**Environmental Assessment for the IFR on Use of Materials Derived from
Cattle in Human Food and Cosmetics.**

July 9, 2004

Table of Contents

I. Description of the Selected Action

II\. Need for Action

III\. How the Selected Action Addresses the Need for Action

IV\. Regulatory Authority

A.  FDCA

B. NEPA

V. Background of Current U.S. Regulations

VI\. Uses of Cattle Products in Human Foods and Cosmetics

VII. Alternatives to the Selected Action

A. Alternative 1: No Action

> B. Alternative 2: Ban Use of Prohibited Cattle Materials in Human Food
> and Cosmetics, the Selected Action

1\. Food Ingredients Affected

2\. Environmental Consequences of the Selected Action

> C. Alternative 3: Ban Use of all Non-Meat Material from Cattle in
> Human Food and Cosmetics.
>
> D. Alternative 4: Ban Use of Prohibited Cattle Material from Cattle
> over 12 Months in Human Food and Cosmetics

VIII. Mitigation Measures

IX. Preparer

X.  References

XI. Appendix A: Cattle Industry and Slaughtering By-products

**Environmental Assessment for the IFR on Use of Materials Derived from
Cattle in Human Food and Cosmetics**

July 9, 2004

**I. Description of the Selected Action.**

> The Food and Drug Administration is issuing an interim final rule to
> prohibit the use of certain cattle material (referred to as prohibited
> cattle materials), because of the risk of bovine spongiform
> encephalopathy (BSE), in human food, including dietary supplements,
> and cosmetics. Prohibited cattle materials include specified risk
> materials, the small intestine of all cattle, material from
> non-ambulatory disabled cattle, material from cattle not inspected and
> passed for human consumption, and mechanically separated (MS) (Beef).
> Specified risk materials (SRMs) are the brain, skull, eyes, trigeminal
> ganglia, spinal cord, vertebral column (excluding the vertebrae of the
> tail, the transverse processes of the thoracic and lumbar vertebrae,
> and the wings of the sacrum), and dorsal root ganglia of cattle 30
> months and older; and the tonsils and distal ileum of the small
> intestine of all cattle. Prohibited cattle materials do not include
> tallow with 0.15% or less insoluble impurities or tallow derivatives.
> The United States Department of Agriculture (USDA) issued an IFR on
> January 12, 2004, declaring SRMs and the carcasses and parts of
> nonambulatory disabled cattle to be inedible, unfit for human food,
> and prohibiting their use in human food. The agency is issuing this
> IFR, consistent with USDA\'s IFR, to minimize human exposure to the
> materials that scientific studies have demonstrated to contain the BSE
> agent in cattle infected with BSE.

**II. Need for Action.**

> Based on the information presented in the preamble to the rule and
> consistent with USDA's regulation issued in an IFR on January 12,
> 2004, (69 FR 1862), FDA has determined that the tissues of highest
> risk of harboring BSE infectivity (the SRMs) are the brain, skull,
> eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the
> vertebrae of the tail, the transverse processes of the thoracic and
> lumbar vertebrae, and the wings of the sacrum), and dorsal root
> ganglia of animals 30 months and older and tonsil and distal ileum of
> cattle of all ages. Though the skull and the vertebral column have not
> been shown to harbor BSE infectivity, they contain tissues that have
> been shown to be infectious; therefore, the agency is including the
> skull and the vertebral column in the list of SRMs. The agency is not
> including the vertebrae of the tail, the transverse processes of the
> thoracic and lumbar vertebrae, and the wings of the sacrum as SRMs
> with the rest of the vertebral column, because they do not contain
> spinal cord or dorsal root ganglia. The preamble to the IFR also
> discusses in detail the basis for tissue selection and for animal age
> selection as well as the source of the prohibited cattle materials.
>
> The prohibition would cover the same materials prohibited by USDA\'
> IFR and also materials from cattle that are not inspected and passed
> for human consumption. Because SRMs, the small intestine,
> non-ambulatory disabled cattle, and MS (beef) are subject to USDA's
> disposition requirements (e.g., destruction or use in inedible
> rendering), we assume that generally these materials are not likely to
> be widely available for use in the manufacture of FDA-regulated human
> food and cosmetics. The manufacturers and processors of products
> currently using materials that are considered SRMs (e.g., the brain,
> skull, and spinal cord) would presumably be able to continue to use
> these ingredients, but exclusively from cattle younger than 30 months
> of age. The manufacturers of FDA-regulated food products that use
> rendered material would continue to use rendered material that is the
> product of edible rendering (e.g., edible tallow). The manufacturers
> of products using the tonsils and small intestine of all cattle,
> material from non-ambulatory disabled cattle, material from cattle not
> inspected and passed for human consumption, and mechanically separated
> (MS) (Beef) would need to find substitutes for these ingredients. We
> assume that the recent USDA rulemaking has already led many of these
> manufacturers to search for alternative ingredients.
>
> FDA believes that there is a need for the IFR to reduce risk to human
> health from uses of prohibited cattle materials in domestic and
> imported human food and cosmetics.

