Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations 20509 

21For similar reasons, the amendment does not 

require analysis under the Regulatory Flexibility 

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

the Small Business Regulatory Enforcement 

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

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

which the agency publishes a general notice of 

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

purposes of Congressional review of agency 

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

rule of agency organization, procedure or practice 

that does not substantially affect the rights or 

obligations of non-agency parties). 

22See 5 U.S.C. 553(d)(3). 

23 15 U.S.C. 78c(f). 

24 15 U.S.C. 78w(a)(2). 

event of a lapse in appropriations, or a 

day on which the Commission’s 

Washington, DC office is otherwise 

closed for regular business due to other 

circumstances. The Commission finds 

that because the amendment is technical 

in nature and pertains to the 

Commission’s organization, procedure 

or practice, publishing the amendment 

for comment is unnecessary.21

The APA also requires publication of 

a rule at least 30 days before its effective 

date unless the agency finds otherwise 

for good cause.22 For the same reasons 

described above with respect to notice 

and the opportunity for comment, the 

Commission finds good cause for this 

technical amendment to take effect 

immediately. 

IV. Consideration of Burden on 

Competition, and Promotion of 

Efficiency, Competition and Capital 

Formation 

Section 3(f) of the Exchange Act,23

provides that whenever the Commission 

is engaged in rulemaking and is 

required to consider or determine 

whether an action is necessary or 

appropriate in the public interest, the 

Commission shall consider, in addition 

to the protection of investors, whether 

the action will promote efficiency, 

competition, and capital formation. 

Section 23(a)(2) of the Exchange Act 

requires the Commission, in adopting 

rules under the Exchange Act, to 

consider the competitive effects of such 

rules, if any, and not to adopt a rule that 

would impose a burden on competition 

not necessary or appropriate in the 

furtherance of the purposes of the 

Exchange Act.24

Because the amendment to Exchange 

Act Rule 19b–4 is technical in nature, 

and does not impose any additional 

requirements beyond those already 

required, we do not anticipate that the 

amendment would have a significant 

effect on efficiency, competition, or 

capital formation, and we do not 

anticipate that any competitive 

advantages or disadvantages would be 

created. 

List of Subjects in 17 CFR Part 240 

Brokers, Confidential business 

information, Fraud, Reporting and 

recordkeeping requirements, Securities. 

Statutory Basis and Text of Rules 

The Commission is amending 17 CFR 

part 240, pursuant to authority set forth 

in the Exchange Act, including Sections 

19(b) and 23(a). 

PART 240—GENERAL RULES AND 

REGULATIONS, SECURITIES 

EXCHANGE ACT OF 1934 

■ 1. The authority citation for part 240 

continues to read in part as follows: 

Authority: 15 U.S.C. 77c, 77d, 77g, 77j, 

77s, 77z–2, 77z–3, 77eee, 77ggg, 77nnn, 

77sss, 77ttt, 78c, 78d, 78e, 78f, 78g, 78i, 78j, 

78j–1, 78k, 78k–1, 78l, 78m, 78n, 78n–1, 78o, 

78p, 78q, 78s, 78u–5, 78w, 78x, 78ll, 78mm, 

80a–20, 80a–23, 80a–29, 80a–37, 80b–3, 80b– 

4 and 80b–11, and 7210 et seq., 18 U.S.C. 

1350, and 12 U.S.C. 5221(e)(3), unless 

otherwise noted. 

* * * * * 

■ 2. Amend § 240.19b–4 by: 

■ a. Redesignating paragraph (a) as 

paragraph (a)(1); and 

■ b. Adding new paragraph (a)(2). 

The addition reads as follows: 

§ 240.19b–4 Filings with respect to 

proposed rule changes by self-regulatory 

organizations. 

* * * * * 

(a) * * * 

(2) For purposes of Section 19(b) of 

the Act and this rule, a ‘‘business day’’ 

is any day other than a Saturday, 

Sunday, Federal holiday, a day that the 

Office of Personnel Management has 

announced that Federal agencies in the 

Washington, DC area are closed to the 

public, a day on which the Commission 

is subject to a Federal government 

shutdown or a day on which the 

Commission’s Washington, DC office is 

otherwise not open for regular business. 

* * * * * 

Dated: April 7, 2011. 

By the Commission. 

Elizabeth M. Murphy, 

Secretary. 

