

that organic producers have limitations 

on access to a synthetic parasiticide to 

discourage routine or indiscriminate 

use. 

Removing the Prohibition of 

Parasiticide Use in Slaughter Stock. 

Several comments urged that 

parasiticides on the National List be 

permitted for use in both dairy and beef 

animals during the first year of life 

when an animal’s immune system is 

more susceptible to parasites. The 

existing NOP regulations at section 

205.238(c)(5) prohibit the 

administration of synthetic parasiticides 

to slaughter stock. A comment 

characterized the prohibition on 

parasites in meat producing animals (i.e. 

slaughter stock) as irrational since both 

meat and dairy animals can suffer from 

parasite infections. In addition, one 

comment noted that several years may 

pass from parasiticide treatment until 

slaughter. 

Expanding the use of parasiticides to 

organic slaughter stock is broader than 

the scope of proposed actions 

considered in this rulemaking. Lifting 

the prohibition on the use of 

parasiticides in slaughter stock would 

merit full consideration by the NOSB 

since such a change would establish 

new uses for synthetic substances in 

organic livestock production. 

G. Effective Date 

This final rule reflects 

recommendations submitted to the 

Secretary by the NOSB. The substances 

being added to the National List were 

based upon petitions from the industry 

and were evaluated by the NOSB using 

criteria in the Act and the regulations. 

One of these recommendations was first 

made by the NOSB in 2004, and the 

substance was discussed in two 

subsequent Federal Register 

publications (71 FR 40624 and 72 FR 

70479) prior to the recent proposed rule 

(76 FR 25612). Because these substances 

have been subject to such extensive 

discussion and comment and these 

parasiticides are considered vital as an 

emergency treatment in organic 

livestock production, AMS believes that 

livestock producers should be able to 

use them on their operations as soon as 

possible. Accordingly, AMS finds that 

good cause exists under 5 U.S.C. 

553(d)(3) for not postponing the 

effective date of this rule until 30 days 

after publication in the Federal 

Register. 

List of Subjects in 7 CFR Part 205 

Administrative practice and 

procedure, Agriculture, Animals, 

Archives and records, Imports, Labeling, 

Organically produced products, Plants, 

Reporting and recordkeeping 

requirements, Seals and insignia, Soil 

conservation. 

For the reasons set forth in the 

preamble, 7 CFR part 205, subpart G is 

amended as follows: 

PART 205—NATIONAL ORGANIC 

PROGRAM 

■ 1. The authority citation for 7 CFR 

part 205 continues to read as follows: 

Authority: 7 U.S.C. 6501–6522. 

■ 2. In § 205.603, paragraph (a)(18) is 

revised to read as follows: 

§ 205.603 Synthetic substances allowed 

for use in organic livestock production. 

* * * * * 


wreier-aviles on DSK7SPTVN1PROD with RULES
28476 Federal Register / Vol. 77, No. 94 / Tuesday, May 15, 2012 / Rules and Regulations 

1Political Contributions by Certain Investment 

Advisers, Investment Advisers Act Release No. 3043 

(July 1, 2010) [75 FR 41018 (July 14, 2010)]. 

2Rules Implementing Amendments to the 

Investment Advisers Act of 1940, Investment 

Advisers Act Release No. 3110 (Nov. 19, 2010) [75 

FR 77052 (Dec. 10, 2010)] (‘‘Implementing 

Proposing Release’’). 

3See id. at section II.D.1. 

4 Id. 

5See Rules Implementing Amendments to the 

Investment Advisers Act of 1940, Investment 

Advisers Act Release No. 3221 (June 22, 2011) [76 

FR 42950 (July 19, 2011)] (‘‘Implementing Adopting 

Release’’). 

6 Id. at n.340 (‘‘We are not, however, adopting an 

amendment we proposed to specify that a legal 

entity, not just a natural person, that is a general 

partner or managing member of an investment 

adviser would meet the definition of ‘‘covered 

associate’’ in the rule. Upon reflection, it would 

broaden the application of the rule more than we 

intended.’’). 

7 5 U.S.C. 553(b). 

8For similar reasons, the amendment does not 

require analysis under the Regulatory Flexibility 

Act (‘‘RFA’’) or analysis of major rule status under 

the Small Business Regulatory Enforcement 

Fairness Act. See 5 U.S.C. 601(2) (for purposes of 

RFA analysis, the term ‘‘rule’’ means any rule for 

which the agency publishes a general notice of 

proposed rulemaking); and 5 U.S.C. 804(3)(C) (for 

purposes of Congressional review of agency 

rulemaking, the term ‘‘rule’’ does not include any 

rule of agency organization, procedure or practice 

that does not substantially affect the rights or 

obligations of non-agency parties). 

9See 5 U.S.C. 553(d)(3). 

10 44 U.S.C. 3501, 3507. 

11 15 U.S.C. 80b–6(4) and 80b–11(a). 