**III. How the Selected Action Addresses the Need for Action**

The Harvard-Tuskegee risk assessment (referred to below as the
Harvard-Tuskegee study) was published in November 2001, and determined
that the U.S. was highly resistant to any proliferation of BSE or a
similar disease. The Harvard-Tuskegee study determined that the greatest
sources of infectivity are direct consumption of cattle brain and spinal
cord and also meat from advanced meat recovery (AMR) systems that
contains central nervous system tissue. The Harvard-Tuskegee study did
not address potential human exposure to the BSE agent through products
containing ingredients of bovine origin, such as gelatin, beef stocks,
extracts, and flavorings, and did not address potential exposure from
cosmetics. The Harvard-Tuskegee study identified three pathways by which
BSE could be spread or human exposure to it could be increased; these
are:

\(1\) Non-compliance with FDA's ruminant feed regulation prohibiting the
use of certain proteins in feed for cattle and other ruminants;

\(2\) Rendering of animals that die on the farm and use (through illegal
diversion or cross-contamination) of the rendered product in ruminant
feed; and

\(3\) The inclusion of high-risk tissues from cattle, such as brain and
spinal cord, in products for human oral consumption.

> Evaluation of potential risk mitigation measures in the study found
> that a prohibition against rendering of animals that die on the farm
> would reduce the potential cases of BSE following hypothetical
> exposure by 82 percent. In addition, a ban on specified risk materials
> (SRMs) including brains, spinal cord and vertebral column from
> inclusion in human and animal food would reduce potential BSE cases in
> cattle by 88 percent and potential human exposure to BSE by 95
> percent. Consideration of FDA-regulated products was not included in
> the Harvard-Tuskegee study. Hence, the selected action would meet the
> need for the action; specifically, it will provide an increased level
> of protection for human health by ensuring that prohibited cattle
> materials are not used in FDA-regulated human food and cosmetics.
>
> In this interim final rule, FDA is extending similar protections to
> FDA-regulated human food and cosmetics. USDA\'s IFR will reduce but
> will not, by itself, eliminate the availability and use of prohibited
> cattle materials in domestic and imported FDA-regulated human food and
> cosmetics. Domestically, generally food that contains meat only in a
> relatively small proportion or that historically has not been
> considered by consumers to be products of the meat food industry
> (e.g., soup stock, beef flavors and extracts, gelatin), is not
> produced under USDA inspection (see definition of \"meat food
> product\" in 21 USC 601(j)) and may be physically available for use in
> FDA-regulated human food and cosmetics. Further, even when excluded
> from food produced in USDA-inspected establishments, prohibited cattle
> materials may leave the establishments for inedible rendering or
> destruction. These materials, which previously have not been
> explicitly prohibited in human food and cosmetics by FDA, might then
> be used in FDA-regulated human food or cosmetics. For example,
> prohibited cattle materials leaving a USDA-inspected facility might
> not be denatured sufficiently to preclude their use in FDA-regulated
> human food and cosmetics.
>
> Under FSIS' rule, SRMs, small intestine from all cattle, and material
> from non-ambulatory disabled cattle must be designated as inedible.
> However, certain products, such as gelatin and collagen used in
> FDA-regulated human food and cosmetics, have traditionally been
> produced from cattle material deemed inedible by USDA. Therefore, such
> a designation by USDA may not be enough to preclude use of prohibited
> cattle materials in FDA-regulated human food and cosmetics without
> additional regulation by FDA. Further, some cattle are not slaughtered
> under continuous USDA inspection (e.g., some are sent directly to
> rendering). Cattle material from these animals, such as brains or
> bones which include SRMs, could end up as starting material for human
> food, such as meat extracts or gelatin, respectively. Furthermore, if
> prohibited cattle materials were used in FDA-regulated human food or
> cosmetics, the rule would facilitate FDA\'s ability to use the
> enforcement mechanisms of the Act that apply to adulterated products
> (e.g., seizure) to prevent human exposure to prohibited cattle
> materials.
>
> Imported products also may contain the types of materials prohibited
> by USDA, but which would not fall within the scope of USDA's import
> regulations either because of the nature of the products or their
> country of origin. Specifically, although both FSIS and APHIS impose
> BSE-related prohibitions, these prohibitions collectively do not cover
> all FDA-regulated human food and cosmetics. FSIS\' restrictions,
> contained in its IFR described earlier in this document, do not apply
> to importation of dietary supplements, cosmetics, and FDA-regulated
> human food not considered to be \"meat food products\" under the
> Federal Meat Inspection Act (21 USC 601(j)). APHIS\' BSE-related
> restrictions on imports do not cover gelatin for human use (beyond
> requiring a permit) or cosmetics, and apply only to a limited number
> of countries (9 CFR 94.18).
>
> In conclusion, the agency believes that the selected action would
> satisfy the need for the action, specifically, protection of public
> health, by 1) making it clear that prohibited cattle materials cannot
> be used in FDA- regulated human food and cosmetics; 2) creating an
> additional regulatory barrier, beyond existing USDA and FDA
> regulations, between consumers and human food and cosmetics
> potentially contaminated with BSE; and 3) clarifying FDA\'s ability to
> prohibit importation of products, such as gelatin, beef extracts, and
> dietary supplements, that may contain the types of materials
> prohibited by USDA, but may not fall under the scope of USDA's import
> restrictions.

