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![](media/image1.png){width="1.5013888888888889in"
height="1.0972222222222223in"}

EMBASSY OF AUSTRALIA

WASHINGTON DC

  ----------------------------------- -----------------------------------
                                      13 August 2004

  ----------------------------------- -----------------------------------

+-------------------------+--------------------+-----------------------+
| APHIS Docket Clerk      | FSIS Docket Clerk  | FDA Docket Clerk      |
|                         |                    |                       |
| Docket No. 04-047-1     | Docket No. 04-021  | Docket No. 2004N-0264 |
|                         | ANPR               |                       |
| Regulatory Analysis and |                    | Division of Dockets   |
| Development,            | Room 102, Cotton   | Management (HFA-305), |
|                         | Annex              |                       |
| PPD, APHIS, Station     |                    | Rm 1061, 5630 Fishers |
| 3C71,                   | 300 12^th^ Street, | Lane,                 |
|                         | SW                 |                       |
| 4700 River Road, Unit   |                    | Rockville, MD 20852.  |
| 118,                    | Washington DC      |                       |
|                         | 20250.             |                       |
| Riverdale, MD           |                    |                       |
| 20737-1238.             |                    |                       |
+-------------------------+--------------------+-----------------------+

Dear Sir or Madam

**AUSTRALIAN GOVERNMENT SUBMISSION ON --**

**Federal Measures to Mitigate BSE Risks: Consideration for Further
Action**

> **Docket No. 04-047-1 (APHIS)**
>
> **Docket No. 04-021ANPR (FSIS)**
>
> **Docket No. 2004N-0264 (FDA)**
>
> **Docket No. 2004N-0081 (FDA)**
>
> **Docket No. 2004N-0257 ((FDA)**

Australia notes the recent invitation from US authorities to provide
comment on a number of regulatory initiatives and proposals which,
collectively, have the stated purpose of safeguarding animal and public
health against the risks posed by the disease bovine spongiform
encephalopathy (BSE). The specific regulatory initiatives and proposals
are:

a.  FSIS Interim Final Rules, P*rohibition of the use of specified risk
    materials for human food and requirements for the disposition of
    non-ambulatory disabled cattle*; M*eat produced by advanced
    meat/bone separation machinery and meat recovery (AMR) systems*;
    *Prohibition of the use of certain stunning devices used to
    immobilize cattle during slaughter*

b.  FDA Interim Final Rule, U*se of materials derived from cattle in
    human food and cosmetics*

c.  FDA Proposed Rule, *Recordkeeping requirements for human food and
    cosmetics manufactured from, processed with, or otherwise
    containing, material from cattle*

d.  USDA and FDA Advanced Notice of Proposed Rule Making, *Federal
    Measures to Mitigate BSE Risks: Consideration for Further Action*
    (herein after called the ANPRM).

It is further noted that the earlier APHIS Proposed Rule, *BSE Minimal
Risk Regions and Importation of Commodities* released in 2003, remains
to be finalised and is a closely related and relevant development.

Australia recognises the right of US authorities, and those of any other
World Trade Organisation (WTO) Member Economy, to determine their own
Appropriate Level of Protection (ALOP) for BSE risk. Important
principles of the WTO's Sanitary Phyto-Sanitary (SPS) Agreement include
that sanitary measures are not more trade restrictive than required to
achieve a Member's ALOP, and that Members accept the measures of other
Members as equivalent, if the exporting Member objectively demonstrates
that its measures achieve the importing Member's ALOP.

These comments are therefore primarily directed at matters relating to
the application of the principle of equivalence under these BSE
regulatory initiatives and proposals. Additionally, an opportunity is
taken to comment on matters relating to the auditing of record keeping
requirements of the type currently proposed by FDA, by exporting country
competent authorities.

# EQUIVALENCE

# Introduction

Australia has a strong interest in the matter of equivalence - section
VI D, questions 34, 35 and 36 of the ANPRM. Australia would argue that
it has in place a comprehensive range of control measures to prevent the
entry and/or amplification of the BSE agent. These measures protect and
maintain Australia's BSE-free status. It is Australia's view that these
measures, in combination with our recognised BSE-free status, should
constitute equivalent sanitary measures that provide the same level of
protection as that achieved domestically in the US by the new BSE Rules.
In January 2004, Australia provided a technical submission to FSIS
detailing its range of BSE control measures for the purpose of
equivalence assessment. In addition, we have provided detailed comments
on equivalence in regard to the FSIS Interim Final Rule on BSE Measures
(69 Fed Reg 1862, 12 January 2004). These comments were provided in
April 2004 through the Federal Register comment process, and were also
attached to a letter to Secretary Veneman from Australia's Ambassador to
the US, Michael Thawley.

