[Federal Register: June 22, 2005 (Volume 70, Number 119)]
[Rules and Regulations]               
[Page 36021-36025]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jn05-17]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 2002F-0160]

 
Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Vitamin D3

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correcting amendments.

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SUMMARY: The Food and Drug Administration (FDA) is responding to 
objections and is denying requests that it has received for a hearing 
on the final rule that amended the food additive regulations 
authorizing the use of vitamin D3 as a nutrient supplement 
in calcium-fortified fruit juices and fruit drinks, excluding fruit 
juices and fruit juice drinks specially formulated or processed for 
infants, at levels not to exceed 100 International Units (IU) per 
serving. (In the final rule, FDA used the term ``fruit drink;'' 
however, the common or usual name of the product is ``fruit juice 
drink.'' Therefore, FDA is replacing the term ``fruit drink'' with 
``fruit juice drink.'') In response to one of the objections, FDA is 
amending the vitamin D3 regulation to replace the current 
100 IU per serving limits on the vitamin D3 fortification of 
fruit juices and fruit juice drinks with limits of 100 IU per 240 
milliliters (mL). This document also corrects three errors that 
appeared in the codified portion of the vitamin D3 final 
rule.

DATES: This rule is effective June 22, 2005. Submit written or 
electronic objections and requests for a hearing by July 22, 2005. See 
section IX of this document for information on the filing of 
objections.

ADDRESSES: You may submit written or electronic objections and requests 
for a hearing, identified by Docket No. 2002F-0160, by any of the 
following methods:
     Federal eRulemaking Portal: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 

Follow the instructions for submitting comments.
     Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting comments on the agency Web site.
     E-mail: fdadockets@oc.fda.gov. Include Docket No. 2002F-
0160 in the subject line of your e-mail message.
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and docket number for this rulemaking. All objections received will be 
posted without change to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm, 

including any personal information provided. For detailed instructions 
on submitting objections, see the ``Objections'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
objections received, go to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm 

and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Judith L. Kidwell, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1071.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In the Federal Register of April 25, 2002 (67 FR 20533), FDA 
published a notice announcing the filing of a food additive petition 
(FAP 2A4734) by the Minute Maid Co. (Minute Maid), to amend the food 
additive regulations in part 172 Food Additives Permitted for Direct 
Addition to Food for Human Consumption (21 CFR part 172) to provide for 
the safe use of vitamin D3 as a nutrient supplement in 
calcium-fortified fruit juices and fruit juice drinks. In response to 
FAP 2A4734, in the Federal Register of February 27, 2003 (68 FR 9000), 
FDA issued a final rule permitting the safe use of vitamin 
D3 as a nutrient supplement in calcium-fortified fruit 
juices and fruit juice drinks\1\, excluding fruit juices and fruit 
juice drinks specially formulated or processed for infants, at levels 
not to exceed 100 IU per serving. This regulation was codified in Sec.  
172.380. FDA based its decision on data contained in the petition and 
in its files.
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    \1\ In the final rule (68 FR 9000), FDA used the term ``fruit 
drink.'' In 21 CFR 102.33, the common or usual name of the product 
is ``fruit juice drink.'' To be consistent with Sec.  102.33, FDA is 
replacing the term ``fruit drink'' with ``fruit juice drink'' in 
Sec.  172.380(d) and elsewhere in this document.
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    The preamble to the final rule advised that objections to the final 
rule and requests for a hearing were due within 30 days of the 
publication date, by March 31, 2003. FDA received several submissions 
within the 30-day objection period. Some of the submissions sought 
revocation of the final rule and requested a hearing. In response to 
one of the objections received during the 30-day objection period, FDA 
is amending the food additive regulation to replace those portions of 
the vitamin D3 regulation that prescribe limits on vitamin 
D3 fortification of fruit juices and fruit juice drinks of 
100 IU per serving with limits of 100 IU per 240 mL. This document also 
corrects three errors that appeared in the codified portion of the 
vitamin D3 final rule.

