This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

59287 

Vol. 77, No. 188 

Thursday, September 27, 2012 

1The Sunset 2012 ANPR also pertained to the 

exemptions for synthetic substances and 

prohibitions for nonsynthetic substances used in 

crop and livestock production. 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Document Number AMS–NOP–10–0083; 

NOP–10–09IR] 

RIN 0581–AD17 

National Organic Program (NOP); 

Sunset Review (2012) for Nutrient 

Vitamins and Minerals 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Interim rule with request for 

comments. 

SUMMARY: This interim rule addresses a 

recommendation submitted to the 

Secretary of Agriculture (Secretary) by 

the National Organic Standards Board 

(NOSB) on April 29, 2011. This 

recommendation pertains to the 2012 

Sunset Review for the exemption (use) 

of nutrient vitamins and minerals in 

organic handling on U.S. Department of 

Agriculture’s (USDA) National List of 

Allowed and Prohibited Substances 

(National List). On January 12, 2012, 

AMS published a proposed rule on the 

2012 Sunset Review which proposed to 

continue the exemption (use) for 

nutrient vitamins and minerals on the 

National List for 5 years after its October 

21, 2012 sunset date. The proposed rule 

also proposed to correct an inaccurate 

cross reference to U.S. Food and Drug 

Administration (FDA) regulations in the 

listing for vitamins and minerals on the 

National List. AMS continues to review 

the public comments on the proposed 

rule and assess the extent of impacts on 

the industry that could result from 

correcting the cross reference to FDA 

regulations. Therefore, due to the 

impending sunset of the allowance for 

nutrients vitamins and minerals from 

the National List on October 21, 2012, 

and based on the NOSB 

recommendation, this interim rule 

renews, without change, the exemption 

(use) for nutrient vitamins and minerals 

on the National List. This interim rule 

provides for the continued use of 

nutrients vitamins and minerals in 

organic products until the agency 

completes the January 12, 2012, 

rulemaking. 

DATES: Effective Date: This interim rule 

becomes effective October 21, 2012. All 

comments received by December 26, 

2012 will be considered prior to the 

issuance of a final rule. 

ADDRESSES: Interested persons may 

submit written comments on this 

interim rule using the following 

addresses: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Toni Strother, Agricultural 

Marketing Specialist, National Organic 

Program, USDA–AMS–NOP, 1400 

Independence Ave. SW., Room 2646- 

So., Ag Stop 0268, Washington, DC 

20250. 

Instructions: All submissions received 

must include the docket number AMS– 

NOP–10–0083; NOP–10–09IR, and/or 

Regulatory Information Number (RIN) 

0581–AD17 for this rulemaking. All 

comments received will be posted 

without change to http:// 

www.regulations.gov. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov. Comments 

submitted in response to this interim 

rule will also be available for viewing in 

person at USDA–AMS, National Organic 

Program, 1400 Independence Ave. SW., 

Room 2646-South Building, 

Washington, DC, from 9 a.m. to 12 noon 

and from 1 p.m. to 4 p.m., Monday 

through Friday, (except official Federal 

holidays). Persons wanting to visit the 

USDA South Building to view 

comments received in response to this 

proposed rule are requested to make an 

appointment in advance by calling (202) 

720–3252. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Bailey, Ph.D., Director, 

Standards Division, Telephone: (202) 

720–3252; Fax: (202) 205–7808. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Organic Foods Production Act of 

1990 (OFPA) (7 U.S.C. 6501–6522), 

authorizes the establishment of the 

National List. The National List 

identifies synthetic substances that are 

exempted (allowed) in organic 

production and nonsynthetic substances 

that are prohibited in organic crop and 

livestock production. The National List 

also identifies nonagricultural 

nonsynthetic, nonagricultural synthetic 

and nonorganic agricultural substances 

that may be used in organic handling. 

