Federal Register / Vol. 72, No. 51 / Friday, March 16, 2007 / Rules and Regulations 12557 

PART 39—AIRWORTHINESS 

DIRECTIVES 

■ 1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

■ 2. The Federal Aviation 

Administration (FAA) amends § 39.13 

by removing amendment 39–14300 (70 

FR 57732, October 4, 2005) and by 

adding the following new airworthiness 

directive (AD): 

2007–06–12 Airbus: Amendment 39–14993. 

Docket No. FAA–2006–26324; 

Directorate Identifier 2006–NM–214–AD. 

Effective Date 

(a) This AD becomes effective April 20, 

2007. 

Affected ADs 

(b) This AD supersedes AD 2005–20–07. 

Applicability 

(c) This AD applies to Airbus Model A330–

201, –202, –203, –223, –243, –301, –321, 

–322, –323, –341, –342, and –343 airplanes, 

certificated in any category; except those on 

which Airbus Modification 49202 has been 

incorporated in production. 

Unsafe Condition 

(d) This AD results from cracking found at 

the circumferential joint of frame (FR) 53.3. 

We are issuing this AD to prevent fatigue 

cracking of the fuselage, which could result 

in reduced structural integrity of the fuselage. 

Compliance 

(e) You are responsible for having the 

actions required by this AD performed within 

the compliance times specified, unless the 

actions have already been done. 

Requirements of AD 2005–20–07 

Installation for Model A330–300 Series 

Airplanes 

(f) For Airbus Model A330–301, –321, 

–322, –323, –341, –342, and –343 airplanes, 

except those on which Airbus Modification 

41652S11819 has been incorporated in 

production: At the later of the times in 

paragraphs (f)(1) and (f)(2) of this AD, install 

the butt straps at FR53.3 on the fuselage skin 

between left-hand (LH) and right-hand (RH) 

stringer (STR) 13, and do all related 

investigative and corrective actions before 

further flight. Except as provided by 

paragraph (g) of this AD, do all actions in 

accordance with the Accomplishment 

Instructions of Airbus Service Bulletin A330–

53–3127, Revision 01, dated November 21, 

2003. 

(1) Before the accumulation of 14,700 total 

flight cycles or 51,400 total flight hours, 

whichever occurs earlier. 

(2) Within 6 months after October 19, 2005 

(the effective date of AD 2005–20–07). 

Contact the FAA/Direction Ge ́ne ́rale de 

l’Aviation Civile (DGAC)/European Aviation 

Safety Agency (EASA) for Certain Repair 

Instructions 

(g) For Airbus Model A330–301, –321, 

–322, –323, –341, –342, and –343 airplanes, 

except those on which Airbus Modification 

41652S11819 has been incorporated in 

production: If any crack is detected during 

the related investigative actions (rototest) 

required by paragraph (f) of this AD, before 

further flight, repair the crack according to a 

method approved by the Manager, 

International Branch, ANM–116, Transport 

Airplane Directorate, FAA; the DGAC (or its 

delegated agent); or the EASA (or its 

delegated agent). 

New Requirements of This AD 

Installation for Model A330–200 and –300 

Series Airplanes 

(h) For Airbus Model A330–201, –202, 

–203, –223, –243, –301, –321, –322, –323, 

–341, –342, and –343 airplanes, on which 

Airbus Modification 41652S11819 has been 

incorporated in production or in accordance 

with paragraph (f) of this AD, except those 

airplanes on which Airbus Modification 

49202 has been incorporated in production: 

At the later of the times in paragraphs (h)(1) 

and (h)(2) of this AD, install the butt straps 

at FR53.3 on the fuselage skin between LH 

and RH STR13; and do all related 

investigative and other specified actions 

before further flight, as applicable. Do all 

actions in accordance with the 

Accomplishment Instructions of Airbus 

Service Bulletin A330–53–3143, Revision 01, 

including Appendix 01, dated June 29, 2006; 

except if any crack is detected during a 

related investigative action (rototest), before 

further flight, repair the crack using a method 

approved by the Manager, International 

Branch, ANM–116; or the EASA (or its 

delegated agent). 