II. Objections and Requests for a Hearing

    Section 409(f) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 348(f)), provides that, within 30 days after 
publication of an order relating to a food additive regulation, any 
person adversely affected by such order may file objections, specifying 
with particularity the provisions of the order ``* * * deemed 
objectionable, stating reasonable grounds therefore, and requesting a 
public hearing [based] upon such objections.'' FDA may deny a hearing 
request if the objections to the regulation do not raise genuine and 
substantial issues of fact that can be resolved at a hearing.
    Under 21 CFR 171.110 of the food additive regulations, objections 
and requests for a hearing are governed by part 12 (21 CFR part 12) of 
FDA's regulations. Under Sec.  12.22(a) each

[[Page 36022]]

objection must: (1) Be submitted on or before the 30th day after the 
date of publication of the final rule; (2) be separately numbered; (3) 
specify with particularity the provision of the regulation or proposed 
order objected to; (4) specifically state the provision of the 
regulation or proposed order on which a hearing is requested; failure 
to request a hearing on an objection constitutes a waiver of the right 
to a hearing on that objection; and (5) include a detailed description 
and analysis of the factual information to be presented in support of 
the objection if a hearing is requested; failure to include a 
description and analysis for an objection constitutes a waiver of the 
right to a hearing on that objection.

III. Standards for Granting a Hearing

    Specific criteria for deciding whether to grant or deny a request 
for a hearing are set out in Sec.  12.24(b). Under that regulation, a 
hearing will be granted if the material submitted by the requester 
shows, among other things, that: (1) There is a genuine and substantial 
factual issue for resolution at a hearing; a hearing will not be 
granted on issues of policy or law; (2) the factual issue can be 
resolved by available and specifically identified reliable evidence; a 
hearing will not be granted on the basis of mere allegations or denials 
or general descriptions of positions and contentions; (3) the data and 
information submitted, if established at a hearing, would be adequate 
to justify resolution of the factual issue in the way sought by the 
requester; a hearing will be denied if the data and information 
submitted are insufficient to justify the factual determination urged, 
even if accurate; and (4) resolution of the factual issue in the way 
sought by the person is adequate to justify the action requested; a 
hearing will not be granted on factual issues that are not 
determinative with respect to the action requested (e.g., if the action 
would be the same even if the factual issue were resolved in the way 
sought).
    A party seeking a hearing is required to meet a ``threshold burden 
of tendering evidence suggesting the need for a hearing'' (Costle v. 
Pacific Legal Foundation, 445 U.S. 198, 214-215 (1980), reh. denied, 
446 U.S. 947 (1980), citing Weinberger v. Hynson, Westcott & Dunning, 
Inc., 412 U.S. 609, 620-621 (1973)). An allegation that a hearing is 
necessary to ``sharpen the issues'' or to ``fully develop the facts'' 
does not meet this test (Georgia Pacific Corp. v. EPA, 671 F.2d 1235, 
1241 (9th Cir. 1982)). If a hearing request fails to identify any 
factual evidence that would be the subject of a hearing, there is no 
point in holding one. In judicial proceedings, a court is authorized to 
issue summary judgment without an evidentiary hearing whenever it finds 
that there are no genuine issues of material fact in dispute, and a 
party is entitled to judgment as a matter of law (see Rule 56, Federal 
Rules of Civil Procedure). The same principle applies in administrative 
proceedings (see Sec.  12.28).
    A hearing request must not only contain evidence, but that evidence 
should raise a material issue of fact concerning which a meaningful 
hearing might be held (Pineapple Growers Ass'n v. FDA, 673 F.2d 1083, 
1085 (9th Cir. 1982)). Where the issues raised in the objection are, 
even if true, legally insufficient to alter the decision, the agency 
need not grant a hearing (see Dyestuffs and Chemicals, Inc. v. 
Flemming, 271 F.2d 281 (8th Cir. 1959), cert. denied, 362 U.S. 911 
(1960)). FDA need not grant a hearing in each case where an objector 
submits additional information or posits a novel interpretation of 
existing information (see United States v. Consolidated Mines & 
Smelting Co., 455 F.2d 432 (9th Cir. 1971)). In other words, a hearing 
is justified only if the objections are made in good faith and if they 
``draw in question in a material way the underpinnings of the 
regulation at issue.'' (Pactra Industries v. CPSC, 555 F.2d 677 (9th 
Cir. 1977)). Finally, courts have uniformly recognized that a hearing 
need not be held to resolve questions of law or policy (see Citizens 
for Allegan County, Inc. v. FPC, 414 F.2d 1125 (D.C. Cir. 1969); Sun 
Oil Co. v. FPC, 256 F.2d 233, 240 (5th Cir.), cert. denied, 358 U.S. 
872 (1958)).
    Even if the objections raise material issues of fact, FDA need not 
grant a hearing if those same issues were adequately raised and 
considered in an earlier proceeding. Once an issue has been so raised 
and considered, a party is estopped from raising that same issue in a 
later proceeding without new evidence. The various judicial doctrines 
dealing with finality can be validly applied to the administrative 
process. In explaining why these principles ``self-evidently'' ought to 
apply to an agency proceeding, the U.S. Court of Appeals for the 
District of Columbia Circuit wrote:
    The underlying concept is as simple as this: Justice requires 
that a party have a fair chance to present his position. But overall 
interests of administration do not require or generally contemplate 
that he will be given more than a fair opportunity.
Retail Clerks Union, Local 1401 v. NLRB, 463 F.2d 316, 322 (D.C. Cir. 
1972). (See Costle v. Pacific Legal Foundation, supra at 215-220. See 
also Pacific Seafarers, Inc. v. Pacific Far East Line, Inc., 404 F.2d 
804 (D.C. Cir. 1968), cert. denied, 393 U.S. 1093 (1969).)
    In summary, a hearing request must present sufficient credible 
evidence to raise a material issue of fact and the evidence must be 
adequate to resolve the issue as requested and to justify the action 
requested.

