Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 589

[Docket No. 96N-0135]

RIN 0910-AA91

Substances Prohibited From Use in Animal Food or Feed; Animal

Proteins Prohibited in Ruminant Feed

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its

regulations to provide that animal protein derived from mammalian

tissues for use in ruminant feed is a food additive subject to certain

provisions in the Federal Food, Drug, and Cosmetic Act (the act). The

final rule establishes a flexible system of controls designed to ensure

that ruminant feed does not contain animal protein derived from

mammalian tissues and to encourage innovation in such controls. FDA is

taking this action because ruminants have been fed protein derived from

animals in which transmissible spongiform encephalopathies (TSE's) have

been found. Such proteins may cause TSE's in ruminants. TSE's are

progressively degenerative central nervous system diseases of man and

other animals that are fatal. Epidemiologic evidence gathered in the

United Kingdom suggests an association between an outbreak of a

ruminant TSE, specifically bovine spongiform encephalopathy (BSE), and

the feeding to cattle of protein derived from sheep infected with

scrapie, another TSE. Also, there may be an epidemiologic association

between BSE and a form of human TSE known as new variant Creutzfeldt-

Jakob disease (nv-CJD) reported in England. BSE has not been diagnosed

in the United States, and the final rule is intended to prevent the

establishment and amplification of BSE in the United States through

feed and thereby minimize any risk to animals and humans.

DATES: This final rule becomes effective on August 4, 1997, except

Sec. 589.2000(e)(1)(iv), which contains collection of information

provisions subject to review and clearance by the Office of Management

and Budget (OMB). FDA is announcing that the proposed collection of

information has been submitted to OMB for review and clearance under

the Paperwork Reduction Act of 1995. The provision of this section will

be effective upon approval. FDA will announce the effective date of

Sec. 589.2000(e)(1)(iv) in the Federal Register. Submit written

comments on the collection of information provisions by July 7, 1997.

FOR FURTHER INFORMATION CONTACT: George A. (Bert) Mitchell, Center for

Veterinary Medicine (HFV-6), Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 301-827-5587.

SUPPLEMENTARY INFORMATION:

I. Introduction

In the Federal Register of January 3, 1997 (62 FR 552), FDA

published a proposed rule that would regulate persons that manufacture,

blend, process, and distribute certain animal protein products and

ruminant feeds containing such products. The proposed rule would create

a new Sec. 589.2000 entitled, ``Animal proteins prohibited in ruminant

feed.'' In general, the proposed rule would state that protein derived

from ruminant and mink tissues is not generally recognized as safe

(GRAS) for use in ruminant feed, but rather a food additive subject to

certain requirements under the act. The proposed rule also would

require certain cautionary statements on products that contain or may

contain such proteins, and establish recordkeeping requirements. These

proposed recordkeeping requirements were intended to facilitate

compliance with the rule. For example, an invoice obtained from a feed

manufacturer for a protein product not labeled with the cautionary

statement could be used to trace the product back to the supplier to

ensure that the supplier manufactures and distributes animal protein

products from nonruminant sources. The proposed rule also would reduce

or eliminate certain regulatory requirements upon the development of

methods for detecting or deactivating TSE agents, or for verifying

product identity.

The preamble to the proposed rule contained information regarding

available scientific information about TSE's, industry practices, and

regulatory efforts concerning TSE's. The agency refers interested

persons to that document for such information. A list of recently

published, relevant scientific information also appears later in this

document.

The preamble to the proposed rule also contained five alternatives

to the proposed restriction on the use of ruminant protein in ruminant

feed. These alternatives, which are discussed in greater detail later

in this document, included a restriction on the use of all ruminant and

mink materials (except those that have not been found to present a risk

of transmitting TSE's) in ruminant feed, a restriction on the use of

all mammalian protein in ruminant feed, a restriction on the use of

materials from domestic species (such as sheep, goats, mink, deer, and

elk) diagnosed as having a TSE, a restriction on the use of specified

sheep and goat offal in ruminant feed, and a ``no action'' alternative.

The final rule restricts the use of protein derived from mammalian

tissues, with certain exceptions, in ruminant feed. Thus, the final

rule represents a regulatory approach that covers more material and is

easier to implement than the proposed restriction on the use of

ruminant protein in ruminant feed, but is more flexible and better

suited to current industry practices than the alternative restriction

on the use of all mammalian protein in ruminant feed.

FDA continues to believe, as it stated in the preamble to the

proposed rule, that it is prudent to take action prohibiting the use of

certain animal protein products in ruminant feed even though BSE has

not been diagnosed in the United States and there is scientific

uncertainty as to its origin, transmissibility, etc. This final rule

will prevent the establishment and amplification of BSE in the United

States through feed, an action the agency believes is necessary to

protect animal and public health.

FDA received numerous comments, as discussed below, on its proposed

rule. Based on those comments, the agency, in the Federal Register of

April 17, 1997 (62 FR 18728), published the codified provisions of the

draft final rule and provided an opportunity for comment. The codified

provisions of the draft final rule were similar to those in the

proposed rule, but the draft final rule would prohibit the use of

protein derived from mammalian tissue with certain specific exceptions

(such as blood, gelatin, inspected and processed meat products that

have been cooked and offered for human consumption, and products whose

mammalian protein consists entirely of porcine protein). Additionally,

the codified provisions of the draft final rule would eliminate the

cautionary statements on pet food sold at retail, define the term

``ruminant,'' eliminate certain regulatory requirements if a renderer

used exclusively a validated, publicly-available method for controlling

the manufacturing process that minimizes the risk of the TSE agent

entering the product, and simplify the recordkeeping requirements.

[[Page 30937]]

The agency received over 60 comments on the codified provisions of

the draft final rule. Most comments supported the draft final rule,

although several comments suggested technical changes, additional

exemptions, or clarifications. Other comments reiterated their

objections to any rulemaking that would declare tissues to be nonGRAS

for use in ruminant feed or advocated other alternatives (particularly

the use of hazard analysis critical control point programs).

Based on those comments, the agency has made some changes in this

final rule. The final rule provides that protein derived from mammalian

tissues (with certain exclusions) is a food additive under the act. The

act defines a ``food additive'' as ``any substance the intended use of

which results or may reasonably be expected to result, directly or

indirectly, in its becoming a component or otherwise affecting the

characteristics of any food * * * if such substance is not generally

recognized, among experts qualified by scientific training and

experience to evaluate its safety, as having been adequately shown

through scientific procedures (or, in the case of a substance used in

food prior to January 1, 1958, through either scientific procedures or

experience based on common use in food) to be safe under the conditions

of its intended use * * *'' (see section 201(s) of the act (21 U.S.C.

321(s))). Expert opinion that the tissues are GRAS would need to be

supported by scientific literature, and other sources of data and

information, establishing that there is a reasonable certainty that the

material is not harmful under the intended conditions of use. Expert

opinion would need to address topics such as whether it is reasonably

certain that BSE does not, or will not, occur in the United States;

whether it is reasonably certain that the BSE agent will not be

transmitted through animal feed, i.e., that the processed tissues are

not infected by the agent, are deactivated by the rendering process or

are not transmitted orally; and whether it is reasonably certain that

the agent will not be transmitted to humans through consumption of

ruminant products. ``General recognition'' cannot be based on an

absence of studies that demonstrate that a substance is unsafe; there

must be studies to establish that the substance is safe. Also, the

burden of establishing that a substance is GRAS is on the proponent of

the substance (see U.S. v. An Article of Food * * * Coco Rico, 752 F.2d

11 (1st Cir. 1985).

The preamble to the proposed rule included an extensive discussion

of the basis of FDA's preliminary conclusion that protein derived from

ruminant and mink tissue for use in ruminant feed is not GRAS, but

rather is a food additive under the act. As discussed in detail in the

agency's responses to the comments received on the proposed rule, FDA

did not receive any information that would refute its conclusion that

protein derived from ruminant and mink tissue for use in animal feed is

not GRAS.

With regard to the scope of the final rule, protein derived from

mammalian tissues includes both ruminant and nonruminant tissues. FDA's

basis for its nonGRAS determination for ruminant and mink tissue is

discussed extensively in the preamble to the proposed rule and no

information was submitted to refute that determination. With regard to

nonruminant tissue besides mink, such tissues may include animals such

as cats, dogs, horses, swine, etc. As the preamble to the proposed rule

discussed concerning a mammalian-to-ruminant prohibition (62 FR 552 at

568), industry comments indicated that the usual practice at feed mills

and rendering facilities is to commingle ruminant and nonruminant

protein products. FDA indicated that regular commingling could provide

a basis to determine that protein from mammalian tissues is not GRAS

for use in ruminant feed. The description of industry practice received

in comments on the proposed rule again indicated that the practice is

to commingle ruminant and nonruminant protein. Because of the potential

TSE infectivity caused by mixing tissues from ruminant and mink and

other mammalian tissues, FDA has determined that protein derived from

mammalian tissues (with certain exclusions discussed later in this

preamble) is not GRAS for use in ruminant feed. FDA notes that the

ruminant-to-ruminant prohibition in the proposed rule also would have

prohibited the use in ruminant feed of this commingled tissue because

the definition of protein derived from ruminant and mink tissue would

apply to pure ruminant or mink tissue as well as other mammalian tissue

that could contain ruminant or mink protein due to commingling. This

final rule also reduces the risk of cattle and other ruminants being

exposed to an agent that causes feline spongiform encephalopathy and

acknowledges that feline protein could be a commingled component of

mammalian protein products.

The definition of food additive in section 201(s) of the act does

not apply to substances used in accordance with a sanction or approval

granted prior to enactment of section 201(s) of the act and granted

under the act, the Poultry Products Inspection Act (21 U.S.C. 451 et

seq.), or the Federal Meat Inspection Act (21 U.S.C. 601 et seq.). The

Commissioner of Food and Drugs (the Commissioner) is unaware of any

prior sanction applicable to the use of protein derived from mammalian

tissue in ruminant feed. No one asserted a prior sanction for the use

of protein derived from ruminant and mink tissues in ruminant feed

based on the agency's discussion of a possible mammalian-to-ruminant

ban in the preamble to the proposed rule (62 FR 552 at 566). In

addition, no one asserted a prior sanction for use of protein derived

from mammalian tissues in ruminant feed in response to the agency's

discussion of a possible mammalian-to-ruminant prohibition in the

preamble to the proposed rule. The failure of any person to come

forward with proof of an applicable prior sanction is a waiver of the

right to assert or rely on a prior sanction at any later time.

The agency notes, that for substances not included in the scope of

the definition of protein derived from mammalian tissues, persons may

continue to self determine whether such substances are GRAS for use in

ruminant feed. FDA's authority to determine substances to be food

additives under the act is discussed in further detail below in

responses to the comments on the proposed rule.

The final rule also simplifies the cautionary statement for animal

feeds containing mammalian-derived proteins, eliminates the labeling

requirements for pet food products sold at the retail level and feeds

for nonruminant laboratory animals, and elaborates on the information

that must be kept and made available for inspection. These changes are

further discussed below in the responses to comments received on the

proposed rule.

II. Comments on the Proposed Rule and Draft Codified Text

FDA received more than 700 comments on the proposed rule. The

comments came from a wide variety of organizations, such as cattlemen,

renderers, feed manufacturers, and pharmaceutical firms, Federal

agencies, foreign governments, State agriculture departments, trade

associations, professional organizations, universities and research

institutions, consumer organizations, and individual consumers.

Additionally, FDA held two public meetings on the proposed rule. The

first meeting was held in St. Louis, MO, on February 4, 1997, and

focused on the rule's economic impact and issues of interest to the

affected industries. The second meeting was

[[Page 30938]]

held in Washington, DC, on February 13, 1997, and focused on the rule's

environmental analysis and issues of interest to consumer groups and

organizations.

Additionally, in the Federal Register of April 17, 1997 (62 FR

18728), FDA published the codified provisions of the draft final rule

and provided an opportunity for public comment. FDA received over 60

comments on the draft codified text.

Most comments (including remarks made at the public meetings)

agreed that the Federal Government should take action to prevent the

establishment and amplification of BSE in the United States through

feed. However, many comments disagreed as to whether more or less

stringent regulatory efforts were needed. FDA also received comments

supporting and opposing each alternative that was described in the

preamble to the proposed rule, as well as numerous comments that

recommended new alternatives. To simplify the nature of the ideas

expressed in the comments, the comments can be divided into two groups.

One group would maximize the scope of the regulations, and the other

would minimize the scope of regulations.

A large number of comments encouraged FDA to increase the scope of

the regulations to include a partial or complete mammalian-to-ruminant

prohibition or a mammalian-to-farm animal prohibition, or to apply a

feed prohibition on all food-producing animals, either to achieve a

greater reduction in the potential risk of human exposure or easier

compliance with less need for enforcement actions. For example, a few

comments asked that the proposed regulations be expanded to prohibit

the feeding of ruminant proteins to felines and zoo animals, and the

feeding of proteins from these animals to ruminants. Some comments

noted the presence of scrapie and other TSE diseases in the United

States and the epidemiological association between scrapie or a

modified scrapie agent and BSE in the United Kingdom in support of

enlarging the scope of the rule. One comment requested a ban on the

feeding of all animal remains to other animals, regardless of species

or processing method. Another comment noted that the specifications for

tallow allowed for the presence of a small amount of protein and the

possibility of a protein-associated infectivity.

Other comments supported a ``minimalist'' approach. For example, a

significant number of comments pointed out that BSE has not been

diagnosed in the United States despite a most exhaustive surveillance

effort by Federal and State veterinary laboratory diagnosticians,

veterinarians accredited by the U.S. Department of Agriculture (USDA),

and veterinary practitioners who have been specifically trained to

diagnose the early clinical signs of BSE in cattle. The USDA through

statutes administered by the Animal and Plant Health Inspection Service

(APHIS) and the Food Safety and Inspection Service (FSIS) has taken

actions to ensure that the border defenses against importing the BSE

agent are as secure as possible. FDA has advised manufacturers of human

and animal drugs and devices, human biologics, dietary supplements, and

cosmetics to obtain bovine derived ingredients from countries which are

free of BSE. Some comments stated that the adoption by industry of

voluntary measures to avoid the rendering of fallen sheep or sale of

sheep proteins for use in ruminant rations, or to stop the feeding of

ruminant proteins to ruminants are sufficient, and no regulation is

warranted. Other comments reminded the agency of its public statements

that the risk of BSE occurring in the United States is low and getting

lower. A comment from a foreign regulatory official observed that zero

risk cannot be achieved and that the calculation of risk through a

mathematical model is essential; this comment also expressed the view

that the agency's proposed regulatory approach exceeded the risk of BSE

in the United States.

A description of the comments and FDA's responses follows.

A. General Comments

1. Exclusions for Certain Products

(Comment 1). Several comments, in addressing either the proposed

rule or the agency's alternatives to a ruminant-to-ruminant

prohibition, suggested exclusions for specific products. The suggested

exclusions included proteinaceous tissues (such as meat),

nonproteinaceous materials (such as grease, fat, tallow, amino acids,

and dicalcium phosphate as a byproduct of the gelatin manufacturing

process), and materials that are not considered to be tissues (such as

paunch meal, feces, and urine). A few sought exclusions for specific

organs, such as hearts and kidneys, or even exclusions for tissues

(such as distal ileum) that have been shown to be infective for TSE's

in experimental studies.

The agency has carefully considered the various exclusions

suggested by the comments and has revised Sec. 589.2000(a)(1) to define

``protein derived from mammalian tissue'' as any protein-containing

portion of mammalian animals, excluding blood and blood products,

gelatin, inspected and processed meat products which have been cooked

and offered for human consumption and further heat processed for feed

(such as plate waste and used cellulosic food casings), milk products,

and products whose only mammalian protein consists entirely of porcine

or equine protein.

FDA excluded these items from the definition because the agency

believes that they represent a minimal risk of transmitting TSE's to

ruminants through feed. The excluded proteins and other items are

materials that the available data suggests do not transmit the TSE

agent, or have been inspected by the FSIS or an equivalent State agency

at one time and cooked and offered for human food and further heat

processed for feed and thus are of lower risk than those products that

the agency has determined to be nonGRAS, or current industry practices

can provide assurances that certain mammalian products can be produced

without becoming commingled with potentially infective materials.

