[Comments of the Government of Australia]{.smallcaps}

on Notice of Proposed Rulemaking

[Establishment and Maintenance of Records]{.smallcaps}

under the

[Public Health Security and Bioterrorism Preparedness]{.smallcaps}

[and Response Act of 2002]{.smallcaps}

# Federal Register Docket No. 02N-0277

RIN 0910 -- AC39

## Overall comments

The Government of Australia welcomes the opportunity to provide comments
on the United States of America Government's proposed requirements for
record keeping by domestic and foreign food manufacturing facilities, as
published in the Notice of proposed rulemaking on Establishment and
Maintenance of Records Under the *Public Health Security and
Bioterrorism Preparedness and Response Act of 2002*. Australia, as an
exporter of substantial quantities of food and agricultural products to
the United States of America (USA), has a direct interest in the USA
requirements for the importation of these products. Australia is
committed to a food safety system that delivers high quality food
produced at Australian Quarantine and Inspection Service (AQIS)
registered facilities.

The Government of Australia understands and supports the initiatives of
the Government of the USA to establish controls and counter-measures to
help contain threats of serious adverse health consequences or death to
humans or animals from accidental or deliberate contamination of food,
thus enhancing the security of the US food supply. The USA, through its
Bioterrorism Act, proposes to introduce four new rules to enforce/embody
the principles contained within the Bioterrorism Act. These rules should
be considered as a package of measures, and not necessarily just in
isolation from each other, as the impacts of these rules, on both
domestic and foreign trade, are inter-related.

The Government of Australia is not opposed in principle to the
imposition of new legislative measures for the importation of food and
agricultural products to the USA, provided these measures:

-   are based on sound risk assessment that address real risks;

-   are not more trade restrictive than necessary to meet its
    objective/s;

-   focus on outcomes rather than prescribing specific measures to
    achieve them, and allow for the application of equivalence in
    achieving its objective/s; and

-   avoid arbitrary or unjustifiable differences in the level of
    protection applied in different situations.

## Trade impact of proposed rules for the US Bioterrorism Act

Australia seeks the United States' assurance that all of the proposed
measures under the US *Bioterrorism Act* will meet the latter's SPS
and/or TBT obligations. Australia is particularly concerned that the
proposed rules:

-   do not allow for equivalence determinations;

-   in some instances, focus on prescribing specific measures;

-   may lead to more restrictive measures applied to imports than to
    food and agricultural products produced in the USA for the domestic
    market;

-   appear to be more trade restrictive than necessary;

-   in some instances, may lead to duplication of some measures; and

-   do not consider whether the stated objectives are already achieved
    through the existing controls.

As stated previously, Australia supports initiatives to establish
controls and counter-measures for bioterrorism. We note, that "***C
Highlights of the Proposed Rule***" of the record keeping proposed rule
states that the "*FDA will comply fully with its international trade
obligations, including the applicable World Trade Organisation (WTO)
agreements*." The Food and Drug Administration (FDA) should therefore
ensure that the proposed rule for record keeping requirements is not
more trade restrictive than necessary to meet the objectives of the US
*Bioterrorism Act*, and thus, does not impose unnecessary obstacles,
barriers or requirements for international trade. The FDA should also
ensure that the proposed rule's requirements are flexible, and that such
flexibility should include the principle of equivalence as expressed in
Article 4 of the WTO Agreement on the Application of Sanitary and
Phytosanitary Measures (the SPS Agreement). Australia would welcome such
approaches by the USA. The Government of Australia acknowledges and
welcomes the USA's efforts to limit the prescriptive nature of the
proposed rule on record keeping and the flexibility it has built into
the timeframe for full compliance with the ruling. These gestures will
be well-received by all food manufacturers, both domestic and
international traders.

## 

## Summary of Australia's concerns and comments

**Australian legislation** -- Australia seeks recognition of equivalence
for the Commonwealth of Australia *Export Control Act 1982* legislation
and the export inspection and certification system underpinning the
operation of this legislation for commodities covered by FDA. This
recognition of equivalence will be consistent with recognition already
accorded to this legislation and system by the US Food Safety and
Inspection Service (FSIS) for the provision of safe and wholesome meat
and ratite products to the USA for human consumption.