(1) Before the accumulation of 17,600 total 

flight cycles or 61,600 total flight hours, 

whichever occurs earlier. 

(2) Within 6 months after the effective date 

of this AD. 

Credit for Actions Done in Accordance With 

Previous Service Bulletin 

(i) Actions done before the effective date of 

this AD in accordance with Airbus Service 

Bulletin A330–53–3143, including Appendix 

01, dated December 24, 2004, are acceptable 

for compliance with the corresponding 

requirements of paragraph (h) of this AD. 

Alternative Methods of Compliance 

(AMOCs) 

(j)(1) The Manager, International Branch, 

ANM–116, has the authority to approve 

AMOCs for this AD, if requested in 

accordance with the procedures found in 14 

CFR 39.19. 

(2) Before using any AMOC approved in 

accordance with § 39.19 on any airplane to 

which the AMOC applies, notify the 

appropriate principal inspector in the FAA 

Flight Standards Certificate Holding District 

Office. 

Related Information 

(k) EASA airworthiness directive 2006–

0266, dated August 30, 2006, also addresses 

the subject of this AD. 

Material Incorporated by Reference 

(l) You must use Airbus Service Bulletin 

A330–53–3127, Revision 01, dated November 

21, 2003; and Airbus Service Bulletin A330–

53–3143, Revision 01, including Appendix 

01, dated June 29, 2006; as applicable, to 

perform the actions that are required by this 

AD, unless the AD specifies otherwise. 

(1) The Director of the Federal Register 

approved the incorporation by reference of 

Airbus Service Bulletin A330–53–3143, 

Revision 01, including Appendix 01, dated 

June 29, 2006, in accordance with 5 U.S.C. 

552(a) and 1 CFR part 51. 

(2) On October 19, 2005 (70 FR 57732, 

October 4, 2005), the Director of the Federal 

Register approved the incorporation by 

reference of Airbus Service Bulletin A330–

53–3127, Revision 01, dated November 21, 

2003. 

(3) Contact Airbus, 1 Rond Point Maurice 

Bellonte, 31707 Blagnac Cedex, France, for a 

copy of this service information. You may 

review copies at the FAA, Transport Airplane 

Directorate, 1601 Lind Avenue, SW., Renton, 

Washington; or at the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

material at the NARA, call (202) 741–6030, 

or go to: http://www.archives.gov/federalregister/cfr/ibr-locations.html. 

Issued in Renton, Washington, on March 7, 

2007. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. E7–4740 Filed 3–15–07; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2006–26401; Directorate 

Identifier 2006–CE–72–AD; Amendment 39–

14987; AD 2007–06–06] 

RIN 2120–AA64 

Airworthiness Directives; B–N Group 

Ltd. BN–2, BN–2A, BN–2B, BN–2T, and 

BN–2T–4R Series (All Individual 

Models Included in Type Certificate 

Data Sheet (TCDS) A17EU, Revision 

16, Dated December 9, 2002), and BN–

2A–Mklll Trislander Series (All 

Individual Models Included in Type 

Certificate Data Sheet (TCDS) A29EU, 

Revision 4, Dated December 9, 2002) 

Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), Department of 

Transportation (DOT). 

ACTION: Final rule. 


sroberts on PROD1PC70 with RULES
12558 Federal Register / Vol. 72, No. 51 / Friday, March 16, 2007 / Rules and Regulations 

SUMMARY: We are adopting a new 

airworthiness directive (AD) for the 

products listed above. This AD results 

from mandatory continuing 

airworthiness information (MCAI) 

issued by an aviation authority of 

another country to identify and correct 

an unsafe condition on an aviation 

product. The MCAI describes the unsafe 

condition as: 

* * * incidences have been reported to 

Britten-Norman Aircraft Ltd where cracks 

have been found in the inner shell of the 

pitot/static pressure heads. This could result 

in incorrect readings on the pressure 

instrumentation, e.g. altimeters, vertical 

speed indicators (rate-of-climb) and airspeed 

indicators. 

