[Federal Register: November 7, 2005 (Volume 70, Number 214)]
[Notices]
[Page 67490-67494]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07no05-92]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
DEPARTMENT OF AGRICULTURE
Food Safety Inspection Service
[Docket No. 05-013N]
Meeting To Discuss Possible Changes to the Regulatory
Jurisdiction of Certain Food Products Containing Meat and Poultry
AGENCIES: Food and Drug Administration, HHS; Food Safety Inspection
Service, USDA.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA), in the Department of
Health and Human Services, and the Food Safety Inspection Service
(FSIS), in the United States Department of Agriculture (USDA), are
jointly announcing a public meeting to discuss and solicit information
on an approach for providing consistency and predictability with
respect to which of the two agencies should have jurisdiction over
certain types of food products that contain meat and poultry as
ingredients, as well as the opening of a joint agency docket to receive
written comments. This notice outlines that approach and solicits
comments on it and on the specific questions asked in section II below.
DATES: The public meeting will be held on December 15, 2005, from 10
a.m. to 4 p.m.
ADDRESSES: The public meeting will be held at the Donald E. Stephens
Convention Center, 5555 North River Road, Rosemont, IL 60018, 847-692-
0222.
You may submit comments, identified with Docket No. 05-013N, by any
of the following methods:
Electronic mail:
FSIS: FSIS regulationsComments@fsis.usda.gov. Follow the
instructions for submitting comments on the Agency's Web site.
[[Page 67491]]
FAX:
FSIS: 202-690-0486.
Mail/Hand delivery/Courier (For paper, disk, or CD-ROM
submissions):
FSIS: Docket Clerk, U.S. Department of Agriculture, Food Safety and
Inspection Service, 300 12th Street, SW., Room 102 Cotton Annex,
Washington, DC 20250
FDA: Division of Dockets Management, 5630 Fishers Lane, Room 1061,
Rockville, MD 20852.
Instructions: All submissions received must include Docket No. 05-
013N. All comments received will be posted without change to: (FSIS)
http://www.fsis.usda.gov/regulations_&_policies/2005_Notices_Index/index.asp; (FDA) http://www.fda.gov/dockets/ecomments.
://
marion.allen@fda.hhs.gov.
Please see Section III. Registration, for information on how to
register for the Public Meeting.
For technical questions about the subject of the meeting: FDA:
Karen Carson, Director, Executive Operations Staff (EOS), Center for
Food Safety and Applied Nutrition (HFS-22), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-1664, FAX: 301-436-2668, e-mail: kcarson@cfsan.fda.gov.
FSIS: Philip S. Derfler, Assistant Administrator, Office of Policy,
Program, and Employee Development (OPPED), Food Safety Inspection
Service, 1400 Independence Ave., SW., Suite 350-E Whitten Building,
Washington, DC 20250, (202) 720-2709, FAX: (202) 720-2025, e-mail:
Philip.Derfler@fsis.usda.gov.
SUPPLEMENTARY INFORMATION
I. Background
Both FSIS and FDA have regulatory authority over the food supply.
Under the Federal Meat Inspection Act (FMIA), Poultry Products
Inspection Act (PPIA), and Egg Products Inspection Act (EPIA), FSIS has
authority over all meat and poultry products and processed egg
products. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), FDA
has authority over all foods not under FSIS' jurisdiction (e.g., dairy,
bread and other grain products, vegetables and other produce, and other
products such as seafood).
Over the years, FSIS has made jurisdictional decisions based on
various factors, including the amount of meat or poultry in the
product; whether the product is represented as a meat or poultry
product (that is, whether a term that refers to meat or poultry is used
on labeling); and whether the product is perceived by consumers as a
product of the meat or poultry industries. With regard to the consumer
perception factor, FSIS has made decisions on a case-by-case basis,
mostly in response to situations involving compliance and enforcement.
Although this case-by-case approach resulted in decisions that made
sense at the time, a recent review by the agencies highlighted that
some decisions do not appear to be fully consistent with other product
decisions and that the reasoning behind various determinations were not
fully articulated. For example, the reasoning for deciding that a
``bagel dog'' (a product composed of a hotdog wrapped in bagel dough
which is then baked) was not a meat product was conveyed in a letter
from FSIS to a trade association in 1979 (Letter from Irwin Fried,
Acting Director, Meat and Poultry Standards and Labeling Division, to
Pacific Coast Meat Association, January 8, 1979). The letter stated
that the product was viewed as a ``closed-face'' sandwich and, thus,
was not under FSIS jurisdiction. However, the Agency did not explain
why such products were viewed as closed-face sandwiches or the
importance of this view. Moreover, the letter did not explain why bagel
dogs were different than other products that were similarly configured,
e.g., ``corn dogs'' and ``sausage turnovers,'' that were, and continue
to be, manufactured under FSIS jurisdiction.