**Risk assessment** -- Australia concurs with the FDA risk assessment on
food for animals and food from foreign facilities as it is presented in
the Federal Register Notice of Proposed Rulemaking Establishment and
Maintenance of Records under the *Public Health Security and
Bioterrorism Preparedness and Response Act of 2002*. Therefore,
Australia seeks risk mitigation measures to be instituted in the final
rule making on record keeping to reflect the lower level of risk
represented by foreign facilities and foods for animals.

**Registration/prior notice proposed rules** -- The FDA cost benefit
analysis for the proposed rule on record keeping indicates that food for
animals, both food producing and non food producing, and imported food
present lower levels of risk to the US human and animal populations.
Given this FDA assessment, and the Australian Government request for
risk mitigation measures to be instituted in the final rule making on
record keeping to reflect the lower level of risk represented by foreign
facilities and foods for animals, Australia also requests that the USA
reconsider its proposed rulemaking for facility registration and prior
notice of imported food to allow similar risk mitigation measures to be
instituted to reflect the lower levels of risk presented by animal and
imported food.

**Australia's favourable BSE health status** -- Given Australia's
favourable BSE animal health status, Australia urges the USA to
consider, under Article 4 of the World Trade Organisation (WTO)
Agreement on the Application of Sanitary and Phytosanitary Measures (SPS
Agreement) official recognition of Australia's equivalence of
21CFR589.2000, the US BSE rule.

Attached are Australia's justifications for its requests for recognition
of equivalence and adjustments to the measures proposed by the USA to
implement the *Bioterrorism Act* in light of the FDA's own risk
assessment. All clarification requests on the proposed rule are included
in the final section of this document.

## ATTACHMENT

## 

## Animal food -- Risk assessment

Australia concurs with the FDA risk assessment that the consequences of
a potential terrorist attack or food-related emergency are of greater
concern for the human food chain than for animal food. Australia also
concurs with the FDA risk assessment that the consequences of a
potential terrorist attack or food-related emergency is of greater
concern for food for food-producing animals than for food for non-food
producing animals (i.e. pet food[^1]). Given the lower risks of
potential bioterrorism or food-related emergencies associated with food
for food-producing animals and for pet food, the applied measures to
protect human and animal health should be lower or different to those
measures applied to protect food intended for human consumption.

The FDA requested comments on four questions relating to the risk
assessment and treatment of animal food[^2] and pet food. Australia
provides the following responses:

Q1 and Q2. *Should we exempt all types of animal food entities from all
or part of this proposed rule*? *Should we exempt all pet food entities
from all or part of this proposed rule*?

The FDA provides only one reference in the Federal Notice of proposed
rulemaking discussing bacterial contamination of animal feeds and its
relationship to human foodborne illness and cites a couple of examples
of animal/pet food contamination. These cited examples occurred in 1996
and 2002.

There is some potential risk of contaminated animal/pet food affecting
humans, although the potential impact on humans would be of a more
limited nature in comparison to contamination occurring in human food.

Transfer of bacteria from contaminated animal or pet food to humans
would largely be the result of poor hygiene practices of the people
handling the animal/pet food products. Such bacterial contamination, and
subsequent illness, could also result from poor hygiene practices when
handling the animals themselves rather than their food *per se*. For
example, parents visiting petting zoos or agricultural shows with their
children need to encourage hand washing and cleanliness to prevent
potential bacterial contamination and illness resulting from handling
the animals. Similarly, reptile owners must rely on good animal handling
practices to avoid episodes of salmonellosis, as reptiles are known to
carry *Salmonella*.

Poor handling of contaminated animal/pet foods could result in direct
contamination of the animal/pet food handler or in unintentional
cross-contamination of cooking surfaces or utensils. However, such
contamination would tend to be sporadic in occurrence. In contrast,
human illness arising from contaminated human food potentially could
affect many more people and thus appear more explosive in nature.