[FR Doc. 2011–8919 Filed 4–12–11; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 179 

[Docket No. FDA–1998–F–0072] (Formerly 

98F–0165) 

Irradiation in the Production, 

Processing, and Handling of Food 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; denial of requests for 

a hearing and response to objections. 

SUMMARY: The Food and Drug 

Administration (FDA) is responding to 

objections and is denying requests that 

it received for a hearing on the final rule 

that amended the food additive 

regulations to provide for the safe use of 

ionizing radiation for the reduction of 

Salmonella in fresh shell eggs. After 

reviewing objections to the final rule 

and requests for a hearing, the Agency 

has concluded that the objections do not 

raise issues of material fact that justify 

a hearing or otherwise provide a basis 

for revoking or modifying the 

amendment to the regulation. 

FOR FURTHER INFORMATION CONTACT: 

Teresa A. Croce, Center for Food Safety 

and Applied Nutrition (HFS–265), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740– 

3835, 301–436–1281. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

In the Federal Register of March 20, 

1998 (63 FR 13675), FDA published a 

notice announcing the filing of a food 

additive petition (FAP), FAP 8M4584, 

submitted by Edward S. Josephson, 

University of Rhode Island, Food 

Science and Nutrition Research Center, 

to amend the regulations in part 179, 

Irradiation in the Production, 

Processing, and Handling of Food (21 

CFR part 179), to provide for the safe 

use of ionizing radiation for the 

reduction of Salmonella in fresh shell 

eggs. In response to the petition, FDA 

issued a final rule in the Federal 

Register of July 21, 2000 (65 FR 45280), 

permitting the irradiation of fresh shell 

eggs for the reduction of Salmonella at 

doses not to exceed 3.0 kiloGray (kGy) 

(hereafter referred to as the ‘‘egg 

irradiation rule’’). FDA based its 

decision on data in the petition and in 

its files. In the preamble to the final 

rule, FDA outlined the basis for its 

decision and stated that objections to 

the final rule and requests for a hearing 

were due within 30 days of the 


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20510 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations 

1FDA also received letters after the close of the 

objection period that expressed general opposition 

to the egg irradiation rule. Tardy objections fail to 

satisfy the requirements of 21 U.S.C. 348(f)(1) and 

need not be considered by the Agency (see ICMAD 

v. HEW, 574 F.2d 553, 558 n.8 (D.C. Cir), cert. 

denied, 439 U.S. 893 (1978)). 

publication date (i.e., by August 21, 

2000). 

II. Objections and Requests for a 

Hearing 

Section 409(f)(1) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 348(f)(1)) 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 therefor, and 

requesting a public hearing upon such 

objections.’’ 

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 § 12.22(a), each 

objection must meet the following 

conditions: (1) Must be submitted on or 

before the 30th day after the date of 

publication of the final rule; (2) must be 

separately numbered; (3) must specify 

with particularity the provision of the 

regulation or proposed order objected 

to; (4) must specifically state each 

objection 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) must 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. 

Following publication of the final rule 

permitting the irradiation of fresh shell 

eggs for the reduction of Salmonella, 

FDA received 26 submissions with 

objections to the rule within the 30-day 

objection period. All but one of these 

submissions either expressed general 

opposition to the final rule, or objected 

to the rule based on issues that are 

outside the rule’s scope such as the 

living conditions and practices in 

commercial egg production. Although 

most of these letters requested a hearing, 

no evidence was identified in support of 

any of these objections that could be 

considered in an evidentiary hearing 

(§ 12.22(a)(5)). Therefore, these 

objections do not justify a hearing.1 The 

Agency will not discuss these 

submissions further. The one 

submission raising specific objections 

was a letter from Public Citizen (letter 

to Docket No. 98F–0165, August 17, 

2000). The letter from Public Citizen 

sought revocation of the final rule based 

on five objections and requested a 

hearing on issues raised by each 

objection. A more detailed response to 

Public Citizen’s objections is found in 

section IV of this document. In addition, 

FDA also received one letter in support 

of the egg irradiation rule. 

III. Standards for Granting a Hearing 

Specific criteria for deciding whether 

to grant or deny a request for a hearing 

are set out in § 12.24(b). Under that 

regulation, a hearing will be granted if 

the material submitted by the requester 

shows, among other things, the 

following: (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 requestor; 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. Pac. Legal Found., 

445 U.S. 198, 214 (1980), reh. denied, 

446 U.S. 947 (1980), citing Weinberger 

v. Hynson, Westcott & Dunning, Inc., 

412 U.S. 609, 620–21 (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. U.S. 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 Fed. R. 