**IV. Regulatory Authority.**

A.  **FDCA.**

> FDA is issuing these regulations under the adulteration provisions in
> sections  402(a)(2)(C), 402(a)(3), 402(a)(4), 402(a)(5), 601(c), and
> under section 701(a) of the act (21 U.S.C. 342 (a)(2)(C), (a)(3),
> (a)(4), (a)(5), 361(c), and 371(a)). The preamble to the IFR discusses
> also in detail the legal authority regarding prior sanctions, GRAS,
> color additives, dietary supplements, and cosmetics. The IFR discusses
> enforcement.

**B. NEPA.**

Sec. 101 \[42 USC § 4331\] of Title I of the National Environmental
Policy Act (NEPA) declares that it is the continuing policy of the
Federal government, in cooperation with State and local governments, and
other concerned public and private organizations, to use all practicable
means and measures to create and maintain conditions under which man and
nature can exist in productive harmony, and fulfill the social,
economic, and other requirements of present and future generations of
Americans.

According to Sec. 102 \[42 USC § 4332\] of Title I of the Act, all
agencies of the Federal Government shall include in every recommendation
or report on proposals for legislation and other major Federal actions
significantly affecting the quality of the human environment, a detailed
statement by the responsible official on:

1\. The need for action,

2\. The environmental impact of the selected action,

> 3\. Any adverse environmental effects which cannot be avoided should
> the proposal be implemented,
>
> 4\. Alternatives to the selected action,
>
> 5\. Mitigation measures if the action may result in significant
> environmental impacts

The policies and goals set forth in NEPA provide Federal agencies with
authority supplemental to those set forth in existing authorizations of
Federal agencies (Sec. 105 of Title I of NEPA).

**V. Background of Current U.S. Regulations.**

> In an effort to minimize human exposure to materials that contain the
> BSE agent in cattle infected with the disease, following
> identification of a BSE-positive cow in the U.S., USDA published on
> January 12, 2004, an interim final rule banning the use of SRMs from
> animals 30 months and older and tonsils and small intestine from all
> animals, materials from non-ambulatory disabled animals, and MS (beef)
> from human food. From the early 1990s, FDA has published guidance and
> regulations and issued letters to the industry on the sourcing of
> bovine materials from BSE countries and other BSE-related measures. A
> detailed discussion of CVM/FDA BSE regulations and guidance are
> available at CVM's web site at <http://www.fda.gov/cvm>. For
> CFSAN/FDA's current BSE regulations and guidelines, see the preamble
> to the IFR, and for USDA's current BSE regulations see 69 FR 1862,
> January 12, 2004.

VI. **Uses of Cattle Products in Human Food and Cosmetics.**

When cattle are slaughtered, abdominal fat is pooled with fat trimmings
from primary cuts of meat. This edible fat is processed to produce
edible tallow and tallow derivatives for use in human food applications
such as frying, pizza, soups, frozen dinners, and other food products.
Organs and tissues not commonly considered meat, henceforth referred to
as by-products, are harvested during slaughter. These by-products are
separated into edible (e.g., liver, heart, kidneys, spleen, thymus,
testicles, and pancreas) and inedible (e.g., lungs and condemned parts)
by-products. The former can be used in FDA-regulated bovine-origin food
(e.g., stocks, flavoring, and dietary supplements) and cosmetic
products; the latter are, in general, not used in human food or cosmetic
products. While cattle hides are not treated as edible tissues in
slaughter plants, some parts of hides are transformed into hide gelatin,
which can be used in food products. As for diseased, dead, dying, and
disabled cattle, and cattle not inspected and passed for human
consumption, they are otherwise considered in-edible by USDA and are not
permitted for use in human food. This material is either disposed of or
is sent to inedible rendering where they are cooked down to produce (1)
meat and bone meal (MBM), which is not used in FDA-regulated human food
and cosmetics, and (2) inedible tallow and tallow derivatives that have
many uses. Before December 2003, surveillance had not indicated that
there was BSE in the U.S., so tissues now considered prohibited cattle
materials were allowed in human food by both USDA and FDA. However, USDA
published its interim final rule in January 12, 2004, to label these
materials as inedible and prohibit their use in human food.