We are issuing this AD to require 

actions to correct the unsafe condition 

on these products. 

DATES: This AD becomes effective April 

20, 2007. 

The Director of the Federal Register 

approved the incorporation by reference 

of certain publications listed in this AD 

as of April 20, 2007. 

ADDRESSES: You may examine the AD 

docket on the Internet at http:// 

dms.dot.gov or in person at the Docket 

Management Facility, U.S. Department 

of Transportation, 400 Seventh Street 

SW., Nassif Building, Room PL–401, 

Washington, DC. 

FOR FURTHER INFORMATION CONTACT: 

Taylor B. Martin, Aerospace Engineer, 

FAA, Small Airplane Directorate, 901 

Locust, Room 301, Kansas City, 

Missouri, 64106; telephone: (816) 329–

4138; facsimile: (816) 329–4090. 

SUPPLEMENTARY INFORMATION: 

Streamlined Issuance of AD 

The FAA is implementing a new 

process for streamlining the issuance of 

ADs related to MCAI. The streamlined 

process will allow us to adopt MCAI 

safety requirements in a more efficient 

manner and will reduce safety risks to 

the public. This process continues to 

follow all FAA AD issuance processes to 

meet legal, economic, Administrative 

Procedure Act, and Federal Register 

requirements. We also continue to meet 

our technical decision-making 

responsibilities to identify and correct 

unsafe conditions on U.S.-certificated 

products. 

This AD references the MCAI and 

related service information that we 

considered in forming the engineering 

basis to correct the unsafe condition. 

The AD contains text copied from the 

MCAI and for this reason might not 

follow our plain language principles. 

Discussion 

We issued a notice of proposed 

rulemaking (NPRM) to amend 14 CFR 

part 39 to include an AD that would 

apply to the specified products. That 

NPRM was published in the Federal 

Register on December 22, 2006 (71 FR 

76952). That NPRM proposed to correct 

an unsafe condition for the specified 

products. The MCAI states that: 

* * * incidences have been reported to 

Britten-Norman Aircraft Ltd. where cracks 

have been found in the inner shell of the 

pitot/static pressure heads. If not corrected 

this could result in incorrect readings on the 

pressure instrumentation, e.g. altimeters, 

vertical speed indicators (rate-of-climb) and 

airspeed indicators. 

Comments 

We gave the public the opportunity to 

participate in developing this AD. We 

considered the comments received. 

Comment Issue No. 1: Reference to 

Service Bulletin 

Jack Buster of the Modification and 

Replacement Parts Association 

(MARPA) comments that the correct 

reference to the service bulletin is 

Britten-Norman Service Bulletin 

Number SB 310, Issue 2, dated March 1, 

2006. 

When referencing what is in the 

MCAI, we reference it as ‘‘B–N Service 

Bulletin 310 Issue 2’’ because we try to 

use terminology straight from the MCAI 

when we can. We are not able to use 

this reference in the actual AD portion 

because to incorporate by reference 

(IBR) this service bulletin, we must 

reference it exactly how it appears in 

the reference document. Therefore, we 

will reference it in the AD as follows: 

• When referencing the MCAI: We 

will reference it as B–N Service Bulletin 

310 Issue 2. 

• All other references: We will 

reference it as Britten-Norman Service 

Bulletin Number SB 310, Issue 2, dated 

March 1, 2006. 

Comment Issue No. 2: Incorporation of 

Service Documents 

MARPA comments that it was 

informed service documents are usually 

not incorporated into proposed actions 

(NPRMs), but only into final actions. 