IV. Analysis of Objections and Response to Hearing Requests

    Objections to the vitamin D3 final rule can be grouped 
into five broad categories that include the following: (1) 
Inconsistencies between the codified language and the intent of the 
petitioner; (2) the use of an animal-derived food additive; (3) the 
effect on milk consumption and obesity; (4) hypercalcemia concerns; and 
(5) inconsistency with FDA's fortification policy\2\. FDA addresses 
each of the objections listed in this document, as well as the evidence 
and information filed in support of each. If a hearing was requested, 
we compared each objection and the information submitted to support it 
to the standards for granting a hearing in Sec.  12.24.
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    \2\ FDA received several letters within the 30-day objection 
period that expressed general opposition to the use of vitamin 
D3 in fruit juices and fruit juice drinks. These letters 
identified no substantive issue to which the agency can respond, and 
did not request a hearing. These submissions will not be discussed 
further.
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A. Inconsistencies Between Codified Language and Intent of Petitioner

    One submission, from Unilever United States, Inc. (Unilever), 
objected to vitamin D3 fortification limits based on serving 
size rather than reference amount customarily consumed (RACC). The 
RACC, a fixed amount established by regulation Sec.  101.12 (21 CFR 
101.12), is to be used as the basis for determining serving sizes for 
specific products. Serving sizes, however, may vary depending on how a 
product is packaged (Sec.  101.9(b)).
    Unilever pointed out that the fortification levels based on serving 
size, rather than RACC, will result in levels of vitamin D3 
in fortified fruit juices and fruit juice drinks that are inconsistent, 
on a per-mL basis, with the levels of vitamin D3 in milk and 
also with the levels of vitamin D3 in differently sized 
containers of fortified fruit juices and fruit juice drinks. According 
to Unilever, this would not be consistent with the intent of the 
petition that initiated the rulemaking and also would be confusing to 
consumers. Unilever stated that the intent of the petition is achieved 
when the fruit juice and fruit juice drinks are fortified with vitamin

[[Page 36023]]

D3 at 100 IU per RACC value of 240 mL, rather than 100 IU 
per serving. As explained in the preamble to the vitamin D3 
final rule (68 FR 9000), the RACC for fruit juices and fruit juice 
drinks intended for the general population is 240 mL.
    FDA has reviewed the issues raised by Unilever. FDA determined that 
the petitioned uses of vitamin D3 are safe based on a 
fortification level of 100 IU of vitamin D3 per RACC (240 
mL) of fruit juice and fruit juice drinks and had intended to establish 
such a limit but inappropriately used the term ``serving'' as a synonym 
for RACC. There will be no adverse effect on the public health if the 
term ``serving'' is replaced with the RACC value ``240 mL.'' Therefore, 
the agency concludes that replacing ``100 IU per serving'' with ``100 
IU per 240 mL'' is consistent with the record for this petition as 
evidenced by both the petitioner's intentions and FDA's safety 
evaluation of FAP 2A4734. For the foregoing reasons, under Sec.  12.26, 
FDA is replacing the term ``serving'' with ``240 mL'' in Sec.  
172.380(c) and (d). As discussed in section VI of this document, Sec.  
172.380 limits the vitamin D3 fortification of fruit juices 
to those with greater than or equal to 33 percent of the Reference 
Daily Intake (RDI) of calcium per RACC and, for fruit juice drinks, to 
those with greater than or equal to 10 percent of the RDI of calcium 
per RACC (emphasis added). To be consistent with specifying the vitamin 
D3 fortification limits in terms of the RACC value of 240 
mL, FDA also is replacing the terms ``Reference Amount Customarily 
Consumed'' and ``RACC'' as used in Sec.  172.380(c) and (d) with ``240 
mL.''