Additional information on specific exemptions appears later in this

document.

The agency did not revise the definition to exclude nonproteins or

items that are not considered tissues. Such products, for example,

tallow, fats, oils, grease, amino acids, and dicalcium phosphate as a

byproduct of the gelatin manufacturing process, are not covered under

this rule and thus do not require a specific exclusion. Moreover,

infectivity studies conducted on some of these products (e.g., tallow)

have demonstrated that they are at low risk of transmitting the TSE

agent. As for those comments suggesting exclusions for specific organs

or tissues, FDA declines to exempt such organs or tissues either

because of their demonstrated infectivity or because they have not been

sufficiently studied to confirm that they cannot transmit TSE disease

to ruminants or may present a higher risk of transmitting a TSE to

ruminants or because current industry practice does not support

separation of these organs or tissues from other higher-risk organs or

tissues. For example, under current industry practices, separation of

muscle meat from potentially infective nervous tissue from spinal cords

or nerve tissue connected to spinal cords cannot be assured. In

addition, FDA notes that the origin of these materials is not easily

determined when they arrive at a rendering facility.

The agency may revise the rule further to add or delete items from

the

[[Page 30939]]

list of exclusions and make necessary corresponding changes to the rule

when sufficient scientific information becomes available about the

ability of those items to transmit TSE disease.

2. Scientific Issues

Numerous comments raised scientific issues regarding BSE, nv-CJD,

and the need for additional scientific research.

a. Causes of BSE.

(Comment 2). Several comments stated that BSE is unlikely to occur

spontaneously in an individual animal.

Although the theory that TSE's occur spontaneously as well as the

other theories as to BSE's origins (see 62 FR 552 at 558 and 559) are

not proven, FDA has not discounted any theory. The final rule would

prevent the establishment and amplification of BSE in ruminants through

feed by prohibiting the use of proteins derived from mammalian tissue

in ruminant feed regardless of whether BSE may occur spontaneously or

enter the United States through imported animals or animal products or

may result from a cross-species or intra-species transmission of a TSE

agent.

(Comment 3). Many comments claimed that scrapie in sheep was the

cause of BSE in the United Kingdom.

FDA agrees that the use of sheep with scrapie which were rendered

and fed to cattle as meat and bone meal is a possible cause of BSE in

the United Kingdom. This final rule prevents sheep materials from being

processed and fed back to cattle and other ruminants. Additionally,

some comments stated that the adoption by industry of voluntary

measures to avoid rendering of fallen sheep and the sale of sheep

proteins to ruminants should provide sufficient safeguards to allow

sheep to be excluded from the final rule. FDA disagrees with this

statement because sheep are known to have a TSE (scrapie) that has a

long incubation period and because of information from an FDA survey

conducted in 1992 that clearly showed that a voluntary ban was not

fully implemented and that sheep that had died of causes other than

slaughter were being rendered and that rendered sheep protein was being

sold for use in the manufacture of cattle feed. This survey is

discussed in the preamble to the proposed rule (62 FR 552 to 582).

(Comment 4). Several comments argued that, in the United Kingdom,

BSE was spread by ruminant-to-ruminant recycling.

FDA agrees that, in the United Kingdom, BSE was spread by the

practice of feeding ingredients from processed BSE-infected cattle to

other cattle, including young calves. The processes that were used did

not completely inactivate the BSE agent. This final rule prevents

ruminant-to-ruminant recycling.

(Comment 5). Several comments pointed out that the cause of BSE is

unknown.

Even though the exact nature of the cause of BSE and many aspects

of its etiology and pathogenesis are unknown, studies indicate that the

feeding of BSE-infected material to cattle spread the disease to

uninfected animals. The final rule is intended to prevent the

establishment and amplification of BSE in the United States through

feed even though many details regarding the BSE agent are unknown.

b. Epidemiology of BSE.

(Comment 6). Numerous comments expressed concern that transmissible

mink encephalopathy (TME) resulted from mink being fed materials

derived primarily from downer cattle. These comments suggested that

this possible link between cattle and TME may indirectly indicate that

BSE is already present in the United States cattle population.

The exact cause of these TME outbreaks, the most recent occurring

in 1985, has not been proven, but FDA agrees that there is a

possibility that the theory is correct. The final rule, however, would

prevent cattle-to-cattle transmission of any undetected BSE in the

United States as well as the transmission of TSE's from mink to cattle.

(Comment 7). Several comments claimed that BSE is present in pigs

in the United States.

Based on the available evidence, FDA does not believe that BSE is

present in pigs in the United States. A naturally-occurring TSE has not

been identified in pigs in the United States or elsewhere in the world.

FDA is aware that, in a study conducted in the United Kingdom, 1 out of

10 pigs appeared to develop TSE lesions after exposure to BSE (Ref. 1),

but this infection occurred through intracerebral, intraperitoneal, and

intravenous inoculation rather than under natural conditions (such as

feeding). Despite these new inoculations, the other nine pigs did not

develop a TSE. In another experiment, newborn pigs fed the BSE agent

have remained healthy at 72 months of age (Ref. 2).

(Comment 7a). One comment claimed that a TSE was observed in U.S.

pigs in 1979.

The cause of the clinical signs and lesions cannot be affirmed or

completely refuted. FDA notes that it has been over 17 years since the

incident was reported and that there have been no reports of a

recurrence. From FDA's evaluation of this comment, the agency notes

that the condition caused by salt toxicity/water deprivation, produces

similar clinical signs and lesions as those reported in the 1979

incident.

(Comment 8). Many comments pointed out that TSE's already exist in

animals in the United States. These comments usually referred to TSE's

in sheep, goats, elk, mink, and deer.

FDA agrees that TSE's already exist in some animals in the United

States and identified several such TSE's in the preamble to the

proposed rule (see 62 FR 552 at 556 and 557 (describing scrapie, TME,

and chronic wasting disease (CWD))). By prohibiting the use of proteins

derived from mammalian tissues in ruminant feed, the final rule should

prevent the transmission of these diseases to ruminants through feed.

(Comment 9). Several comments cited feline spongiform

encephalopathy (FSE) as an example of the BSE agent's ability to cross

species barriers.

The epidemiology of FSE supports this theory, but the risk of BSE

crossing species barriers is present only in a country where BSE

exists. The United States has no BSE, and the final rule provides the

necessary feed controls to limit the risk of BSE crossing species

barriers and infecting U.S. cattle and other ruminants through feed

uses of protein products from infected animals should BSE occur here

(i.e., a preventive barrier to the establishment and amplification of

BSE through feed).

(Comment 10). Some comments argued that TSE diseases may occur in

all animals, and prions have been identified in species as diverse as

salmon and fruit flies.

Prions are proteins and are normal constituents of many living

organisms ranging from yeast to mammals. The function of prions are

unknown. Under one theory, the TSE or BSE agent is an abnormal,

infectious protein that changes a normal ``host'' protein or prion in

an animal or organism into the causative agent (see 62 FR 552 at 558).

At this time, a naturally occurring TSE has not been identified in all

animals. For example, although horses, pigs, poultry, salmon, and fruit

flies have prions, they are not known to have naturally-occurring

TSE's.

(Comment 11). Several comments discussed the possibility of BSE

being present in the feces of poultry that consumed cattle meat and

bone meal in their diets. These comments expressed concern that the BSE

agent would spread to cattle which might consume poultry litter in

their feed or to plants to which poultry litter was applied as a

fertilizer.

[[Page 30940]]

FDA is unaware of any research on this issue that would indicate

that the agency should take regulatory action on poultry litter at this

time.

c. Transmission of BSE.

(Comment 12). Many comments addressed the safety of various tissues

(such as blood, bone, and muscle) relative to TSE diseases. For

example, some comments asserted that ruminant blood will not transmit

TSE whereas others claimed that blood presents some risk of

infectivity. Other comments asserted that bone and muscle are safe, but

that brain, spinal cord, and eyes are high-risk tissues for TSE. Some

comments claimed that oral transmission of TSE is very inefficient.

The research to date on TSE diseases and the infectivity of various

tissues from infected animals consists of 2 types. The first consists

of extensive research carried out over a long period of time in sheep,

using sheep as the model for evaluating scrapie and other TSE diseases.

This research has provided valuable information about the nature of the

diseases in animals and comparatively little on the infectivity of

tissues. The second consists of recent studies that have been carried

out in other animals using agents such as BSE in cattle and TSE's in

mice. Many of the tissue infectivity studies for scrapie and BSE have

been carried out using several different strains of laboratory mice

which have various degrees of natural susceptibility to TSE's. Samples

of tissues taken from TSE infected animals are inoculated into the

brain of these laboratory animals. The assessment of the infectivity of

tissues has been based on the outcome of these studies. The results of

this research indicate that blood, bone, certain other tissues, and

tallow do not transmit TSE to the experimentally exposed mice whereas

samples of brain, spinal cord, eyes, and some areas of the intestinal

tract from cattle that died of BSE transmit a TSE to the mice.

FDA agrees with the comments regarding the comparative infectivity

of oral versus intracerebral routes of exposure and the estimate that

the oral route might be as much as 100,000 times less infective than by

injection (Ref. 3). However, at this time, research has not provided

adequate data on the level of infectivity from oral transmission.

(Comment 13). Other comments pointed to the unproven nature of the

rodent bioassay for safety evaluation of various animal tissues. The

comments stated that the TSE agent may be in other tissues at amounts

below the detection limit of the rodent bioassay. The comments asserted

that, if the lowest infectious dose of BSE is very small, undetected

small amounts of agent in tissues could theoretically transmit TSE to a

new host.

FDA agrees that the infective dose of TSE agents is small and that

bioassays have limitations. The results of these assays cannot

presently be confirmed by more traditional chemical or microbiological

methods. Therefore, while small undetected amounts of the TSE agent

could be present in the tissue, at this time, the agency believes these

amounts present a minimal risk.

(Comment 14). Several comments discussed recent information

describing maternal transmission of BSE. These comments stated that

maternal transmission is at a very low rate and would not maintain the

epidemic in the United Kingdom. Other comments claimed that lateral

transmission (from one animal to another in the same herd) is not

detected in BSE, whereas some comments stated that BSE crosses species

barriers.

FDA acknowledges these characteristics of BSE, and the preamble to

the proposed rule identified possible maternal transmission and BSE's

ability to cross species barriers as being among the various factors

justifying FDA's regulation of proteins intended for use in ruminant

feed in order to prevent the establishment and amplification of BSE in

the United States through feed (see 62 FR 552 at 559 and 560). While it

may be true that the risk of maternal transmission is very low and will

not sustain a significant epidemic as discussed in the preamble to the

proposed rule, the possible use of infected protein from mammalian

tissues in cattle feed may lead to establishment and amplification of

BSE in the United States through feed. Thus, the final rule ensures

that, whatever the mode of transmission, the TSE agent will stop with

the infected animal.

(Comment 15). One comment suggested that FSE-infected cats

transported to the United States from the United Kingdom could

introduce BSE into the United States if the carcasses of those cats

were permitted to be rendered into meat and bone meal.

The probability that such a scenario would occur appears to be

remote since fewer than 100 cats in the United Kingdom have been

diagnosed with FSE, and, therefore, the probability that an infected

cat would be transported to the United States is small. Furthermore,

relatively few domestic cats (those that are considered family pets)

are rendered upon their deaths. Rendering of cat carcasses is much more

common for feral or stray animals, but in the event that FSE-infected

tissues were rendered into meat and bone meal, the final rule prohibits

the use of proteins derived from mammalian tissues, including feline

tissues, in ruminant feed. Therefore, FSE-infected cats will not cause

BSE in the United States through feed.

(Comment 16). Two comments expressed the view that protein derived

from cats and zoo animals should be prohibited from use in feeds

intended for ruminants, cats, and zoo animals. This recommendation was

based on the fact that domestic cats and other members of the family,

Felidae, including zoologic specimens are susceptible to TSE.

The agency agrees that the concerns raised in the comments are

valid, and the final rule prohibits the use of feline and ruminant

protein in ruminant rations including the rations of ruminants

maintained in zoological exhibits. The final rule does not prohibit the

use of mammalian-derived protein in feeds intended for felids or

nonruminant zoo animals because the intent of the rule is to prevent

the establishment and amplification of BSE in the United States through

feed and thereby minimize risk to animals and humans. The feed use of

protein from felids and zoo animals in feed for cats and nonruminant

zoo animals should not present a risk of establishing and amplifying

BSE in the United States through feeds for ruminants.

d. New Variant Creutzfeldt-Jakob Disease (nv-CJD).

(Comment 17). Many comments expressed concern about the emergence

of nv-CJD in the United Kingdom and France and that it may have been

transmitted to humans through meat consumption. Some comments raised

concerns that nv-CJD might occur in the United States.

FDA shares this concern about nv-CJD and, in conjunction with the

Centers for Disease Control and Prevention, is monitoring it closely.

As stated in the preamble to the proposed rule, the epidemiological

studies conducted in the United Kingdom do not directly link nv-CJD to

meat consumption, but suggest that the nv-CJD cases are linked to

exposure to BSE before the introduction of specified tissue bans in the

United Kingdom in 1989 (62 FR 552 at 561). In October 1996, a study

using strain typing techniques for TSE's compared nv-CJD's strain

characteristics against BSE transmitted to mice and macaques. The

results showed nv-CJD's strain characteristics to be consistent with

BSE as the source of nv-CJD. This study, which appeared in the October

24, 1996, issue of Nature (Ref. 4), provided a suggested link between

BSE

[[Page 30941]]

and nv-CJD, but was not direct proof of such a link.

The Centers for Disease Control and Prevention completed a survey

in 1996 of cases of CJD in the United States and found no cases that

fit the characteristics of nv-CJD. Additionally, most meat products

consumed by humans are subject to USDA's jurisdiction, and USDA is

examining this issue to identify any risk and ways to minimize the

risks, if any, to consumers.

e. Research needs for BSE.

(Comment 18). Numerous comments expressed concern about the lack of

adequate published research on TSE diseases, inactivation of the

agents, and public health implications. For example, some comments

noted the lack of information about the minimum infective dose for BSE

while others expressed a need to develop a process to inactivate or

eliminate the BSE agent during rendering or to develop specific and

sensitive analytical methods for animal feeds that would detect

rendered proteins from various species.

FDA agrees, as discussed in the preamble to the proposed rule, that

many scientific issues related to TSE's remain unresolved. The agency

encourages research that addresses these needs, specifically (but not

limited to): Determination of minimum infective oral dose for

establishment of BSE in cattle; development and validation of a process

to inactivate or eliminate the BSE agent during rendering; development

of specific and sensitive analytical methods for the detection of

rendered proteins from various species in animal feeds; development of

a highly sensitive bioassay for determination of the TSE agent presence

in animal tissues; and development of specific antemortem tests to

detect the presence of TSE agents and diseases in animals.

f. New scientific information.

Several recently published articles on TSE's, BSE, and nv-CJD are

not referenced in the proposed rule. In brief, the most relevant of

these scientific publications are listed in the references in section

IX of this document.

In one article, the physicochemical properties of the BSE and nv-

CJD molecules were characterized to identify strain variations with nv-

CJD (Ref. 4). It was found that nv-CJD is distinct from other types of

CJD and resembles BSE transmitted to mice, cats, and macaque, which is

consistent with BSE being the source of nv-CJD.

In another article, the authors used mathematical models to make

assumptions about the incubation period for nv-CJD and the number of

exposed people (Ref. 5). Based on these assumptions, they outlined a

range of scenarios to estimate the future incidence of nv-CJD in the

United Kingdom. A large measure of uncertainty surrounds any modeling

that is based on 14 cases of nv-CJD and a lack of reliable information

about the incubation period for nv-CJD.

The results of USDA's examination of 5,427 cattle brains were

discussed in a recent article (Ref. 6).

Another article discussed the detection of scrapie in peripheral

nerves of scrapie-diseased sheep and concluded that mutton of scrapie-

diseased animals should not be regarded as being free of the scrapie

agent (Ref. 7).

