[Federal Register Volume 59, Number 70 (Tuesday, April 12, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8698]
[[Page Unknown]]
[Federal Register: April 12, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 93N-0352]
Polychlorinated Dibenzo-p-dioxins and Polychlorinated
Dibenzofurans in Bleached Food-Contact Paper Products; Response to
Referral for Action by the Environmental Protection Agency and Request
for Comment
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is issuing this notice
in response to a notice of referral for action on the use of bleached
food-contact paper products contaminated with polychlorinated dibenzo-
p-dioxins (PCDD's) and polychlorinated dibenzofurans (PCDF's) that was
issued by the Environmental Protection Agency (EPA) under the Toxic
Substances Control Act (TSCA). FDA agrees with EPA's decision to refer
this issue to FDA because, under the Federal Food, Drug, and Cosmetic
Act (the act), FDA has authority to take appropriate action to ensure
that paper and paperboard intended for food-contact use are safe. This
notice sets out the various options that FDA is considering regarding
the issue of PCDD and PCDF contamination of bleached food-contact paper
products and encourages interested persons to submit pertinent data and
other comments on this issue.
DATES: Comments by June 13, 1994.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Edward J. Machuga, Center for Food
Safety and Applied Nutrition (HFS-216), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-254-9511.
SUPPLEMENTARY INFORMATION:
I. Background
PCDD's and PCDF's are formed in trace amounts as byproducts of
certain chemical processes, such as bleaching of paper, incineration,
and manufacturing of certain chlorinated phenols. They are generally
produced as a complex mixture of related compounds or congeners. The
PCDD's and PCDF's are classes of 75 and 135 congeners, respectively,
the most toxic of which is 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD).
TCDD has been shown to be a potent animal carcinogen, and EPA has
classified it as a ``probable human carcinogen.''
In order to assess the hazards of mixtures of PCDD's and PCDF's,
scientists have agreed on the use of international toxicity equivalency
factors to express the comparative toxicity of these chemicals as
fractions of the toxicity of TCDD, the most toxic and most studied
congener of the group (Ref. 1). This system expresses the amount of
PCDD's and PCDF's present in terms of TCDD toxic equivalents and
estimates the risk for a mixture as if it were one chemical compound.
Under this system, 2,3,7,8-dibenzofuran (TCDF), the most potent of the
PCDF's, has been assessed a TCDD toxic equivalency of 0.1.
Although the occurrence of low levels of PCDD's and PCDF's in the
environment has been known for years, it has been only recently that
scientists' ability to identify and quantify them has greatly improved.
Based on data obtained in studies carried out in several countries, the
average person is exposed to approximately 1.2 picograms (pg) (10-
12 grams) of TCDD equivalents/kilogram (kg) body weight/day (Ref. 2).
This low level background exposure is mostly dietary, from foods such
as meat, poultry, fish, dairy products, and eggs.
In 1987, results of EPA's National Dioxin Study showed that fish
located downstream from paper mills had higher than expected levels of
TCDD and TCDF. This finding prompted EPA and the American Paper
Institute (API) to conduct a joint study of five paper mills to
discover the source of the TCDD and TCDF contamination. The results of
this study: (1) Confirmed the presence of parts per trillion (ppt)
levels of TCDD and TCDF in pulp and sludge; (2) confirmed parts per
quadrillion (ppq) levels of these substances in wastewater from these
mills; and (3) identified a particular chlorine bleaching process as
the source of the contaminants. Chlorine or chlorine derivatives are
often used as the primary bleaching agent in the process of making
bleached paper products.
These results prompted FDA to begin its own investigation of TCDD
and TCDF contamination of wood pulp and finished paper products that
may contact food and ultimately migrate into the packaged food. Because
the bulk of the TCDD toxic equivalents associated with PCDD and PCDF
contamination of bleached food-contact paper products are attributable
to the presence of TCDD and TCDF, FDA's investigation has focused on
the levels of these two chemicals in bleached food-contact paper
products.
On April 24, 1987, FDA met with representatives of the National
Council of the Paper Industry for Air and Stream Improvement (NCASI) to
discuss protocols for analyzing for residual TCDD and TCDF levels in
bleached wood pulp and in various food-contact paper products. Under
these protocols, newly developed, highly sensitive analytical methods
were used by individual pulp mills to identify those specific processes
that contributed to the formation of TCDD and TCDF so that industry
could identify manufacturing changes that could be made to reduce or
eliminate such contaminants in the finished paper products. FDA also
asked industry representatives to conduct extraction studies to measure
the extent of migration of TCDD and TCDF from uncoated and coated paper
and paperboard into food simulating solvents.