The exemptions and prohibitions 

granted under the OFPA are required to 

be reviewed every 5 years by the 

National Organic Standards Board 

(NOSB). The Secretary has authority 

under the OFPA to renew such 

exemptions and prohibitions. If the 

substances are not reviewed by the 

NOSB within 5 years of their inclusion 

on the National List and addressed by 

the Secretary, then their authorized use 

or prohibition expires under OFPA’s 

sunset provision. 

On March 26, 2010, the National 

Organic Program (NOP) published an 

Advance Notice of Proposed 

Rulemaking (ANPR) to announce the 

pending sunset of substances on the 

National List and opened the public 

comment process on whether existing 

exemptions for specified synthetic and 

nonsynthetic substances in organic 

handling should be continued (75 FR 

14500).1 The ANPR indicated that the 

exemption for the use of nutrient 

vitamins and minerals as ingredients in 

or on processed products labeled as 

‘‘organic’’ or ‘‘made with organic 

(specified ingredients or food group(s))’’ 

would expire after October 21, 2012, if 

the listing was not renewed. The public 

comment period lasted 60 days. 

Comments were received from organic 

handlers, ingredient suppliers and trade 

associations. Comments received 

supported the continued listing of 

nutrient vitamins and minerals in 

organic handling. The written 

comments can be retrieved at http:// 

www.regulations.gov by searching for 

the document ID number: AMS–NOP– 

09–0074. The NOP provided the NOSB 

with these public comments to consider 

in their deliberations on the status of 

nutrient vitamins and minerals in 


tkelley on DSK3SPTVN1PROD with RULES
59288 Federal Register / Vol. 77, No. 188 / Thursday, September 27, 2012 / Rules and Regulations 

2NOSB, 2011, Formal Recommendation by the 

National Organic Standards Board (NOSB) to the 

National Organic Program (NOP), Nutrient Vitamins 

and Minerals Sunset, available at http:// 

www.ams.usda.gov/AMSv1.0/ 

getfile?dDocName=STELPRDC5091724. 

3FDA Response to NOP—Questions and Answers 

Regarding Nutrient Fortification of Foods. April 14, 

2011. Available at http://www.ams.usda.gov/ 

AMSv1.0/getfile?dDocName=STELPRDC5090415. 

organic products after the 2012 sunset 

date. 

At their April 2011 public meeting, 

the NOSB approved a recommendation 

to renew the listing for nutrient 

vitamins and minerals after its October 

21, 2012 sunset date. Their 

recommendation stated that the listing 

should be renewed as codified at 7 CFR 

205.605(b): ‘‘Nutrient vitamins and 

minerals, in accordance with 21 CFR 

104.20, Nutritional Quality Guidelines 

for Foods’’.2 In addition to the ANPR for 

Sunset 2012 published on March 26, 

2010, the NOSB received additional 

public comment concerning the pending 

sunset of this listing in response to three 

Federal Register notices announcing 

meetings of the NOSB and its planned 

deliberations on recommendations 

involving Sunset 2012 substances. The 

notices were published in the Federal 

Register as follows: March 17, 2010 (75 

FR 12723), September 20, 2010 (75 FR 

57194), and March 4, 2011 (76 FR 

12013). The NOSB received further 

written and oral testimony concerning 

nutrient vitamins and minerals at all 

three of these public business meetings 

which occurred in Woodland, CA on 

April 26–29, 2010, in Madison, WI on 

October 25–28, 2010, and in Seattle, WA 

on April 26–29, 2011. The written 

comments can be retrieved via http:// 

www.regulations.gov by searching for 

the document ID numbers: AMS–NOP– 

10–0021 (May 2010 meeting); AMS– 

NOP–10–0068 (October 2010 meeting); 

and AMS–NOP–11–05 (April 2011 

meeting). The oral comments were 

recorded in the meeting transcripts 

available on the NOP Web site, http:// 

www.ams.usda.gov/nop. 