Prion protein was not detected by Western blot analysis in 55

percent of mice inoculated intra-cerebrally with BSE, although it was

detected in 100 percent in subsequent passages (Ref. 8).

The hypothesis that BSE is a zoonosis was described and the risk

characterized as low (Ref. 9).

TSE's, including clinical signs, gross and microscopic lesions, and

ancillary test findings, in wild deer and elk in north-central Colorado

from 1981 to 1995 were described (Ref. 10). The disease in wild cervids

is indistinguishable from that reported in captive deer and elk.

The articles do not provide entirely new information, but rather

add to the basic knowledge about TSE's and the need for this final

rule. FDA has placed these articles in the administrative record for

the final rule.

3. Enforcement-Related Issues

A number of comments addressed issues related to enforcement of the

rule.

(Comment 19). Several comments stated that the proposed rule would

be enforceable. However, several others argued that the rule would not

be enforceable. The latter comments gave several reasons for their

position, including the following: (1) There is no practical analytical

test to distinguish ruminant protein from nonruminant protein.

Enforcement, therefore, would depend on compliance with the rule's

labeling and recordkeeping requirements which could be vulnerable to

falsification or other abuse; (2) the rule's reliance on invoices may

be inadequate because invoices may not contain sufficient information

and may not be kept routinely; and (3) the clean-out procedures for

firms that intend to separate ruminant from nonruminant protein (as

provided by the proposed rule) would not be readily enforceable.

Several comments recommended that the agency adopt a mammalian-to-

ruminant prohibition because a practical analytical test (feed

microscopy) for distinguishing mammalian from nonmammalian proteins is

available.

When the agency issued the proposed rule, it acknowledged that the

mammalian-to-ruminant alternative might be more easily enforced than

the ruminant-to-ruminant prohibition in the proposed rule. However, the

agency intended to commit the resources necessary to enforce the

ruminant-to-ruminant option if adopted. The agency believed that the

rule which it proposed could be enforced. For example, the

establishments that would not separate ruminant from nonruminant

protein would be subject to the simple, enforceable requirement that

labeling for all outgoing products bear the statement cautioning

against use of the product in ruminant feed. The agency estimated that

the great majority of affected establishments--independent renderers,

blenders, and feedmills--would elect not to separate products. Those

that did separate products would be subject to additional scrutiny,

such as on-site inspection that would include inspection of incoming

product as well as observation of facilities and processes for

separation. In addition, the agency has had experience in enforcing the

act in other settings in which it was unable to test for violative

products.

Limiting the mammalian species exclusion to pure porcine or equine

products narrows the number of acceptable mammalian protein sources for

ruminant feeds, thus simplifying the agency's records review and trace

back efforts. The fact that some comments from regulated industries

suggested support for a mammalian-to-ruminant prohibition should foster

voluntary compliance.

(Comment 20). Several comments stated that the role of the States

in enforcing the rule is unclear, but that State agencies lack the

authority to enforce some aspects of the rule. Some comments also asked

whether the rule imposed an unfunded mandate upon States.

Because this regulation is a Federal rule, only those State

employees that are commissioned by FDA under section 702(a) of the act

(21 U.S.C. 372(a)) would have a role in enforcing this rule. For

commissioned State employees that have the same enforcement authority

as FDA employees, such employees would be able to fully enforce the

rule. State employees who are not commissioned do not have authority to

enforce this rule. Comments about unfunded mandates imposed on States

are discussed elsewhere in this document.

[[Page 30942]]

(Comment 21). Several comments suggested additional approaches to

enhance the rule's enforceability. One comment suggested that the

agency allow firms to substitute commercial contract guarantees (that

the product does not contain ruminant material) instead of maintaining

and providing sales invoices. The guarantees would be available for FDA

inspection and copying. The comment asserted that use of such a

guarantee would provide assurance that meat and bone meal containing

ruminant or mink protein would not be inadvertently accepted for

delivery at commercial feedmills.

FDA agrees that such a provision could enhance enforcement, through

both self-regulation within the industry and enforcement of the act

which makes the giving of a false guarantee a violation of section

301(h) of the act (21 U.S.C. 331(h)). However, it is unclear from the

comments whether the commercial contract guarantees would provide

adequate information for FDA to trace back purchases of protein

products and feeds. Therefore, it is unclear whether the guarantees

would enhance enforcement. In any event, the final rule, as written,

provides the necessary tools for enforcement. Therefore, the agency

declines to accept the comment's suggestion.

(Comment 22). One comment suggested that the agency revise the rule

to require renderers to register with FDA.

Through the use of publicly available sources (such as trade

publications), the agency has access to a comprehensive list of

renderers, so a registration requirement is, at this time, unnecessary.

(Comment 23). One comment asked FDA to clarify the penalties that

would be associated with a violation of the rule. Other comments asked

the agency to discuss the consequences of a violation of the regulation

and whether a person must knowingly have committed a violation.

The agency notes that it intends to implement a vigorous

enforcement program. Although FDA cannot specify the penalty that would

be imposed in any given scenario or case, the agency does note that the

act provides several possible sanctions, including, but not limited to,

injunctions (see section 302 of the act (21 U.S.C. 332)), criminal

penalties (see section 303 of the act (21 U.S.C. 333)) and seizure of

the adulterated or misbranded product (see section 304 of the act (21

U.S.C. 334)). Seizure and injunction actions generally do not require

knowledge on the part of responsible persons, and criminal violations

may or may not require such knowledge.

(Comment 24). Some comments asked about the disposition of

adulterated feed, animals that have been fed adulterated feed, and

products, such as milk, from animals that were fed adulterated feed.

The agency has guidance documents for the disposition of products

found to be violative under the act (see for example CPG 675.200). This

guidance can be used to facilitate the disposition of products

determined to be violative as a result of this final rule.

Alternatively, the agency can consider the disposition based upon the

unique factors of the situation.

(Comment 25). One comment expressed concern about the adequacy of

FDA's enforcement resources, stating a need for more frequent

inspections of regulated firms such as feedmills. Another comment

stated that an ``unlevel playing field'' would exist in the animal feed

industry such that FDA would devote more regulatory attention to a

relatively small number of registered (as opposed to unregistered)

feedmills.

FDA reiterates its intention to commit adequate resources to

enforcing this rule and to implement a vigorous enforcement program.

FDA will allocate those resources in such a way that all segments of

the industry receive attention commensurate with the risk presented by

a violation in each segment.

(Comment 26). Several comments expressed the expectation that a

mammalian-to-ruminant prohibition, if adopted by the agency, would also

simplify the requirements placed on the affected industries. For

example, the comments stated that, under a mammalian-to-ruminant

prohibition, no special labeling would be required and that

recordkeeping could be simplified.

Because the mammalian-to-ruminant prohibition in this final rule

includes certain exceptions, the labeling and recordkeeping

requirements are necessary, and the agency has retained them (with some

revisions) in the final rule.

(Comment 27). Several comments implied that certain options, other

than a ruminant-to-ruminant or mammalian-to-ruminant prohibition, would

be enforceable. These options included a partial ruminant-to-ruminant

prohibition, a prohibition only of proteins from TSE species, and a

plan for ``certified ruminant derived protein'' based on a hazard

analysis critical control point (HACCP) program approach. Some comments

also stated that the ruminant-to-ruminant prohibition would be

unenforceable.

As stated earlier, the final rule adopts a mammalian-to-ruminant

prohibition with certain exceptions. The agency agrees that there are

alternatives to a ruminant-to-ruminant or a mammalian-to-ruminant

prohibition. Each alternative, including a ruminant-to-ruminant or a

mammalian-to-ruminant prohibition, presents various enforcement

challenges. FDA believes, however, that the final rule is a reasonable

approach in terms of enforcement.

(Comment 28). One comment, from a cattle producers' organization,

referred to that organization's commitment (along with many others) to

ensure enforcement of the final rule. The organization pledged that it

would work diligently to inform producers of their role in enforcement.

Several other comments advocated use of educational programs, including

education to consumers, and guidelines.

The agency appreciates the comment's commitment and intends to work

closely with industry associations in educational efforts. The agency

also expects to implement an educational program for consumers and the

affected industries and will provide guidance documents to the affected

industries.

4. Comments on the Alternatives

a. Background.

The preamble to the proposed rule listed 6 regulatory alternatives

to prevent the establishment and amplification of BSE in the United

States through feed (62 FR 552 at 567). The alternatives ranged from a

prohibition on the use of mammalian tissue in ruminant feed to a ``no

action'' alternative. FDA received comments supporting and opposing

each alternative, as well as numerous comments that suggested new

alternatives.

The principal alternative was a prohibition on the use of ruminant

proteins in ruminant feed; this was the alternative initially selected

by the agency and used in the proposed rule. Comments on the

``ruminant-to-ruminant'' prohibition are addressed later in this

document. The other alternatives and the comments submitted on those

alternatives are described below.

b. The partial ruminant-to-ruminant prohibition.

The second alternative was to exclude all ruminant and mink

materials, except those that have not been found to present a risk of

transmitting TSE's, from ruminant feed. This was commonly known as the

``partial

[[Page 30943]]

ruminant-to-ruminant'' ban. The exclusions, in addition to milk

products, gelatin, and bovine blood, might have covered products such

as bovine byproducts that have been inspected and passed in inspected

slaughter facilities (except for the brain, eyes, spinal cord, and

distal ileum because these tissues have been shown to transmit TSE's).

This alternative had the advantage of having its prohibitions based

primarily on scientific information related to the infectivity of

specific tissues, yet it also had several important disadvantages. For

example it may be impractical in the slaughter and rendering processes

to segregate and to exclude the protein tissues that have not been

found to present a risk of transmitting TSE disease. USDA expressed

reservations that separating the distal ileum from other intestinal

offal could jeopardize a slaughter plant's ability to meet pathogen

reduction goals required by USDA's HACCP regulations. (The ``ileum'' is

the terminal part of the small intestine, from the free edge of the

ileocecal fold to the ileocecal orifice, and enters the junction of the

cecum and colon obliquely on the medial surface. ``Offal'' refers

generally to material left as a byproduct from the preparation of some

specific product, less valuable portions and the byproducts of

milling.) Enforcement would also be impractical because there is no

specific diagnostic method for identifying protein derived from such

tissues. Additionally, the alternative would not address the risk that

other tissues may present a risk of infectivity (62 FR 552 at 567 and

568).

(Comment 29). Several comments supported this alternative, although

most would modify it to cover only some tissues (such as tissues that

are known to be infective in sheep, cattle, or other species),

conditioned their support on the addition of other requirements (such

as a HACCP program and good manufacturing practices (GMP's)), or

conditioned their support on the feasibility of enforcing this

alternative. A smaller number of comments opposed this alternative;

most reiterated the arguments set forth in the preamble to the proposed

rule by stating that there is inadequate scientific information to

determine whether a particular tissue is or is not safe for use in

ruminant feed, that separating certain tissues may be unsafe or

impractical, and that the absence of a test to detect the TSE agent

warrants rejection of this alternative.

The agency agrees with those comments that oppose a partial

ruminant-to-ruminant prohibition. The agency is persuaded that under

current industry practice, separating acceptable ruminant tissues from

unacceptable ruminant tissue may be impractical, and the current lack

of scientific knowledge about the TSE agent and BSE, coupled with the

lack of a detection method, makes this alternative less acceptable

compared to a mammalian-to-ruminant prohibition which is more

enforceable and also endorsed by the most affected industries.

(Comment 30). Two comments raised the concern that the stunning of

cattle at slaughter by captive bolt results in the formation of brain

emboli which lodge in tissues that are normally considered to be

incapable of transmitting TSE diseases. If protein derived from those

tissues was permitted for use in ruminant rations, it potentially could

transmit TSE diseases to ruminant animals. For this reason, it was

argued that a partial ruminant-to-ruminant prohibition may fail to

prevent the introduction and amplification of BSE in the United States.

The probability of introducing BSE into the United States from the

small amount of nervous tissue that would be expected to result from

brain emboli is minimal under a partial ruminant-to-ruminant

prohibition; however, the final rule eliminates even this minimal

probability because it provides that all mammalian tissues (with

certain exceptions) are prohibited from use in ruminant rations.

c. The mammalian-to-ruminant prohibition.

The third alternative was to prohibit the use of all mammalian

protein in ruminant feed (``mammalian-to-ruminant'' prohibition). The

preamble to the proposed rule noted that some rendering and feed

associations supported this alternative because separating ruminant

from nonruminant materials or proteins might not be feasible due to the

routine industry practice of commingling protein products (62 FR 552 at

568). The preamble to the proposed rule also noted that this

alternative would provide greater assurance of industry compliance than

a partial or total ruminant-to-ruminant prohibition because practical

analytical methods exist for distinguishing mammalian from nonmammalian

proteins and that this alternative would not require additional or new

labeling. Furthermore, the preamble to the proposed rule stated that

this alternative would avoid concerns about permitting some products

containing meat and bone meal to be used in ruminant feeds while

prohibiting others and the effect on financially sensitive commodities

markets for animal protein.

The disadvantages to a mammalian-to-ruminant prohibition included

the absence of scientific data establishing or suggesting TSE

infectivity in nonruminant animals (other than in cats or mink) and

claims from some industries that they would prefer or had the ability

to separate ruminant from nonruminant tissues.

(Comment 31). The mammalian-to-ruminant alternative received the

most support among the alternatives to a ruminant-to-ruminant

prohibition discussed in the preamble to the proposed rule. These

comments came from the affected industries (although most would prefer

alternatives to this rulemaking), consumer groups, other government

agencies (including a foreign government), and academia. Most comments

supporting this alternative explained that it would provide the same or

more protection than the proposed rule, would be both practical and

enforceable, would give greater assurance of industry compliance, and

would be consistent with international initiatives. However, some

comments acknowledged that the current scientific evidence provides

more support for a specified tissue prohibition or ruminant-to-ruminant

prohibition rather than a mammalian-to-ruminant prohibition.

FDA has revised the rule to prohibit the use of protein derived

from mammalian (rather than ruminant) tissues, with certain exclusions.

Numerous comments from the rendering and feed industries advocated a

mammalian-to-ruminant prohibition. These industries indicated that a

mammalian-to-ruminant prohibition would result in easier and greater

compliance (because the usual industry practice is to commingle

ruminant and nonruminant material rather than separate ruminant from

nonruminant material) and provide a higher degree of confidence in the

feed or feed ingredients produced and sold. Given this practice of

commingling tissues, the possibility of cross-contamination of

nonruminant mammalian tissues through contact with ruminant tissues,

and reasons explained elsewhere in this document, FDA has determined

that protein derived from mammalian tissues (as defined in the rule) is

not GRAS for use in ruminant feed and has revised the final rule

accordingly. The agency recognizes that, under current industry

practices, pigs and horses may be slaughtered at dedicated slaughtering

facilities which produce either pure porcine or pure equine material.

The exclusion of equine material in addition to porcine material in the

final rule is a change from the proposed codified

[[Page 30944]]

material. This change was made in response to comments (see comment 44

response) that for mammals which are considered to be major food

animals, neither porcine nor equine species have ever been diagnosed

with a naturally occurring TSE. For porcine and equine materials,

persons may continue to self determine whether their use in ruminant

feed is GRAS.

FDA also considered various exclusions to the rule. These

exclusions are discussed elsewhere in this document.

(Comment 32). Several comments offered alternatives to a mammalian-

to-ruminant prohibition, such as the exclusion of sheep under 12 months

of age and cattle under 30 months of age. The comments claimed that

animals in these age groups seldom exhibit clinical signs of TSE.

FDA declines to revise the rule as suggested by the comments.

Because of the long incubation period for TSE's, an infected animal may

not exhibit any clinical signs. Scrapie has been detected in 7-month-

old sheep (discussed fully in the preamble to the proposed rule) and

results of a BSE maternal transmission study conducted in the United

Kingdom suggest that the risk of maternal transmission is approximately

10 percent for BSE infected cows. Additionally, there is little

specific knowledge about the infectivity of tissues and organs during

this period.

d. The prohibition of materials from U.S. species diagnosed with

TSE's.