> As we discussed in the last paragraph of Section III of this EA, FDA's
> IFR will
>
> make it clear that prohibited cattle materials cannot be used in FDA-
> regulated human food and cosmetics, will create an additional
> regulatory barrier, beyond existing USDA and FDA regulations, between
> consumers and food and cosmetics potentially contaminated with BSE,
> and will clarify FDA\'s ability to prohibit importation of human food
> and cosmetics, such as gelatin, beef extracts, and dietary
> supplements, that may contain the types of materials prohibited by
> USDA, but may not fall under the scope of USDA's import restrictions.

-   Edible fat gets rendered into edible tallow for use in human food,
    mainly for baking and frying. Soaps and many cosmetics also use a
    tremendous amount of tallow derivatives, which may come from edible
    or inedible tallow. Tallow derivatives are exempt from the
    regulation in the IFR.

-   Edible by-products that may become part of FDA-regulated human food
    or cosmetics include the brain, spinal cord, and eyes of cattle
    [under]{.underline} 30 months of age, and the liver, heart, kidneys,
    spleen, thymus, testicles, pancreas, esophagus, bile, mesentery,
    stomachs, and probably a few other body parts from cattle of all
    ages. These may be used in dietary supplements and other human food
    including soups, stocks, flavorings, extracts, collagen, and amino
    acids.

**VII. Alternatives to the Selected Action.**

> Consistent with NEPA, with CEQ's regulations, and with FDA's
> regulations in 21 *CFR* 25.40, this EA provides a brief discussion of
> the alternatives to the selected action. In making the decision on the
> preferable alternative, FDA evaluated the impact of the action and its
> alternative in the context of the larger effort to minimize and manage
> the potential risks posed by BSE to the populations of the U.S. In
> making its decision of what alternatives it could consider, the agency
> weighed the environmental cost of more prohibitive actions that may be
> more protective of human health and the environmental benefit of the
> less prohibitive action that is less protective of human health;
> specifically, no action.
>
> The agency believes that the selected action is the one that provides
> the most reasonable protection of human health and the least
> environmental impacts. The only alternative with no impact, No Action,
> is not responsive to the problem. The alternatives discussed are:

**A. Alternative 1:** No Action;

> **B. Alternative 2:** Ban use of prohibited cattle materials in human
> food and cosmetics, the selected action;
>
> **C. Alternative 3:** Ban Use of all Non-Meat Material from Cattle in
> Human Food and Cosmetics.
>
> **D. Alternative 4:** Ban Use of Prohibited Cattle Material from
> Cattle over 12 Months in human food and cosmetics.

**A. Alternative 1: No action.**

As long as the country was free of BSE, the responsible Federal agencies
relied on a firewall that consisted of import restrictions, surveillance
of the U.S. cattle population, and FDA\'s animal feed ban to prevent the
introduction of BSE and to detect it if it were introduced in the U.S.
Shortly after BSE was diagnosed in one cow in the State of Washington,
the USDA published its IFR to strengthen the firewall and minimize the
risk to humans from BSE. FDA, consistent with USDA, and to provide
greater protection for public health, decided to act by publishing the
current IFR.

> The first alternative the agency considered was "no action." Under
> this option, FDA would not publish any rules but would continue
> monitoring the disease. This option would not be the best option to
> protect human health after the discovery of a BSE positive animal in
> the U.S. The "No Action Alternative" would have the least
> environmental consequences because the status quo practices of the
> cattle and rendering industries would continue with no additional
> material destined for disposal. However, this is not the best
> alternative for protecting public health, which is the main
> responsibility of the FDA. Domestically, generally food that contains
> meat only in a relatively small proportion or that historically has
> not been considered by consumers to be products of the meat food
> industry (e.g., soup stock, beef flavors and extracts, gelatin), is
> not produced under USDA inspection (see definition of \"meat food
> product\" in 21 USC 601(j)) and may be physically available for use in
> FDA-regulated human food and cosmetics. Further, even when excluded
> from for food produced in USDA-inspected establishments, prohibited
> cattle materials may leave the establishments for inedible rendering
> or destruction. These materials, which previously have not been
> explicitly prohibited in human food and cosmetics by FDA, might then
> be used in FDA-regulated human food or cosmetics. As a result, by not
> acting, the agency would not be explicitly prohibiting use of material
> considered by USDA to be inedible and unfit for food because of the
> possible presence of the BSE infectious agent.
>
> **B. Alternative 2:** Ban use of prohibited cattle materials in human
> food and cosmetics, the selected action
>
> The USDA rule prohibits the use of SRMs, small intestine of all
> cattle, material from non-ambulatory disabled cattle, and MS (Beef) in
> human food. FDA\'s IFR bans the use of prohibited cattle materials in
> human food, including dietary supplements, and cosmetics.