The comments provided below are consistent with the comments already
provided to FSIS on BSE equivalence matters, and in some cases are
direct extracts from those comments.

**Question 34**, S*hould FSIS provide an exemption for "BSE free"
countries or countries with some other low-risk BSE designation?*

Australia is of the strong view that such exemptions should be catered
for in the relevant USDA and FDA rules and regulations. This view
applies to all BSE-related measures contained in the FSIS and FDA Final
Interim Rules on BSE, and those contained in the ANPRM. The FSIS and FDA
Final Interim Rules as presently drafted do not allow for an exemption
for countries that do not present a BSE risk, a flexibility that exists
in the comparable food-safety regimes of Canada and the European Union
(EU). In the EU, this flexibility also extends to BSE-related measures
concerned with animal feeding, animal identification and sanitation. It
is also relevant that USDA has stated its intention to adopt, to the
extent practicable, a uniform approach to BSE control measures with
Canada. We understand that Canada intends to continue its policy of
exemptions for countries that do not present a BSE risk in finalising
proposed enhancements to animal feeding requirements, announced on 9
July 2004.

Strong precedents exist for adopting an approach to exempt "BSE-free"
countries. Relevant considerations include:

1\. A number of countries, including Australia, are regions free of BSE
as defined under current US regulation 9 C.F.R. § 94.18. This is the
situation that existed before BSE was identified in North America, and
continues to be the case. By contrast, other USDA initiatives, such as
the meat-borne pathogen reduction requirements introduced during the
1990s, were justifiably applied to other countries as the pathogens of
concern existed in their cattle populations and beef supply. Animal
products exported from countries with a recognized BSE-free status, pose
no BSE-risk to animal or public health in the US. Their importation
should not be restricted or prohibited on the grounds of BSE, beyond the
recommendations of the World Organisation for Animal Health (OIE)
*Terrestrial Animal Health Code* Chapter on BSE.

2\. The principle of the recognition of equivalent foreign food safety
and animal health systems, for the purposes of importing animals and
their products into the US, has been enshrined in many US rules and
regulations. This principal has operated, and has been shown to operate,
effectively for many years to protect the health of US livestock and US
citizens. There is no justification for departing from this established
principle in the case of BSE.

3\. The US has previously catered for the question of equivalence in the
proposed rule, *BSE Minimal Risk Regions and Importation of Commodities*
released in 2003. This rule proposed measures for the importation of
animals and animal products from BSE minimal risk regions, that had
implemented BSE risk reduction measures that produced equivalent food
safety and animal health outcomes to those that applied in the US at
that time. APHIS determined that the nature of this equivalence remained
unchanged despite the subsequent detection in the US of an imported case
of BSE from Canada, a proposed minimal risk region defined in the
proposed rule. This was detailed in both an ensuing reopening of comment
and explanatory note to this proposed rule. The proposed rule also
detailed a possible mechanism for the assessment of a country's BSE
status that has relevance to questions 35 and 36 (see below).

4\. The OIE *Terrestrial Animal Health Code* Chapter on BSE clearly
differentiates between the BSE risks posed by BSE free or provisionally
free countries, and those posed by other BSE risk country categories.
For example, this differentiation means that risk management measures
involving the removal of specified risk materials (SRMs) are only
recommended for minimal, moderate or high BSE risk countries.

We believe that the US joins Australia in seeking consistency in
international standards in these critically important areas of food
safety and animal health. In view of the exemptions for BSE-free
countries that have been incorporated into the Canadian and European
regulations, we suggest that it makes sense for the US to adopt similar
exemptions in its response to BSE. Furthermore, such an approach would
be consistent with meeting the SPS Agreement obligations of the US as a
WTO Member Economy.

Our request that provision be made for an exemption and/or recognition
of equivalence is also based on the high likelihood of unreasonable
current and future economic harm resulting from the burdens and
restrictions imposed by the FSIS and FDA Final Interim Rules on the
Australia cattle production system. Additionally, it is based on the
potential economic and environmental burden that would arise from
application of the measures contained in the ANPRM, such as an inability
to dispose of downer/dead-on-farm cattle through salvage for rendering
and pet food use. If the ANPRM measures on enhancements to the US feed
ban were to apply to Australia, it would have significant effects on
Australian industries. ANPRM measures would need to be applied Australia
wide, as it would not be feasible to have US-only livestock feed and
animal production systems applying to part of the Australian farm and
agri-food sectors. There would be significant economic and environmental
consequences for Australia if, for example, SRMs had to be removed from
all Australian animal feeds and no parts of downer or dead-on-farm
cattle could be salvaged for stock feed or pet food use. Australia is
not aware that these adverse effects are supported by any scientific or
risk-based justification. Furthermore, their application to the
Australian farm and agri-food sectors would not confer any additional
protection for the animal or public health situation of the US, because
of the most favourable BSE status of the Australian cattle herd.