Civ. P. 56). The same principle applies 

in administrative proceedings (see 

§ 12.24). 

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, 286 (8th Cir. 

1959), cert. denied, 362 U.S. 911 

(1960)). 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, 684 (9th Cir. 1977)). 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, 1128 

(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, such as collateral 

estoppel, can be validly applied to the 

administrative process (see Pac. 

Seafarers, Inc. v. Pac. Far East Line, 

Inc., 404 F.2d 804, 809 (D.C. Cir. 1968), 

cert. denied, 393 U.S. 1093 (1969)). In 

explaining why these principles 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 also Costle v. Pac. Legal 

Found., 445 U.S. at 215–17). 

IV. Analysis of Objections and 

Response to Hearing Requests 

The letter from Public Citizen 

contains five numbered objections and 

requests a hearing on each of them. FDA 

addresses each of the objections in this 

document, as well as the evidence and 

information filed in support of each, 

comparing each objection and the 

information submitted in support of it to 


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Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations 20511 

the standards for granting a hearing in 

§ 12.24(b). 

A. Findings of Study Co-Authored by 

Donald Thayer 

The first objection raised by Public 

Citizen in response to this rule contends 

that the Agency misrepresented the 

findings of the 1990 study co-authored 

by Donald Thayer (Ref. 1). Specifically, 

the rule (65 FR 45280 at 45281) states, 

‘‘* * * S. enteritidis was found to have 

similar sensitivities to ionizing radiation 

as five other strains of Salmonella’’ (S. 

is referring to Salmonella) when, in the 

original study, Thayer et al. state, 

‘‘S. enteritidis was significantly more 

resistant to ionizing radiation than the 

other five strains of Salmonella tested 

* * *.’’ Public Citizen asserts that by 

stating the findings in this manner FDA 

gives ‘‘* * * the false impression that 

the same level of radiation can be used 

to eliminate S. enteritidis as other 

strains of Salmonella.’’ 

The full sentence in the final rule 

states that ‘‘Salmonella strains, in 

addition to S. enteritidis, in fresh shell 

eggs should also be reduced by 

irradiation since S. enteritidis was 

found to have similar sensitivities to 

ionizing radiation as five other strains of 

Salmonella * * *.’’ (65 FR 45280 at 

45281). The reasoning supporting the 

statement’s conclusion is that because 

irradiation reduces S. enteritidis it 

would be expected to reduce other 

strains of Salmonella. To the extent that 

S. enteritidis is more resistant to 

ionizing radiation than the other strains, 

the conclusion is strengthened. Further, 

FDA made clear in the final rule that 

irradiation of fresh shell eggs at the 

doses requested in the petition will 

reduce, but not entirely eliminate, 

microorganisms in eggs (65 FR 45280 at 

45281). 

FDA evaluated data provided by the 

petitioner on the absorbed radiation 

required to achieve inactivation of S. 

enteritidis in shell eggs. The data 

showed that irradiation at a dose as low 

as 1 kGy reduces the viability of S. 

enteritidis by 3-log10 (99.9 percent 

reduction) (Ref. 2). These data are 

comparable to the results seen by 

Thayer, et al., in a similar medium 

inoculated with S. enteritidis, which 

showed a 3- to 4-log10 reduction of this 

pathogen at a dose of 1 kGy (Ref. 1). 

Furthermore, the standards for 

microbiological safety of fresh shell eggs 

are independent of the final rule 

permitting the irradiation of fresh shell 

eggs. Irradiation is a potential control 

point in the mitigation of S. enteritidis 

and other food-borne pathogens. The 

rule is not predicated on the approved 

treatment, by itself, resulting in fresh 

shell eggs that are pathogen-free. FDA is 

denying the request for a hearing on this 

point because the action would be the 

same even if the factual issue were 

resolved in the manner sought 

(§ 12.24(b)(4)). 

B. Vitamin A Loss 

In the egg irradiation final rule, FDA 

states that the vitamin A retention 

resulting from the irradiation of shell 

eggs at a maximum absorbed dose of 

1.0 kGy (65 FR 45280 at 45281) yields 

a relative retention rate of 76 percent 

following a 24-day storage period. 