Confusion persists about the reasoning used with respect to various
decisions about which agency has jurisdiction over certain food
products containing meat and poultry. For example, manufacturers have
wanted to change the original formulations of products that were the
subject of jurisdictional decisions, e.g., bagel dogs and pepperoni
rolls.\1\ By adding new ingredients, e.g., adding cheese and other meat
and poultry ingredients, manufacturers have created ``bagel dogs with
cheese'' and ``pepperoni, ham, and cheese rolls.'' Although the
manufacturers requested that FSIS categorize these new products like
their predecessors, FSIS has denied these kinds of requests because,
without a clear rationale supporting the original decisions, FSIS
believed that confusion would be compounded further by perpetuating the
rationale contained in the original decision.
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\1\ Pepperoni rolls are a product that was the subject of a FSIS
jurisdictional decision in 1986. They are a product that is composed
of pieces of pepperoni that are distributed in bread dough which is
then baked.
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In other situations, manufacturers have expressed confusion about
the classification of new versions of traditional food products because
products with similar composition are produced under the jurisdiction
of a different agency. For example, FSIS decided decades ago that
closed-face sandwiches made with meat ingredients were not meat
products and, thus, were products under FDA's regulatory jurisdiction.
Recently, manufacturers of ``wrap-type sandwiches with meat'' have
argued that wraps are similar enough to closed-face sandwiches such
that wraps should fall under FDA's jurisdiction. There are wrap-like
products, (meat burritos, meat egg rolls, and meat tamales), which FSIS
has categorized as meat products and which are more similar in
composition to the wrap-sandwich. Because wrap-type sandwiches are new
to the market and the historic decision about closed-face sandwiches
did not include them, FSIS concluded that wrap-type sandwiches are meat
products.
These and other circumstances led FSIS and FDA to conduct an in-
depth examination of the historic decisions about regulatory
jurisdiction made by FSIS. An FSIS-FDA working group met to explore the
issue and to develop an approach for making sound, clear, and
transparent decisions about product categorization and agency
jurisdiction.
As a result of the working group's findings, the agencies concluded
that a clearer approach to determining jurisdiction is possible. This
approach involves considering the contribution of the meat or poultry
ingredients to the identity of the food. In some cases, the meat or
poultry ingredients are distinctive and significantly contribute to a
food's basic nature by characterizing the food. In other cases, the
meat or poultry ingredients are used in such a way that they do not
contribute to the product's basic nature because they are not easily
distinguished and are used to simply add flavor. The agencies
recognized, however, that application of this approach could lead to
changes in jurisdiction for certain foods and categories of foods and
thus felt that it was important to present this approach
[[Page 67492]]
for public comment before taking steps to implement any changes.
A change in jurisdiction may be in order for the products and
product categories described below. Bagel dogs, closed-face meat and
poultry-containing sandwiches, and natural casings, regulation of which
would move from FDA to FSIS jurisdiction, are products or product
categories characterized by the meat or poultry ingredients that they
contain. Further, these products are identified by terms that refer to
the meat and poultry ingredients, reflecting the contribution of the
meat and poultry components. In contrast, meat and poultry components
are added to other products/product categories, such as bread/rolls/
buns, cheese products, flavors, pizzas, and salad dressings, to add
flavor but not to alter the character of the products. Such products
would move from FSIS to FDA jurisdiction.
Bagel Dogs
Bagel dogs were the subject of a jurisdiction decision that FSIS
made almost 20 years ago. The decision made at that time was that a
product composed of a cooked hotdog wrapped in bagel dough, which is
baked, is not itself a meat product. Bagel dogs thus fell under FDA
jurisdiction. Bagel dogs, however, are similar to other meat-filled,
dough-encased or wrapped products--such as corn dogs and sausage
turnovers--which have historically been under FSIS jurisdiction. These
products are composed of a meat or poultry filling that is encased or
wrapped in dough or crust which provides a convenient container for the
ingredients for hand-held eating. The meat and poultry components
characterize the products and the characteristics of the meat/poultry
ingredients are not changed by the bread, dough, or crust around it.
Because the agencies have not been able to distinguish bagel dogs from
corn dogs and similar products, the agencies are considering changing
the jurisdiction of bagel dogs from FDA to FSIS.