During their April 2011 deliberations 

on the renewal of nutrients vitamins 

and minerals, the NOSB explained that 

the Food and Drug Administration 

(FDA) had recently provided a response 

to the NOP regarding the reference to 21 

CFR 104.20 in the current annotation for 

nutrient vitamins and minerals on the 

National List.3 The reference to 21 CFR 

104.20 refers to the fortification policy 

for food under the FDA’s jurisdiction. 

The NOP had requested the information 

from FDA to consider whether changes 

to the annotation were necessary to 

correct an inaccurate cross reference to 

FDA policy and to clarify what 

synthetic substances are allowed as 

vitamins and minerals in products 

labeled as ‘‘organic’’ or ‘‘made with 

organic (specified ingredients or food 

group(s)).’’ The fortification policy at 21 

CFR 104.20 provides for the rational 

addition of essential nutrients to food 

for human consumption. FDA considers 

only ‘‘essential nutrients’’ to be within 

the scope of its fortification policy at 21 

CFR 104.20. The nutrients which FDA 

has determined to be essential are 

enumerated in 21 CFR 101.9(c)(8)(iv) 

with corresponding Reference Daily 

Intakes (RDIs), and 21 CFR 101.9(c)(9), 

which includes potassium and its 

corresponding Daily Reference Value 

(DRV). FDA stated that substances such 

as omega-3 and omega-6 fatty acids, 

inositol, choline, carnitine, and taurine 

are not essential nutrients listed under 

101.9(c)(8)(iv) and are, therefore, not 

within the scope of FDA’s fortification 

policy at 21 CFR 104.20. The FDA also 

clarified that infant formula is not 

within the scope of the fortification 

policy; the requirements in 21 CFR part 

107 pertain to required and essential 

nutrients for infant formula and include 

minimum and maximum amounts for 

those nutrients. 

Based on this information, the NOSB 

signaled its intent to issue another 

recommendation for an annotation 

change to the listing for nutrients 

vitamins and minerals at their 

November 2011 public meeting. 

However, since NOP intended to take 

action to amend the listing through a 

proposed rule, the NOSB opted to 

remove proposing a recommendation for 

an annotation change on nutrient 

vitamins and minerals from their 

November 2011 meeting agenda. 

On January 12, 2012, AMS published 

a proposed rule on the 2012 Sunset 

Review for nutrient vitamins and 

minerals (77 FR 1980). The rule 

proposed to address the April 2011 

NOSB recommendation and to revise 

the cross reference to FDA regulations to 

specify that only vitamins and minerals 

which are declared essential for food in 

21 CFR 101.9 and vitamins and minerals 

that are required for infant formula in 21 

CFR 107.10 and 107.100, may be used 

in organic products. As a result, under 

the proposal, any ingredient not 

specified by these cross references to 

FDA regulations would be excluded 

from use in organic products and would 

need to be petitioned to the NOSB for 

separate exemptions on the National 

List. Examples of affected ingredients 

which would need separate exemptions 

on the National List include 

docosahexanoic acid (DHA) algal oil, 

arachidonic acid (ARA) single-cell oil, 

taurine, inositol, choline, ascorbyl 

palmitate, synthetic beta-carotene, Lcarnitine, lycopene, nucleotides, lutein, 

and L-methionine. Further, AMS would 

need to conduct separate rulemaking to 

codify the exemptions based on NOSB 

recommendations for any petitioned 

substances. A detailed discussion of the 

proposal, including further discussion 

of the examples of ingredients that 

would be affected and an initial 

assessment of the impacts of correcting 

the cross references to FDA regulations, 

is available in the proposed rule (77 FR 

1980). 

The proposed rule provided a 60 day 

comment period, which closed on 

March 12, 2012. Comments were 

specifically requested on: (i) The actual 

economic impacts of the proposed 

action; (ii) the adequacy of the estimated 

impact of the proposed action on small 

entities; and (iii) the length of the 

proposed compliance date. AMS 

received 26 written comments in 

response to the proposed rule. The 

written comments can be retrieved via 

www.regulations.gov by searching for 

the document ID number: AMS–NOP– 

10–0083. Persons wanting to visit the 

USDA South Building to view 

comments in response to the proposed 

rule are requested to make an 

appointment in advance by calling (202) 

720–3252. 