The fourth alternative was to prohibit the use of materials from

species in which TSE's have been diagnosed in the United States (sheep,

goats, mink, deer, and elk) in ruminant feed. The preamble to the

proposed rule noted that this alternative would eliminate the scrapie

agent, TME, and CWD from ruminant feed, and thereby reduce the risk of

BSE in cattle by TSE transmission from other animal species (62 FR 552

at 568). However, it also noted that this alternative would not prevent

the spread of BSE in the United States if BSE occurred for another

reason, such as spontaneous mutation in cattle or the importation of

animals infected with BSE (when such imported animals are subsequently

processed and used in ruminant feed).

(Comment 33). FDA received several comments supporting this

alternative and a smaller number opposing it. The comments supporting

this alternative stated that it was the most prudent and pragmatic

alternative and is supported by current scientific evidence. Comments

opposed to this alternative stated that it would not prevent

amplification of BSE, would not exclude cattle (because no U.S. cattle

have been diagnosed as having BSE or a TSE), and would make it more

difficult to exclude potentially infective tissues from ruminant feed.

One comment questioned whether this alternative would extend to

prohibiting any feed materials to any animal, including nonruminants.

After considering the comments, FDA declines to adopt this

alternative. As stated in the preamble to the proposed rule and

elsewhere throughout this document, the rule is intended to prevent the

establishment and amplification of BSE in the United States through

feed. This alternative would restrict some, but not all, routes for the

BSE agent to enter ruminant feed. Consequently, FDA is not adopting

this alternative.

e. The sheep-specified offal prohibition.

The fifth alternative was to prohibit the feeding of specified

sheep and goat offal to ruminants. This alternative would eliminate

scrapie from ruminant feed, but would not prevent the spread of BSE

among cattle if BSE occurred spontaneously or entered the United States

(62 FR 552 at 568 and 569).

(Comment 34). Very few comments addressed this alternative. Two

comments supported this alternative, stating that no TSE's have been

found in the United States or that this alternative would remove much

unsafe protein from ruminant feed.

Three comments opposed this alternative. One comment stated that,

if BSE is already present in the United States, this alternative would

not prevent it from spreading to other cattle. Another comment

expressed similar views, but added that the long incubation period for

TSE's and the infectivity of tissues from preclinical or asymptomatic

animals increased the risk of BSE amplification. Another comment stated

that this alternative had limited effectiveness because it did not

protect against other known TSE's in other species.

The agency agrees with those comments opposing this alternative.

Although it would remove scrapie from ruminant feed, this alternative

would be ineffective against BSE and other TSE's. As a result, FDA is

not adopting this alternative.

f. The ``no action'' alternative.

The sixth alternative was to take no action. The preamble to the

proposed rule explained that this alternative is arguably supported by

the fact that data and information do not document a recognized

immediate threat to the public health in the United States and that any

threat may be minimal. Other arguments supporting this alternative

included: (1) BSE has not been detected in the United States; (2)

surveillance efforts are in place and have not detected BSE; and (3)

there is no empirical evidence available to establish that BSE will be

transmitted to cattle from another species, will occur spontaneously in

cattle, or will be transmitted from imported animals or animal feed (62

FR 552 at 553). The preamble to the proposed rule further noted that:

There is no conclusive scientific evidence that BSE would be spread

through animal feed (although there is strong epidemiological evidence

suggesting that widespread BSE infections in the United Kingdom

occurred through contaminated animal feed and that enforced feed

control regulations appear to be the reason for BSE's decline in the

United Kingdom); the industrial practices in the United Kingdom

believed to be associated with the BSE epidemic in the United Kingdom

differ from those in the United States; transfer of TSE's from sheep to

cattle is suggested by epidemiological evidence, but has not been

confirmed by direct scientific data; and while there is an

epidemiological association between BSE and the nv-CJD cases in the

United Kingdom, the available evidence has not established that BSE

causes nv-CJD.

Arguments against a ``no action'' alternative focused on the

potentially high cost, in animal and human lives and economics, if BSE

appeared in the United States and was transmitted and amplified through

the feeding of ruminant protein to cattle. The preamble to the proposed

rule noted that TSE transmission from other species, spontaneous

occurrence, and transmission from imported animals or animal products

was possible. Experimental evidence also indicated that the BSE agent

may be more susceptible to oral transmission (such as through animal

feed) than other TSE's, thereby increasing the chances that BSE could

spread through the United States whether or not the BSE agent developed

spontaneously, was transmitted by another species, or was introduced by

some other means. Yet the greatest risk factor identified in the

preamble to the proposed rule was the potential for unrecognized

amplification of the BSE agent given the long incubation period for BSE

and the absence of methods for detecting the agent (62 FR 552 at 555).

(Comment 35). Very few comments expressly addressed the ``no

action'' alternative. One comment, without any explanation, supported

the no action alternative, while another comment claimed that the

proposed rule was essentially a ``no action'' alternative

[[Page 30945]]

because it would permit the use of tallow and fat in ruminant feed, and

the comment opposed the use of tallow. Six comments opposed this

alternative, declaring that the Federal Government must act to protect

animal and human health and food safety now, that TSE's are known to

exist in the United States, and that if TSE's exist in cattle, steps

need to be taken to prevent amplification. Other comments opposing a

``no action'' alternative claimed that an undiagnosed TSE may already

exist in the United States cattle population (arguing that TME may have

originated as an undiagnosed TSE in cattle that was transferred to mink

through contaminated feed), that this alternative would not protect

against asymptomatic animals infected with a TSE, and that this

alternative is not acceptable for purposes of international trade

(because other countries will reject U.S. products if they cannot be

assured that the products are not infected with BSE or a TSE).

FDA agrees with the comments that oppose a ``no action''

alternative. The most appropriate course of action is to take steps to

prevent the establishment and amplification of BSE in the United States

through feed before BSE is manifested in the United States. FDA will,

as it does for all regulations, amend or modify its regulations to

reflect any advances in scientific or industry technology, but the

potential consequences to human and animal health are simply too great

to justify a ``no action'' alternative at this time.

5. Miscellaneous Alternatives Suggested by the Comments

Many comments suggested other regulatory approaches, ranging from

more comprehensive prohibitions on the use of animal proteins in feed

to less restrictive alternatives that would focus solely on sheep or

cattle or certain types of cattle. Other comments suggested

alternatives to the nonGRAS status (e.g., issuing a compliance policy

guide (CPG), an interim food additive regulation, a GRAS listing with

restrictions, temporary ban to suspend the use of ruminant protein in

ruminant feed, and HACCP programs). The discussion of these

alternatives and the agency's response appears in section I.B.1.b of

this document, comments 56 through 60. Few comments offered any

detailed rationale or explanation supporting their alternatives.

a. Alternatives involving ``downer'' animals.

(Comment 36). FDA received hundreds of comments (in response to

write-in campaigns) requesting that ``downer'' (nonambulatory) animals

not be used for human food and not processed as ingredients in animal

feed. Few comments offered any detailed rationale (scientific or

otherwise) for their request, although some comments suggested that

downed animals may be unable to walk because they have a TSE agent or

suffer from some central nervous system (CNS) disease.

FDA declines to revise the rule as suggested by the comments. The

final rule is limited to the use of proteins derived from mammalian

tissues in ruminant feed. The rule is intended to prevent the

establishment and amplification of BSE in the United States through

feed. Because BSE has never been detected in the United States, the

agency believes that the actions it has taken in this final rule will

accomplish this regulatory objective.

FDA notes that issues involving downer animals actually have two

components: (1) Animals that are ``down'' and are condemned on

antemortem examination, such as those with clinical signs of CNS

disorders; and (2) animals that are ``down'' but which are passed as

``suspects'' pending post-mortem examination, such as those with broken

legs, mastitis, paralysis, etc. This final rule will prevent any downed

(including CNS-condemned) ruminants from being used in ruminant feed.

This final rule does not address issues related to nonruminant feed

uses. The agency does not have any information that such uses for

nonruminants at this time, present a risk of TSE infection to

ruminants. The use of carcasses of downer animals and the offal of

animals that are slaughtered as suspect for a CNS disorder in the

manufacture of meat and bone meal for use in swine, poultry, and pet

rations presents no known risk to humans. The risk to nonruminants

other than ruminants appears to be limited to felids and mink and is

considered to be extremely small.

Additionally, revising the rule to prohibit the use of all downers

in nonruminant feeds would create significant environmental and

economic problems. Issues further related to use of meat and poultry

for human consumption are outside the scope of this rulemaking since

they are regulated by USDA.

b. Alternatives covering other animals.

(Comment 37). Several comments advocated more inclusive

alternatives, such as prohibiting the use of animals or mammals in

mammalian feed, prohibiting the use of animal byproducts in feed for

all animals or all farm animals, or prohibiting the use, in any

livestock feed, of any potentially infectious tissue from any species

known to have a TSE. Few explained their reasons for such alternatives

other than to declare that a broader alternative would be more

protective, to argue that noncarnivorous animals should eat only

plants, or to argue that the practice of feeding animal protein to

animals was ``cannibalism'' or ``unnatural.''

In developing this rule, the agency sought to create regulatory

requirements that would prevent the establishment and amplification of

BSE in the United States through feed while simultaneously considering

the impact on the affected industries. The comments did not provide

sufficient information to determine that the alternatives suggested by

the comments would be equally or more effective in preventing the

establishment and amplification of BSE in the United States through

feed, and so FDA declines to revise the rule as suggested by the

comments.

(Comment 38). Several comments advocated less restrictive

alternatives to the rule, such as prohibiting cattle-derived protein

from being fed to other cattle, or to sheep and cattle, or to other

animals, prohibiting the use of sick and dying animals in human and

animal food, or prohibiting the use of spinal cords and heads in animal

feed.

FDA declines to revise the rule as suggested by the comments. These

less restrictive alternatives would not meet the agency's goals. The

comments did not offer any explanation as to how these alternatives

would prevent the establishment and amplification of BSE in the United

States through feed.

c. Alternatives covering other subjects.

(Comment 39). One comment requested that FDA revise the rule to

address all food hazards (rather than focus on BSE in ruminants),

prohibit the use of all meat protein supplements in all animal feed,

prohibit the use of antibiotics in food-producing animals, and

concentrate on possible causes of disease.

The agency declines to revise the rule as requested by the comment.

The comment does not explain how the suggested change would prevent BSE

from being established and amplified in the United States through feed.

The comment's requests appear to address issues which are outside the

scope of this rulemaking.

B. Comments on Specific Sections in the Proposed Rule

1. Section 589.2000(a)--Definitions

Proposed Sec. 589.2000(a) would define various terms, such as

``protein derived from ruminant and mink tissues,'' ``renderer,''

``blender,'' ``feed

[[Page 30946]]

manufacturer and distributor,'' and ``nonruminant protein.''

All comments addressing proposed Sec. 589.2000(a) focused on the

terms ``protein derived from ruminant and mink tissues.'' Proposed

Sec. 589.2000(a)(1) would define such proteins as ``any protein-

containing portion of ruminant animals or mink, excluding blood from

bovines, milk proteins and gelatin.''

As noted earlier in this document, the agency has revised

Sec. 589.2000(a)(1) to refer to protein derived from mammalian tissues

and has excluded specific items from that definition. In general, the

exclusions represent tissues that the available data suggests do not

transmit the TSE agent or were, at one time, inspected by FSIS and

found fit for human consumption and further heat processed for feed use

or tissues from species without TSE's that, under current industry

practice, are slaughtered in single species slaughter facilities.

Comments on specific tissues are as follows:

(Comment 40). Several comments would exclude plate waste (food that

has been inspected, prepared, and/or served to humans) from the rule.

Some comments explained that all food products which compose plate

waste have already been cooked and inspected several times before being

offered for human consumption and later thrown away and that commercial

processors of plate waste dehydrate the product at temperatures

reaching 290 to 400 deg.F when converting it to an animal feed

ingredient. The comments also asserted that the plate waste comes from

institutions (universities, retirement homes, hospitals, prisons,

etc.), fast-food establishments, and large restaurants/cafeterias, and

does not consist of tissues that have demonstrated infectivity in

cattle, e.g., brain, spinal column, eye and distal ileum of cattle.

Furthermore, some comments stated that plate waste consists mostly

(approximately 98 percent) of nonmeat products and is high in moisture.

The high moisture content requires the addition of 50 to 60 percent

corn, soybeans, or similar products to aid in the dehydration and the

extrusion process. The comments also noted that the feeding of plate

waste remains a common practice in many parts of the United States and

around the world and that plate waste comprises approximately 8.9

percent of the Municipal Solid Waste stream in the United States.

The draft codified provisions that appeared in the Federal Register

of April 17, 1997, included as an exclusion from the definition protein

derived from mammalian tissue, ``inspected and processed meat products

which have been cooked and offered for human consumption (plate waste

and used cellulosic food casings).'' The initial decision to exclude

plate waste was based on the fact that a small proportion of meat is

included in plate waste and that plate waste represents a small

proportion of ruminant feed. Additionally, the heat and pressure used

to process plate waste should further reduce the risk of transmitting

the TSE agent through feed in a product that is of minimal risk prior

to the processing as plate waste.

Several comments addressed the reference to ``plate waste,'' and

the majority of the comments supported the exclusion of plate waste

from the definition of ``protein derived from mammalian tissues.''

However, many of these comments also sought a broader exemption by

expanding the rule to include ruminant meat which had passed Federal or

state inspection for human consumption. In contrast, one comment, from

the USDA/APHIS, opposed an exclusion for plate waste, stating that the

exclusion was too broad and could be interpreted to be similar to the

USDA definition for garbage at 9 CFR 166.9 and that trimmings (bone and

nervous tissue) from TSE-susceptible species might be included under

the exclusion.

FDA agrees with the USDA/APHIS that the inclusion of trimmings or

high-risk tissue, such as brain and eyes, is inappropriate for use in

ruminant feed. FDA declines to expand the exclusion to include all

ruminant meat that has passed Federal or state inspection for human

consumption. FDA's approach to eliminating trimmings was to describe an

acceptable product as one which was ``cooked and offered for human

consumption.'' After further consideration FDA has revised the

definition of protein derived from mammalian tissues to exclude

``inspected meat products which have been cooked and offered for human

food and further heat processed for feed (plate waste and used

cellulosic food casings).'' This is to clarify that the high risk

tissues USDA/APHIS described in their comment are not covered by this

exclusion.

FDA declines to expand the exclusion to include all ruminant meat

that has passed Federal or state inspection for human consumption

because this would require FDA to remove the safeguard against

trimmings and also would allow brains and eyes which have passed

inspection to be fed to ruminants.

The agency acknowledges that accurately describing products which

are acceptable under this exclusion is difficult. In general, FDA

interprets this exclusion as being restricted to food prepared in

restaurants or restaurant-like establishments, offered to consumers for

consumption on the premises, and then discarded by the consumer.

Precooked food items, such as hot dogs, casings from cooked hot dogs,

and cooked deli items, would be excluded from regulation under this

rule by this exclusion. FDA has revised the definition to better

reflect its position that the product must be cooked, offered to the

consumer for human food, and then further heat processed before it can

be fed to animals.

The Association of American Feed Control Officials, Inc. (AAFCO) is

in the process of developing definitions for products described in this

section. In general, the ``plate waste'' exclusion is similar to the

AAFCO definition of ``restaurant waste.''

(Comment 41). A few comments questioned why meat and meat products

inspected by the USDA and found acceptable for human consumption are

not acceptable for ruminant consumption.

The risks posed to humans and those posed to animals are different.

The significant steps advanced by this rule are supported by public

health experts as an effective means to decrease the risk of TSE's in

ruminants through feed and the potential risk to humans. To date, the

occurrence of nv-CJD in Europe has not been definitively linked to

human consumption of meat, and no cases of nv-CJD have been detected in

the United States.

(Comment 42). One comment objected to the exclusion of gelatin and

blood from the definition of ``protein derived from ruminant and mink

tissues.'' The comment argued that gelatin and blood meal may be

infectious and that blood meal may not be used as a feed ingredient or

a fertilizer in the United Kingdom. The comment further noted that the

USDA prohibits the importation of ruminant protein and blood meal from

countries with documented BSE cases; the comment stated that if the

USDA prohibits such imports because they may be infective, then FDA

should not permit the use of domestic gelatin and blood meal.