B. Animal-Derived Food Additive

    FDA received several letters from vegetarians and vegans expressing 
opposition to the rule because vitamin D3 can be derived 
from fish liver oil. Some of these objectors stated that, because 
vitamin D3 may be derived from an animal source, its 
addition to fruit juices and fruit juice drinks would limit their food 
choices. Others objected to the rule because listing the ingredient as 
vitamin D3 will not make it apparent that the vitamin 
D3-fortified fruit juices and fruit juice drinks may contain 
an animal product. One objector requested that FDA require a label 
statement alerting consumers that the additive is derived from an 
animal product.
    The final rule permits the use of vitamin D3 only in 
calcium-fortified fruit juices and fruit juice drinks. Data from the 
U.S. Department of Agriculture (USDA) Continuing Survey of Food Intake 
by Individuals conducted from 1994 through 1996 indicate that only a 
small fraction (approximately less than 5 percent) of the fruit juices 
and fruit juice drinks available to consumers is fortified with 
calcium. More recent data, however, indicate that the percentage of 
calcium-fortified fruit juices and fruit juice drinks could be somewhat 
higher (approximately 20 percent to 30 percent market share) due to the 
increasing demand and marketability of calcium-fortified products (Ref. 
1). Nevertheless, there remains a relatively large percentage of fruit 
juices and fruit juice drinks that will not be fortified with vitamin 
D3. Additionally, all food ingredients are required to be 
listed on the label of the product; therefore, consumers can choose to 
avoid a product that contains a specific ingredient.
    To justify a revocation of the food additive regulation, an 
objector must establish that FDA failed to conduct a fair evaluation of 
the evidence in the record and, thus, erroneously concluded that the 
use is safe (see section 409(c)(3) of the act (21 U.S.C. 348(c)(3)). 
The objections summarized previously in this document cited no data or 
information relevant to FDA's safety evaluation. Because these 
objections cited no data or information to demonstrate that the use of 
an animal-derived food additive is not safe, FDA has concluded that 
there is no basis to modify or revoke the food additive regulation for 
vitamin D3.
    Some of the objections summarized previously in this document 
requested a hearing on the subject but did not point to any specific 
aspect of the rule that they sought to challenge. Because no evidence 
was submitted to support these objections, they raise no factual issue 
for resolution and, therefore, do not justify a hearing (Sec.  
12.24(b)(1)).