Terrorist attack on the animal food chain seems to be a much lower risk
compared to potential attacks on the human food chain. This risk would
be even lower for pet food. Thus, the FDA should give serious
consideration to adjusting the requirements of this proposed rule as
they apply to animal and pet food suppliers and transporters.
Consideration should be given to limiting the proposed rule requirements
to retaining all current business records, including those given to
animal/pet food businesses as well as those generated by the businesses
themselves, without the added burden of supplying more information (i.e.
re-designing forms), and without imposing access time limits. Such
considerations and adjustments to record keeping requirements would
reflect the lower levels of risk to human health represented by animal
food and pet food contamination.

Given these lower levels of risk for animal/pet foods, the FDA should
also consider revising the requirements as they apply to foreign
establishments to reflect the different levels of risk posed by these
commodities. The FDA should consider limiting the requirements for the
proposed rule for the establishment and maintenance of records to only
the [final]{.underline} establishment handling the product prior to its
arrival in the USA.

The proposed rule, as it stands, does not require transport companies in
foreign countries to establish and maintain records of any food
transportation, irrespective of whether it is intended for human or
animal use within the USA. Given this appropriate level of protection
(ALOP) assessment and requirement by the USA, Australia cannot see the
reasoning for expecting all establishments producing and manufacturing
food (for human and animal consumption) in the food chain to establish
and maintain records over and above current business and Australian
regulatory requirements.

Australia acknowledges that the USA only foresaw a limited number of
foreign establishments having to comply with the proposed rules ensuring
compliance with the *Bioterrorism Act*, namely the last establishment to
manufacture/process the food and any facility conducting only de minimis
activities, such as applying a label. Unfortunately, as explained in the
Government of Australia's comments on registration submitted to the FDA
by 4 April 2003, many more businesses will need to be registered with
the FDA to ensure that shipments are not detained at port of entry due
to registration issues. The Government of Australia stated in its
submission that: "*Effectively for Australian businesses, this
requirement* (facility registration) *would necessitate that all
Australian facilities register with the FDA just in case their product
is exported to the USA to avoid any US port of entry problems with
detained shipments because of lack of registration issues. This scenario
means that many more facilities need to be registered under the
Bioterrorism Act than the FDA anticipated*."

Thus, in view of the large number of foreign facilities that require
registration, and the FDA acknowledged lower level of risk presented by
animal food and pet food, Australia urges the USA to consider limiting
the requirements of this rule, the establishment and maintenance of
records, to only the final establishment handling the product prior to
its arrival in the USA. Current business and foreign country
(Australian?) regulatory requirements should be able to supply adequate
information on prior handlers of the animal or pet food should any
traceback investigation be required.

Q3 and Q4. *Should we treat pet food the same as other types of animal
food by requiring all pet food entities to meet the record keeping
requirements under this regulation, not just those subject to the BSE
rule*? *Should we use criteria other than the scope of the BSE rule to
determine which pet food entities should be exempt*?

Australian responses to these two questions are limited to only a
consideration of Australian exports.

Australia currently enjoys a highly favourable animal health status in
general, and in particular for transmissible spongiform encephalopathies
(TSEs), including bovine spongiform encephalopathy (BSE). This status is
widely recognised in many jurisdictions, and has been accorded the most
favourable geographical BSE risk (GBR) rating of Level 1 by the
Scientific Steering Committee of the European Commission. Australia
maintains its favourable status by undertaking measures to protect this
status. Such measures follow the OIE guidelines for BSE, and includes
ruminant feeding bans.

Australia's current ruminant feeding ban exceeds OIE recommendations for
countries recognised as being 'BSE free'. Australia's current
legislation bans the feeding of ruminants with products derived from
vertebrate animals, with the exception of milk, tallow and gelatine.
This ruminant feed ban also exceeds current US legislative requirements
which allow the feeding of equine or porcine proteins to ruminants (see
21 CFR 589.2000, otherwise known as the BSE rule). The Government of
Australia endorses health certificates for Australian processed animal
products being exported to the USA with the following endorsement:

"*This product:*

(1) *was derived from animals that have never been in;*

(2) *did not originate in and was never stored, rendered or otherwise
    processed in;*

(3) *was not otherwise physically associated with a facility located in;
    and*

(4) *has not been otherwise physically associated with or exposed to, or
    commingled with ruminant material from;*

> *any region listed in Title 9, Code of Federal Regulations part
> 94.18(a)*."