The agency disagrees with the comment. As the agency discussed in

the preamble to the proposed rule (62 FR 552 at 572) available data

suggests that gelatin and blood do not transmit the TSE agent and USDA

surveillance has not detected BSE in the United States. However, to

minimize the risk of infected material being imported into

[[Page 30947]]

the United States, USDA has prohibited the importation of such

products.

(Comment 43). Several comments addressed the reduction in TSE titer

that results from the process that is used to make gelatin. Two

comments added that dicalcium phosphate, which is derived from the

gelatin manufacturing process, should be excluded from the rule; one

described the processes for obtaining dicalcium phosphate. Another

comment sought clarification whether amino acids derived from gelatin

would be exempt from the rule.

Amino acids and dicalcium phosphate are excluded from the final

rule because both products are by-products or the result of further

processing of gelatin and do not contain proteins. Dicalcium phosphate

is an inorganic mineral source that does not contain protein, and

individual amino acids are not proteins. (Instead, proteins consist of

amino acids.) Although the codified provision to the draft rule that

was published in the Federal Register of April 17, 1997, expressly

exempted amino acids and dicalcium phosphate derived from gelatin, and

one comment sought to revise that language regarding dicalcium

phosphate, the agency has reconsidered the need for this express

language and decided that, because amino acids and dicalcium phosphate

are not proteins, the express language is unnecessary.

(Comment 44). Several comments requested that FDA revise the rule

to exclude pure porcine (swine) products. These comments argued that

swine are not known to have TSE's and are often slaughtered in

dedicated swine slaughter facilities so that pure porcine products can

be easily separated from other mammalian products.

Other comments, submitted after the publication of the draft

codified provisions in the Federal Register of April 17, 1997,

suggested that FDA revise the rule to exclude pure equine products.

FSIS commented that the rationale for the change from a ruminant-to-

mink prohibition in the proposed rule to a mammalian prohibition, with

porcine exclusion, is insufficiently supported by scientific fact and

suggested that FDA consider an alternative to the draft final.

The agency agrees with the comments and has excluded products whose

only mammalian protein consists entirely of porcine or equine protein

from the definition of ``protein derived from mammalian tissues.'' This

exclusion is scientifically defensible because swine and horses have

not been shown or reported to have a condition that can be linked to a

TSE and can be accomplished within the current industry structure and

practice. Because most swine and horses are slaughtered in dedicated

facilities, and the ease of verifying compliance at the source, FDA has

excluded products containing pure porcine or pure equine protein from

the rule and, where appropriate, revised other provisions in the final

rule to reflect an exclusion for pure porcine or equine protein. FSIS

is in agreement with these changes.

(Comment 45). A few comments asked the agency to provide a

mechanism for exempting animals from flocks or herds that are

designated by a Federal agency to be absent from TSE's, such as the

USDA's Voluntary Scrapie Flock Certification Program.

The agency supports any initiative such as this which is designed

to reduce or eliminate a naturally occurring TSE. However, there

appears to be little assurance that the proteins derived from these

flocks or herds could be kept separate as pure single-species proteins,

and therefore, FDA declines to revise the rule as suggested by the

comments.

(Comment 46). Proposed Sec. 589.2000(a)(2) would define

``renderer,'' in part, as ``any firm or individual that processes

slaughter byproducts, animals unfit for human consumption, meat scraps

or food waste.''

The agency has removed ``food waste'' from the definition. This

change is necessary because, as explained above, the agency has

excluded plate waste from the definition of ``protein derived from

mammalian tissues.'' The agency does note, however, that it interprets

the term ``animals unfit for human consumption'' as including parts of

animals that are unfit for human consumption.

(Comment 47). Proposed Sec. 589.2000(a)(3) would define the term

``blender.''

The agency received no comments on this definition and has

finalized it without change.

(Comment 48). Proposed Sec. 589.2000(a)(4) would define ``feed

manufacturer and distributor'' as including manufacturers and

distributors of complete and intermediate feeds intended for animals,

including on-farm and off-farm feed manufacturing and mixing

operations.

FDA has revised the definition to separate ``feed manufacturer''

from ``distributor.'' The agency made this change to clarify that both

feed manufacturers and distributors are subject to the rule rather than

persons who perform both functions (manufacturing and distributing).

Thus, Sec. 589.2000(a)(4) defines ``feed manufacturer'' as including

manufacturers of complete and intermediate feeds intended for animals

and including on-farm in addition to off-farm feed manufacturing and

mixing operations. Section 589.2000(a)(6) defines ``distributor'' as

including persons who distribute or transport feeds or feed ingredients

intended for animals. The substance of these definitions are similar to

the definition in the draft codified provisions that appeared in the

Federal Register of April 17, 1997. The agency has also made

corresponding changes throughout the rule to clarify that feed

manufacturers are distinct from distributors and deleted the reference

to ``haulers'' from proposed Sec. 589.2000(e) because the definition of

``distributor'' includes persons who transport feed and feed

ingredients.

(Comment 49). Proposed Sec. 589.2000(a)(5) would define

``nonruminant protein'' as including protein from nonruminant animals

and vegetable sources.

The agency has revised Sec. 589.2000(a)(5) to define ``nonmammalian

protein'' as including protein from nonmammalian animals and vegetable

sources. This corresponds to the final rule's change to a mammalian-to-

ruminant prohibition.

(Comment 50). As stated earlier, FDA has revised the rule to create

a new Sec. 589.2000(a)(6) to define ``distributor.'' While the codified

provisions of the draft rule that appeared in the Federal Register of

April 17, 1997, initially defined ``distributor'' as including

distributors of complete and intermediate feeds intended for animals,

FDA, on its own initiative, has revised the definition further to

clarify that persons who transport feed or feed ingredients intended

for animals are distributors.

(Comment 51). The agency has also revised the rule to create a new

Sec. 589.2000(a)(7) to define ``ruminant'' as including ``any member of

the order of animals which has a stomach with four chambers (rumen,

reticulum, omasum, and abomasum) through which feed passes in

digestion. The order includes, but is not limited to, cattle, buffalo,

sheep, goats, deer, elk, and antelopes.'' FDA elected to define the

word ``ruminant'' because several comments noted that some people might

not know what animals are ``ruminants.''

2. Section 589.2000(b)--Food Additive Status

Proposed Sec. 589.2000(b) would state that protein derived from

ruminant and mink tissues is not generally recognized as safe for use

in ruminant feed because it may contain TSE's and is a food

[[Page 30948]]

additive subject to section 409 of the act (21 U.S.C. 348). Thus, under

the proposed rule, the use or intended use of any ruminant or mink-

derived protein in ruminant feed would cause the feed to be adulterated

and in violation of the act (unless it was the subject of an effective

notice of claimed investigational exemption for a food additive or was

the subject of a food additive regulation). Proposed Sec. 589.2000(b)

would also state that FDA has determined that ruminant and mink-derived

protein is not prior sanctioned for use in ruminant feeds.

a. NonGRAS status.

At the outset, FDA notes that no comments provided FDA with any

published studies, data, or other information or expert opinions upon

which FDA could conclude that the material is safe or that there is a

reasonable certainty that the material is not harmful under the

intended conditions of use. FDA received no scientifically valid

information, or expert opinion based on that information, that

addressed: (1) Whether it is reasonably certain that BSE does not, or

will not, occur in the United States; (2) whether the BSE agent can be

detected; (3) whether it is reasonably certain that the BSE agent will

not be transmitted to ruminants through animal feed, i.e., that the

processed tissues are not infected by the agent, are deactivated by the

rendering process or are not transmitted orally; or (4) whether it is

reasonably certain that the agent will not be transmitted to humans

through consumption of ruminant products. As discussed extensively in

the preamble to the proposed rule (see 62 FR 552 at 553 and 564) and

herein, these significant safety questions have been raised by credible

currently available information about the transmission of BSE and TSE's

to ruminants through feed. As a result of these questions, as provided

in this final rule, FDA has determined that protein derived from

mammalian tissues in ruminant feed is not GRAS.

(Comment 52). Many comments stated that ruminant protein had been

safely used as components of animal feed for 100 years as well as

before the enactment of the Food Additive Amendments of 1958. These

comments seemed to assert that ruminant protein for use in ruminant

feed is GRAS based on common use in food prior to 1958, and based on

this history of safe use, FDA cannot now declare it to be a food

additive.

FDA disagrees. As noted in the preamble to the proposed rule, if a

substance was used in food before 1958, general recognition that the

use of a feed ingredient is safe can be based on scientific procedures

or experience based on common use in food (see 62 FR 552 at 566;

section 201(s) of the act (21 U.S.C. 321(s)); and 21 CFR 570.30(a)).

General recognition of safety through experience based on common use in

food prior to January 1, 1958, may be determined without the quantity

or quality of scientific procedures required for approval of a food

additive regulation, but it nonetheless requires a demonstration of:

(1) Safe use based on common use, and (2) an expert consensus of

safety, based on that common use (see 21 CFR 570.30). The simple

assertion of this safe use thus does not satisfy the burden the

proponents of the use bear to establish general recognition. Although

FDA agrees that, until recently, this material appears to have had a

long history of use without known adverse effects (see 62 FR 552 at

566), FDA has never affirmatively declared the material to be GRAS

based on common use in food.

Moreover, even if a substance is GRAS based on common use in food

or GRAS based on scientific procedures, FDA may reassess the GRAS

status of a food ingredient based on new information (see 21 CFR

530.30(g); see also, e.g., 51 FR 25021, July 9, 1986 (Sulfiting Agents;

Revocation of GRAS Status for Use on Fruits and Vegetables to be Served

or Sold Raw to Consumers)). Thus, even if ruminant protein for use in

ruminant feed were GRAS based on common use in feed prior to 1958, that

does not preclude FDA from reassessing it now that there exist new

studies, data, or other information that show that the substance is, or

may be, no longer safe (this is true whether the studies or data are

published or unpublished (see 50 FR 27294 at 27296 (July 2, 1985))) or

that there is no longer the basis for an expert consensus that it is

safe.

Expert opinion that the substance for use in ruminant feed is GRAS

would need to be supported by scientific literature, and other sources

of data and information. ``General recognition'' cannot be based on an

absence of studies that demonstrate that a substance is unsafe; there

must be studies or other information to establish that the substance is

safe (see U.S. v. An Article of Food * * * Coco Rico, 752 F.2d 11 (1st

Cir. 1985)). Furthermore, if there are studies and other data or

information that raise questions about the safety of the use of the

material, this conflict--just like a conflict in expert opinion--may

prevent general recognition of the substance.

As the agency explained in the preamble to the proposed rule,

research and other information have raised questions regarding the safe

use of protein derived from certain animal tissue in ruminant feeds.

The agency stated that ``the evidence as discussed in sections I and

II.A through II.D of this document, for the development of a new

pattern of disease transmission, now indicates that these ingredients

can no longer be categorically regarded as safe'' (see 62 FR 552 at

566).

Because the expert opinion must be ``general,'' a substance is not

GRAS if there is no recognition among experts, or there is a genuine

dispute among the experts, as to whether it is safe. Although there

need not be unanimity among qualified experts that a substance is safe

for ``general recognition'' of its safety to exist, an ``expert

consensus'' is required (see Weinberger v. Hynson, Wescott & Dunning,

Inc., 412 U.S. 606, 632 (1073)).

Accordingly, there must be no genuine difference of opinion among

qualified experts as to the substance's safety (see Coco Rico, 752 F.2d

at 15 n.6; United States v. Articles of Drug * * * 5,906 Boxes, 745

F.2d 105, 119 n.22 (1st Cir. 1984)). As the Court of Appeals for the

Second Circuit explained in Premo Pharmaceutical Laboratories, Inc. v.

United States, 629 F.2d 795, 803 (2d Cir. 1980), when there is a

dispute among experts as to ``general recognition,''

The * * * issue (of actual safety) is to be determined by the

FDA which, as distinguished from a court, possesses superior

expertise, usually of a complex scientific nature, for resolving

that issue.

See also 5,906 Boxes, 745 F.2d at 119 n.22; United States v. 50 Boxes *

* * Cafergot P-B Suppositories, 721 F.Supp. 1462, 1465 (D. Mass. 1989),

aff'd, 909 F.2d 24 (1st Cir. 1990); An Article of Drug * * * Furestrol

Vaginal Suppositories, 251 F.Supp. 1307 (N.D. Ga. 1968), aff'd, 415

F.2d 390 (5th Cir. 1969).

The World Health Organization (WHO), in an April 1996 consultation

on public health issues related to TSE, recommended that all countries

ban the use of ruminant tissues in ruminant feed. This recommendation

was intended to minimize the risk associated with exposure to BSE from

beef and beef products. The background for WHO recommendation pointed

out that the BSE epidemic in the United Kingdom appeared to have been

due mainly to the recycling of infected bovine material back to cattle.

In response to the agency's request in the preamble to the proposed

rule for comments on a ruminant-to-ruminant prohibition as well as

other alternatives including a full mammalian to ruminant

[[Page 30949]]

ban, no one submitted or cited published studies to support the

contention that the use of protein derived from ruminant tissue or from

mammalian tissue in ruminant feed is GRAS. Furthermore, no comments

refuted the agency's basis for determining protein derived from

ruminant tissue for use in ruminant feed to be nonGRAS as set out in

the preamble to the proposed rule. In addition, no one submitted or

cited published studies to support a finding that the use of mammalian

tissue in ruminant feed is GRAS either in response to the request for

comments on the alternative set out in the preamble to the proposed

rule or the request for comments on the draft rule, which included the

mammalian (with certain exclusions) to ruminant ban. FDA believes that

the same research and information set out in the proposed rule and the

industry practice of commingling mammalian, including ruminant and

mink, tissues, demonstrate that the use of protein derived from

mammalian tissues can no longer be categorically regarded as safe.

Therefore, this final rule provides that such protein for use in

ruminant feed is a food additive subject to section 409 of the act.

(Comment 53). Numerous comments appeared to argue that the agency

could not promulgate a rule declaring ruminant protein to be a food

additive when intended for ruminant feed because there is no BSE in the

United States.

Because these comments did not provide any legal or scientific

explanation to support this argument, it is unclear to FDA whether they

are arguing: (1) That FDA cannot rely on new information from foreign

sources to reassess the GRAS status of a food ingredient, or (2) that

FDA cannot take action until BSE actually occurs on United States soil.

Whichever argument is meant, FDA disagrees. First, the act does not

require evidence of actual harm to exist before a substance can be

declared to be not GRAS by FDA; all that is required is information--

which exists here--that the use of certain protein in ruminant feed may

not be safe or that there is no expert consensus that the use of the

substance is safe.

In addition, in response to comments that point out that there is

no evidence of BSE in the United States, FDA notes that nothing in the

act would support a blanket conclusion that FDA should only rely on

data generated or conditions present in the United States when making

this reassessment. Indeed, since, under the act, FDA must take into

account relevant evidence of foreign use when assessing a claim that a

food ingredient is GRAS based on common use in food prior to 1958 (see

Fmali Herb, Inc. v. Heckler, 715 F.2d 1385 (9th Cir. 1985)), FDA

believes it should likewise take relevant foreign data and expertise

into account when reassessing safety and general recognition. Here,

while there have been no reported cases of BSE in the United States,

other conditions exist that make the foreign experience relevant, such

as the fact that, in the United Kingdom, BSE was spread by the practice

of feeding ingredients from processed BSE-infected cattle to other

cattle, and the processes that were used failed to inactivate the BSE

agent.

Moreover, the act as a whole and the 1958 Food Additives Amendment

in particular were intended to give FDA the tools to prevent harm to

the public health before it occurs (see, e.g., United States v. Ewig

Bros Co., 502 F.2d 715, 721 & n.24 (7th Cir. 1974), cert. denied, 420

U.S. 945 (1975); see also S. Rep. No. 2422, 85th Cong., 2d Sess. 1-3

(1958); H.R. Rep. No. 2284, 85th Cong., 2d Sess. 1 (1958)). As a result

of the 1958 amendment, the burden of proof shifted to manufacturers,

and the 1958 amendment ``permit(s) FDA to regulate the use of

substances affecting foods without first determining that they are in

fact dangerous; the method is to require that such substances be

established as safe before being used'' (see Natick Paperboard Corp. v.