To have a better understanding of how much material is produced by the
slaughtering and rendering industries, we are providing relevant
information about these industries in Appendix A. It is imperative to
keep in mind that USDA\'s prohibitions on cattle material theoretically
should prevent most animals that were not inspected and animals that
were condemned by USDA from being used in FDA-regulated human food and
cosmetics.

**1. Food ingredients affected.**

> Prohibited cattle materials include specified risk materials (SRMs),
> small intestine from all cattle, material from non-ambulatory disabled
> cattle, material from cattle not inspected and passed for human
> consumption, and mechanically separated (MS)(Beef). SRMs are the
> brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column
> (excluding the vertebrae of the tail, the transverse processes of the
> thoracic and lumbar vertebrae, and the wings of the sacrum), and
> dorsal root ganglia of cattle 30 months of age and older; and the
> tonsils and distal ileum of the small intestine of cattle of all ages.
> Tallow may be used if it contains no prohibited cattle materials or if
> it contains 0.15% or less hexane-insoluble impurities.  Tallow
> derivatives are exempt from the rule.
>
> This alternative would only prohibit the use of ingredients produced
> by the processing of by-products that contain, in whole or in part,
> prohibited cattle materials from cattle and that are intended for use
> in human food, including dietary supplements, and cosmetics (See
> Figure 1, below). Most of the rendered materials used in FDA-regulated
> human food and cosmetics are tallow and tallow derivatives. Because
> the proposed BSE agent is a protein and has not been detected in fat
> (MAFF, 1993), FDA would not prohibit the use of tallow and tallow
> derivatives from this source as long as they comply with the
> specifications set forth in the interim final rule.
>
> **Figure1:** A Flow Diagram of Material Fate from Slaughter to Final
> Product

**2. Environmental Consequences of the Selected Action.**

> Under USDA's IFR, slaughterers separate SRMs and arrange for their
> disposal. Slaughterers will modify their animal killing operations to
> arrange for the separation of SRMs, and delivery of the materials to a
> disposal or disposal/rendering operation.
>
> USDA has banned the use of SRMs from food for human consumption. Until
> now, SRMs have generally gone to rendering where they contribute to
> the production of meat and bone meal (MBM) and tallow. For the purpose
> of this analysis, we are assuming that SRMs will be rendered and the
> tallow will be recovered; the tallow will be purified to meet the
> specifications set forth in the IFR if it is to be used in human food
> or cosmetics. The rendered MBM from SRMs then will be used as
> discussed below.
>
> This analysis is based on the SRM definition used by USDA and FDA in
> their interim final rules. SRMs are defined as:

(1) The brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral
    column (excluding the vertebrae of the tail, the transverse
    processes of the thoracic and lumbar vertebrae, and the wings of the
    sacrum), and dorsal root ganglia of cattle 30 months of age and
    older.

(2) The tonsils of all cattle;

(3) The distal ileum of all cattle.

> Because of USDA\'s IFR, we are assuming that slaughterers are already
> not including deads and downers in their slaughtering operations;
> thus, we are not including the SRMs produced from dead and downers
> (692,150,000 pounds) in our analysis. Only SRMs produced from healthy
> slaughtered cattle (1,423,044,000 pounds) is included in this
> analysis. We are also presuming that meat processors are not expected
> to handle SRMs and are excluded from this analysis.
>
> As indicated in the shaded part of Figure 1, almost all of the cattle
> products currently used as human food or in human food come from
> cattle parts considered edible by USDA. As a result of USDA's IFR,
> SRMs from slaughtered cattle have to be segregated early in the
> process to avoid contamination of the materials considered edible and
> destined for human food. Consequently, FDA's action is not the primary
> reason why these materials must be segregated from edible material in
> cattle slaughtering facilities and are made unavailable for uses in
> human food and cosmetics.

The environmental impact of most consequence as a result of the IFR
would be the disposal of SRMs that will be clearly prohibited from use
in FDA-regulated human food and cosmetics (FDA's IFR).

> **a. Protein Use**: In Appendix A, we estimated that 355,761,000
> pounds of protein result from material considered SRMs collected by
> renderers from slaughtering facilities. We expect most of this protein
> to be used in poultry feed (36%), pet food (36%), swine food (15%),
> and other uses. We have no evidence to believe that the category
> "other uses" include uses in human food, such as food additives and
> dietary supplements or in cosmetics; however, if we assume that all
> this material (13% of total protein produced) is currently being used
> in the subject FDA-regulated human food or cosmetics, then renderers
> have to dispose of only 46,248,930 pounds (355,761,000 \* 13%). This
> material is a very small fraction of the total material that cattle
> farmers and renderers have to dispose off. Specifically this material
> constitutes only 1% of the materials of dead and downers that
> slaughterers have to dispose of (4,621,250,000 pounds-Appendix A). In
> addition, this material could be diverted for use in animal feed which
> is the main market for use of this protein. Therefore, we do not
> expect this IFR to lead to a significant environmental impact as a
> result of disposal of proteins not used in the regulated products
> mentioned in the rule.
>
> **b. Tallow Use:** The interim final rule allows the use of tallow
> that contains no more than 0.15 percent hexane-insoluble impurities as
> outlined in the rule. Consequently, we expect renderers to purify the
> rendered tallow to meet the required specifications and do not expect
> FDA's IFR to result in additional waste. In addition, tallow
> derivatives are exempt from the rule.
>
> **C. Alternative 3:** Ban Use of all Non-Meat Material from Cattle in
> Human Food and Cosmetics.

