**[EMULSION POLYMERS COUNCIL, INC.]{.smallcaps}**

**1250 Connecticut Avenue, N.W. • Suite 700 • Washington, D.C. 20036**

**Phone: 202-637-9040 • Fax: 202-637-9178**

##### April 4, 2003 

Dockets Management Branch (HFA-305)

Attention Docket Numbers 02N-0276; 02N-0278

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

[www.fda.gov/dockets/ecomments](http://www.fda.gov/dockets/ecomments)

> [Re:]{.underline} [EPC Comments on the Proposed Regulation on
> Registration of Food Facilities and Prior Notice of Imported Food
> Under the Public Health Security and Bioterrorism Preparedness and
> Response Act of 2002 \[Docket No. 02N-0276; 02N-0278\]]{.underline}

To Whom It May Concern:

On behalf of the Emulsion Polymers Council (EPC), I am pleased to submit
comments on the U.S. Food and Drug Administration's (FDA) proposals
concerning the Registration of Food Facilities (68 Fed. Reg. 5378) and
Prior Notice of Imported Food (68 Fed. Reg. 5428) Under the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002
(the "Bioterrorism Act").[^1] EPC is a nonprofit trade association
representing North American manufacturers of emulsion polymers
including: Air Products & Chemicals, Inc., BASF Corporation, The Dow
Chemical Company, Dow Reichhold Specialty Latex LLC, Eastman Chemical
Company, Johnson Polymer, National Starch and Chemical Company, Noveon,
Inc., and Rohm and Haas Company.

Emulsion polymers (EPs) are high molecular weight polymers produced by
emulsion polymerization that are strategically important products in
today's society. EPs are often used over other similarly performing
products because of their favorable environmental profile particularly
where there is a desire to reduce emissions of volatile organic
compounds. Billions of pounds of these products are produced and used in
North America and can be found in everyday household items such as
paints and coatings, paper and board, adhesives, textiles, construction
and carpet backing. EPs are often used in the manufacture of food
contact materials and as such are regulated as "indirect food
additives."

**Chemical Industry Is Actively Supporting Programs to Enhance Facility
Security**

The chemical industry has a concerted program underway to promote
security at all stages of chemical production, storage and use. As a
major component of the chemical industry, the emulsion polymers industry
wholeheartedly supports and embraces these initiatives directed at
reducing the likelihood and potential impacts that could result from
terrorist activities. Members of EPC are also members of the various
other more generic chemical associations (including the American
Chemistry Council (ACC) and the Synthetic Organic Chemical Manufacturers
Council (SOCMA)) who have been working with the Department of Homeland
Security and other governmental agencies to minimize the threat of
terrorist activities.

The industry, largely through its national associations, has developed
guidelines and is currently implementing procedures for enhancing
security at its facilities. Of particular note is the [Site Security
Guidelines for the US Chemical Industry]{.underline} recently developed
by ACC, SOCMA and The Chlorine Institute. This guide[^2] addresses the
same issues covered by FDA's Food Security Preventive Guidance.

Additionally, the emulsion polymers industry, as part of the chemical
industry, is required to comply with a wide range of environmental and
health and safety regulations intended to minimize the likelihood of a
significant large-scale risk of accidental releases to the environment
or exposure of workers and the public to hazardous substances. Example
regulatory programs include:

> **Process Safety Management Standard --** The Occupational Safety and
> Health Administration (OSHA) Process Safety Management Standard (PSM)
> \[29 CFR 1910.119\] requires facilities that have a highly hazardous
> substance above a certain threshold to implement measures to mitigate
> hazards, including conducting process hazard analysis and maintaining
> the mechanical integrity of equipment.
>
> **Worker Training and Safety -** Worker training and safety is another
> area critical to plant safety and security. The OSHA PSM standard
> requires employers to train employees on the specific health and
> safety standards, emergency operations including shutdown, and safe
> work practices applicable to the employee's job tasks. Additionally,
> OSHA's Hazard Communication standard requires that the hazards of all
> chemicals produced or imported are evaluated, and that information
> concerning their hazards is transmitted to employers and employees.
>
> **Coordination with Emergency Responders -** Under Title III of the
> Superfund Amendments and Reauthorization Act (SARA), Emergency
> Planning and Community Right-to-Know Act (EPCRA), facilities that have
> listed chemicals above a certain threshold quantity are required to
> prepare and submit a hazardous chemical inventory form to their local
> emergency planning committee, state emergency response commission, and
> local fire department. Also, EPCRA requires the establishment of Local
> Emergency Planning Committees (LEPC) to work with industry to develop
> emergency response plans addressing potential risks from a chemical
> related accident, to collect and store information provided by
> facilities; and make the information available to the public.
> Representatives to the LEPC include individuals from the fire
> department, emergency management agencies, local health agencies and
> hospitals, local officials, community groups, media and local
> businesses.