Weinberger, 525 F.2d 1103, 1106 (1st Cir. 1975), cert. denied, 429 U.S.

819 (1976); see also Ewig Bros., 502 F.2d at 721).

Thus, to claim that FDA cannot declare a substance to be a food

additive until it has actually done damage in the United States and FDA

can prove that actual harm has occurred would eviscerate the act. It

would be contrary to the public health if FDA could not use this

authority--based data and other relevant information from other

countries--to prevent harm from occurring through the use of certain

ingredients in feed.

FDA notes that section 801 of the act (21 U.S.C. 381), which gives

the agency the authority to prevent the import into the United States

of food that violate the act unless such items are intended for export

rather than domestic distribution, underscores the weakness of the

comments' arguments. If the act did not allow FDA to consider

conditions that exist in, or evidence from, other countries when

determining whether an article violates the provisions of the act, FDA

would not be able to implement section 801 of the act and keep

violative food from entering the country. Furthermore, if the comments'

interpretation of the act is correct--that FDA can only look at

conditions in this country--then FDA would not be able to declare

animal protein from other countries to be an unsafe food additive, even

if there had been cases of BSE reported in the country in which the

animal protein originated.

(Comment 54). Several comments argued that more research is needed

before FDA can take action and that the agency must establish that all

feed components affected by this rulemaking may transmit TSE's.

These comments misunderstand the structure of the food safety

provisions of the act. As noted above and in the preamble to the

proposed rule (62 FR 552 at 566), the act places the burden to

establish safety of a feed component on the proponent of the substance,

not on the government to prove actual harm. Research of the type

suggested by the comments could take years to complete. The agency

believes that it is neither required nor appropriate to delay

regulatory action to prevent transmission of BSE pending the completion

of research.

The information presented in the preamble to the proposed rule set

out the basis for the agency's nonGRAS determination for the use of

protein derived from ruminant and mink tissue in ruminant feed. As

discussed earlier in this preamble to the final rule, after evaluating

the issues and information presented in the comments on the proposal

and all other evidence, the agency has determined that a consensus does

not exist that the use of protein derived from mammalian tissues is

safe for use in ruminant feed. The agency finds that the potential

remains for ruminants to be exposed to TSE agents in ruminant feed.

When a ruminant is fed protein derived from mammalian tissues, TSE's

may be transmitted. Therefore, FDA concludes that the use of protein

derived from mammalian tissues in ruminant feed can no longer be

considered GRAS.

(Comment 55). The draft rule that appeared in the Federal Register

of April 17, 1997, revised Sec. 589.2000(b) to eliminate unnecessary

phrases that were included in proposed Sec. 589.2000(b). These phrases

were statements referring to FDA's determination that these proteins

are nonGRAS, the absence of a regulation providing for safe use, and

FDA's determination that these proteins are not prior sanctioned for

use in ruminant feeds. A small number of comments questioned why the

language was removed (because it did not alter the fact that proteins

derived from

[[Page 30950]]

mammalian tissues for use in ruminant feed are food additives subject

to section 409 of the act), and one comment asked FDA to restore the

nonGRAS language.

FDA eliminated the text described above from Sec. 589.2000(b)

because the language was unnecessary. These revisions are solely

editorial in nature and do not affect the substance of the agency's

rulemaking or its determination that protein derived from mammalian

tissues is not GRAS for use in ruminant feed and is not prior

sanctioned for use in ruminant feeds.

b. Alternatives to nonGRAS status and other legal comments.

Several comments advocated alternatives to declaring proteins

derived from ruminant tissues to be nonGRAS.

(Comment 56). Several comments suggested that FDA refrain from

issuing the rule and instead issue a CPG. Some comments stated that a

CPG could be used to determine that certain proteins are adulterants

when added to ruminant feed and that use of a CPG would meet FDA's goal

of increasing prevention of BSE. Some comments stated that a CPG would

prevent the loss of GRAS status for the protein products and claimed

that this loss will have serious ramifications, such as stigmatizing

the protein products, as well as affecting the companies' ability to

compete in the global market. One comment advocated the use of a CPG

because it would allow the agency additional time to do a reasoned

analysis of the scientific information before taking a final action.

Some comments stated that use of a CPG would allow the agency to

respond more quickly to scientific and technical changes than the use

of notice and comment rulemaking.

FDA disagrees with these comments. Contrary to the arguments

presented in the comments, FDA cannot use CPG's to impose any

requirement. CPG's are guidance documents issued by the agency. These

documents are not binding on the agency or any person. As the agency

explained in its ``Good Guidance Practice'' document published in the

Federal Register of February 27, 1997 (62 FR 8961), guidance documents

``represent the agency's current thinking on (a) subject'' and ``do not

themselves establish legally enforceable rights or responsibilities and

are not legally binding on the public or the agency.'' To issue a

binding prohibition, the agency must follow an appropriate rulemaking

procedure (see Community Nutrition Institute v. Young, 818 F.2d 943

(D.C. Cir. 1987)). Therefore, if the agency issues a CPG, it would not

be binding and, as such, would be an ineffective means of banning the

use of protein derived from certain tissues in ruminant feed.

Furthermore, a CPG that states that certain proteins used in ruminant

feed are adulterants under the act would require the agency, on a case-

by-case basis, to bring enforcement actions for violations of section

402(a)(1) or section 402(a)(2)(C) of the act. Again, the agency does

not believe this is an effective approach to preventing the

establishment and amplification of BSE through feed. The agency

believes it has made a reasoned analysis of the scientific information

available and based on this analysis, the agency is taking the approach

set out in this final rule.

(Comment 57). Several comments urged FDA to use an interim food

additive regulation rather than declare certain proteins for use in

ruminant feed are not GRAS. These comments explained that an interim

food additive regulation would prevent their products from being

stigmatized by a not GRAS determination. These comments also explained

that the interim food additive regulation would keep the administrative

record open to new evidence, permit FDA and the industry to react to

new research findings, and permit FDA to require the industry to

conduct planned research. Some comments cited the regulations in part

180 (21 CFR part 180) and the interim selenium rule as precedent for

FDA issuing an interim food additive regulation.

FDA disagrees with these comments. The regulations in part 180,

issued under section 409 of the act, apply to ``substances having a

history of use in food for human consumption or in food contact

surfaces'' (see Sec. 180.1(a)). The definition of ``food'' for the

subchapter (which includes part 180) includes ``human food, substances

migrating to food from food-contact articles, pet food, and animal

feed'' (see 21 CFR 170.3(m)). The language of Sec. 180.1, however, only

refers to human food and substances migrating to food from food contact

surfaces. The limiting language in Sec. 180.1 makes it clear that it

does not apply to pet food or animal feed. The agency recognizes that

Sec. 570.38(c)(2) (21 CFR 570.38(e)(2)), applicable to animal feeds,

provides that an interim food additive regulation may be issued. This

provision was carried over when the rules at part 121 (21 CFR part 121

(1976)), which addressed both human food and animal feed additives,

were reorganized to separate the human food and animal feed provisions.

Section 121.41 of FDA's regulations, which included the reference to

interim food additive regulations, was republished as Sec. 570.38. The

provisions governing promulgation of interim food additive regulations

at Sec. 121.4000 (now Sec. 180.1) were not republished in part 570 (21

CFR part 570) governing animal feed (41 FR 38618, September 10, 1976).

A decision to extend the use of interim food additive regulations to

animal feeds and the creation of a procedure for doing so would likely

require rulemaking under the Administrative Procedure Act (5 U.S.C. 501

et seq.)

Furthermore, even if this procedure were available to the agency

here, it would not prevent the stigma that the comments state is

created by the agency's determination that protein derived from certain

tissues for use in ruminant feed is not GRAS since the same

determination must be made to issue an interim food additive regulation

(see, e.g., 61 FR 7990 March 1, 1996) (interim food additive for

mannitol). Any determination by the agency that a substance is a food

additive is also a determination that the substance is not GRAS. This

is true regardless of whether the agency takes an action as in this

final rule or the agency issues an interim food additive regulation.

With regard to the interim rule on selenium cited by some comments

as an interim food additive regulation, the agency disagrees that the

interim rule on selenium is an interim food additive regulation like

those for human food issued under part 180. The selenium regulation at

21 CFR 573.920 was initially based on an approved food additive

petition submitted under section 409 of the act. The interim final rule

on selenium that appeared in the Federal Register of October 17, 1995

(60 FR 53702) was issued as an interim rule under the Administrative

Procedure Act (5 U.S.C. 501 et seq.), not as an interim food additive

regulation under section 409 of the act. The interim selenium rule

implements Pub. L. 103-354 regarding the allowable levels of selenium

in certain animal feeds. The rule is designated as an interim rule

because it was issued under an exception in the Administrative

Procedure Act (5 U.S.C. 553(b)(B)). This exception allows a final rule

to be issued without prior notice and public comment if use of the

procedures is impracticable, unnecessary, or contrary to the public

interest. As stated in the preamble to the selenium rule, the agency

determined that prior notice and public comment was unnecessary because

the rule merely repeated the terms of Pub. L. 103-354 (see 60 FR 53702

and 53703). As stated above, an interim food additive regulation would

be issued under section 409 of the act. Therefore, the interim selenium

rule is

[[Page 30951]]

not precedent for the agency to issue an interim food additive

regulation in this case.

(Comment 58). One comment stated that, instead of publishing a

regulation under part 589 (21 CFR part 589) which lists substances

prohibited in animal feed, the agency should do a GRAS listing with

restrictions similar to the action taken in the propylene glycol rule

that was published in the Federal Register of May 10, 1995 (60 FR

24808). The comment asserted that the GRAS listing (which is referred

to as a ``GRAS affirmation'') would reduce the possible taint from

listing the protein in part 589 as a prohibited substance. The comment

explained that the GRAS listing could limit the animal feed that could

contain the protein as it is listed in the proposed rule and include an

exemption for use of approved deactivation and detection methods. The

comment stated that the preamble to the rule should state the agency's

view that all uses excepted from GRAS status must be subject to a food

additive provision.

FDA does not agree with this comment. The action on propylene

glycol that the comment cites was a proposed rule that would exclude

from GRAS status propylene glycol used in or on cat food. The final

rule was published in the Federal Register of May 2, 1996 (61 FR

19542). The proposed rule cited by the comment, as well as the final

rule, included two provisions. One provision amended Sec. 582.1666 (21

CFR 582.1666), which sets out the GRAS status of propylene glycol, to

except its use in cat food. The second provision was a new

Sec. 589.1001 which lists propylene glycol in or on cat food as a

substance prohibited from use in animal food or feed. In this case, no

regulation exists that sets out a FDA determination of GRAS for protein

derived from certain tissues for use in animal feed. Therefore, there

is no GRAS regulation to amend as in the case with propylene glycol.

Furthermore, this final rule, like the propylene glycol regulation,

will list the substances as prohibited from use in animal feed in part

589.

The current regulations at Secs. 570.30 and 570.35 (21 CFR 570.30

and 570.35) describe the information necessary to determine a substance

as GRAS or to affirm GRAS status. The comment did not include or cite

any information that would provide a basis for the agency to determine

that the other feed uses of protein derived from certain tissues is

GRAS or to affirm it as GRAS. FDA notes, however, that the act does not

preclude manufacturers from making their own decisions on the GRAS

status of uses not covered by this final rule. If FDA disagrees with

this self-determination, FDA may take action, as it has done in this

final rule or by enforcement action, to end that self-determined GRAS

status (see FDA's proposed rule, Substances Generally Recognized as

Safe, published on April 17, 1997 (62 FR 18938), for proposed revisions

to the GRAS affirmation process.

(Comment 59). Several comments suggested that FDA adopt a

``temporary ban'' or a ``temporary moratorium'' to suspend the use of

the ruminant protein in ruminant feed. The comments claimed that such

temporary measures, unlike a formal rule, would be quickly modified or

rescinded based on new information. The comments also stated that FDA

should consider other alternative, yet effective, approaches and that

FDA has the ability to use other available regulatory options.

The agency declines to adopt the comments' suggestions. The

comments did not indicate what legal authority FDA should use or how

``temporary'' a ban or moratorium should be. While the agency has

several authorities related to the regulation of animal feed, they are

not applicable or would not be the most effective means of

accomplishing the rule's goals. The agency believes that the approach

used in this final rule is the most effective approach to accomplish

the agency's objective of preventing the establishment and

amplification of BSE in the United States through feed.

As stated in a response to an earlier comment, the agency could

bring adulteration charges under section 402(a)(1) of the act (21

U.S.C. 342(a)(1)) or section 402(a)(2)(C) on a case-by-case basis. The

agency does not believe this is a viable, efficient solution to

preventing BSE because it would require FDA to prove, on a case-by-case

basis, that mammalian protein is not GRAS when intended for use in

ruminant feed. In addition, the burden of proof would be on the agency

in such enforcement actions.

Under section 404 of the act (21 U.S.C. 344), the agency may issue

regulations providing for the issuance of permits governing the

manufacture, processing, or packaging of any class of food which the

agency has found may be injurious to health due to contamination with

micro-organism during such manufacture, processing, or packing.

However, in this case, the agency may be unable to determine adequately

whether a food may be injurious after the food has entered interstate

commerce. The lack of information required to establish necessary

conditions, coupled with the fact that the incubation period for BSE

may range from 2 to 8 years, effectively precludes use of section 404

of the act.

Section 406 of the act (21 U.S.C. 346) authorizes the agency to set

tolerances for food additives that are required for the production of a

food or cannot be avoided by good manufacturing practice. However, in

this case, section 406 of the act is inapplicable because protein

derived from certain tissues is not required to produce ruminant feed

nor is the protein an unavoidable contaminant. Even if section 406 of

the act were applicable, FDA does not have sufficient information to

set a tolerance because the quantity of the BSE agent necessary to

product infection is currently unknown.

Finally, the agency has the authority to make and enforce

regulations to prevent the spread of communicable diseases under

section 361 of the Public Health Service Act (42 U.S.C. 264). This

authority is available to the agency to address issues related to

TSE's. FDA, however, has determined that, at this time, use of its

authority under the food additive provisions of the act is appropriate.

(Comment 60). Comments from several individuals and organizations

strongly opposed the agency's proposal to declare certain animal-

derived feedstuffs as nonGRAS. As an alternative, the comments

suggested that adequate methods could be instituted which would reduce

to an acceptable level the risk that these feeds could transmit TSE's

to ruminants. Such methods included, inter alia, eliminating high risk

sources of raw materials (e.g., downer animals, specified ovine

tissues) from processing into feedstuffs intended for ruminant rations,

processing (rendering) conditions specifically designed to reduce the

infectivity of the raw materials if TSE agents were present in such

materials, and adequate clean-out, transport, and storage practices

which would minimize the risk from carryover or contamination of feeds

or feedstuffs with potentially infective materials.

Many comments, including some from the industries directly affected

by this rule, suggested that the agency issue regulations to require

risk reduction processes. These comments suggested that regulatory

oversight would be facilitated through GMP's, HACCP programs, or

similar instruments, and commercial firms determined by the agency to

be in compliance with such regulations would be permitted to label

feedstuffs produced under those conditions as ``Certified Ruminant

Derived Protein.'' Feed bearing such labeling would be permitted for

use in

[[Page 30952]]

all animal feed, including ruminant feed. One comment even provided a

detailed example of an HACCP program applicable to rendering

facilities, including a quantitative risk analysis specifying the

reduction in BSE infectivity at each critical control point. A comment

from the rendering trade association provided a detailed generic HACCP

plan which could be adapted by individual rendering establishments to

their specific operation. This comment also contained proposed codified

language for implementing HACCP. Several other comments provided

examples of practices intended to prevent high risk animals from

entering rendering channels.

In the preamble to the proposed rule, the agency agreed that the

need for mandatory HACCP, supported by GMP's for animal-derived

proteins, could be considered in future rulemaking (62 FR 552 at 567).