Natural Casings
At least as far back as the 1950's, USDA made a jurisdictional
decision that natural casings, which are used for sausages and other
stuffed and formed meat and poultry products, are not meat byproducts
because they serve as a container or packaging for the meat or poultry
put in the casing. As a result, natural casings have been under FDA
jurisdiction. But natural casings originate from meat byproducts,
(specifically, from parts of livestock digestive tracts) which are
under FSIS jurisdiction. The process of sanitizing and sizing the
livestock materials does not change them to the degree that their basic
identity as meat byproducts such as bungs, stomachs, intestines is
changed. Therefore, the agencies are considering changing the
jurisdiction of this category of products from FDA to FSIS.
Closed-Face Sandwiches Made With Meat or Poultry
According to FSIS policy going back to the 1930's, closed-face
sandwiches (products containing at least 35% cooked meat and poultry
products, by weight, placed between 2 slices of bread, biscuit, or bun,
which are less than 50 percent of the weight of the product) were not
meat or poultry products because consumers viewed them as products
primarily prepared in local food service establishments (FSIS Food
Standards and Labeling Policy Book, 2003). Today, however, sandwiches
containing meat or poultry components in their majority are made in
manufacturing facilities and are shipped in interstate commerce.
Moreover, in determining regulatory jurisdiction, it makes sense to
consider the contribution of the meat ingredient to the product.
Meat and poultry sandwiches are generally consumed for the
distinctive meat and poultry ingredients, not for the bread that
surrounds them. In other words, it is the meat or poultry ingredients
that characterize the sandwich, which is not changed by the bread,
biscuit, or bun between which they are placed. Furthermore, sandwiches
are similar to the other meat- or poultry-filled, dough-encased or
wrapped products that were discussed earlier have historically been
under FSIS jurisdiction. Therefore, the agencies are considering
changing the jurisdiction of these products from FDA to FSIS.
Cheese and Cheese Products (Including Cheese Dips) Made With Less Than
50 Percent Meat or Poultry
Products that meet the standards of identity in 21 CFR Part 133 for
Cheeses and Cheese Products (i.e., pasteurized blended cheese, process
cheese, cheese food, cheese spread) are not considered meat or poultry
products. The standard of identity for such products allows for
optional ingredients, including meat ingredients. Based on this
standard, FSIS decided many years ago that some cheese products such as
cheese balls and cheese logs that include small pieces of inspected and
passed ready-to-eat meat (e.g., dried sausage or cooked bacon) at less
than 50 percent of their formulation (by weight) were not meat products
and should fall under FDA jurisdiction. However, this FSIS decision has
never been extended to all cheese and cheese products or to those that
contain poultry. The agencies have considered this decision and, as a
result, the agencies are suggesting that the addition of less than 50
percent inspected and passed ready-to-eat meat or poultry ingredients
does not change the characteristics of cheese or cheese products
(whether or not the product is covered by an FDA standard of identity)
because, at less than 50 percent of the weight of the product, the meat
or poultry added is used for flavoring effect. Therefore, the agencies
are considering changing the jurisdiction of these products from FSIS
to FDA.
Bread, Rolls, and Buns Made With Less Than 50 Percent Meat or Poultry
The jurisdiction of pepperoni rolls is an example of a bread-based
product that has caused confusion since a decision was made in 1986 by
FSIS that such a product is not a meat product, and is, therefore,
under FDA's jurisdiction (Letter from Margaret O. Glavin to State of
West Virginia, Department of Agriculture, January 8, 1986). The
original decision was made for a product that was composed of small
pieces of pepperoni that were dispersed throughout bread dough and
baked. At the time, the product was prepared in such a way that it was
viewed by FSIS as being a product of the bakery industry. More
recently, FSIS has viewed products with variations of the original
formulation (e.g., pepperoni, ham, and cheese rolls) as meat and
poultry products because these products are not consistent with the
formulation of the product for which the original jurisdictional
decision was made.
In reviewing the decision about pepperoni rolls and the other
decisions made about bread-based products over the years, the agencies
considered the standards of identity for bakery products in 21 CFR Part
136, Bakery Products. Such products, which include bread, rolls, and
buns, are foods produced by baking dough made from farinaceous
ingredients into which optional ingredients may be dispersed for
flavor. Meat and poultry are not permitted optional ingredients in the
standards for breads, rolls, and buns in Part 136. Therefore, these
foods to which meat or poultry are added are non-standardized foods.
The agencies believe that meat and poultry ingredients can be added to
any bakery product for flavoring.