MARPA notes there is no indication in 

the NPRM the FAA intends to 

incorporate by reference the necessary 

service information. In addition, there is 

no indication of which service 

documents are mandatory and which 

are merely sources of additional service 

information. Therefore, the reader is 

unsure of the FAA’s intent. MARPA 

asks that future proposed actions 

indicate the FAA’s intent by including 

the following, or a similar statement: 

‘‘We intend to incorporate by reference 

the following publications.’’

We do not concur with the 

commenter’s request to indicate in an 

NPRM our intent to incorporate service 

information by reference. When we 

propose that actions be accomplished in 

accordance with certain service 

information in an NPRM, the public 

may assume we intend to Incorporate by 

Reference (IBR) that service information, 

as requested by the Office of the Federal 

Register. Service information that is 

cited in the proposed AD as a source of 

additional information is not presented 

as a requirement, and the public may 

assume we do not intend to IBR that 

service information. No change to this 

final rule is necessary in regard to the 

commenter’s request. 

Conclusion 

We reviewed the available data, 

including the comments received, and 

determined that air safety and the 

public interest require adopting the AD 

with the changes described previously. 

We determined that these changes will 

not increase the economic burden on 

any operator or increase the scope of the 

AD. 

Differences Between This AD and the 

MCAI or Service Information 

We have reviewed the MCAI and 

related service information and, in 

general, agree with their substance. But 

we might have found it necessary to use 

different words from those in the MCAI 

to ensure the AD is clear for U.S. 

operators and is enforceable. In making 

these changes, we do not intend to differ 

substantively from the information 

provided in the MCAI and related 

service information. 

We might also have required different 

actions in this AD from those in the 

MCAI in order to follow FAA policies. 

Any such differences are highlighted in 

a Note within the AD. 

Costs of Compliance 

We estimate that this AD will affect 

135 products of U.S. registry. We also 

estimate that it will take about 2 workhours per product to comply with this 

AD. The average labor rate is $80 per 

work-hour. Required parts will cost 

about $10,000 per product. Where the 

service information lists required parts 

costs that are covered under warranty, 

we have assumed that there will be no 

charge for these parts. As we do not 

control warranty coverage for affected 

parties, some parties may incur costs 

higher than estimated here. Based on 

these figures, we estimate the cost of 


sroberts on PROD1PC70 with RULES
Federal Register / Vol. 72, No. 51 / Friday, March 16, 2007 / Rules and Regulations 12559 

this AD to the U.S. operators to be 

$1,371,600, or $10,160 per product. 

Authority for This Rulemaking 

Title 49 of the United States Code 

specifies the FAA’s authority to issue 

rules on aviation safety. Subtitle I, 

section 106, describes the authority of 

the FAA Administrator. ‘‘Subtitle VII: 

Aviation Programs,’’ describes in more 

detail the scope of the Agency’s 

authority. 

We are issuing this rulemaking under 

the authority described in ‘‘Subtitle VII, 

Part A, Subpart III, Section 44701: 

General requirements.’’ Under that 

section, Congress charges the FAA with 

promoting safe flight of civil aircraft in 

air commerce by prescribing regulations 

for practices, methods, and procedures 

the Administrator finds necessary for 

safety in air commerce. This regulation 

is within the scope of that authority 

because it addresses an unsafe condition 

that is likely to exist or develop on 

products identified in this rulemaking 

action. 

Regulatory Findings 

We determined that this AD will not 

have federalism implications under 

Executive Order 13132. This AD will 

not have a substantial direct effect on 

the States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government. 

For the reasons discussed above, I 

certify this AD: 

(1) Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866; 

(2) Is not a ‘‘significant rule’’ under 

DOT Regulatory Policies and Procedures 

(44 FR 11034, February 26, 1979); and 

(3) Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

We prepared a regulatory evaluation 

of the estimated costs to comply with 

this AD and placed it in the AD Docket. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http://dms.dot.gov; or in 

person at the Docket Management 

Facility between 9 a.m. and 5 p.m., 

Monday through Friday, except Federal 

holidays. The AD docket contains the 

NPRM, the regulatory evaluation, any 

comments received, and other 

information. The street address for the 

Docket Office (telephone (800) 647–

5227) is in the ADDRESSES section. 