C. Effect on Milk Consumption and Obesity

    FDA received objections from the American Academy of Pediatrics 
(AAP), the National Dairy Council (NDC) and the University of 
California at Davis, Department of Nutrition (UC-Davis), that assert 
FDA did not consider the effect that vitamin D3 
fortification of fruit juices and fruit juice drinks would have on 
consumption of these beverages. They were concerned that vitamin 
D3 fortification of fruit juices and fruit juice drinks 
would promote increased intake of these drinks, and that higher intakes 
of these beverages may be a contributing factor in childhood obesity. 
These objectors also expressed concern that fortified fruit juices and 
fruit juice drinks would likely result in decreased consumption of milk 
and the associated vitamins and minerals in that food. The NDC 
expressed a concern that fortification of fruit juice drinks with 
vitamin D is inconsistent with Dietary Guidelines for Americans and the 
USDA Food Guide Pyramid because these guidelines recommend limiting the 
intake of sugar from foods and beverages, including fruit juice drinks. 
The NDC contends that the vitamin D3 rule should be stayed 
until the issues they raised have been resolved. The AAP requested a 
hearing on its objections.
    As a basis for their objections, AAP and UC-Davis cited a report 
from the National Institute of Child Health and Human Development that 
reviewed evidence supporting a role for dietary calcium and, possibly, 
dairy intake in the regulation of body adiposity. The report concluded 
that the available, limited, data support a conclusion that dietary 
calcium may (emphasis added) play a role in body weight regulation and 
lend support to the hypothesis that increasing dietary calcium or dairy 
intake may be associated with reduced incidence of adiposity. The 
report recommended that well-designed, population-based clinical trials 
be carried out to determine the actual mechanism involved.
    The subject of the vitamin D3 rulemaking is whether the 
use of the additive in fruit juices and fruit juice drinks, within the 
limits provided, is safe. As stated in Sec.  12.24(b)(1), a hearing 
will not be granted on issues of policy or law. Therefore, FDA is 
denying AAP's request for a hearing. Additionally, FDA has concluded 
that there is no basis in NDC's objections to stay the food additive 
regulation for vitamin D3.
    Furthermore, FDA notes that objectors did not submit any evidence 
that demonstrates that vitamin D3 fortification of fruit 
juices and fruit juice drinks will lead to an increased consumption of 
these beverages or that such fortification will lead to a decrease in 
milk consumption. Additionally, these objectors also provided no 
evidence that demonstrates that there is a link between increased fruit 
juice and fruit juice drink consumption and childhood obesity.

D. Hypercalcemia

    Another issue raised by AAP was that FDA did not evaluate the 
potential effects of exposure to calcium from vitamin D3 
fortification of calcium-fortified fruit juices and fruit juice drinks. 
They stated that, while the potential for adverse effects from excess 
vitamin D or calcium is minimal, there are not sufficient consumption 
data

[[Page 36024]]

available for assessing children's risk of higher combined intakes of 
these two nutrients. The AAP asserts that individuals with renal 
disease might be at special risk due to hypercalcemia associated with 
hypervitaminosis D.
    FDA explicitly considered the issue of hypercalcemia, as reflected 
in the record. In addressing the issue of hypercalcemia, the agency 
relied upon upper tolerable daily intake levels (ULs) for vitamin D 
established by the Institute of Medicine (IOM) in 1997, as well as 
publications on vitamin D that appeared in the literature subsequent to 
the 1997 IOM report. IOM established the ULs based on multiple factors, 
including the significant dose-dependent increases in serum calcium 
concentration followed by daily supplementation of vitamin D, sensitive 
individuals, short duration of available studies, and limited sample 
sizes. Studies published after the 1997 IOM report support that vitamin 
D supplementation is without adverse effects at the IOM UL of 2,000 IU 
for adults, including elderly women and adults with osteoporosis. The 
IOM stated that the adult UL is appropriate for children based on 
increased rates of bone formation in children and because no data 
indicated difficulties in renal clearance by 1 year of age. No new 
reported studies on the effects of vitamin D supplementation in 
children have been published since 1997.
    The agency agrees that hypercalcemia could result from excessive 
consumption of vitamin D-fortified foods and was the primary basis for 
the 1985 final rule affirming the use of vitamin D as GRAS with 
specific limitations as a direct human food ingredient (50 FR 30149, 
July 24, 1985). In the final rule, FDA concluded that ``* * * a 
petition for new food uses of vitamin D is necessary so that the agency 
can assure that total dietary exposure will not increase significantly, 
and that any increase in exposure is safe.'' As with any food additive, 
FDA will re-evaluate the safety of vitamin D-fortification of foods as 
new data become available.
    The agency recognizes that hypercalcemia may accelerate the 
progression of renal disease. While there are individuals that must 
carefully monitor or limit the amount of calcium intake for medical 
reasons, both vitamin D and calcium must be declared on the label if 
they are added to foods. Listing these on the food label makes it 
possible for people to avoid these ingredients, if necessary. The AAP 
has not pointed to any evidence that supports that FDA failed to 
consider potential safety effects of combined exposure to vitamin D and 
calcium.