The action, prohibition of use of SRMs, reduces the risk posed to humans
from BSE but does not eliminate it. The removal of SRMs removes over 95%
of the infectivity in an animal infected with BSE (FSA-
<http://www.foodlaw.rdg.ac.uk/news/uk-03028.htm>). One alternative to
reduce further the potential for exposure to infectious material would
be to ban not just SRMs but all cattle by-products. Specifically, all
organs and tissues not commonly considered meat that are harvested
during slaughter in a sanitary manner could be banned. This alternative
would result in the need to find alternative methods of disposal of
almost 50 percent of the live weight of cattle because less than 50
percent of a cow ends up as prime cut for human consumption. This
alternative would result in huge amounts of waste needing disposal. The
costs associated with this alternative would be high, while providing
only minimal additional protection to humans.

> **D. Alternative 4:** Ban Use of Prohibited Cattle Material from
> Cattle over 12 Months in human food and cosmetics.
>
> This option is the ban of prohibited cattle materials from animals
> over 12 months of age. The European Union requires removal of SRMs
> from animals over 12 months of age. The EU set their age limit at the
> level they deemed appropriate for countries that experienced
> widespread BSE among cattle. USDA and FDA believe an SRM ban in
> animals over 30 months of age is protective of human health based on
> research described in the preamble of the IFR.

This alternative would increase the amount of waste for disposal. The
costs associated with this alternative would be higher, while providing
additional protection to humans only from the relatively small number of
cattle between the ages of 12 and 30 months that would be expected to be
infectious for BSE.

**VIII. Mitigation Measures.**

The agency has concluded that no significant environmental impacts are
expected as a result of the action; therefore, there is no need to
discuss mitigation measures.

IX. **Preparer.**

> Layla I. Batarseh, Ph.D.

Environmental Review Group/Supervisor

Division of Chemistry Research and Environmental Review

Center for Food Safety and Applied Nutrition

> Food and Drug Administration
>
> [Qualifications]{.underline}: Layla I. Batarseh is the supervisor for
> the Environmental Review Group in the Office of Food Additive Safety.
> She is CFSAN's Senior Environmental Scientist. She joined the agency
> in 1993 and serves as CFSAN's focal point for technical and procedural
> matters dealing with compliance with the NEPA. She holds a B.Sc. and
> an M.Sc. in Biology from the American University of Beirut and an
> M.Sc. in environmental Health Sciences and a Ph.D. in Toxicology, both
> from The University of Michigan/Ann Arbor.

X.  **References.**

-   Livestock Mortalities: Methods of Disposal and Their Potential
    Costs. 2002. Sparks Companies, Inc. Washington, DC, pp.30.

-   Prohibition of the Use of Specified Risk Material for Human Food and
    Requirements for the Disposition of Non-ambulatory Disabled Cattle;
    Meat Produced by Advanced Meat/Bone Separation Machinery and Meat
    Recovery (AMR) Systems; Prohibition of the Use of Certain Stunning
    Devices to Immobilize Cattle During Slaughter; Bovine Spongiform
    Encephalopathy Surveillance Program; Interim Final Rules and
    Notices. January 2004. U.S. Department of Agriculture.
    Washington, DC. *Federal Register* 69 (7), 1861-1874.

-   Introduction and Profile of the Meat Animal Producing, Slaughtering,
    and Rendering Industries.
    <http://www.fda.gov/cvm/index/bse/bse2.pdf>

-   Alternatives to Rendering for Meat Processors. 2004.
    <http://ecm.ncms.org/ERI/Meat/rendaltsum.htm>

-   National Renderers Association Public Response to USDA-APHIS. 2004.
    National Renderers Association.
    <http://www.rendermagazine.com/news/USDA-ANPRDownerAppendices.htm>

-   Emission Factor Documentation for AP-42 Section 9.5.3. Meat
    Rendering Plants. 1995. US Environmental Protection Agency. MRI
    Project No. 4602-03.
    <http://www.epa.gov/ttn/cheif/ap42/ch09/bgdocs/b09s05_3.pdf>

-   Substances Prohibited from Use in Animal Food or Feed; Animal
    Proteins Prohibited in Ruminant Feed. 1997. US Food and Drug
    Administration. Washington DC. *Federal Register* 62 (108),
    30935-30978.