Comments will be available in the AD 

docket shortly after receipt. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

Adoption of the Amendment 

■ Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA amends 14 CFR part 39 as 

follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

■ 1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by adding 

the following new AD: 

2007–06–06 B–N Group Ltd: Amendment 

39–14987; Docket No. FAA–2006–26401; 

Directorate Identifier 2006–CE–72–AD. 

Effective Date 

(a) This airworthiness directive (AD) 

becomes effective April 20, 2007. 

Affected ADs 

(b) None. 

Applicability 

(c) This AD applies to B–N Group Ltd BN–

2, BN–2A, BN–2B, BN–2T, and BN–2T–4R 

Series (all individual models included in 

Type Certificate Data Sheet (TCDS) A17EU, 

Revision 16, dated December 9, 2002), and 

BN–2A–Mklll Trislander Series (all 

individual models included in TCDS A29EU, 

Revision 4, dated December 9, 2002) 

airplanes, certificated in any category. 

Reason 

(d) The mandatory continuing 

airworthiness information (MCAI) states: 

* * * incidences have been reported to 

Britten-Norman Aircraft Ltd. where cracks 

have been found in the inner shell of the 

pitot/static pressure heads. If not corrected 

this could result in incorrect readings on the 

pressure instrumentation, e.g. altimeters, 

vertical speed indicators (rate-of-climb) and 

airspeed indicators. 

Actions and Compliance 

(e) Unless already done, do the following 

actions in accordance with Britten-Norman 

Service Bulletin Number SB 310, Issue 2, 

dated March 1, 2006: 

(1) Within the next 60 days after the 

effective date of this AD, perform the 

inspection procedure and the leak test 

procedure as detailed in Section 6 Action, of 

Britten-Norman Service Bulletin Number SB 

310, Issue 2, dated March 1, 2006. Repeat this 

inspection procedure and the leak test 

procedure at intervals not to exceed 500 

hours time-in-service (TIS). 

(2) In addition, within 500 hours after the 

initial inspection, perform an initial 

inspection of the drain traps for moisture. 

Repeat this inspection at intervals not to 

exceed 500 hours TIS. 

(3) Before further flight, after any 

inspection or procedure required by this AD, 

correct, modify, or replace, as specified in the 

service information. 

FAA AD Differences 

Note: This AD differs from the MCAI and/ 

or service information as follows: This AD 

references the service bulletin as BrittenNorman Service Bulletin Number SB 310, 

Issue 2, dated March 1, 2006; and the MCAI 

references the service bulletin as B–N Service 

Bulletin 310 Issue 2. 

Other FAA AD Provisions 

(f) The following provisions also apply to 

this AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, Standards Staff, 

FAA, ATTN: Taylor B. Martin, Aerospace 

Engineer, FAA, Small Airplane Directorate, 

901 Locust, Room 301, Kansas City, Missouri 

64106; telephone: (816) 329–4138; facsimile: 

(816) 329–4090, has the authority to approve 

AMOCs for this AD, if requested using the 

procedures found in 14 CFR 39.19. 

(2) Airworthy Product: For any requirement 

in this AD to obtain corrective actions from 

a manufacturer or other source, use these 

actions if they are FAA-approved. Corrective 

actions are considered FAA-approved if they 

are approved by the State of Design Authority 

(or their delegated agent). You are required 

to assure the product is airworthy before it 

is returned to service. 

(3) Reporting Requirements: For any 

reporting requirement in this AD, under the 

provisions of the Paperwork Reduction Act 

(44 U.S.C. 3501 et seq.), the Office of 

Management and Budget (OMB) has 

approved the information collection 

requirements and has assigned OMB Control 

Number 2120–0056. 