AMS continues to assess the public 

comments on the proposed rule and 

evaluate the impact of clarifying the 

cross reference to FDA regulations. 

Given that the current allowance for 

nutrient vitamins and minerals is due to 

sunset (‘‘expire’’) from the National List 

on October 21, 2012, AMS is issuing 

this interim rule with request for 

comments to provide continuity to the 

organic industry and avoid widespread 

disruption that would result if the 

allowance for vitamins and minerals 

were to sunset. For example, if the 

current allowance for vitamins and 

minerals was to sunset, Vitamins A and 

D, used to fortify fluid milk, and Bvitamins, used in bread and cereal to 

replace vitamins lost during processing, 

could no longer be added to organic 

products. 

AMS believes that renewing the 

current listing for nutrient vitamins and 

minerals on the National List is the most 

appropriate action at this time. When 

AMS published the proposed rule in 

January 2012, the agency requested 

comments on the adequacy of the 

economic analysis that was presented 

and the two year compliance date that 

was proposed. AMS received limited 

public comment on the impacts of 

correcting the cross reference to FDA 

regulations. The NOSB has made final 

recommendations to AMS on four 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 188 / Thursday, September 27, 2012 / Rules and Regulations 59289 

petitioned substances, petitions for eight 

substances remain outstanding. A 

summary of the status of these petitions 

is provided in Table 1. 

TABLE 1—STATUS OF NATIONAL LIST PETITIONS FOR AFFECTED INGREDIENTS a

Ingredient 

Petition 

submitted 

to NOSB 

NOSB recommendation 

Docosahexanoic Acid (DHA) algal oil b .. Yes ........................ NOSB recommended the addition to § 205.605(a): DHA algal oil, not hexane 

extracted; other ingredients that are agricultural must be organic. 

Arachidonic Acid (ARA) single-cell oil b .. Yes ........................ NOSB recommended the addition to § 205.605(a): Arachidonic Acid (ARA) from 

fungal oil, not hexane extracted; other ingredients that are agricultural must 

be organic. 

Inositol ..................................................... Yes ........................ NOSB recommended the addition to § 205.605(b): CAS #87–89–8 (myo-inositol) and 6917–35–7 (non-specific isomer) for use in infant formula and medical nutritional enteral products labeled organic or made with organic (specified ingredients or food group(s)). 

Choline (two separate petitions for infant 

formula and infant food, and all other 

foods).

Yes ........................ NOSB recommended the addition to § 205.605(b): Choline chloride (CAS #67– 

48–1) and Choline bitartrate (CAS #87–67–2) for use in infant formula and 

medical nutritional enteral products labeled organic or made with organic 

(specified ingredients or food group(s)). 

Ascorbyl Palmitate .................................. Yes ........................ NOSB Handling Subcommittee proposal posted; NOSB Recommendation expected at October 2012 public meeting.c

Beta-carotene d ....................................... Yes ........................ NOSB Handling Subcommittee proposal posted; NOSB Recommendation expected at October 2012 public meeting. 

L-carnitine ............................................... Yes ........................ NOSB Handling Subcommittee proposal posted; NOSB Recommendation expected at October 2012 public meeting. 

Lycopene ................................................. Yes ........................ NOSB Handling Subcommittee proposal posted; NOSB Recommendation expected at October 2012 public meeting. 

Lutein ...................................................... Yes ........................ NOSB Handling Subcommittee proposal posted; NOSB Recommendation expected at October 2012 public meeting. 

L-Methionine ........................................... Yes ........................ NOSB Handling Subcommittee proposal posted; NOSB Recommendation expected at October 2012 public meeting. 

Nucleotides ............................................. Yes ........................ NOSB Handling Subcommittee proposal posted; NOSB Recommendation expected at October 2012 public meeting. 