In May of 1988, NCASI released a report entitled ``Assessment of
the Risks Associated with Potential Exposure to Dioxin Through
Consumption of Coffee Brewed Using Bleached Paper Coffee Filters''
(Ref. 3). This study was conducted because given the presence of
residual dioxin contaminants in bleached paper coffee filters and the
high temperature of the water that is passed through the filters, there
appeared to be a high potential for migration of such contaminants into
the brewed coffee. Analysis of 5 different bleached paper coffee
filters found measurable levels of TCDD and TCDF ranging from 2.2 to
6.6 ppt TCDD toxic equivalents in the paper. Migration studies
indicated that 65 to 90 percent of the TCDD equivalents present in the
bleached paper coffee filters could migrate into the coffee, depending
on brewing conditions.
In October of 1988, FDA received the results of a Canadian
Government survey that detected TCDD and TCDF in milk packaged in
bleached paper cartons (Ref. 4). TCDD was found in five of eight
samples of whole milk packaged in coated, bleached paper milk cartons
at concentrations ranging from 0.014 to 0.056 ppt with an average
concentration of 0.038 ppt. TCDF was found in all eight samples at
concentrations ranging from 0.064 to 2.46 ppt (average concentration of
0.98 ppt). Somewhat higher levels were found in cream packaged in
coated, bleached paper milk cartons. Analyses of similar food products
packaged in plastic or glass containers showed at least tenfold lower
levels of TCDD and TCDF, which were most likely a result of background
contamination.
In the spring of 1989, FDA conducted a survey of milk packaged in
bleached paper cartons from five U.S. manufacturers (Ref. 5). TCDD was
found in 4 of 15 samples of whole milk packaged and stored in one-half
pint cartons at refrigerated temperatures for 14 days. The TCDD
concentrations, which ranged from 0.02 to 0.07 ppt, were obtained using
an analytical method that could determine amounts at or above 0.02 ppt.
TCDF was detected in 7 of 15 samples at levels from 0.14 to 0.62 ppt.
The detection limit for TCDF was 0.1 ppt. Because neither TCDD nor TCDF
was detected in bulk or nonpackaged milk collected at the same dairies
before being packaged, the results confirm that these contaminants can
migrate out of the bleached paper carton and into the milk.
Because of FDA's concern about the potential for exposure to TCDD
and TCDF from other bleached paper food-contact articles, FDA requested
that the paper industry provide detailed information that could be used
to determine what other bleached paper articles should be the subject
of detailed migration studies. Based on the results of the industry
survey, FDA also requested, in February 1989, that the paper industry
develop migration data for those paper food-contact articles posing the
greatest potential for exposure to TCDD and TCDF. In response to this
request, the paper industry submitted the results of migration studies
for the following paper articles: (1) Milk cartons (Ref. 6), (2) coffee
filters (Ref. 3), (3) half-and-half (cream) cartons (Ref. 7), (4)
orange juice cartons (Ref. 8), (5) coffee cups (Ref. 9), (6) soup cups
(Ref. 10), (7) dual-ovenable trays (Ref. 11), (8) plates (Ref. 12), and
(9) microwave popcorn bags (Ref. 13).
In 1990, FDA used data from these migration studies, to develop a
quantitative risk assessment for bleached paper food-contact articles
containing TCDD and TCDF residues. The procedures that FDA used in this
evaluation were similar to the methods that the agency has used to
examine the risk associated with the presence of minor amounts of
carcinogenic impurities in various food and color additives (see 49 FR
13018, April 2, 1984). This risk evaluation of carcinogenic
contaminants has two aspects: (1) Assessment of dietary exposure to the
contaminants from the consumption of the additive and (2) extrapolation
of the risk observed in the animal bioassays to the conditions of
probable human exposure.
In addition to the exposure data derived from the industry studies
described above, FDA considered exposure from four other bleached paper
articles that were not subjected to migration testing (bakery cartons,
ice cream cartons, tea bags, and margarine wrappers). An exposure
estimate for each of these articles was derived using an estimated
migration level based on an assumed residue of 17 ppt TCDD equivalents
in the paper article (the average level of TCDD equivalents found to be
in paper pulp in a study of 104 paper mills carried out in 1988 and
1989) (Ref. 14). In its exposure estimates, FDA also considered the
types of food that come into contact with paper articles and the
amounts of these types of food that are ingested daily by consumers.