Related Information 

(g) Refer to MCAI European Aviation 

Safety Agency (EASA), AD No.: 2006–0143, 

dated May 30, 2006; and Britten-Norman 

Service Bulletin SB 310, Issue 2, dated March 

1, 2006, for related information. 

Material Incorporated by Reference 

You must use Britten-Norman Service 

Bulletin Number SB 310, Issue 2, dated 

March 1, 2006 to do the actions required by 

this AD, unless the AD specifies otherwise. 

(1) The Director of the Federal Register 

approved the incorporation by reference of 

this service information under 5 U.S.C. 

552(a) and 1 CFR part 51. 

(2) For service information identified in 

this AD, contact Britten-Norman Aircraft 

Limited, Bembridge Airport, Isle of Wight, 

United Kingdom, PO35 5PR. 

(3) You may review copies at the FAA, 

Central Region, Office of the Regional 

Counsel, 901 Locust, Room 506, Kansas City, 

Missouri 64106; or at the National Archives 

and Records Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, or go 

to: http://www.archives.gov/federal_register/

code_of_federal_regulations/

ibr_locations.html. 


sroberts on PROD1PC70 with RULES
12560 Federal Register / Vol. 72, No. 51 / Friday, March 16, 2007 / Rules and Regulations 

Issued in Kansas City, Missouri, on March 

6, 2007. 

Kim Smith, 

Manager, Small Airplane Directorate, Aircraft 

Certification Service. 

[FR Doc. E7–4729 Filed 3–15–07; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 584 

[Docket No. 1995G–0321] (formerly 95G–

0321) 

Food Substances Affirmed as 

Generally Recognized as Safe in Feed 

and Drinking Water of Animals: 25- 

Hydroxyvitamin D3

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulations to affirm that the use of 25- 

hydroxyvitamin D3 is generally 

recognized as safe (GRAS) as a source of 

vitamin D3 activity in broiler chicken 

feeds and drinking water when used in 

accordance with certain limitations. 

This action is in response to a petition 

filed by Amoco BioProducts Corp. 

Subsequently, the sponsorship for this 

petition was changed to IsoGen L.L.C., 

Monsanto Co., Roche Vitamins, Inc., 

and lastly, to DSM Nutritional Products, 

Inc. 

DATES: This rule is effective March 16, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

Michaela Alewynse, Center for 

Veterinary Medicine (HFV–228), Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20855, 240–453–

6866, e-mail: 

mika.alewynse@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with the procedures 

described in 21 CFR 570.35, Amoco 

BioProducts Corp., P.O. Box 3011, 

Naperville, IL, 60566, submitted a 

petition (GRASP 2449) requesting that 

25-hydroxyvitamin D3 (25-OH D3) be 

affirmed as GRAS for use as a source of 

vitamin D3 activity in broiler chicken 

feeds. In the original petition, 25-OH D3

was proposed for use in feed only. The 

proposed use was amended in a 

submission dated January 7, 1998, to 

include administration through drinking 

water. Furthermore, all data for feed are 

applicable to water. 

FDA published a notice of filing of 

this petition in the Federal Register of 

October 24, 1995 (60 FR 54505), and 

gave interested parties an opportunity to 

submit comments to the agency. FDA 

did not receive any comments in 

response to that notice. Subsequent to 

the filing of the petition, sponsorship 

was changed to IsoGen L.L.C., Monsanto 

Co., Roche Vitamins, Inc., and lastly, to 

DSM Nutritional Products, Inc., 45 

Waterview Blvd., Parsippany, NJ, 

07054–1298. 