Taurine .................................................... Yes ........................ NOSB Handling Subcommittee proposal posted; NOSB Recommendation expected at October 2012 public meeting. 

Amino Acids for pet food ........................ Yes ........................ NOSB Livestock Subcommittee proposal posted; NOSB Recommendation expected at October 2012 public meeting. 

aPetitions are available on the NOP Web site in the petitioned substances database: http://www.ams.usda.gov/NOPNationalList. bSome of the DHA and ARA used in organic products is derived from fish oil, currently provided for in section 205.606 of the National List, 

rather than algal and microbial sources. cAll NOSB subcommittee proposals are available online at http://www.ams.usda.gov/NOSBCommitteeRecommendations. Information for the 

October 15–18, 2012 NOSB public meeting is available online at http://www.ams.usda.gov/NOSBMeetings. dThe beta-carotene petition is for the synthetic form. Beta-carotene extract color is currently listed in section 205.606 as a nonorganically produced agricultural ingredient allowed in products labeled ‘‘organic’’ when an organic version is not commercially available. 

Once the NOSB completes its review 

and has issued recommendations on all 

petitioned nutrients, the public will be 

able to more fully comment on the 

implications of correcting the FDA cross 

reference as proposed. For this reason, 

we are requesting comments through 

this interim rule. After consideration of 

comments submitted to both the 

proposed rule and this interim rule, 

AMS intends to issue a final rule that 

will address the proposed correction to 

the listing for nutrient vitamins and 

minerals on the National List. As 

previously noted, AMS would need to 

conduct separate rulemaking to codify 

the exemptions based on 

recommendations by the NOSB for any 

petitioned substance. 

Therefore, consistent with the April 

2011 NOSB recommendation, this 

interim rule continues the allowance for 

nutrient vitamins and minerals at 

section 205.605(b) as follows: ‘‘Nutrient 

vitamins and minerals, in accordance 

with 21 CFR 104.20, Nutritional Quality 

Guidelines for Foods.’’ This action 

enables the industry to continue with 

the status quo until additional public 

comments are received and a final rule 

is published. This action avoids the 

widespread disruption to the organic 

market that would occur if the 

allowance for any synthetic vitamins 

and minerals were to sunset (‘‘expire’’) 

from the National List on October 21, 

2012. 

II. Statutory and Regulatory Authority 

The OFPA authorizes the Secretary to 

make amendments to the National List 

based on proposed amendments 

developed by the NOSB. Sections 

6518(k)(2) and 6518(n) of 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. 


tkelley on DSK3SPTVN1PROD with RULES
59290 Federal Register / Vol. 77, No. 188 / Thursday, September 27, 2012 / Rules and Regulations 

4U.S. Department of Agriculture, Economic 

Research Service. 2008. U.S. Organic Agriculture, 

1992–2008, data set, available at www.ers.usda.gov/ 

data/organicERS. The number of U.S. organic 

operations at the end of 2011 is from data compiled 

by the National Organic Program, http:// 

www.ams.usda.gov/AMSv1.0/ 

getfile?dDocName=STELPRDC5097523. 

5 Ibid. 

6Organic Trade Association, 2012. 2012 Organic 

Industry Survey. Brattleboro, VT. 

This interim 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 by 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 interim 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 EPA under the Federal 

Insecticide, Fungicide and Rodenticide 

Act (FIFRA) (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 

final 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 

of the RFA is to fit regulatory actions to 

the scale of businesses subject to such 

actions in order that small business will 

not be unduly or disproportionately 

burdened. 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 interim rule 

on small entities. The effect of this rule 

would be to allow the continued use of 

nutrients vitamins and minerals in 

organic handling. AMS concludes that 

the economic impact of continuing this 

allowance for nutrient vitamins and 

minerals in organic handling would 

avoid market disruption and would be 

beneficial to small agricultural service 

firms. Therefore, AMS certifies that this 

rule would 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. 