Based on the results of the migration studies and migration estimates
as well as food consumption information, FDA estimated the daily intake
of TCDD equivalents occurring as a result of migration into food from
bleached paper food-contact articles to be no greater than 0.15 pg/kg
body weight/day (Ref. 14).
In its 1990 risk assessment, the agency used data from a 2-year
chronic toxicity and oncogenicity study carried out by Kociba et al.
(Ref. 15) on TCDD fed to rats to estimate the upper-bound level of
lifetime human risk from exposure to TCDD toxic equivalents resulting
from the use of bleached food-contact paper products. The results of
the bioassay on TCDD showed that the material was carcinogenic for rats
under the conditions of the study. The test material caused
significantly increased incidences of hepatocellular carcinomas and
adenomas as well as squamous cell carcinomas of the lung, hard palate,
nasal turbinates, and tongue. FDA's toxicologists further concluded
that given the paucity of TCDD bioassay data, the Kociba et al.
bioassay provided the appropriate basis on which to calculate an
estimate of the upper-bound level of lifetime carcinogenic risk from
exposure to TCDD toxic equivalents stemming from the use of bleached
food-contact paper products.
The agency used a linear-at-low-dose extrapolation from the doses
used in the Kociba et al. bioassay to the very low levels of TCDD toxic
equivalents encountered under actual conditions of use of bleached
food-contact paper products. This procedure is not likely to
underestimate the actual risk from very low doses and may, in fact,
exaggerate it because the extrapolation models used are designed to
estimate the maximum risk consistent with the data. Using a linear-at-
low-dose extrapolation method and the tumor incidence data based on the
original classification of tumors found in the Kociba et al. study, the
FDA estimated a carcinogenic unit risk of 16 x 10-6 for an intake
of 1 pg/kg body weight/day of TCDD toxic equivalents. Using this
carcinogenic risk for TCDD and a daily dietary exposure of 0.15 pg of
TCDD equivalents/kg body weight/day (based on data obtained from 1988
to 1990), FDA's 1990 risk assessment estimated that the upper-bound
limit of individual lifetime risk from TCDD toxic equivalents that
result from the use of bleached food-contact paper products at that
time would be 2.5 x 10-6 or 2.5 in 1 million (Ref. 16). Because of
the conservative assumptions used to obtain the exposure estimate,
actual lifetime-averaged individual exposure to TCDD toxic equivalents
is expected to be substantially less than the estimated daily intake,
and therefore, the actual risk would be less than the calculated upper-
bound limit of risk.
This risk was considered low by both FDA and EPA (December 26,
1990, 55 FR 53047). However, because the then current levels of PCDD's
and PCDF's (mostly TCDD and TCDF) in bleached white paper were capable
of being reduced by the pulp and paper industry through changes in
manufacturing procedures, EPA considered the risk associated with
PCDD's and PCDF's in food-contact paper products to be ``unreasonable''
in accordance with section 9(a) of TSCA (55 FR 53047).
EPA has the authority to require the reduction of ``unreasonable''
risk associated with bleached paper products under section 6(a) of
TSCA, which states that EPA may prohibit or limit production of a
chemical substance that presents an ``unreasonable'' risk to human
health or the environment. However, under section 9(a) of TSCA, if EPA
determines that the risk can be reduced by an action taken by another
agency, it may refer such action to the other agency.
In the notice published in the Federal Register of December 26,
1990, EPA announced that under section 9(a) of TSCA, it was referring
action to FDA on the use of food-contact paper products contaminated
with PCDD's and PCDF's. Specifically, EPA has requested that FDA do the
following: (1) Assess the risk associated with PCDD and PCDF
contaminated bleached food-contact paper products; (2) determine if
this risk may be prevented or reduced by action taken under its own
authority, and (3) if so, initiate the appropriate regulatory action.