Title 9, Code of Federal Regulations part 94.18(a) lists those regions
(countries) where meat and edible products have restrictions placed on
their importation to the USA due to BSE concerns in the nominated
countries. Processed animal products covered by this endorsement include
meat and bone meal (MBM), fish meal, poultry meal, inedible offal,
tankage, unprocessed ruminant fat and tallow etc., and any other product
containing such materials, including processed pet food. Furthermore,
the FDA requires the following cautionary statement to appear on an
accompanying documentation (such as invoice or bill of lading) for
Australian ruminant derived protein exported to the USA: "*Do not feed
to cattle or other ruminants*".

Therefore, given Australia's favourable BSE animal health status,
Australia urges the USA to consider, under Article 4 of the WTO
Agreement on the Application of Sanitary and Phytosanitary Measures (SPS
Agreement) official recognition of Australia's equivalence of
21CFR589.2000, the US BSE rule, thus exempting Australia from
maintaining the specified records under the BSE rule.

## Human food -- Risk assessment

Australia concurs with the concept that it is important to be able to
track food distribution, both one step forward and one step backward,
arising from a detection of adulterated food or other food-related
emergency. Tracing forward is an important tool for the prevention of
further consumption of adulterated food still circulating in the market
place, or in people's homes thereby protecting people's lives and
limiting the negative impacts of adulterated food. Tracing back will
allow regulatory authorities and businesses to effect measures to
prevent further occurrences of adulterated food. Current AQIS export
registration processes already fulfil this product tracing requirement
without the need for FDA to duplicate the process. Such duplication
could present a burdensome compliance requirement on Australian
industries exporting to the USA.

Australia questions the benefits to the USA human and animal populations
of the FDA's need and ability to trace adulterated product back to its
original source within a foreign country, where the demonstrated risk is
so low. Australia feels that in the situation where our products present
such a low level of risk, our being able to determine which exporter is
implicated in supplying the adulterated products should be sufficient to
provide protection to the USA human and/or animal populations. The FDA
acknowledges that the final holders may be the most accessible foreign
facility to contact in the event of an FDA traceback.

Surely it is the domain and legal right of foreign (i.e. exporting)
country authorities to determine the extent of product tracing and
conduct product tracing investigations on their own national soil, and
thus set its own requirements for record keeping and time frames for
access to documents according to its own country statutory legislation
rather than to a USA Government Departmental authority's specifications.
It is questionable what international legislative action the FDA can
take against foreign companies that do not comply with the proposed
regulations under the *Bioterrorism Act*, for example where a foreign
company does not update its registration details as required by Section
305, or does not establish and maintain the records as specified under
Section 306.

Australia acknowledges that it will be in the interests of both foreign
(i.e. exporting country) regulatory authorities and businesses to
promptly ascertain the source and reason for any adulterated food
detected in the USA, be it human or animal food, and to take the
necessary steps and regulatory action to rectify the situation. Such
prompt corrective and regulatory action will assure the USA that
adequate measures have been taken to protect not only the health of US
citizens and/or its animal population, but also the health of the
foreign country's citizens and/or its animal population. Such prompt
action will ensure continuing good relations and food trade with the
USA.

Australia concurs with the FDA risk assessment that: "...*imported food
accounts for a small percentage of total domestic food consumption*..."
(Source: ***III Analysis of Economic Impact**, B. Initial Regulatory
Flexibility Analysis, Option 10, same as option 4 except the foreign
coverage is the same as for the registration proposed rule*). The FDA
assesses that the amount of food consumed within the USA and sourced
from foreign facilities will be less than the amount of food that
originates from US facilities. The FDA acknowledges that a reduction in
the number of foreign facilities that have to comply with the proposed
rulemaking will only result in a much smaller impact on the relative
benefits obtained by the rule. Conversely, the FDA believes that
excluding domestic facilities, eg intrastate facilities will have a much
greater reduction in benefits obtained by the rule. In fact, the FDA, in
discussion of Option 11, states: "..*the proportionally smaller
importance of imported foods in the domestic food supply implies that
the exemption* (i.e. the option where the rule only applies to
facilities that are final holders before export) *should have relatively
little effect in benefits*." Australia urges the USA to abide by its WTO
obligations by considering the FDA risk assessment and modify its rule
requirements for foreign animal and human food facilities to reflect
their lower level of risk to the US human and animal populations
compared with domestically sourced human and animal food.