E. Inconsistency With FDA's Fortification Policy

    In its objections, NDC questions whether the fortification of fruit 
juices and fruit juice drinks is consistent with the principles in 
Sec.  104.20(b)(1) (21 CFR 104.20(b)(1)). Section 104.20(b)(1) states 
that the nutrients listed in Sec.  104.20(d)(3) may be appropriately 
added to a food to correct a dietary insufficiency recognized by the 
scientific community if there is sufficient information available to 
identify the nutritional problem and the affected population groups, 
and the food is suitable to act as a vehicle for the added nutrients.
    FDA's fortification policy is intended to provide a consistent set 
of guidelines to be followed when nutrients are added to foods. To 
preserve a balance of nutrients in the diet, manufacturers who elect to 
fortify foods are urged to utilize these principles. The policy does 
not prohibit the addition of nutrients to fruit juices and fruit juice 
drinks, or to any foods, as long as the proposed use of the additive is 
safe. The petitioner provided sufficient information for FDA to 
determine that the use of vitamin D3 at the petitioned level 
in calcium-fortified fruit juices and fruit juice drinks is safe. The 
NDC cited no data or information to suggest that the intended use is 
not safe.
    Moreover, in its submission, the petitioner provided a number of 
recent publications that identified clinical findings of vitamin D 
insufficiency and, in some cases, vitamin D deficiency, in several 
population groups (e.g., the elderly, toddlers, vegetarians, and young 
men and women during the winter months). Also, as evidence that 
calcium-fortified fruit juices and fruit juice drinks are suitable 
vehicles for vitamin D3, the petitioner provided results of 
a clinical study that confirmed the bioavailability of vitamin 
D3 in juice.

V. Summary and Conclusions

    Section 409 of the act requires that a food additive be shown to be 
safe prior to marketing. Under 21 CFR 170.3(i), a food additive is 
``safe'' if there is a reasonable certainty in the minds of competent 
scientists that the substance is not harmful under the intended 
conditions of use. In the final rule approving vitamin D3, 
FDA concluded that the data presented by the petitioner to establish 
safety of the additive demonstrate that vitamin D3 is safe 
for its intended use in calcium-fortified fruit juices and fruit juice 
drinks.
    The petitioner has the burden to demonstrate the safety of the 
additive in order to gain FDA approval. Once FDA makes a finding of 
safety, the burden shifts to an objector, who must come forward with 
evidence that calls into questions FDA's conclusion (American Cyanamid 
Co. v. FDA, 606 F2d. 1307, 1314-1315 (D.C. Cir. 1979)).
    Only one objection contained evidence to support a genuine and 
substantial issue of fact. It should be noted that this objection does 
not call into question FDA's safety evaluation; it merely addresses an 
inconsistency between the petitioner's intent and the codified portion 
of the regulation. As a result of the objection, FDA is amending Sec.  
172.380 to replace those portions of the vitamin D3 
regulation that prescribe limits on the vitamin D3 
fortification of fruit juices and fruit juice drinks of 100 IU per 
serving with limits of 100 IU per 240 mL and to replace the terms 
``Reference Amount Customarily Consumed'' and ``RACC'' as used in the 
regulation with ``240mL.''

VI. FDA's Corrections to the Final Rule (Sec.  172.380)

    In addition to the issues raised by Unilever, FDA discovered three 
errors in the codified portion of the vitamin D3 final rule. 
This document corrects these errors. Section 172.380(c) and (d) 
prescribes limits on the minimum levels of calcium fortification of 
fruit juice and fruit juice drinks with added vitamin D3. In 
section B of the petition (Use and Purpose) (FAP 2A4734), Minute Maid 
stated that the proposed use was ``intended for use at levels currently 
approved for vitamin D-fortified milk, [s]pecifically, 100% fruit juice 
products fortified with >=33% of the Recommended Daily Intake (RDI) of 
calcium per Reference Amount Customarily Consumed (RACC), and juice and 
juice drinks fortified with >=10% of the RDI of calcium per RACC, are 
intended to be fortified with 100 IU (2.5 [mu]g) vitamin D3 
per RACC.'' In Section F of the petition (Proposed Food Additive 
Regulation) (FAP 2A4734), however, the regulation mistakenly prescribed 
limits of calcium fortification of fruit juice and fruit juice drinks 
at ``greater than 33%'' and ``greater than 10%,'' respectively. In the 
codified section of the final rule, FDA listed the limitations on 
calcium fortification as ``greater than,'' rather than the petitioner's 
intention of ``greater than or equal to'' these percentages. FDA is 
changing the language in Sec.  172.380(c) and (d) to ``greater than or 
equal to.'' Additionally, in its proposed food additive regulation, the 
petitioner used the term ``Recommended Daily Intake'' to describe the 
levels of calcium in fruit juices and fruit juice drinks. The correct