The agency continues to encourage the voluntary adoption of HACCP on a

plant-by-plant basis in both the rendering and feed industries. To the

extent that HACCP is adopted, FDA will be able to examine whether safe

conditions of use for some or all of the prohibited protein in ruminant

feed, using an HACCP plan, can be established under a food additive

regulation or whether such uses using an HACCP plan are GRAS. However,

a regulatory action to make HACCP mandatory for all manufacturers in

these industries is outside the scope of this final rule.

The agency agrees, in concept, that procedures which inactivate TSE

agents in feedstuffs or methods that detect the presence of TSE agents

in feedstuffs could form the basis for determining whether HACCP, GMP,

or similar process validation programs were sufficient to ensure that

TSE's could not be transmitted to ruminants through consumption of

feedstuffs produced under those programs. Additionally, under the final

rule, renderers are exempt from labeling and certain recordkeeping

requirements under this rule if they use routinely a test method that

FDA has validated to detect the presence of the agent that causes TSE's

and whose design has been made available to the public; or use

exclusively a method for controlling the manufacturing process that

minimizes the risk of the TSE entering the product and whose design has

been made available to the public and validated by FDA.

Presently, the agency has not validated any methods to detect the

TSE agent or any methods for controlling the manufacturing process that

would minimize the risk of the TSE agent entering the product. Although

some comments argued that rendering systems used widely in the United

States have been shown by European researchers to inactivate BSE under

specific parameters, such that products produced using these rendering

systems should be exempted from the rule, it should be noted that

mammalian meat and bone meal produced under the European system is not

permitted to be fed to ruminants in the European Union (Ref. 11).

The agency believes that the information provided is insufficient

to validate specific rendering processes. Although these rendering

processes appear to reduce the infectivity of materials in the mouse

model, the infective dose of a TSE agent remains unknown. The assay

method used to measure reduction of infectivity has been questioned as

to whether it is the appropriate assay for determining the infectivity

of tissues under natural conditions. When the mouse bioassay has been

used, there remain questions whether the test materials (tissues from

BSE-infected cattle) contained sufficient titres of the TSE agent to

ensure that materials produced under these rendering systems will not

transmit TSE's to ruminants (see comment 41 of this document and the

agency response). When sufficient data are available for the agency to

validate a process for inactivating TSE agents in processed feedstuffs,

a method for controlling the manufacturing process, or a test for

detecting the TSE agent in feed, FDA will be able to examine whether

safe conditions of use for mammalian protein in ruminant feed, using

such validated processes or tests, can be established under a food

additive regulation or whether such uses using the validated process or

test are GRAS.

3. Section 589.2000(c)--Requirements for Renderers That Are Not

Included in Paragraph (e) of This Section

Proposed Sec. 589.2000(c) would set forth the requirements for most

renderers. Proposed Sec. 589.2000(c)(1)(i) would require renderers

whose products contain or may contain protein derived from ruminant and

mink tissues and intended for use in animal feed to label the materials

as follows: Contains (or may contain) protein derived from ruminant and

mink tissues. Do not feed to ruminant animals, and do not use to

manufacture feed intended for ruminant animals. Proposed

Sec. 589.2000(c)(1)(ii) would require renderers to maintain copies of

sales invoices and to make them available to FDA for inspection and

copying. Proposed Sec. 589.2000(c)(2) would exempt renderers from the

labeling and recordkeeping requirements if they use exclusively a

manufacturing method that FDA has validated to deactivate the TSE agent

and make that method available to the public or routinely use a test

method, also validated by FDA, for detecting the TSE agent, under

proposed Sec. 589.2000(c)(2)(ii), would be labeled ``Not for Use in

Animal Feed,'' and records of test results would be made available for

FDA inspection. Proposed Sec. 589.2000(c)(3) would exempt renderers

from recordkeeping requirements if they use a permanent method,

approved by FDA, to mark the presence of protein derived from ruminant

and mink tissues. If the marking method could not be seen on visual

inspection, the proposed rule would require the method to be validated

by FDA and made available to the public.

a. Cautionary statement.

Several comments addressed the statement in proposed

Sec. 589.2000(c)(1)(i).

(Comment 61). Several comments requested that FDA revise the rule

to make the labeling statement simpler and more concise. Many suggested

that the statement simply say, ``Do Not Feed to Ruminants.''

FDA agrees and has revised the cautionary statement in

Sec. 589.2000(c)(1)(i) to read, ``Do not feed to cattle or other

ruminants.'' This statement has the advantages of being simple and

concise, and it refers to cattle as an example of a ruminant animal.

(Comment 62). In contrast, some comments asked FDA to revise

Sec. 589.2000(c)(1)(i) by placing the word ``warning'' or ``caution''

in the heading; requiring the use of bold type; referring to FDA

regulations or some other statement to indicate a legal prohibition;

and specifying the type, size, color or location of the label to ensure

it is noticeable.

The agency agrees in part and disagrees in part with the comments.

Section 403(f) of the act (21 U.S.C. 343(f)) requires that any word,

statement, or other information required to appear on food labels or

labeling to be ``prominently placed thereon with such conspicuousness

(as compared with other words, statements, designs, or devices, in the

labeling) and in such terms as to render it likely to be read and

understood by the ordinary individual under customary conditions of

purchase and use.'' Here, the essential point of the cautionary

statement is that the product should not be fed to cattle and other

ruminants; thus, citing FDA regulations to indicate

[[Page 30953]]

a legal prohibition would provide little useful information to the vast

majority of consumers and would be contrary to keeping the statement

simple and concise.

The agency does agree that the cautionary statement should be

noticeable. The statement should appear on product labels (such as

those attached to or are part of a bag or other container) and other

labeling for the product. For bulk products, the statement should

appear on the placard and invoice that accompany the shipment and on

any other labeling for the product. The agency does not have a

regulation that provides additional direction, beyond the statutory

language quoted above, regarding the prominence of the cautionary

statement and does not believe it is necessary to do so in this final

rule. However, the agency suggests that the statement be distinguished

by different type size or color or other means of highlighting the

statement so that it is easily noticed by a purchaser. Additional

information on animal food labeling may be found at part 501 (21 CFR

part 501).

(Comment 63). One comment indicated a need for clear end user

labeling of any and all human foods containing the specified offal

(eye, spinal column, tonsil, thymus, spleen, and intestine) and/or

mechanically recovered meat.

The USDA is responsible for labeling most meat products destined

for human consumption as food. Thus, the comment's suggestion is

outside the scope of this rule.

b. Records.

Proposed Sec. 589.2000(c)(1)(ii) would require renderers to

maintain copies of sales invoices and to make copies available for

inspection and copying by FDA. The preamble to the proposed rule

indicated that such records are a usual and customary part of normal

business activities (see 62 FR 552 at 570 and 579) and that FDA would

use such records to verify compliance with the rule.

(Comment 64). FDA received several comments concerning records.

Several comments supported the use of such records for compliance

purposes. However, a few comments suggested that sales invoices may not

always accompany products, that persons may not retain sales invoices

or records, or that sales invoices may not contain sufficient

information for enforcing the regulation.

In considering these comments, the agency reviewed several

Establishment Inspection Reports (EIR's) and supporting material that

had been collected as part of routine inspections or surveys of feed

ingredient manufacturers and feedmills. The supporting material for the

EIR's confirmed that some invoices contained detailed information

(regarding the items being sold and the identities of the seller and

purchaser) while others contained only a vague description of the

product and the name (without any address) of the company or person

receiving the product. Given the diversity in the sales invoices, and

the concerns expressed in some comments, FDA revised

Sec. 589.2000(c)(1)(ii) to require renderers to maintain records

sufficient to track the materials throughout their receipt, processing,

and distribution (rather than refer to sales invoices only), and to

make the copies available for inspection and copying by FDA. The final

rule enables renderers (and other parties that must comply with the

record requirement in Sec. 589.2000(c)(1)(ii)) to use sales invoices or

other records or a combination of such information so long as they

provide sufficient information to enable FDA to determine the receipt,

processing, and distribution of materials.

The recordkeeping requirement can be satisfied by an invoice or

other similar document reflecting receipt or purchase, and sale or

delivery of the product by the renderer. The information normally

expected to be included in these documents includes: (1) Date of the

receipt or purchase, or sale or delivery; (2) seller's name and

address; (3) consignee's name and address; (4) identification of the

product; and (5) quantity. Regarding an identification of the product,

FDA notes that invoices or similar sales documents may serve as labels

for bulk rendered products.

The act generally requires that the label of a regulated product

contain the product's customary or usual name. The common or usual

names of rendered products typically are those included in the

definitions published by AAFCO, such as ``meat and bone meal.'' Thus,

the use of the common or usual name on the invoice or similar sales

document will satisfy, in part, the ``records'' requirement in

Sec. 589.2000(c)(1)(ii) as well as the ``common or usual name''

requirement in the act. As discussed later in this document, the

records must be made available for FDA inspection and copying. They

should be kept so they are legible and readily retrievable.

c. Exemptions for manufacturing and test methods.

As stated earlier, proposed Sec. 589.2000(c)(2)(i) would exempt

renderers from the labeling and recordkeeping requirements if they use

exclusively a manufacturing method for deactivating the TSE agent that

has been validated by FDA and made available to the public. Proposed

Sec. 589.2000(c)(1)(ii) would exempt renderers from the label and

recordkeeping requirements if they routinely use a test method,

validated by FDA, for detecting the TSE agent and make that method

available to the public. Products found to contain a TSE agent would be

labeled ``Not for Use in Animal Feed,'' and records of test results

would be made available for FDA inspection.

Several comments strongly supported this provision because it would

provide flexibility to the industry or would make methods available to

the public where they could be discussed and analyzed. Other comments

suggested amendments or clarification.

(Comment 65). One comment concerning proposed

Sec. 589.2000(c)(2)(i) suggested that ruminant protein rendered by an

FDA-validated procedure should be labeled as ``Contains inactivated

bovine protein.''

FDA declines to revise the rule as suggested by the comment. The

agency will make any necessary changes to the labeling requirements by

rulemaking when it validates the first rendering process.

(Comment 66). One comment claimed that, in proposed

Sec. 589.2000(c)(2)(ii), the label statement for products found to

contain the TSE agent did not go far enough. The comment stated that

such products should be destroyed and positive tests reported to FDA.

FDA declines to revise the rule as suggested by the comment at this

time. However, as explained below, FDA has revised the labeling

requirement so that products that are found to have a TSE agent must be

labeled ``Do not feed to cattle or other ruminants.'' Products intended

for use in ruminant feed that are found to contain a TSE agent are

violative under the act, and the agency has guidance documents

pertaining to the disposition of violative products.

(Comment 67). Several comments raised issues related to the concept

of acceptable risk. One comment stressed that a definition of

``acceptable risk'' was necessary in order to develop a regulatory

program with a targeted end point. Other comments indicated that

regulatory programs should be based on some acceptable level of risk

reduction rather than defining a finite level of acceptable risk. One

comment suggested that FDA establish working groups comprised of

members from industry and consumer organizations to establish the

necessary level of risk reduction. Several comments cautioned that

establishing a zero level of risk could unnecessarily destroy certain

industries

[[Page 30954]]

and adversely impact the environment through the disposal of dead

animals and animal tissues by means other than rendering.

The agency determines the safety of substances intended to become a

part of food by approval of a food additive petition or by general

recognition of safety. In either case, it must be established that

there is a reasonable certainty in the minds of competent scientists

that the substance is not harmful under the intended conditions of use.

Reasonable certainty of no harm does not imply a zero level of risk

(see 21 CFR 570.3(i)). Congress, when enacting the Food Additive

Amendments of 1958, recognized that it is impossible to establish with

complete certainty that any substance is absolutely safe for use.

For the agency to determine that protein derived from mammalian

tissue would be safe for use in ruminant rations, it must be

demonstrated by scientific procedures that there is a reasonable

certainty that such feedstuffs could not transmit TSE's to ruminants.

The agency has determined that there is insufficient research on TSE

diseases to determine a minimum infective dose of the TSE agents in

ruminant rations, dose and age-related susceptibility factors, methods

for inactivation of the TSE agents, or methods for reliably detecting

the TSE agent in animal feeds. Such information is fundamental to the

establishment of any safe use of protein derived from mammalian tissue

in ruminant feed, and, under FDA's current statutory and regulatory

requirements, questions regarding the safe use of the tissues are to be

answered and presented to the agency in a food additive petition

submitted under section 409 of the act. Alternatively, consistent with

section 201(s) of the act (21 U.S.C. 321(s)) and Sec. 570.30, the

agency may be able to determine that the tissues are generally

recognized as safe based on scientific procedure. The provisions of

Sec. 589.2000(c)(2)(i), (c)(2)(ii), and (c)(2)(iii) of this final rule

provide that products containing protein derived from mammalian tissues

are exempt from the labeling and recordkeeping requirements if a method

for inactivation of the TSE agents is presented to and validated by the

agency, a test method to detect the presence of the agent that causes

TSE's is presented to and validated by the agency, or if validated

methods for controlling the manufacturing process that minimizes the

risk of the TSE entering the product are presented to and validated by

the agency. These developments and their validation by FDA should

provide relevant information on the establishment of safe conditions of

use for protein derived from mammalian tissues.

(Comment 68). Proposed Sec. 589.2000(c)(2)(ii) would require, in

part, products that are found, through the use of validated test method

to detect the presence of a TSE agent, to be labeled, ``Not for Use in

Animal Feed.''

Upon further reflection, FDA realized that the proposed labeling in

Sec. 589.2000(c)(2)(ii) was not consistent with the agency's objective

to prevent the establishment and amplification of BSE in the United

States through ruminant feed. Because products found to contain the TSE

agent are high risk FDA has revised the regulation to provide that for

renders using validated test methods, such renders must continue to

comply with the labeling and recordkeeping requirements in

Sec. 589.2000(c)(1) for products that test positive for the TSE agents.

(Comment 69). FDA, on its own initiative, has created a new

Sec. 589.2000(c)(2)(iii) to provide an exemption from the rule's

labeling and recordkeeping requirements if a renderer uses exclusively

a validated method for controlling the manufacturing process that

minimizes the risk of the TSE entering the product. Under

Sec. 589.2000(c)(2)(iii), the method must be made available to the

public and validated by the agency. The agency added this provision to

complement Sec. 589.2000 (c)(2)(i) and (c)(2)(ii) and because an

exemption from the labeling and recordkeeping requirements would be

appropriate if such a method were developed, validated, and used.

d. Exemptions for marking methods.

Proposed Sec. 589.2000(c)(3) would exempt renderers from the

recordkeeping requirement if they use a permanent method, approved by

FDA, to mark the presence of protein derived from ruminant and mink

tissues.

(Comment 70). FDA received very few comments on this provision. Two

comments supported the provision, although one comment conceded that it

was unaware of any permanent marking methods. Another comment suggested

that, for used cellulosic food casings, the casings themselves act as a

marker for ruminant proteins inside the casing.

As stated elsewhere in this document, FDA has revised the

definition of ``protein derived from mammalian tissues'' to exclude

used cellulosic food casings. As a result, it is unnecessary to

consider whether used cellulosic food casings are a permanent method of

marking.

FDA has made minor changes to this provision. The final rule omits

the reference to renderers ``who are not exempted under paragraph

(c)(2)(i) or paragraph (c)(2)(ii) of this section.'' FDA deleted this

language because it is unnecessary. A second minor change consists of

revising the phrase ``to mark the presence of the materials'' to ``to

make a mark indicating the presence of the materials.'' This change

reflects the fact that the presence of a material cannot be marked, but

that the product can be marked to show that it contains or may contain

protein derived from mammalian tissues.

4. Section 589.2000(d)--Requirements for Protein Blenders, Feed

Manufacturers, and Distributors That Are Not Included in Paragraph (e)

of This Section

Proposed Sec. 589.2000(d)(1) would require protein blenders and

feed manufacturers and distributors to comply with labeling and

recordkeeping requirements. Proposed Sec. 589.2000(d)(2) would provide

exemptions if a protein blender or feed manufacturer and distributor

purchased animal protein products from renderers that certified

compliance with the requirements for deactivating or detecting the TSE

agent or complied with such requirements itself. Proposed

Sec. 589.2000(d)(3) would exempt a protein blender or feed manufacturer

and distributor from the recordkeeping requirement if it purchased

animal protein products that had been marked or complied with the

marking requirement itself. Proposed Sec. 589.2000(d)(4) would require

copies of the certified compliance statements to be made available to

FDA for inspection and copying.

a. Cautionary statement.