Australia feels that the ranking applied in Table 38 -- "*Ranking of
Effectiveness of each Mechanism under each Option*" does truly reflect
the lower level of risk represented by food from foreign facilities. The
ranking of the intrastate facility exemption should be lower than the
options with reducing numbers of foreign facilities (i.e. options 10 --
12), as the relative detrimental impact and loss of benefits from the
intrastate exemption would be greater than from the options 10 -- 12.

## Trade restrictive issues of the proposed rule

**Foreign Facilities** During the cost benefit analysis process, the
FDA's sensitivity analysis, maintained consistency with the proposed
rule on facility registration, by estimating that 16% of manufacturers
exporting 10 or fewer line entries to the USA would stop exporting
rather than incur costs imposed by the burden of complying with the
proposed record keeping rule. There are four proposed regulations for
compliance with the *Bioterrorism Act* -- facility registration, prior
notice for imported food, record keeping and administrative detention
--each with their own associated costs for compliance. The proposed rule
for record keeping has indicated that businesses will potentially have
increased costs for learning about the regulation, re-designing forms,
and record storage and access. These costs will be in addition to the
increase in costs arising from compliance with facility registration and
prior notice on imported food regulations.

The FDA has not shown in its sensitivity analysis the cumulative cost
increases that all the regulations for the *Bioterrorism Act* will have
on foreign exporters. Such accumulated costs may lead to a greater than
expected decrease in foreign exporters participating in trade with the
USA (i.e. greater than a 16% drop in exporters accessing the USA
market). Although the US *Bioterrorism Act* is not designed to
discriminate against foreign exporters, unless it can be substantially
simplified, the assumed and potentially underestimated reduction in
exports to the USA may be an unintended consequence. This unintended
consequence could be considered discriminatory and not consistent with
WTO/SPS principles.

**Lot Coding** The recording of lot codes and batch numbers as a
mandatory field in the required records under the proposed rule for the
establishment and maintenance of records could potentially be trade
restrictive depending on the business practices currently used by food
manufacturers and transport companies. It is plausible that some
companies may have in place technology that will easily allow or already
records such lot code/batch number information. An example of such
technology is bar coding[^3]. The use of this technology would
facilitate precise recalls of only the affected product without
involving unaffected product in the recall action.

For those businesses that do not have access to or use of bar coding
technology the imposition of recording lot codes/batch numbers could
potentially and drastically change current businesses practices and
culture. The impact and costs of such technological changes were not
factored into the FDA cost benefit analysis. It may take businesses a
lot longer than FDA anticipated to introduce and take up new and
potentially innovative bar coding technology that would make their
business compliant with the FDA proposed rule on record keeping.

Australia believes that the requirement for lot code/batch number
information should be made optional. This would allow flexibility in the
rulemaking to accommodate the various types of business practices and
cultures involved in the food and transport industries, thus limiting
trade restrictive measures.

**Record Retrieval** Australia believes that the FDA should introduce
flexibility into the proposed timeframes for companies and businesses to
retrieve records. Such timeframes (4 hours and 8 hours) may not be
feasible or reasonable depending on the volume of records required by
FDA and the timing of the request being lodged with a company. For
example, a request for one or two records being presented to a company
in the morning, say 10 am, could possibly be easily accommodated within
the specified 4 hour time limit, whereas an FDA request for several
weeks or months worth of records being lodged with a company at 5.30 pm
may possibly not be met within the regulatory 4 hour time limit. The FDA
must consider the reasonableness of specifying a "one-size fits all"
time limit. A more flexible approach could be for the FDA to negotiate
with the company when the records would be available or for the FDA
determine a reasonable time limit on a case-by-case basis.