(a) * * * 

(18) Parasiticides. Prohibited in 

slaughter stock, allowed in emergency 

treatment for dairy and breeder stock 

when organic system plan-approved 

preventive management does not 

prevent infestation. Milk or milk 

products from a treated animal cannot 

be labeled as provided for in subpart D 

of this part for 90 days following 

treatment. In breeder stock, treatment 

cannot occur during the last third of 

gestation if the progeny will be sold as 

organic and must not be used during the 

lactation period for breeding stock. 

(i) Fenbendazole (CAS # 43210–67– 

9)—only for use by or on the lawful 

written order of a licensed veterinarian. 

(ii) Ivermectin (CAS # 70288–86–7). 

(iii) Moxidectin (CAS # 113507–06– 

5)—for control of internal parasites 

only. 

* * * * * 

Dated: May 10, 2012. 

David R. Shipman, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2012–11722 Filed 5–14–12; 8:45 am] 

BILLING CODE 3410–02–P 

SECURITIES AND EXCHANGE 

COMMISSION 

17 CFR Part 275 

[Release No. IA–3403; File No. S7–36–10] 

Political Contributions by Certain 

Investment Advisers 

AGENCY: Securities and Exchange 

Commission. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Securities and Exchange 

Commission (‘‘Commission’’) is making 

a technical amendment to the definition 

of ‘‘covered associate’’ in rule 206(4)–5 

under the Investment Advisers Act of 

1940 (‘‘Advisers Act’’) to correct an 

inadvertent error in the rule as 

published in the Federal Register on 

July 19, 2011. 

DATES: Effective date: May 15, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Vanessa M. Meeks, Attorney-Adviser, or 

Melissa A. Roverts, Branch Chief, at 

(202) 551–6787 or IArules@sec.gov, 

Office of Investment Adviser 

Regulation, Division of Investment 

Management, U.S. Securities and 

Exchange Commission, 100 F Street NE., 

Washington, DC 20549–8549. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Commission adopted rule 206(4)– 

5 in July 2010 to prohibit an investment 

adviser from providing advisory 

services for compensation to a 

government client for two years after the 

adviser or certain of its executives or 

employees (‘‘covered associates’’) make 

a contribution to certain elected officials 

or candidates.1 In November 2010, the 

Commission proposed new rules and 

rule amendments under the Advisers 

Act to implement provisions of the 

Dodd-Frank Wall Street Reform and 

Consumer Protection Act.2 In that 

release, the Commission also proposed 

several amendments to rule 206(4)–5, 

including a minor change to the rule’s 

definition of a ‘‘covered associate’’ to 

replace the word ‘‘individual’’ with the 

word ‘‘person.’’ 3 The proposed change 

would have specified that a legal entity, 

not just a natural person, that is a 

general partner or managing member of 

an investment adviser would meet the 

definition of ‘‘covered associate.’’ 4

In June 2011, the Commission 

adopted many of the new rules and rule 

amendments set forth in the 

Implementing Proposing Release, 

including amendments to rule 206(4)– 

5.5 The Commission specified in the 

‘‘Discussion’’ section of the 

Implementing Adopting Release that it 

was not adopting the proposed 

amendment to the definition of 

‘‘covered associate,’’ i.e., that the 

definition would continue to use the 

word ‘‘individual.’’ 6 However, the text 

of rule 206(4)–5(f)(2)(i) published in the 

‘‘Text of Rule and Form Amendments’’ 

section of the Implementing Adopting 

Release, and subsequently in the 

Federal Register, incorrectly reflected 

the replacement of the word 

‘‘individual’’ with the word ‘‘person,’’ 

as though that proposed change had 

been adopted. To correct this mistake, 

the Commission is making a technical 

amendment to rule 206(4)–5(f)(2)(i) to 

replace the word ‘‘person’’ with the 

word ‘‘individual.’’ 

II. Certain Findings 

Under the Administrative Procedure 

Act (‘‘APA’’), notice of proposed 

rulemaking is not required when an 

agency, for good cause, finds ‘‘that 

notice and public procedure thereon are 

impracticable, unnecessary, or contrary 

to the public interest.’’ 7 The 

Commission is making a technical 

amendment to rule 206(4)–5 to reflect 

the Commission’s stated intent in the 

Implementing Adopting Release. The 

Commission finds that because the 

amendment is technical and is being 

made solely to correct a mistake, 

publishing the amendment for comment 

is unnecessary.8

The APA also requires publication of 

a rule at least 30 days before its effective 

date unless the agency finds otherwise 

for good cause.9 For the same reasons 

described above with respect to notice 

and opportunity for comment, the 

Commission finds that there is good 

cause for this technical amendment to 

take effect on May 15, 2012. 

The amendment the Commission is 

adopting does not make substantive or 

material modifications to any collection 

of information requirements as defined 

by the Paperwork Reduction Act of 

1995, as amended.10

The Commission is sensitive to the 

costs and benefits of its rules. The rule 

amendment the Commission is adopting 

today is technical and is being made 

solely to correct a mistake and therefore 

will have minimal, if any, economic 

effect. 

III. Statutory Text and Text of 

Amendment 

We are adopting this technical 

amendment to rule 206(4)–5 under the 

authority set forth in sections 206(4) and 

211(a) of the Advisers Act.11


wreier-aviles on DSK7SPTVN1PROD with RULES