-   Animal Disposition Reporting System- Total Livestock Slaughtered and
    Condemned. 2002. US Department of Agriculture. Washington DC.
    <http://www.fsis.usda.gov/ophs/adrsdata/2002/02rm2.htm>

-   Agriculture Statistics Board- Cattle. 2004. US Department of
    Agriculture.

-   Finding of No Significant Impact and Environmental Assessment for 21
    CFR 589.2000 Prohibition of Protein Derived from Ruminant and Mink
    Tissue in Ruminant Feeds. 1996. US Food and Drug Administration.
    Washington DC. pp. 86.

-   Dave Harlan (2004): By-products Marketing Manager for Cargill Taylor
    Beef Business Unit.

**Appendix A: Cattle Industry and Slaughtering By-products**

In the United States, there are about 900 slaughtering facilities that
are inspected by USDA. These account for at least 95% of the total
animals slaughtered for meat. The rest of the animals are slaughtered in
non-Federal inspected facilities, which are inspected by individual
States.

Under USDA\'s IFR, slaughterers will be asked to separate SRMs and
arrange for their disposal. Slaughterers are expected to modify their
animal killing operations to arrange for the separation of SRMs and
delivery of the materials to a disposal or disposal/rendering operation.
USDA has banned the use of SRMs in food for human consumption. Until
now, SRMs have generally gone to rendering where they contribute to the
production of meat and bone meal (MBM) and tallow.

This analysis is based on the SRM definition used by USDA and FDA in
their interim final rules. SRMs are defined as:

1.  The brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral
    column (excluding the vertebrae of the tail, the transverse
    processes of the thoracic and lumbar vertebrae, and the wings of the
    sacrum), and dorsal root ganglia of cattle 30 months of age and
    older.

> 2\. The tonsils of all cattle; and

3.  The distal ileum of all cattle.

Under this definition, older cows generate considerably more SRM per
head than younger animals. To quantify the SRM generation, the agency
used estimates provided by Dave Harlan, Byproducts Marketing Manager for
Cargill Taylor Beef Business Unit (Harlan, 2004). In the estimates
presented in Table 1 below, slaughterers are forecast to extract on
average 28.3 lbs of SRM from cattle under 30 months of age and 88.5 lbs
from cattle over 30 months of age. The average total cattle weight at
slaughter was calculated in 2003 at approximately 1,250 lbs, of which
hides and skin represent approximately 5 percent and for which cattle
offal represents 34.1 percent (Sparks International, Inc, 2001). This
translates to approximately 425 lbs of offal per animal before SRM are
removed. Based on these calculations, SRM will represent 6.7 or 20.8
percent of offal of the animal. \[Other sources provide slightly
different estimates of the weight of SRM per cow. ERG used the Harlan
estimates based on the judgment that they were reasonably consistent
with other estimates and were combined in his analysis with other useful
data for this analysis. Some of the other estimates of SRM weights are
somewhat higher, such as sources estimating 100 lbs for SRM in older
cattle. Weight estimates for specific SRM components are also variable,
depending partly on the interpretation of the definition of each SRM
component.\]

**Table 1. Estimated Volumes and Value of Specified Risk Material, per
Ambulatory Cow Slaughtered**

+-----------------------------------------------+----------------------+
| ** **                                         | ** **                |
|                                               |                      |
| **Cattle part**                               | **Pounds SRM/Head**  |
+-----------------------------------------------+----------------------+
| Brain                                         | 0.936                |
+-----------------------------------------------+----------------------+
| Spinal cord                                   | 0.374                |
+-----------------------------------------------+----------------------+
| Eyes                                          | 0.220                |
+-----------------------------------------------+----------------------+
| Dorsal root ganglia                           | NA                   |
+-----------------------------------------------+----------------------+
| Tonsils                                       | 0.300                |
+-----------------------------------------------+----------------------+
| Skull (including trigeminal ganglia)          | 15.200               |
+-----------------------------------------------+----------------------+
| Vertebral column                              | 36.500               |
+-----------------------------------------------+----------------------+
| Small intestine (incl. distal ileum) - \< 30  | 28.000               |
| months (a)                                    |                      |
+-----------------------------------------------+----------------------+
| Small intestine (incl. distal ileum) - \> 30  | 35.000               |
| months (a)                                    |                      |
+-----------------------------------------------+----------------------+
| **Total - for cattle not over 30 months**     | 28.3                 |
|                                               |                      |
| **(Includes only tonsils and small intestine) |                      |
| (lbs)**                                       |                      |
+-----------------------------------------------+----------------------+
| **Total - for cattle over 30 months old       | 88.5                 |
| (lbs)**                                       |                      |
+-----------------------------------------------+----------------------+

> NA=Not applicable or not available
>
> \(a\) The source estimates different values for cattle below or over
> 30 months of age
>
> Source: Harlan, 2004a. Other sources provide different average weights
> for various cow parts, with some estimates as high as 100 lbs of
> material for older cattle.