The agencies are now considering changing the jurisdiction from
FSIS to
[[Page 67493]]
FDA of the original pepperoni roll products, as well as those foods
with variations of this original formulation. Such products would be
prepared with less than 50 percent inspected and passed ready-to-eat
meat or poultry, dispersed throughout the dough for a flavoring effect.
(As a general matter, most products containing meat or poultry are
composed of well below or well above 50 percent meat or poultry by
weight.)
Dried Poultry Soup Mixes
Dried meat soup mixes, regardless of the amount of meat they
contain, are currently under FDA jurisdiction based on a FSIS decision
made decades ago, which is reflected in the FSIS Food Standards and
Labeling Policy Book (2003). Dried poultry soup mixes, however, have
historically been considered to be poultry products (FSIS Food
Standards and Labeling Policy Book). This has been a point of disparity
and confusion. Based on FSIS' experience in reviewing product
formulations, dried soup mixes with meat or poultry are composed of
less than 50 percent inspected and passed dried/powdered meat/poultry
(by weight). The meat and poultry components used to prepare these
products are not in a form that is recognized as ``meat'' or
``poultry'' and are used at low levels for seasoning or flavoring
effects. For this reason and for the sake of parity, the agencies are
considering changing the jurisdiction of dried poultry soup mixes from
FSIS to FDA.
Flavor Bases/Flavors
Flavor bases and reaction/process flavors are produced by rigorous
heating (e.g., 100 [deg]C or higher) and by chemical processes (e.g.,
hydrolysis/enzymolysis). Such products that are prepared with inspected
and passed meat or poultry ingredients are in a powder, slurry, or
paste form. They are used in other products for a flavoring effect, not
for their contribution to the meat or poultry content of the food
products. Furthermore, such products are typically sold for use within
the food industry, not for use by household consumers. Therefore, the
agencies are considering changing the jurisdiction of this category of
products from FSIS to FDA.
Pizzas With Meat or Poultry
In 2003, FSIS eliminated the standard of identity for traditional
pizzas with meat or poultry (68 FR 44859, July 31, 2003). Thus,
traditional pizzas composed of sauce, cheese, and inspected and passed
meat or poultry toppings on a layered crust need only contain 2 percent
meat or poultry by weight to be under FSIS jurisdiction. However, the
base onto which toppings are placed represents the majority of the
product, and meat or poultry ingredients may be among any number of
toppings used for flavoring purposes. While the meat or poultry
toppings provide flavoring to the finished food, they do not change the
character of the food. Because non-meat/poultry pizzas have always been
under FDA's jurisdiction, and the meat or poultry ingredients are
generally used to provide flavor, the agencies are considering changing
the jurisdiction of these products from FSIS to FDA.
Salad Dressings Made With Less Than 50 Percent Meat or Poultry
Over the years, FSIS has made jurisdictional decisions that salad
dressing products made with cooked meat ingredients (e.g., cooked
bacon) are not meat products. The basis for the decisions was that such
products were consistent with the standards of identity for
``dressings'' in 21 CFR Part 169, Food Dressings and Flavorings.
Although the standards do not list meat ingredients as optional
ingredients, the meat ingredients were not considered to characterize
the dressings as meat products, nor were they considered to
characterize non-standardized dressings, such as vinaigrettes. As
optional ingredients, the meat or poultry ingredients are intended to
provide flavor and do not contribute to the characterization of the
products as salad dressings. There has, however, been occasional
confusion regarding under which agency would regulate the product. The
agencies therefore are contemplating making clear that salad dressings
that contain less than 50 percent inspected and passed, ready-to-eat
meat or poultry ingredients by weight (e.g., cooked bacon), are not
meat or poultry products and are under FDA jurisdiction.
The agencies recognize that these jurisdictional changes would
affect firms and establishments, as well as the agencies themselves. It
is unlikely that, in most cases, affected firms or establishments would
have to overhaul production facilities or processing operations,
significantly alter marketing approaches, or change product
formulations to take actions to meet the regulatory requirements of one
or the other agency. It is likely, however, that with the suggested
changes in jurisdiction, there will be additional administrative,
inspection, and labeling requirements. For example, firms moving to
FSIS jurisdiction would need to: receive grants of inspection; develop
and implement hazard analysis and critical control point (HACCP) plans,
sanitation standard operating procedures (SSOPs), and pathogen control
and other laboratory testing procedures; develop and implement systems
of recordkeeping; and obtain product label approvals.