Based on USDA data from the 

Economic Research Service (ERS), the 

total acreage of certified organic land 

grew from 1.8 million acres in 2000 to 

4.8 million acres in 2008, of which 

approximately 2.2 million acres was 

pasture and rangeland.4 The number of 

certified organic producers in the U.S. 

has more than doubled in that time 

period rising from approximately 7,000 

in 2000 to nearly 17,700 by the end of 

2011.5 ERS, based upon the list of 

certified operations maintained by the 

NOP, estimated the number of certified 

handling operations was 3,225 in 2007. 

AMS believes that most of these entities 

would be considered small entities 

under the criteria established by the 

SBA. 

The increasing production capacity 

for organic agricultural products 

parallels growth trends in sales of 

organic products. Since implementation 

of the NOP, the organic industry has 

experienced consecutive years of growth 

demonstrated by increasing sales to 

consumers. In 2011, U.S. retail sales of 

organic food and beverages totaled over 

$29.2 billion.6 The pace of double-digit 

sales growth that persisted from 2002– 

2008 has dipped, but the 7.7 percent 

growth recorded from 2009–2010, and 

the 9.4 percent growth recorded from 

2010–2011, marked increases from 

previous years. The top grossing organic 

food categories in terms of sales for 2011 

are fruits and vegetables (40.5%), dairy 

(14.6%) and packaged/prepared foods, 

which includes baby formula and baby 

food (13.6%). Sales of dry breakfast 

goods, which includes cereals, grew 

6.2% in the year 2011, exceeding $1 

billion. Organic frozen prepared foods 

account for the highest sales within the 

packaged/prepared foods category. 

Nutrient vitamins and minerals are used 

to fortify products in the dairy, 

packaged/prepared foods, and breakfast 

goods product categories. 

In addition, USDA has 91 accredited 

certifying agents who provide 

certification services to producers and 

handlers. 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 interim 

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 interim 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 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 188 / Thursday, September 27, 2012 / Rules and Regulations 59291 

and direct effects on Tribal governments 

and will not have significant Tribal 

implications. 

F. Effective Date 

This interim rule reflects a 

recommendation submitted to the 

Secretary by the NOSB for the purpose 

of fulfilling the requirements of 7 U.S.C. 

6517(e) of the OFPA. Section 7 U.S.C. 

6517(e) requires the NOSB to review 

each substance on the National List 

within 5 years of its publication. 

Pursuant to 5 U.S.C. 553, it is found and 

determined upon good cause that it is 

impracticable and contrary to the public 

interest to give preliminary notice prior 

to putting this rule into effect in order 

to ensure the continued use of nutrients 

vitamins and minerals in organic 

products after October 21, 2012, and 

avoid widespread disruption to the 

organic market. Accordingly, this rule 

shall be effective on October 21, 2012. 

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. 

The authority citation for 7 CFR part 

205 continues to read as follows: 

Authority: 7 U.S.C. 6501–6522. 

Dated: September 21, 2012. 

David R. Shipman, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2012–23748 Filed 9–26–12; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

9 CFR Parts 307 and 381 

[Docket No. FSIS–2011–0032] 

RIN 0583–AD48 

Additional Changes to the Schedule of 

Operations Regulations 

AGENCY: Food Safety and Inspection 

Service, USDA. 

ACTION: Final rule. 

SUMMARY: The Food Safety and 

Inspection Service (FSIS) is amending 

the meat and poultry product 

regulations pertaining to the schedule of 

operations. FSIS is amending these 

regulations to define the 8-hour 

workday as including time that 

inspection program personnel need to 

prepare the inspection station, if 

necessary, or retrieve and return lot tally 

sheets; the time necessary for FSIS 

inspection program personnel to 

sharpen knives, if necessary; and the 

time necessary to conduct duties 

scheduled by FSIS, including 

administrative activities. The activities 

are integral and indispensable to 

inspectors’ work and are part of the 

continuous workday as defined by the 

Fair Labor Standards Act. Therefore, 

they are activities that need to be part 

of the Agency’s regulatory definition for 

the 8-hour workday. 