Public Citizen asserts that the final rule 

misrepresents the vitamin A loss from 

fresh shell eggs following irradiation at 

3.0 kGy because FDA based these 

conclusions on vitamin A loss from the 

results of a study that used a maximum 

dose of 1.0 kGy compared to the 

maximum petitioned dose of 3.0 kGy, 

whereas another study in the petition 

showed that vitamin A retention by the 

eggs irradiated at 3.1 kGy and stored for 

2, 15, and 33 days was 41.8 percent, 

35.5 percent, and 20.1 percent, 

respectively (Refs. 3 and 4). 

The studies that Public Citizen refers 

to were included in the petition and 

were analyzed and considered when 

making the safety assessment. FDA 

acknowledges that stating a vitamin A 

retention in the range of 20.1 to 35.5 

percent is more appropriate in light of 

the maximum petitioned dose. 

Importantly, in its review of the 

petition, FDA considered the health 

implications from vitamin A loss in eggs 

at the maximum petitioned dose and 

concluded that the effect on health from 

this vitamin loss is not significant 

because a variety of foods provide 

vitamin A and the intake of other foods 

can compensate for any loss (Refs. 5 and 

6). 

The issue raised by Public Citizen 

must be a material issue concerning 

which a meaningful hearing might be 

held (Pineapple Growers Ass’n v. FDA, 

673 F.2d at 1085). The Agency 

recognizes that irradiation can produce 

nutrient losses under some conditions 

and has concluded that such effects are 

not a safety concern under the 

conditions of this regulation. To justify 

a hearing on the vitamin A issue, Public 

Citizen must provide evidence that the 

nutritional loss in a food irradiated 

under the conditions of this regulation 

raises a safety concern because of its 

cumulative effect on the human diet 

(see 21 U.S.C. 348(c)(5)(B)). While FDA 

has the ultimate burden of proof when 

it approves the use of a food additive, 

once the Agency makes a finding of 

safety in a listing document, the burden 

shifts to an objector to come forward 

with evidence that raises a material 

issue of fact with regard to FDA’s 

conclusion (American Cyanamid Co. v. 

FDA, 606 F.2d 1307, 1314 (DC Cir. 

1979)). Public Citizen has submitted no 

information to support that vitamin A 

loss in fresh shell eggs irradiated under 

the conditions of the regulation is a 

safety concern. Therefore, this objection 

does not raise a genuine and substantial 

issue of fact for resolution at a hearing. 

FDA is denying the request for a hearing 

on this point because a hearing will not 

be granted if there is no genuine and 

substantial factual issue to be resolved 

(§ 12.24(b)(1)). 

C. Analysis of Effects of Irradiation on 

Egg Yolk Carotenoids 

Public Citizen asserts that FDA’s 

analysis regarding the effects of 

irradiation on egg yolk carotenoids is 

flawed because the information used to 

analyze the nutritional information of 

egg yolk carotenoids is based on doses 

of 0.5 kGy and 1.0 kGy, not the 

petitioned maximum of 3.0 kGy. 

FDA acknowledges that Agency’s 

analysis of the effects of irradiation on 

egg yolk carotenoids was based on 

studies performed at lower doses than 

the petitioned maximum dose of 

3.0 kGy; however, because there are a 

number of commonly consumed foods 

that are substantial sources of 

carotenoids in the diet, including 

yellow corn, carrots, and squash (Ref. 7), 

FDA has no health concerns about the 

loss of carotenoids in the diet from the 

irradiation of eggs. Public Citizen’s 

request for hearing suggests that there is 

potential for harm from the loss of 

carotenoids resulting from the 

irradiation of shell eggs, without 

providing any evidence to support this 

suggestion. An objector must make an 

adequate proffer of evidence to support 

its allegations and to show that they 

provide a basis on which to call into 

question the Agency’s conclusions. A 

hearing will be denied if the 

Commissioner of Food and Drugs (the 

Commissioner) concludes that the data 

and information submitted are 

insufficient to justify the factual 

determination urged, even if accurate 

(§ 12.24(b)(3)). FDA concludes that the 

data and information are insufficient; 

therefore, FDA is denying the request 

for a hearing based on this objection. 

D. Request for Updated Analysis for 

Irradiation of Fresh Shell Eggs Not To 

Exceed 3.0 kGy 

Public Citizen objects to the egg 

irradiation final rule on the grounds that 

the Agency did not adequately update 

‘‘[n]umerous issues raised in the two 

initial analysis [sic]’’ after the petition 


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20512 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations 

was amended to allow for doses up to 

3.0 kGy from 1.7 kGy. 