II. Public Meeting
FSIS and FDA are holding this public meeting in order to gain
public input on the ideas set out in this notice and on the impact of
the changes discussed herein. In order to benefit from this public
meeting, the agencies are seeking input on a number of questions,
including:
Is the approach that is suggested by the agencies a
reasonable one? If not, why not?
Are there other food products or product categories that
have been the subject of historical regulatory jurisdictional decisions
by FSIS, which were based on a consumer perception factor, that should
be considered by the agencies?
How many firms or establishments would be affected for
each product and product category? What is the volume of production for
each product or product category?
Would there be modifications in equipment, facility
design, labeling, recordkeeping, or processing and reporting
responsibilities that are needed in order for current operations to
continue making the products that are the subject of the suggested
changes, and what are they?
What would the administrative, operational, marketing, and
labeling costs be associated with changes in product jurisdiction?
What would be a reasonable process and time frame within
which to implement any changes in jurisdiction?
What would be consumers' views of the subject products
under the suggested approach? More particularly, what effect would
changing regulatory jurisdiction have on consumers' perceptions of the
subject products? For example, what would consumers' reaction be to the
fact that dried chicken soup mix is regulated by FDA?
What effects would there be, if any, on the way the
subject products are marketed?
The agencies seek as much information as possible about the impact
of any changes in jurisdiction.
III. Registration
Please submit your registration information (including name, title,
firm name, address, telephone number, e-
[[Page 67494]]
mail address, and fax number) at least 5 workdays before the public
meeting date. We encourage you to register online at https://register.grad.usda.gov/conferences/fda/fda-fsis_reg_form.cfm.
or to fax your registration
directly to Marion V. Allen at 301-436-2605. We will accept
registrations onsite. Space is limited and registration will be closed
when maximum seating capacity is reached (250 people). If you need
special accommodations due to a disability, please notify Marion V.
Allen at least 7 workdays in advance.
We encourage individuals or firms with relevant data or information
to present such information at the meeting or in written comments to
the record. If you would like to make oral comments at the meeting,
please specify your interest in speaking when you register. The amount
of time for each oral presentation will be limited to 5 minutes.
IV. Transcripts
A transcript will be made of the proceedings of the meeting. You
may request a copy of the meeting transcript in writing approximately
30 working days after the public meeting at a cost of 10 cents per page
from:
FDA: FDA's Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857; or
FSIS: FSIS, Freedom of Information Office, USDA, 1400 Independence
Ave., SW., Room 1140 South Building, Washington, DC 20250.
The transcript of the public meeting and all comments submitted
will be available for public examination at the Agencies' Docket
Offices (see ADDRESSES for locations and hours).
V. Comments
In addition to presenting oral comments at the public meeting,
interested persons may submit written or electronic comments on the
subject of this meeting and Federal Register notice to a joint agency
docket housed at FSIS.
FSIS: Submit comments by any of the following methods: Mail,
including floppy disks or CD-ROMs, and hand- or courier-delivered
items.
Comments are to be identified by the Docket No. 05-013N. All
comments submitted in response to this notice will be available for
public inspection in the Agencies' Docket offices and web sites. [See
ADDRESSES section for location and hours].
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to ensure that the
public and in particular minorities, women, and persons with
disabilities, are aware of this notice, FSIS will announce it on-line
through the FSIS Web page located at http://www.fsis.usda.gov/regulations/2005_Notices_Index/index.asp
.
FSIS also will make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, recalls, and other types of
information that could affect or would be of interest to our
constituents and stakeholders. The update is communicated via Listserv,
a free e-mail subscription service consisting of industry, trade, and
farm groups, consumer interest groups, allied health professionals,
scientific professionals, and other individuals who have requested to
be included. The update also is available on the FSIS web page. Through
Listserv and the web page, FSIS is able to provide information to a
much broader, more diverse audience.
In addition, FSIS offers an e-mail subscription service which
provides an automatic and customized notification when popular pages
are updated, including Federal Register publications and related
documents. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/
and allows FSIS customers to sign up
for subscription options across eight categories. Options range from
recalls to export information to regulations, directives and notices.
Customers can add or delete subscriptions themselves and have the
option to password protect their account.
Done in Washington DC on: November 2, 2005.
Jeffrey E. Shuren,
Assistant Commissioner for Policy, Food and Drug Administration.
Sean Altekruse,
Deputy Executive Associate Administrator, OPPED, Food Safety Inspection
Service.
[FR Doc. 05-22123 Filed 11-3-05; 8:45 am]
BILLING CODE 3410-DM-P