II. Standards for GRAS Affirmation 

Under § 570.30 (21 CFR 570.30), 

general recognition of safety of food 

ingredients may be based only on the 

views of experts qualified by scientific 

training and experience to evaluate the 

safety of food substances directly or 

indirectly added to food. The basis of 

such views may be either of the 

following: (1) Scientific procedures, or 

(2) in the case of a substance used in 

food prior to January 1, 1958, through 

experience based on common use in 

food. General recognition of safety based 

upon scientific procedures requires the 

same quantity and quality of scientific 

evidence as is required to obtain 

approval of a food additive regulation 

for the ingredient and ordinarily is to be 

based upon published studies, which 

may be corroborated by unpublished 

studies and other data and information 

(§ 570.30(b)). General recognition of 

safety through experience based on 

common use of a substance in food prior 

to January 1, 1958, may be determined 

without the quantity or quality of 

scientific evidence required for approval 

of a food additive regulation. Ordinarily 

it is to be based upon generally available 

data and information (§ 570.30(c)). 

The subject petition relies on 

scientific procedures evidence to 

support the GRAS affirmation of 25-OH 

D3 as a source of vitamin D3 activity in 

broiler chicken feeds and drinking 

water. 

III. Safety Evaluation 

A. Introduction 

25-OH D3, also called 25- 

hydroxycholecalciferol, is a normal 

metabolite of vitamin D3 in mammals 

and birds. Chemically, the substance is 

9,10-secocholesta-5,7,10(19)-triene-3b, 

25-diol. 25-OH D3 is the principal 

circulating form of vitamin D3, which is 

the primary source of vitamin D activity 

for livestock animals. The metabolism of 

vitamin D in animals is well understood 

and is documented in biochemistry 

textbooks (for example, Ref. 1). In 

poultry, vitamin D regulates calcium 

and phosphorus homeostasis, bone 

growth, eggshell formation, as well as 

other endocrine system functions (Ref. 

2). 

Animals, including poultry, do not 

have a dietary requirement for vitamin 

D when sufficient ultraviolet (UV) light 

is available, because vitamin D is 

produced through action of UV light on 

a provitamin present in the skin. This 

provitamin is synthesized in the body 

and present in large amounts in skin, 

intestinal wall, and other tissues (Ref. 

2). Vitamin D becomes a nutritionally 

important factor in the absence of 

sufficient UV light either from the sun 

or from an artificial source. Under 

modern farming conditions, many 

animals are raised in total confinement 

with limited exposure to UV light thus 

creating the need for a dietary supply of 

vitamin D. 

There are two predominant forms of 

vitamin D for poultry. Vitamin D2 comes 

mainly from plants. Vitamin D3 is 

produced in a bird’s body when 

sunlight reacts with vitamin D 

precursors obtained from the bird’s diet. 

Since vitamin D3 is 30 to 40 times more 

potent than D2, plants are considered 

insignificant sources of vitamin D for 

birds. 

Commonly, broiler chickens are 

grown within the confines of buildings 

with large numbers of birds per building 

and are supplied with bulk feed and 

water for ad libitum consumption. 

Various strains of chicken have been 

developed for broiler production. They 

have been bred primarily for rapid 

weight gain and efficient feed 

utilization. Typically, broilers are 

slaughtered at 6 to 7 weeks of age if size 

and weight requirements are attained. 

Crumbled starter feed is supplied during 

weeks 1 to 3, pelletized grower feed 

during weeks 4 to 6, and finisher feed 

until slaughter. The major differences 

among these types of feed are the levels 

and sources of nutrients provided in the 

feed, such as amino acids, minerals, and 

vitamins. The level of vitamin 

supplementation provided in the broiler 

industry is based on type of diets fed, 

species, age of the bird, dietary 

antagonists, form of vitamin product, 

requirement status (optimum or 

minimum requirements), disease status, 

complexity of the ration, and 

environmental factors, primarily 

ambient temperature. Only after all 

these factors are considered can the 

optimal vitamin requirements for 

poultry be estimated (Ref. 2). 

The National Research Council’s 

(NRC) recommendation for dietary 

vitamin D3 requirement of broiler 

chickens is 200 International Units (IU) 

of vitamin D3 per kilogram (/kg) of feed 

(Ref. 3). One unit of vitamin D3 is 


sroberts on PROD1PC70 with RULES