**Question 35**, *If FSIS were to exempt "BSE free" countries from the
provisions of the SRM rule, what standards should the Agency apply to
determine a country's BSE status?*

As stated above, strong precedents and justification exist for US
authorities granting exemptions from BSE-related measures for countries
which do not pose a BSE risk. This ability to grant exemptions should
not be restricted to FSIS measures as implied by question 35, but should
be applied across all relevant US authorities. Various options exist for
standards that could be applied to determine a country's BSE status.
Some of these are canvassed below.

As a matter of principle, a country, other than one that is recognised
as posing a BSE risk under current US regulation 9 C.F.R. § 94.18,
should not have new FSIS or FDA measures applied to it until any new
determination of BSE status that may be required under other US Statutes
is made. As long as they remain BSE free, these countries should be
allowed to trade under pre-existing conditions that applied under USDA
and FDA rules and regulations, pending the completion of any additional
BSE status assessment that is required.

Some options for determining a country's BSE status include:

Option 1: An assessment of BSE status of relevant countries is already
conducted under current US regulation 9 C.F.R. § 94.18. FDA and FSIS
rules and regulations could recognise equivalence for countries that are
recognised as BSE free under this rule, using whatever standards are
already in place for these assessments.

Option 2: The US could formally adopt its own criteria. We suggest that
these should be based on those promulgated by the OIE for BSE free and
BSE provisionally free countries. Such an approach is consistent with
that in the proposed rule, *BSE Minimal Risk Regions and Importation of
Commodities*. This proposed rule suggests a list of factors that has
been determined by APHIS to evaluate the BSE risk from a region and
classify a region as a BSE minimal-risk. These factors appear to be
largely based on OIE recommendations for this category of country or
region.

As an example of how OIE recommendations can be applied, the Canadian
Food and Drug regulations that entered into force in 2003 define SRMs
similarly to the FSIS Interim Final Rule and prohibit the sale or
importation of food that contains SRMs.[^1] However, the Canadian
regulation also states that the prohibition "does not apply in respect
of food that originates from a country that is designated as being free
from BSE . . . . "[^2] Under a related provision in Canada's Health of
Animals regulations, the government may utilize various criteria to
designate countries which the government considers to be free from the
diseases that pose certain risks.[^3] Pursuant to its regulatory
authority, the Canadian government issued an announcement in 2003
regarding its revised BSE import policies that sets forth the criteria
by which Canada determines whether a country is BSE-free.[^4] US
authorities could decide to adopt an assessment system that incorporates
the Canadian (or similar) criteria. As stated verbatim in the
announcement, these criteria include:

Either

a\. For the preceding seven (7) years, the country of origin must have
reported no cases of BSE in indigenous bovines, AND

b\. no cases of BSE have been attributed to the country of origin from
another country through epidemiological investigation, OR

c all cases of BSE have been clearly demonstrated to originate directly
from the importation of live cattle from a BSE affected country and no
cases of BSE have been attributed to the country of origin from another
country through epidemiological investigation.

AND (all of the following)

d\. The country of origin must have the animal health legislative
authority to regulate BSE and the zoosanitary infrastructure to enforce
surveillance, monitoring, eradication and import controls for BSE.

e\. BSE must have been made a nationally notifiable disease in the
country of origin for the preceding seven (7) years.

f\. The country of origin must have an eradication policy for BSE that
includes the investigation of suspect animals and, if confirmed
positive, their slaughter and destruction and the depopulation of any
bovine animal that epidemiological investigation identifies as
potentially having been exposed to the disease agent or common risk
factor. Animals to be disposed of must be excluded from both the human
and animal food chain.

g\. The country of origin must have implemented a surveillance and
monitoring program for BSE in which clinically suspect cattle older than
24 months of age with clinical signs of progressive neurologic disease
are subject to laboratory examination in accordance with the current
diagnostic protocols recommended by the Office International des
Epizooties (Manual of Standards for Diagnostic Tests and Vaccines). The
BSE surveillance and monitoring system must place emphasis on risks,
taking into account the guidelines in Appendix 3.8.3 of the OIE
International Animal Health Code. Records of the number and results of
the investigations should be maintained for at least 7 years.

h\. The country of origin has performed a risk analysis of feed sources
as risk factors for BSE and appropriate risk management options have
been implemented and effectively enforced; eg. meat-and-bone meal feed
ban, safe sourcing of raw materials and rendering specifications.

i\. The country of origin has a policy that would effectively manage or
prevent risks of BSE associated with the importation. This policy, at a
minimum, should include but not be limited to live ruminants and other
species known to be naturally affected with BSE, ruminant embryos and
ova and meat and bone meal.

j\. The country of origin must have on-going education programme for
veterinarians, farmers, and workers involved in transportation,
marketing and slaughter of cattle to encourage reporting of all cases of
neurological disease in adult cattle.[^5]

Under this regulatory regime, Australia and several other countries are
currently recognized by Canada as BSE-free. If FSIS and FDA were to
amend the Interim Final Rules, and any rule to arise from the ANPRM, to
be more thoroughly consistent with the Canadian regulation, the
standards for a designation of BSE-free would be incorporated into the
Rules. As a result, countries that do not pose a BSE risk would not have
to be subject to the Rules for as long as they remained BSE-free and
therefore did not pose a risk to US animal health or public health.