With all of these initiatives in mind, it is clear that the industry is
well aware and appreciates the importance of programs aimed at
addressing potential accidents including threats from terrorist
activities. It is precisely for this reason, that the industry believes
that FDA's has unnecessarily expanded the scope of its proposal beyond
what is needed to address the goals and objectives of the Bioterrorism
Act.

###### **FDA Has Expanded the Scope of the Regulation Beyond Congress's Intent and More Importantly, Beyond What Is Reasonable and Necessary to Protect the Nation's Food Supply**

As noted by FDA, the intent of the registration program is to establish
a "central database of all domestic facilities producing food \[that\]
would greatly assist FDA in limiting the effects of a food related
emergenc\[ies\]." Section 305 of the Bioterrorism Act directs FDA to
establish regulations that:

> *require that any facility engaged in manufacturing, processing,
> packing, or holding [food for consumption]{.underline} in the United
> States be registered.* \[Emphasis added\]

Through the registration provision of the Bioterrorism Act, Congress
sought to establish a system that is focused on articles of food that
are capable of being consumed in the United States. However, by virtue
of FDA's other regulatory authorities to regulate indirect food
additives, FDA has elected to define "food for consumption in the United
States" in its broadest possible framework and in doing so has included
not only food capable of being consumed*, i.e*., edible foods, but also
"substances that can migrate into food from food packaging and other
articles that contact food."

EPC believes that applying the registration requirement to facilities
manufacturing chemical substances, such as emulsion polymers used on
food-contact materials, is contrary to the intent of Congress. More
importantly, such a regulatory program has the potential to create a
system that will dilute the government's precious resources at
facilities that are highly unlikely to be a focal point for bioterrorism
and in doing so, will minimize FDA's ability to respond quickly to any
real threat to the nation's food supply.

Requiring the registration of facilities that manufacture "substances
that can migrate into food" essentially means there is no logical end to
the food chain. For example, consider an emulsion polymer that is used
in the manufacture of food contact paper. The regulation as proposed
would require the registration of the facility manufacturing the food
contact paper, but also the facility producing the polymers and arguably
the facility producing the monomers. It is difficult to conceive that
any benefit would be derived through the registration or prior notice of
import requirements for such facilities. Additionally, there is a
significant potential for over regulation and excessive import
notification since many chemical suppliers may not be aware whether the
ultimate end use of their products are food-contact related.

EPC also questions whether this was in fact FDA's intent. We are aware
of discussions at a public meeting between the National Food Processors
Association and FDA where Agency officials specifically indicated that
the intent of the proposal is for the rule to cover only finished
packaging that will be in direct physical contact with food. In response
to a question, FDA indicated that the regulations would not cover
polymers, additives, or monomers, but only the "immediate" food
packaging made from such components. The current language in FDA's
proposal, however, goes well beyond and as written, explicitly brings
into the registration program chemical manufacturing facilities
producing substances that become "components" of food packaging.

For these reasons, EPC respectfully submits that facilities
manufacturing substances that are used on food packaging should not be
included within the scope of the registration or the prior notice of
import regulations. This can be achieved by deleting the phrase
"including substances that migrate into food from food packaging and
other articles that contact food" from Section 1.227(c)(4).

EPC further believes that FDA should not include within the scope of its
Prior Notice of Import regulations, substances that migrate into food
from food packaging. In fact, the legislative history suggests that
Congress never intended to include food-packaging materials within the
scope of the prior notice of import provision. For this reason, EPC also
recommends that FDA delete from Section 1.277(c)(3) the phrase
"including substances that migrate into food from food packaging and
other articles that contact food" and clarify that for purposes of this
provision, "food" does not include food-contact materials not yet
containing food at the time of importation.

EPC fully supports efforts to promote homeland security and its members
have active programs underway to safeguard the men and women who work at
America's chemical facilities, the community in which the industry's
facilities are located and the downstream users of products. However, we
respectfully submit that FDA's proposal to extend the registration and
prior notice of import requirements to facilities that manufacture or
process chemical substances (such as emulsion polymers) used in the
manufacture of food-contact articles, will unduly burden industry,
dilute FDA's resources and provide no significant protection against
terrorism.

Please do not hesitate to contact me if I can provide any further
clarification.

> Sincerely,
>
> Robert J. Fensterheim
>
> Executive Director

[^1]: Pub. L. 107-188 amending Federal Food, Drug, and Cosmetic Act
    (FFDCA) (codified at 21 U.S.C. 331 et seq. (2002)).

[^2]: The Site Security Guidelines for the US Chemical Industry can be
    downloaded from www.socma.com.