When the petition (FAP 8M4584) was 

originally submitted, the maximum 

petitioned dose was 1.7 kGy. The 

petition was subsequently amended to 

increase the maximum dose to 3.0 kGy 

and additional chemistry and toxicology 

reviews were performed by FDA 

following this amendment. Based on 

these reviews, FDA concluded that the 

3.0 kGy dose for shell eggs did not 

change the general conclusions from the 

original reviews (Refs. 3 and 6). Public 

Citizen neither specifies the 

‘‘[n]umerous issues’’ nor does it provide 

any information that would cause the 

Agency to change its conclusion that the 

consumption of irradiated shell eggs is 

safe. 

A hearing will be denied if the 

Commissioner concludes that the data 

and information submitted are 

insufficient to justify the factual 

determination urged, even if accurate 

(§ 12.24(b)(3)). FDA concludes that the 

data and information are insufficient; 

therefore, FDA is denying the request 

for a hearing based on this objection. 

E. Bureau of Foods Irradiated Food 

Committee Report of 1980 

Public Citizen alleges that FDA failed 

to follow all of the recommendations 

put forth in 1980 by the Bureau of Foods 

Irradiated Food Committee (BFIFC) 

regarding the evaluation of irradiated 

foods. Specifically, Public Citizen 

quotes the following from a BFIFC 

report: ‘‘Foods irradiated at doses above 

100 Krad [1 kGy] and comprising more 

that 0.01% of the diet are estimated to 

contain URPs [Unique Radiolytic 

Products] in sufficient quantity to 

warrant toxicological evaluation. * * * 

[T]ests must be performed on extracts in 

which the concentration of radiolytic 

products is maximized’’ (Ref. 8). 

Public Citizen then states that there is 

no indication in the egg irradiation rule 

or its references that such tests were 

conducted or reviewed by the FDA 

before the petition was approved. 

The assertion that FDA failed to 

comply with recommendations set forth 

by the BFIFC committee has been raised 

previously by Public Citizen and others 

and has been responded to by the 

Agency in the molluscan shellfish final 

rule (70 FR 48057 at 48069, August 16, 

2005) and in other previous rulemakings 

regarding the irradiation of food (see, 

e.g., 53 FR 53176 at 53179, December 

30, 1988, and 62 FR 64102 at 64105, 

December 3, 1997). 

As discussed previously, the BFIFC 

report was an internal document 

prepared by FDA scientists that 

provided recommendations for 

evaluating the safety of irradiated foods 

based on the known effects of food 

irradiation and on the capabilities of 

toxicological testing. The report was 

made available to the public for 

comment in the Federal Register of 

March 27, 1981 (46 FR 18992). While 

the report and the comments received 

on it have aided FDA’s thinking 

regarding the safety testing of irradiated 

foods, the report established no 

requirements. Furthermore, FDA has not 

adopted regulations that require 

toxicological testing of a food additive if 

that additive constitutes a certain 

portion of the diet, and Public Citizen 

has not cited any regulation that 

imposes such a requirement. 

In addition, the understanding of 

radiolytic products produced by the 

irradiation of foods has evolved since 

1980. As noted in the egg irradiation 

final rule, ‘‘[m]ost of the radiolysis 

products [of shell egg irradiation up to 

3kGy] are either the same as, or 

structurally similar to, compounds 

found in foods that have not been 

irradiated, and are formed in very small 

amounts.’’ (65 FR 45280). Similarly, in 

the Federal Register of December 3, 

1997, for the Agency rulemaking on 

irradiation of refrigerated or frozen 

uncooked meat, meat byproducts, and 

certain meat food products to control 

food-borne pathogens and extend 

product shelf-life, FDA concluded that, 

‘‘[i]n irradiated flesh foods, most of the 

radiolytic products derived from 

proteins have the same chemical 

composition but are altered in their 

secondary and tertiary structures. These 

changes are similar to those that occur 

as a result of heating, but in the case of 

irradiation, such changes are far less 

pronounced and the amounts of reaction 

products generated are far lower.’’ (62 

FR 64107 at 64110, December 3, 1997). 

Consistent with section 409 of the 

FD&C Act, the Agency’s decision on the 

safety of the irradiation of fresh shell 

eggs was based on the entire record. 