[[Page 36025]]

term is ``Reference Daily Intake.'' Reference Daily Intakes are values 
established by FDA for use in nutrition labeling. Most RDIs are based 
on the National Academy of Science's Recommended Daily Allowances. In 
the final rule, FDA inadvertently used the term ``recommended'' instead 
of ``reference'' to describe daily intake. Therefore, FDA is replacing 
the term ``Recommended Daily Intake'' in Sec.  172.380(c) and (d) with 
``Reference Daily Intake.'' Finally, in Sec.  172.380(d), FDA used the 
term ``fruit drink.'' Under Sec.  102.33 (21 CFR 102.33), the common or 
usual name of the product is fruit juice drink. To be consistent with 
Sec.  102.33, FDA is replacing the term ``fruit drink'' with ``fruit 
juice drink'' in Sec.  172.380(d).

VII. Environmental Effects

    When FAP 2A4734 was filed, it contained a claim of categorical 
exclusion under 21 CFR 25.32(k). The agency reviewed this claim and 
found it to be warranted for the petitioned action. As a result, the 
agency stated in the notice of filing for FAP 2A4734 that neither an 
environmental assessment nor an environmental impact statement was 
required. The agency has concluded that the modifications to the 
regulation in response to the objections as well as the corrections 
that are being made to the regulation by this document will not change 
the agency's previous determination that the categorical exclusion in 
25.32(k) is warranted.

VIII. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

IX. Objections

    Any person who will be adversely affected by this amendment to the 
regulation may at any time file with the Division of Dockets Management 
(see ADDRESSES) written or electronic objections. Each objection shall 
be separately numbered, and each numbered objection shall specify with 
particularity the provisions of the regulation to which objection is 
made and the grounds for the objection. Each numbered objection on 
which a hearing is requested shall specifically so state. Failure to 
request a hearing for any particular objection shall constitute a 
waiver of the right to a hearing on that objection. Each numbered 
objection for which a hearing is requested shall include a detailed 
description and analysis of the specific factual information intended 
to be presented in support of the objection in the event that a hearing 
is held. Failure to include such a description and analysis for any 
particular objection shall constitute a waiver of the right to a 
hearing on the objection. Three copies of all documents shall be 
submitted and shall be identified with the docket number found in 
brackets in the heading of this document. Any objections received in 
response to the regulation may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

X. References

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 a.m. and 4 p.m. Monday through Friday.
    1. Memorandum from Folmer, Division of Petition Review, 
Chemistry Review Group, to Kidwell, Division of Petition Review, 
June 19, 2003.

List of Subjects in 21 CFR Part 172

    Food additives, Reporting and recordkeeping requirements.

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
172 is amended to read as follows:
0
1. The authority citation for 21 CFR part 172 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.

0
2. Section 172.380 is amended by revising the introductory text and 
paragraphs (c) and (d) to read as follows:


Sec.  172.380  Vitamin D3.

    Vitamin D3 may be used safely in foods as a nutrient 
supplement defined under Sec.  170.3(o)(20) of this chapter in 
accordance with the following prescribed conditions:
* * * * *
    (c) Vitamin D3 may be added, at levels not to exceed 100 
International Units (IU) per 240 milliliters (mL) to 100 percent fruit 
juices, as defined under Sec.  170.3(n)(35) of this chapter, excluding 
fruit juices that are specially formulated or processed for infants, 
that are fortified with greater than or equal to 33 percent of the 
Reference Daily Intake (RDI) of calcium per 240 mL.
    (d) Vitamin D3 may be added, at levels not to exceed 100 
IU per 240 mL to fruit juice drinks, as defined under Sec.  
170.3(n)(35) of this chapter, excluding fruit juice drinks that are 
specially formulated or processed for infants, that are fortified with 
greater than or equal to 10 percent of the RDI of calcium per 240 mL.

    Dated: June 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12322 Filed 6-21-05; 8:45 am]

BILLING CODE 4160-01-S