Under proposed Sec. 589.2000(d)(1)(i), protein blenders and feed

manufacturers and distributors that manufacture, blend, process, and

distribute products containing protein derived from ruminant and mink

tissue would have to label the product to state, ``Contains (or may

contain) protein derived from ruminant and mink tissues. Do not feed to

ruminant animals, and do not use to manufacture feed intended for

ruminant animals.''

(Comment 71). Several comments would exempt pet food from the

rule's labeling requirement. One comment provided results from

interviews of 350 pet owners in 5 cities. These interviews examined

consumer reaction to the proposed rule's statement ``Contains (or may

contain) protein derived from ruminant and mink tissues. Do not feed to

ruminant animals, and do not use to manufacture feed intended for

ruminant animals.'' Sixty-eight percent of pet owners said they would

be concerned

[[Page 30955]]

about the safety of feeding any food to their pets with the proposed

statement, and more than 71 percent said that they would buy some other

pet food the first time they encountered the proposed statement on the

label of the pet food they generally buy. Other comments argued that

the statement was unnecessary on pet food because pet food is not used

for ruminant feed (due to its smaller quantity and higher price when

compared to ruminant feed). These comments did, however, suggest that

the cautionary statement would be appropriate for pet food products

that are salvaged or distressed and sold for possible use in animal

feed.

Another comment, submitted in response to the draft codified

provisions that appeared in the Federal Register of April 17, 1997,

suggested that FDA also exempt feeds for nonruminant laboratory animals

from the labeling requirement.

FDA agrees that the cautionary statement serves no useful purpose

on pet food and feed for nonruminant laboratory animals and has amended

the rule by creating a new Sec. 589.2000(d)(4) to exclude pet food

products that are sold or intended for sale at retail to non-food-

producing animals and feeds for nonruminant laboratory animals. These

products typically cost substantially more per ton than most complete

feeds intended for food-producing animals. Therefore, there is little,

if any, risk that pet foods or feeds for nonruminant laboratory animals

will be purchased at full price for use in ruminant rations. However,

if the pet food products are sold or are intended for sale as

distressed or salvage items, then, under Sec. 589.2000(d)(4), such

products must state, ``Do not feed to cattle or other ruminants.''

In addressing the labeling requirement for salvaged or distressed

pet food, the draft codified provisions that were published in the

Federal Register of April 17, 1997, initially included the phrase ``for

possible use'' in ruminant feed. FDA has deleted the phrase ``for

possible use'' because it is unnecessary.

(Comment 72). One comment, responding to the draft rule that

appeared in the Federal Register of April 17, 1997, sought

clarification as to what ``pet food'' meant.

FDA interprets pet food as the food product fed to pet animals. A

pet animal is any domesticated animal normally maintained in or near

the household(s) of the owner(s) thereof. Examples include dogs, cats,

rats, mice, hamsters, gerbils, rabbits, ferrets, nonhuman primates,

canaries, psittacine birds, mynahs, finches, tropical fish, goldfish,

snakes, and turtles. FDA does not consider horses or other equids to be

pets because they are routinely slaughtered for human food.

Furthermore, FDA believes that, since feed for horses can be readily

utilized in ruminant rations and is often priced comparably to ruminant

feed, horse feed must be labeled ``Do not feed to cattle or other

ruminants.''

(Comment 73). Some comments suggested revising the rule to require

feeds destined for use in nonruminant livestock to carry the cautionary

statement. In contrast, other comments argued that the cautionary

statement was unnecessary for nonruminant livestock feed.

FDA acknowledges the possibility that very little feed labeled for

use in nonruminant livestock is diverted to ruminant rations and that

which is diverted would likely have to be markedly diluted to be

nutritionally balanced for maximum benefit by the ruminant.

Nevertheless, FDA agrees that a cautionary statement should be

required. Complete feeds for nonruminant livestock typically cost only

slightly more per ton and often contain more protein than complete

ruminant feeds. Therefore, because nonruminant livestock feed may be

diverted to ruminant feed, the final rule requires the cautionary

statement on all animal feed, including nonruminant livestock feeds

(with the exception for pet food products).

(Comment 74). Other comments suggested that the agency revise the

collective terms in Sec. 501.110 (21 CFR 501.110) because, as a result

of the final rule, some feed ingredients would be prohibited in

ruminant rations.

The agency disagrees with the comments. At this time, no revision

to Sec. 501.110 is necessary because there will still be a collective

name/term known as animal protein products and this collective name/

term will include animal products, marine products, and milk products.

The final rule merely prohibits animal protein products containing

protein derived from mammalian tissues from being used in ruminant

feeds. Because of the final rule, however, AAFCO may need to amend its

definition of the collective term ``animal protein products'' to

identify those feed ingredients that are prohibited from use in

ruminant rations. FDA intends to work with AAFCO to accomplish this

change. Although manufacturers of ruminant feeds that use this

collective term may need to reformulate their rations to exclude the

protein derived from mammalian tissue, the ingredients list on the

label for any ruminant feed can continue to use the ``animal protein

products'' collective term.

(Comment 75). Several comments suggested that a mammalian to

ruminant ban would eliminate the need to change the AAFCO definitions.

Except for some current AAFCO ingredients listed under animal

protein products in the collective terms section, FDA agrees with the

comments. AAFCO definitions currently allow the species of origin to be

listed in the name of the product (e.g., swine meat and bone meal).

These AAFCO definitions are flexible enough to allow positive

certification on invoices and convey adequate information to consumers

who are concerned about the presence of mammalian proteins in their

feeds.

b. Records.

Proposed Sec. 589.2000(d)(1)(ii) would require protein blenders and

feed manufacturers and distributors to maintain copies of invoices for

purchases of animal protein products or feeds containing such products

and to make those records available for inspection and copying by FDA.

(Comment 76). One comment stated that this proposal was redundant

to the GMP recordkeeping requirements although, under the proposal, the

retention period would be 1 year longer than those required under the

GMP regulations.

FDA disagrees, in part, with the comment. The GMP recordkeeping

requirement at Sec. 225.202 (21 CFR 225.202) requires records to be

maintained that identify ``the formulation, date of mixing, and if not

for own use, date of shipment'' and that the records be ``adequate to

facilitate the recall of specific batches of medicated feed that have

been distributed. Yet Sec. 225.202, and the regulations in part 225,

(21 CFR part 225) generally, only apply to persons manufacturing,

processing, packing, or holding medicated feed, and it is unlikely that

all protein blenders, feed manufacturers and distributors subject to

Sec. 589.2000 will be manufacturing, processing, packing, or holding

medicated feed. However, because most persons subject to

Sec. 589.2000(d)(1)(ii) may be subject to the GMP recordkeeping

requirement for medicated feed and because Sec. 225.202 only requires

records to be kept for 1-year after the date of last distribution, the

agency has evaluated the relative benefit of a 2-year recordkeeping

requirement and concluded that a 1-year recordkeeping requirement is

adequate. Thus, FDA has revised Sec. 589.2000(h) to adopt a 1-year

record retention period.

FDA advises protein blenders, feed manufacturers, and distributors

that the recordkeeping requirement can be

[[Page 30956]]

satisfied by an invoice or other similar document reflecting receipt or

purchase, and sale or delivery of the product. The information normally

expected to be included in these documents includes: (1) Date of the

receipt or purchase, or sale or delivery; (2) seller's name and

address; (3) consignee's name and address; (4) identification of the

product; and (5) quantity. Regarding an identification of the product,

FDA notes that invoices or similar sales documents may serve as labels

for bulk rendered products, including blended protein products and

feeds. The act generally requires that the label of a regulated product

contain the product's customary or usual name. The common or usual

names of blended protein products and feed ingredients typically are

those included in the AAFCO definitions, such as ``meat and bone

meal.'' Thus, the use of the common or usual name on the invoice or

similar sales document will satisfy, in part, the ``records''

requirement in Sec. 589.2000(d)(1)(ii) as well as the ``common or usual

name'' requirement in the act. As discussed later in this document, the

records must be made available for FDA inspection and copying. They

should be kept so they are legible and readily retrievable.

(Comment 77). One comment stated that the recordkeeping

requirement, as applied to feed containing ruminant tissue, places an

unnecessary burden on all manufacturers of nonruminant feeds and pet

foods.

Because the final rule now prohibits the use of protein derived

from mammalian tissues in ruminant feed, FDA has revised

Sec. 589.2000(d)(1) to state that protein blenders, feed manufacturers,

and distributors that manufacture, blend, process, and distribute

products that contain or may contain protein derived from mammalian

tissues shall comply with the requirements in Sec. 589.2000(c)(1). This

means that the provision does not apply to protein blenders, feed

manufacturers, and distributors who do not manufacture, blend, process

or distribute products that contain or may contain proteins derived

from mammalian tissues.

(Comment 78). A small number of comments would revise this

provision of the proposed rule so that commercial contract guarantees

could be used as evidence of compliance by feed manufacturers. These

comments explained that feed manufacturers should be able to rely on a

guarantee because FDA, itself, would rely on commercial records for

enforcement purposes.

The agency declines to revise the rule as suggested by the

comments. Section 303 (c)(2) and (c)(3) of the act (21 U.S.C. 333

(c)(2) and (c)(3)) and FDA regulations at 21 CFR 7.12 and 7.13 already

establish the statutory and regulatory requirements for a guaranty.

Thus, the change suggested by the comments is unnecessary (see response

to comment 21).

c. Exemptions for purchases from renderers certifying compliance.

Proposed Sec. 589.2000(d)(2)(i) would exempt protein blenders, feed

manufacturers, and distributors from the requirements in Sec. 589.2000

(d)(1)(i) and (d)(1)(ii) if they purchased animal protein products from

renderers certifying that they used methods to deactivate or detect the

presence of the TSE agent. Alternatively, under proposed

Sec. 589.2000(d)(2)(ii), a protein blender, feed manufacturer, or

distributor could obtain the exemption if it complied with the

requirements regarding methods to deactivate or detect the presence of

the TSE agent.

(Comment 79). One comment stated that, insofar as methods for

deactivating the BSE agent are concerned, FDA must examine the accuracy

of the infectivity assessment and the sensitivity and reliability of

the methods used and consider the relationship between the quantity of

material tested and the total quantity in a particular batch. The

comment stated that FDA must use or develop this expertise.

The agency agrees with the comment and intends to carefully

examine, when a claimed method for inactivating a TSE agent is

presented to FDA for validation, whether the method is effective. At

this time, the agency is unaware of any such methods.

(Comment 80). One comment, submitted in response to the draft

provision that appeared in the Federal Register of April 17, 1997,

requested clarification of the type of certification required under

Sec. 589.2000 (d)(2) and (d)(3) if the qualifications for exemption

identified in Sec. 589.2000(c)(2) were met.

FDA has not validated any methods that would meet the requirements

for any of the exemptions in this rule. If and when the agency does so,

it will provide guidance as needed for the implementation of such

exemptions, including certification under Sec. 589.2000 (d)(2) and

(d)(3).

d. Exemptions for purchases of marked protein products.

Proposed Sec. 589.2000(d)(3) would exempt protein blenders, and

feed manufacturers and distributors from recordkeeping requirements if

they purchased animal protein products that had been marked to indicate

the presence of animal protein derived from ruminant or mink tissues

complied with the marking requirement itself.

(Comment 81). One comment would revise this provision to include

products that are ``labeled'' as being in compliance. The comment

contemplated a system whereby persons could certify that their products

did not contain ruminant protein and complied with the rule.

The agency declines to revise the rule as suggested by the comment.

The permanent mark described in Sec. 589.2000(c)(3) serves as a visual

cue or other detectable signal that protein derived from mammalian

tissue may be present. Labeling is not equivalent to a permanent mark

because it may be separated from the product.

e. Copies of certifications.

Proposed Sec. 589.2000(d)(4) would require copies of the

certifications described in Sec. 589.2000 (d)(2) and (d)(3) to be made

available for inspection and copying by FDA.

(Comment 82). FDA received no comments on this provision. However,

because the agency has added a new paragraph (d)(4) to exempt pet food

products and feeds for nonruminant laboratory animals from the labeling

requirement, FDA has renumbered proposed paragraph (d)(4) as paragraph

(d)(5).

5. Section 589.2000(e)--Requirements for Persons That Intend To

Separate Mammalian From Nonmammalian Materials

Proposed Sec. 589.2000(e) would require persons that intend to

separate ruminant and mink materials from nonruminant material to

comply with the labeling requirement for products derived from ruminant

and mink tissues or feeds containing such products, would require

renderers to obtain nonruminant (excluding mink) materials only from

single-species facilities, and would require these persons to provide

for measures to avoid commingling and cross-contamination.

Additionally, the proposal would exempt renderers, blenders, and feed

manufacturers and distributors from these requirements if they met

certain exemption criteria.

a. Cautionary statement.

Proposed Sec. 589.2000(e)(1)(i) would require persons who intend to

separate ruminant/mink and nonruminant/mink materials to comply with

the labeling requirement in Sec. 589.2000 (c)(1) or (d)(1) for products

derived from ruminant and mink tissues or feeds containing such

products.

(Comment 83). One comment would revise this provision to add equine

materials.

[[Page 30957]]

Because the final rule now pertains to protein derived from

mammalian tissues, the agency has revised Sec. 589.2000(e)(1)(i) so

that the labeling requirement only applies to products containing

protein derived from mammalian tissues or feeds containing such

products. Additionally, FDA, on its own initiative, has made two

revisions to this provision. The agency has deleted ``haulers'' from

the Sec. 589.2000(e)(1) because such persons are considered to be

``distributors'' as defined in Sec. 589.2000(a)(6). The final rule also

refers to ``products containing protein derived from mammalian

tissues'' rather than ``products derived from mammalian (other than

pure porcine)'' tissues as used in the codified (62 FR 18728), to be

consistent with the definition of ``protein derived from mammalian

tissues'' in Sec. 589.2000(a)(1).

b. Nonmammalian or pure porcine or equine materials only from

single-species facilities.

Proposed Sec. 589.2000(e)(1)(ii) would require renderers who intend

to separate ruminant/mink and nonruminant/mink materials to obtain

nonruminant (excluding mink) materials only from single-species

facilities.

(Comment 84). FDA received no comments on this provision. However,

because the final rule now pertains to protein derived from mammalian

tissues, the agency has revised Sec. 589.2000(e)(1)(ii) so that the

renderer must obtain nonmammalian or pure porcine or equine materials

only from single-species slaughter facilities. The insertion of the

word ``slaughter'' is intended to clarify the type of facility involved

in this provision. Additionally, FDA interprets the term ``single-

species slaughter facilities'' to mean dedicated slaughter facilities

that only slaughter one type of animal; the term does not include

facilities that slaughter different types of animals on different days

or work shifts.

c. Measures to avoid commingling and cross-contamination.

Proposed Sec. 589.2000(e)(1)(iii) would require persons that intend

to separate ruminant/mink from nonruminant (excluding mink) materials

to provide for measures to avoid commingling or cross-contamination.

This could be achieved through separate equipment or facilities for the

manufacture, processing, or blending of such materials or through

``clean-out procedures or other means adequate to prevent carry-over''

of ruminant and mink derived protein into animal protein products or

feeds intended for use in ruminants.

(Comment 85). No comments focused on the concept of maintaining

separate equipment or facilities for the manufacture, processing, or

blending of materials (although one comment presumed that separate

facilities and equipment could be costly). Nevertheless, FDA advises

interested persons that it interprets this provision as extending to

separate storage of such materials.

(Comment 86). Most comments on proposed Sec. 589.2000(e)(1)(iii)

addressed issues concerning ``adequate'' clean-out and carry-over. Oral

comments from the public meetings and written comments to the proposed

rule requested that FDA define what constitutes ``adequate'' clean-out.

Comments from industry and consumer groups expressed concern that it

would be difficult to verify if adequate clean-out procedures were used

because there is no test that readily differentiates between ruminant

and nonruminant protein. Other comments suggested that firms handling

prohibited and nonprohibi

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