FDA reviewed and evaluated studies 

submitted in the petition as well as 

additional toxicology studies of 

irradiated foods, including red meat, 

chicken, fish and eggs, which are 

available in Agency files. Included in 

the data considered by the FDA in 

review of the petition were at least three 

studies conducted specifically on 

irradiated eggs. 

Once the Agency makes a finding of 

safety in an approval document, the 

burden shifts to an objector to come 

forward with evidence that calls into 

question FDA’s conclusion (see 

§ 12.24(b)(2)). Although Public Citizen 

alleged that the rule did not comply 

with the recommendations in the BFIFC 

report, Public Citizen did not present 

any evidence that these alleged 

inconsistencies, even if true, would 

have led to a different conclusion 

concerning the safety of irradiation of 

fresh shell eggs. Therefore, FDA is 

denying this objection and request for a 

hearing because it raises no factual issue 

that, even if resolved in the way sought 

by the objection, would justify the 

action requested (§ 12.24(b)(4)). 

V. Summary and Conclusion 

Section 409 of the FD&C 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 

Agency’s July 21, 2000, final rule 

approving the use of irradiation of fresh 

shell eggs, FDA concluded, based on its 

evaluation of the data submitted in the 

petition and other relevant material, that 

this use of irradiation is safe for its 

intended use for the reduction of 

Salmonella in fresh shell eggs. 

The petitioner has the burden to 

demonstrate the safety of the additive to 

gain FDA approval. However, once FDA 

makes a finding of safety in an approval 

document, the burden shifts to an 

objector, who must come forward with 

evidence that calls into question FDA’s 

conclusion (see section 409(f)(1) of the 

FD&C Act). 

Despite its allegations, Public Citizen 

has not established that FDA overlooked 

significant information in the record 

while reaching its conclusion that the 

use of irradiation for reduction of 

Salmonella in fresh shell eggs is safe. 

Therefore, the Agency has determined 

that the objections requesting a hearing 

do not raise any genuine and substantial 

issue of fact that would justify an 

evidentiary hearing (§ 12.24(b)). 

Accordingly, FDA is not making any 

changes in response to the objections 

and is denying the requests for a 

hearing. 

VI. References 

The following references are on 

display in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20857, under 

Docket No. FDA–1998–F–0072 

(formerly 98F–0165) and may be seen by 

interested persons between 9 a.m. and 

4 p.m., Monday through Friday. (FDA 

has verified the Web site address, but 

FDA is not responsible for any 

subsequent changes to the Web site after 

this document publishes in the Federal 

Register.) 


emcdonald on DSK2BSOYB1PROD with RULES
Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations 20513 

1Although specific examples for use of 

extraneous protein and antibiotics are not provided, 

the final rule also allows for flexibility in applying 

the existing standards for extraneous proteins and 

antibiotics (§ 610.15(b) and (c)); provided that each 

request for an alternative or exception to these 

requirements is supported by data that establish the 

safety, purity, and potency of the biological 

product. 

1. Thayer, D. W., G. Boyd, W.S. Muller, et al. 

‘‘Radiation resistance of Salmonella,’’ 

Journal of Industrial Microbiology, 5: 

383–390, 1990. 

2. Memorandum for FAP 8M4584 from V. K. 

Bunning, FDA, to W. Trotter, FDA, April 

4, 2000. 

3. Memorandum for FAP 8M4584 from K. 

Morehouse, FDA, to W. Trotter, FDA, 

April 11, 2000. 

4. Memorandum for FAP 8M4584 from K. 

Morehouse, FDA, to W. Trotter, FDA, 

May 14, 1999. 

5. Memorandum for FAP 8M4584 from I. 

Chen, FDA, to W. Trotter, FDA, 

December 11, 1998. 

6. Memorandum for FAP 8M4584 from I. 

Chen, FDA, to W. Trotter, FDA, March 

31, 2000. 

7. U.S. Department of Agriculture, 

Agricultural Research Service, USDA 

National Nutrient Database for Standard 

Reference, Release 23, Nutrient Data 

Laboratory Home Page (http:// 

www.ars.usda.gov/ba/bhnrc/ndl), 2010. 

8. Bureau of Foods Irradiated Foods 

Committee, Recommendations for 

Evaluating the Safety of Irradiated Food, 

Prepared for the Director, Bureau of 

Foods, FDA, July 1980. 