Similarly, Annex V of the relevant EC regulation[^6] effectively
excludes from the definition of SRMs tissues that come from animals
originating in member countries or third countries that fall within the
lowest-risk range of categories of countries as prescribed by the
regulation. EU animal feeding requirements also do not apply to these
countries. The detailed criteria for determination of BSE status are set
forth in Annex II of the EC regulation and, for a Category 1
determination, are similar to the Canadian regulations discussed above.

**Question 36**, *How would FSIS determine that a country meets such
standards? For example, should it rely on third party evaluations, such
as the OIE, or conduct its own evaluation?*

The mechanism by which the assessment is conducted is largely a matter
for the US. However, we would suggest that where assessments need to be
conducted by US authorities, that these should be conducted by a single
US agency. APHIS has experience in conducting foreign animal disease
status evaluations and conducting risk analyses in regard to animal
diseases in countries that supply the US market with animals and their
products. Such an approach would also be consistent with the method of
assessment of a country's BSE status in the proposed rule, *BSE Minimal
Risk Regions and Importation of Commodities*.

As a matter of principle, the US should harmonise its BSE risk
assessment criteria for a country, region or zone, to the extent
practicable, with the relevant international standard (viz. the OIE
*Terrestrial Animal Health Code* Chapter for BSE). Furthermore, when
framing legislation for this purpose, flexibility should be provided to
take into account changes, over time, to this international standard and
to take account of the findings of BSE risk assessments conducted by
international bodies or competent authorities of other countries or
economic groupings.

## Auditing of record keeping requirements

Australia recognises the importance of record keeping in the
verification of the BSE control measures in food and pharmaceutical
processing establishments. We also recognise the importance of
Government access to these records to enable auditing of compliance. We
affirm that it is the responsibility of the companies involved to ensure
that sourcing and BSE requirements are met and as such, submit that
these records should be generated and kept by company management or
relevant Quality Assurance staff/HACCP team. We trust that, in
accordance with accepted international practices and standards, FDA will
recognise that the Competent Authorities in countries exporting to the
US can certify that systems of records verification equivalent to those
required by the Interim Final Rule or the Proposed Rule are in place. We
further trust that, on this basis, FDA will be able to modify the
Interim Final Rule and Proposed Rule to allow FDA to accept assurances
provided by Competent Authorities in exporting countries that the
requirements of the new FDA BSE measures have been complied with,
without the need for FDA to conduct audits at all establishments in
countries exporting to the US.

This approach would not in any way preclude FDA from conducting, from
time to time, verification audits of the control measures instituted by
the competent authorities of exporting countries. Under such an
approach, US authorities could place appropriate reliance on the
certification provided by the competent authorities of exporting
countries.

## Conclusion

For the reasons outlined above we believe that the FSIS and FDA Interim
Final Rules, and any rule that arises from the ANPRM, should ensure that
there is adequate provision to allow trading partners to be granted
exemption from US BSE-related measures in appropriate instances,
including on the basis of BSE-free status, or in situations where
exporting countries can demonstrate that their own measures achieve an
ALOP equivalent to that achieved domestically in the US. Further, we are
of the view that a single US agency should be responsible for assessing
the BSE status of exporting countries and should apply criteria
reflective of the current international (OIE) standards for this
purpose.

We would also welcome favourable consideration of more flexible record
keeping verification procedures for foods and cosmetics than presently
proposed by FDA.

We would be pleased to provide any further information or assistance
that may facilitate more detailed consideration by US authorities of
variations to these BSE-related sanitary measures.

Yours sincerely

Andrew Cupit

Agricultural Counsellor

[^1]: C.R.C., C. 870, s. B.01.047.1.

[^2]: *Id*.

[^3]: C.R.C., C. 296, s.7.

[^4]: Canadian Food Inspection Agency, Canadian Bovine Spongiform
    Encephalopathy (BSE) Import Policies (June 16, 2003), *available at*
    http://www.inspection.gc.ca/english/anima/heasan/policy/ie-2001-17-42.shtml
    (last viewed Mar. 19, 2004).

[^5]: *Id*.

[^6]: EC Regulation No. 999/2001.