## Exports from Australia

Many of the products covered by the proposed measures under Section 305
(Registration) of the *Bioterrorism Act* are already subject to strict
regulatory and certification requirements as 'prescribed goods' under
Australian export legislation (the *Export Control Act 1982*). These
are: milk and dairy products, fish and shellfish, game meat, meat from
species not classified as livestock under Section 301.2(qq) of Chapter 9
of the Code of Federal Regulations, and animal food and products
thereof, including low acid canned foods and pharmaceutical raw
materials derived from animals.

In the Government of Australia's comments on Facility Registration,
Australia sought consideration of equivalence (as per Article 4 of the
SPS Agreement) in the assessment and registration of export food
manufacturing facilities. This request was based on the strong rationale
to utilise the existing Australian export registration requirements
which are already accepted by the USDA's Food Safety and Inspection
Service (FSIS). The FSIS accepts AQIS registration of export facilities
exporting FSIS controlled products (meat and ratite products) to the
USA.

Such recognition of equivalence of the Australian export registration
process, which would be consistent with current US (FSIS) practices, can
also facilitate any product tracing required by the FDA. AQIS is well
positioned to conduct necessary product tracing arising from the
detection of adulterated food originating from Australian 'prescribed
goods' sources.

Nevertheless, Australia concurs with the FDA's assessment that the
registration (Section 305 of the *Bioterrorism Act*) and record keeping
(Section 307) regulations would work cooperatively to identify and track
possible sources of an outbreak. The FDA can contact the facility
involved directly from the information gathered in the registration
process and the prior notice of imports to follow up any food related
emergency or adulterated food.

As raised in the previous discussion on *Animal food -- Risk
assessment*, Australia believes that FDA should further analyse the
potential risk presented by food from foreign facilities. This further
analysis should include both food for animals and food for human
consumption. As ably demonstrated by the current FDA cost benefit
analysis in the Federal Register Notice for the proposed rule on record
keeping, there is very little loss of benefits gained by the proposed
rule from excluding certain categories of foreign facilities. Australia
urges the FDA to reconsider which foreign facilities are required to
comply with the regulations enforcing the US *Bioterrorism Act* in light
of the relative risks presented by imported food compared to
domestically produced food, and the potential underestimation of the
number of foreign facilities obliged to comply with the registration
requirements of Section 305. As stated previously, Australia urges the
USA to consider limiting the requirements of this record keeping rule to
only final foreign holders handling animal and human food prior to its
arrival in the USA.

Australia believes that the regulations under the *Bioterrorism Act* are
potentially trade restrictive and are costly measures, particularly
Sections 305 (Registration of Food Facilities), 306 (Establishment and
Maintenance of Records) and 307 (Prior Notice of Imported Food). These
measures proposed under the *Bioterrorism Act* will impose a substantial
burden of compliance on industries exporting to the USA, and may limit
opportunity for smaller operators to continue to participate in this
trade.

Australia therefore urges the USA to apply its risk mitigation measures
under this Act in a manner that minimises regulatory impact on industry
and has regard to existing food regulation and export certification
systems in Australia as well as to the overall WTO rights and
obligations of Australia and the USA. The additional confidence provided
to the USA in relation to food export businesses by the certifying
authority of the exporting country, in this case AQIS, should be an
important factor in the consideration of mitigatory measures, as well
the US FDA's own risk assessment that animal foods, pet foods, and food
from foreign establishments present a lower level risk to US human and
animal populations and that foreign establishments only represent a
marginal change in the level of benefits gained from their inclusion in
the proposed regulations of the Act.

## Specific questions and comments on the Federal Register Notice of proposed rulemaking requiring clarification

1\. Australia seeks clarification on whether foreign transporters are
expected to comply with the new rule. The language in the proposed rule
is conflicting. In some instances it does not require foreign
transporters to comply with the record keeping rule, as they are not
entities that are obliged to comply with the regulation on facility
registration. On the other hand, in the cost benefit analysis, FDA
claims that the burden of record keeping will be shared by "two covered
entities, including transporters". In fact, the FDA states: "FDA treats
foreign facilities already subject to a similar record keeping
regulation as already in compliance, and assumes that the burden of
additional records maintenance will be shared among an average of two
covered entities, including transporters, for an average of 15 minutes
per week per facility or 13 hours per year per facility." How can the
FDA claim on one hand that foreign transporters are not included in the
new rule but during the cost benefit analysis assume that foreign
transporters will share the burden and costs of compliance for foreign
facilities by keeping the extra record data that is required by other
businesses, the non-transporters?