Dated: April 8, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8815 Filed 4–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 610 

[Docket No. FDA–2010–N–0099] 

Revision of the Requirements for 

Constituent Materials 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

biologics regulations to permit the 

Director of the Center for Biologics 

Evaluation and Research (CBER) or the 

Director of the Center for Drug 

Evaluation and Research (CDER), as 

appropriate, to approve exceptions or 

alternatives to the regulation for 

constituent materials. A request for an 

exception or alternative will be 

considered for approval when the data 

submitted in support of such a request 

establish the safety, purity, and potency 

of the biological product for the 

conditions of use, including indication 

and patient population, for which the 

applicant is seeking approval. FDA is 

taking this action due to advances in 

developing and manufacturing safe, 

pure, and potent biological products 

licensed under the Public Health 

Service Act (the PHS Act) that, in some 

instances, render the existing 

constituent materials regulation too 

prescriptive and unnecessarily 

restrictive. This rule provides 

manufacturers of biological products 

with flexibility, as appropriate, to 

employ advances in science and 

technology as they become available, 

without diminishing public health 

protections. 

DATES: This rule is effective May 13, 

2011. 

FOR FURTHER INFORMATION CONTACT: Paul 

E. Levine, Jr., Center for Biologics 

Evaluation and Research 

(HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

Suite 200N, Rockville, MD 20852–1448, 

301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of March 30, 

2010 (75 FR 15639), FDA published a 

proposed rule to amend the regulations 

for constituent materials under § 610.15 

(21 CFR 610.15). Constituent materials 

include ingredients, preservatives, 

diluents, adjuvants, extraneous protein 

and antibiotics that are contained in a 

biological product. FDA is amending the 

regulation for constituent materials to 

allow the Director of CBER or the 

Director of CDER, as appropriate, to 

approve an exception or alternative to 

the requirements under § 610.15. An 

exception or alternative will be 

considered for approval when the data 

submitted in support of such a request 

establish the safety, purity, and potency 

of the biological product for the 

conditions for which the applicant is 

seeking approval. Under the final rule, 

the Director of CBER or CDER would not 

approve an exception or alternative 

when the data or the conditions of use, 

including indication and patient 

population, for which the applicant is 

seeking approval, do not provide a 

sufficient scientific and regulatory basis 

for such an approval. 

The final rule provides manufacturers 

of biological products with flexibility, as 

appropriate, to employ advances in 

science and technology, as they become 

available. However, the final rule does 

not diminish public health protections 

that are provided by existing laws and 

regulations. The final rule gives 

manufacturers the potential to employ 

advances in science and technology if 

the data provide a sufficient regulatory 

basis for approval of the product. This 

means that each manufacturer’s request 

for an exception or alternative will be 

considered on a case-by-case basis to 

determine whether the product at issue 

meets the statutory and regulatory 

criteria for safety, purity, and potency 

for use in the intended population. The 

Director of CBER or CDER will only 

approve a request for an exception or 

alternative after determining that the 

particular request meets this prescribed 

criteria for the intended population. 

Examples of how the final rule provides 

flexibility (such as alternatives to the 

use of preservatives and modifications 

to the amount of aluminum permitted in 

certain biological products), without 

diminishing public health protections, 

are provided in the paragraphs that 

follow.1

Standards for certain constituent 

materials present in biological products 

are provided under § 610.15. Section 

610.15(a) requires that all ingredients 

used in a licensed product, and any 

diluent provided as an aid in the 

administration of the product, meet 

generally accepted standards of purity 

and quality. Any preservative used must 

be sufficiently nontoxic so that the 

amount present in the recommended 

dose of the product will not be toxic to 

the recipient, and in the combination 

used, it must not denature the specific 

substances in the product to result in a 

decrease below the minimum acceptable 

potency within the dating period when 

stored at the recommended temperature. 

Products in multiple-dose containers 

must contain a preservative, except that 

a preservative need not be added to 

Yellow Fever Vaccine; Poliovirus 

Vaccine Live Oral; viral vaccines 

labeled for use with the jet injector; 

dried vaccines when the accompanying 

diluent contains a preservative; or to an 

allergenic product in 50 percent or more 

volume in volume (v/v) glycerin. 

Furthermore, under § 610.15, an 

adjuvant must not be introduced into a 

product unless there is satisfactory 

evidence that it does not affect 

adversely the safety or potency of the 

product. 

Section 610.15(a) also requires that 

the amount of aluminum in the 

recommended individual dose of a 

biological product not exceed: 

1. 0.85 milligrams if determined by 

assay; 


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