DATES: Effective November 26, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Edelstein, Acting Assistant 

Administrator, Office of Policy and 

Program Development, FSIS, U.S. 

Department of Agriculture, 1400 

Independence Avenue SW., 

Washington, DC 20250–3700, telephone: 

(202) 205–0495. 

SUPPLEMENTARY INFORMATION: 

Background 

The Federal Meat Inspection Act 

(FMIA), 21 U.S.C. 601 et seq., and the 

Poultry Products Inspection Act (PPIA), 

21 U.S.C. 451 et seq., provide for 

mandatory Federal inspection of 

livestock and poultry slaughtered at 

official establishments and of meat and 

poultry products processed at official 

establishments. FSIS bears the cost of 

mandatory inspection provided during 

non-overtime and non-holiday hours of 

operation. Official establishments pay 

for inspection services performed on 

holidays or on overtime. 

On March 19, 2012, FSIS proposed to 

amend its regulations pertaining to the 

schedule of operations (77 FR 15976). 

FSIS proposed to amend these 

regulations to define the 8-hour 

workday as including time that 

inspection program personnel need to 

prepare the inspection station at meat 

slaughter establishments, if necessary, 

or to retrieve and return lot tally sheets 

at poultry slaughter establishments; the 

time necessary for FSIS inspection 

program personnel to sharpen knives, if 

necessary, at meat slaughter 

establishments; and the time necessary 

to conduct duties scheduled by FSIS, 

including administrative activities at 

meat and poultry slaughter 

establishments. The activities are 

integral and indispensable to the 

principal work of inspection program 

personnel as defined in 29 CFR 790.8, 

‘‘Principal’’ activities. Therefore, these 

activities need to be part of the Agency’s 

regulatory definition for the 8-hour 

workday. 

Response to Comments 

FSIS received one comment within 

the scope of the rulemaking regarding 

the proposed rule change from an 

association representing the meat 

industry. The comment raised the 

following issues: 

De Minimis 

The commenter stated that FSIS has 

ignored the Office of Personnel 

Management (OPM) regulation 5 CFR 

551.412(a) that governs the exclusion of 

de minimis actions from compensable 

activities. The commenter stated that 

the OPM rule excludes preparatory 

activities that last less than 10 minutes 

and also stated that the proposed rule 

identified two of three activities 

specified in the proposal— 

administrative activities and 

preparation for inspection—as each 

taking less than 10 minutes per day. 

Therefore, the commenter asserted that 

the OPM regulation precludes the need 

for the proposed rule. 

Response 

As stated in the proposed rule, FSIS 

considers these activities as integral and 

indispensable to the principal work of 

inspection program personnel as 

defined in 29 CFR 790.8, ‘‘Principal’’ 

activities. As integral and indispensable 

work activities under the Fair Labor 

Standards Act, FSIS finds that these 

activities should be included as part of 

the continuous workday when reading 

both 5 CFR 551.412(a) and the OPM 

definition of ‘‘workday’’ at 5 CFR 

551.411(a), together. 5 CFR 551.412(a) 

cannot be properly read alone to 

exclude time spent on indispensable 

work activities during the continuous 

workday from compensable hours of 

work. Any duties scheduled by FSIS, 

including administrative duties, are 

integral and indispensable to the 

essential work of inspection program 

personnel because they enable 

inspection program personnel to carry 

out their work effectively. The 

preparation of the workstation is an 

integral and indispensable activity 

ensuring that inspectors have the 

necessary stamps used to identify 

condemned parts while conducting 

their inspection duties. Therefore, 

administrative duties and the 

preparation of the work station in cattle 

slaughter establishments are integral 

and indispensable to the principal work 

of inspection program personnel as 

defined in 29 CFR 790.8, ‘‘Principal’’ 

activities, and thus, these activities need 

to be part of the Agency’s regulatory 

definition for the 8-hour workday. 


tkelley on DSK3SPTVN1PROD with RULES