Table 2 below (Harlan, 2004) includes estimates of total quantities of
SRMs produced per year from slaughtered animals and from dead and
downers. We have no information to support that material from dead and
downers is used in human food or in the manufacture of FDA-regulated
human food or cosmetics that are the subject of this rule. Therefore,
the weight of SRMs produced from dead and downers will not be included
in the assessment. The SRM calculations were based on the 2003 annual
cattle slaughter of approximately 35.3 million animals (USDA, 2004).

**Table 2. SRMs Quantities from Dead, Downer and Antemortem Condemned
Cattle**

+---------------------+--------+--------+------+----------+----------+
| ** **               | ** **  | ** **  | **   | **Avg.   | **Total  |
|                     |        |        | Numb | SRMs     | SRMs     |
|                     | **     | **Per  | er** | Wt.**    | Wt.**    |
|                     | Number | cent** |      |          |          |
|                     | of**   |        | **Re | **Per    | **(000   |
|                     |        | **R    | nder | Head**   | lbs)**   |
|                     | **Head | endere | ed** |          |          |
|                     | (000   | d(b)** |      | **(lbs)  |          |
|                     | )(a)** |        | *    | (c)**    |          |
|                     |        |        | *(00 |          |          |
|                     |        |        | 0)** |          |          |
+---------------------+--------+--------+------+----------+----------+
| **Slaughtered**     |        |        |      |          |          |
+---------------------+--------+--------+------+----------+----------+
| For cattle over 30  | 7,054  | 100%   | 7    | 88.5     | 624,508  |
| months of age       |        |        | ,054 |          |          |
+---------------------+--------+--------+------+----------+----------+
| For cattle under 30 | 28,217 | 100%   | 28   | 28.3     | 798,535  |
| months of age       |        |        | ,217 |          |          |
+---------------------+--------+--------+------+----------+----------+
| SRM totals          | 35,271 |        | 35   |          | **1,4    |
|                     |        |        | ,271 |          | 23,044** |
+---------------------+--------+--------+------+----------+----------+
| **Dead and          |        |        |      |          |          |
| Downers**           |        |        |      |          |          |
+---------------------+--------+--------+------+----------+----------+
| All deads under 500 | 2,365  | 5%     | 118  | 200.0    | 23,650   |
| lbs                 |        |        |      |          |          |
+---------------------+--------+--------+------+----------+----------+
| Feedlot deads       | 300    | 90%    | 270  | 750.0    | 202,500  |
+---------------------+--------+--------+------+----------+----------+
| Beef cow deads &    | 1,400  | 10%    | 140  | 1,100.0  | 154,000  |
| downers             |        |        |      |          |          |
+---------------------+--------+--------+------+----------+----------+
| Dairy cow deads &   | 400    | 60%    | 240  | 1,300.0  | 312,000  |
| downers             |        |        |      |          |          |
+---------------------+--------+--------+------+----------+----------+
| Deads and downer    | 4,465  | 17%    | 768  |          | **6      |
| totals              |        |        |      |          | 92,150** |
+---------------------+--------+--------+------+----------+----------+
| Total - All SRM and |        |        |      |          | **2,1    |
| dead and downer     |        |        |      |          | 15,194** |
| animals             |        |        |      |          |          |
+---------------------+--------+--------+------+----------+----------+

\(a\) FDA assumed that 20 percent of cattle slaughtered are over 30
months of age. This estimate is within the range defined by various
industry and literature estimates. The total slaughter figure for cattle
is based on 2003 slaughter (USDA, 2004). Dead and downer estimates were
derived from Harlan, 2004a.

\(b\) Estimated by Harlan, 2004a.

\(c\) See calculations in Table 1.

Source: Information provided by Harlan, 2004, except where otherwise
specified.

The total number of dead and downers is 4,465,000 giving a total weight
of 5,581,250,000 pounds (heads\*1250 pounds/head). As shown in the above
table, only 768,000 heads of deads and downers are collected by
renderers leaving 3,697,000 heads, or 4,621,250,000 pounds (3,697,000
heads \* 1,250 pounds/head) to be disposed off by farmers. We found no
specific information on how much of the material not collected by
renderers is disposed of. We expect that cattle producers dispose of
deads and downers that are not picked up by renderers using any of the
following legal methods:1) land burial, 2) incineration, 3) composting,
and 4) landfills.

The total amount of SRM that will be totally prohibited from use in
FDA's human food and cosmetics is 1,423,044,000 pounds. We are not
including the amount of SRMs obtained by renderers from deads and
downers since these are prohibited from use in human food and cosmetics.
According to EPA report, about 50% of this material is moister and 25 %
is fat and 25% is protein. Therefore, rendering of this material
produces 355,761,000 pounds each of fats and proteins. These numbers
will be used in the discussion of the impact of the IFR on the
environment under Section B.2 of the EA.