2\. The proposed section 1.361 states that when the FDA has a reasonable
belief that article of food is adulterated and presents a threat of
serious adverse health consequences or death to humans or animals, any
records or other information is accessible to the FDA and available for
inspection and photocopying or other means of reproduction. Will the
written notice presented by FDA requesting access to company records
provide procedural fairness information explaining the reasonable
grounds that FDA are using to gaining access to records?

3\. What assurances can FDA give to ensure that information stored on
records will not be subject to unauthorised disclosure?

4\. Australia seeks clarification on whether the staggered time frames
(6 months, 12 months, and 18 months) for full compliance with the
proposed rule on establishment and maintenance of records will also
apply to foreign businesses of varying sizes?

5\. We seek clarification on the method utilised by the FDA to determine
business sizes for deciding the timeframe for compliance. This
information is particularly relevant for businesses operating in
separate locations but come under the one umbrella of a single parent
company. Is size worked out using all employees of the parent company as
a whole or according to each individual enterprise/location?

6\. How does this proposed rule affect long shelf life product that was
prepared before the introduction of the new rule, and is still in
storage when full compliance is required? Is the rule retrospective or
does it apply to food manufacture from the date of full compliance?

7\. In the FDA's cost benefit analysis for Option 10, Require all
components of option 4, but only cover foreign facilities covered by the
proposed registration regulation, it reduced the number of "other
facility types" to zero whilst creating a new category solely for de
minimis processors/packagers. The FDA claims that the "other facility
types" is a large and uncertain category whose exclusion under Option
10, the FDA's preferred option, has a significant impact on all cost
estimates. By reducing the foreign facility categories to "final
holders", manufacturers", and "de minimis processors/packagers" there
does not appear to be any option for including food contact packaging
manufacturers. Under the facility registration proposed rule's
definition of "food", the FDA proposes to include "substances that
migrate into food from food packaging and other articles that contact
food". We seek clarification on the impact of this definition of food.
Commercial food packaging is not supposed to have migratory substances
otherwise it would not be suitable for food. Food contact materials are
supposed to be non toxic. Australia does not see the relevance of
including "substances that migrate into food from food packaging and
other articles that contact food" in the definition of food. Australia
again seeks clarification on whether foreign manufacturers of food
contact packaging are required to be covered by the proposed regulations
under the Bioterrorism Act. Namely, are these packaging manufacturers
expected to register with the FDA, and establish and maintain the
required record information specified by the proposed record keeping
rule?

8\. Food samples are exported with the intended end use of analysis,
experimentation and/or subsequent destruction within approved company
premises. Such samples do not enter commerce, and may be carried into
the USA as personal baggage of company representatives or sent
unaccompanied. It is noted in the proposed rule making on facility
registration that the FDA have proposed to exempt food carried in
personal baggage only if it is for "personal enjoyment/use". Australia
seeks clarification on how samples that do not enter commerce are to be
treated by the proposed rules under the Bioterrorism Act, namely
registration of food facilities, prior notice of imports and record
keeping requirements.

[^1]: As per the FDA definition quoted in the proposed rule, pet food is
    for non-food producing animals such as dogs, cats, horses, zoo and
    circus animals etc.

[^2]: Animal food in this document refers to food intended for
    food-producing animals.

[^3]: Bar coding -- Provides industry, transport and retail businesses
    with an automated method of identifying and describing its products
    and the bar coding language can be recognised globally, thus
    facilitating trade. Such globally recognised languages provide
    regulatory authorities and businesses with the ability to limit the
    negative impact of food product recalls by focussing on recalling
    only the affected product. EAN/UCC is a globally recognised bar
    coding language.