II. FDA's Response to EPA's Referral for Action
FDA agrees with EPA's decision to refer the use of bleached food-
contact paper products that may be contaminated with PCDD's and PCDF's
(mostly TCDD and TCDF) to FDA because under the act, FDA has the
authority to take appropriate regulatory action to ensure that bleached
paper and paperboard intended for food-contact use are safe. At the
time that FDA received this referral, the agency considered whether
immediate regulatory action was necessary to ensure the safe use of
bleached food-contact paper products. As stated above, FDA's risk
assessment in 1990 of exposure to TCDD and TCDF, resulting from the use
of those types of bleached food-contact paper products that have the
greatest potential for migration of these substances into food,
produced an estimated upper-bound worst-case lifetime risk of 2.5 in 1
million. However, the estimated daily dietary intake used in this risk
assessment was based on data obtained from 1988 to 1990. By the time
FDA received the referral, many of the paper mills that make bleached
paper had made or were in the process of making manufacturing changes
to reduce or eliminate residual TCDD and TCDF levels in bleached paper
intended for use in contact with food. Therefore, rather than
expressing the risk in terms of an average 70-year lifespan, FDA
believed that it was more appropriate to view the carcinogenic risk in
terms of yearly exposure during the limited time needed by the paper
industry to complete the manufacturing changes necessary to reduce the
levels of such contaminants in paper products.
An upper-bound worst-case lifetime risk of 2.5 in 1 million
corresponds to less than 0.04 in 1 million for each year of exposure.
Based on this level of risk per year of exposure, FDA felt at the time
that it received the referral that the continued use of bleached paper
and paperboard in contact with food was safe during the time needed by
FDA to complete its evaluation of TCDD and TCDF contamination of
bleached food-contact paper products. FDA also felt at that time that
it should conduct a new lifetime risk assessment in light of the
changes in the manufacturing of bleached food-contact paper products
that had occurred.
Given the cooperation that FDA had received from the paper
industry, FDA decided that it was appropriate to explore voluntary
avenues for reducing exposure to PCDD's and PCDF's from the use of
bleached paper and paperboard. At a meeting held on November 16, 1990,
API advised FDA that 100 percent of the U.S. manufacturers of bleached
paper for food-contact applications were participating in a voluntary
program to reduce TCDD levels in all types of food-contact paper
products to 2 ppt or less. In a letter of March 7, 1991, API submitted
data to FDA showing that all bleached paper milk cartons manufactured
since July 30, 1990, had residual TCDD levels of 2 ppt or less (Ref.
17). API also informed FDA that 93 percent of bleached food-contact
paper and paperboard met the 2 ppt or less TCDD standard as of December
31, 1991, and that 98 percent of these products were expected to meet
this standard by the end of 1992 (Ref. 18).
The American Forest and Paper Association (AFPA), formed by the
recent merger of API with other forest related associations, has
submitted to FDA the results of an industry-wide survey conducted
during the first quarter of 1993 to determine the degree of compliance
with the voluntary specification of 2 ppt or less of residual TCDD in
bleached food-contact paper products (Ref. 19). These results show that
all of the U.S. manufacturers responding to the survey have implemented
standard operating procedures that result in bleached food-contact
paper products that meet the voluntary specification of 2 ppt or less
of TCDD. Out of 249 tests conducted on samples of either bleached pulp,
paper, or paperboard, only 3 samples had detectable levels of TCDD that
were above 2 ppt (i.e., 2.1 ppt, 2.2 ppt, and 2.6 ppt). The levels of
TCDD that were found to be above 2 ppt in the survey are likely to be
the result of normal variability associated with both the methodology
used to analyze for the TCDD and the manufacturing procedures used to
produce the bleached paper products. Moreover, although the paper
industry's voluntary program specifically deals with residual levels of
TCDD in bleached food-contact paper products, industry data have shown
that the manufacturing changes that have resulted in the significant
reduction of TCDD in such products also have resulted in a
corresponding decrease in TCDF (Ref. 17).
In 1992, FDA also conducted its own analysis of uncoated bleached
paper destined for use in milk cartons (Ref. 20) to confirm whether it
meets the voluntary specification of 2 ppt or less of TCDD. These tests
used analytical methodology developed by FDA's Chicago District
Laboratory (Ref. 21). FDA collected samples in late 1991 and early 1992
from five U.S. manufacturers that produce over 90 percent of the
domestic paper stock used for milk cartons. Paper stock from two of the
manufacturers contained very low levels of TCDD (1.4 and 1.5 ppt,
respectively) and TCDF (4.0 and 4.7 ppt, respectively). Residual levels
of TCDD and TCDF could not be detected in the paper stock from the
other three manufacturers using an analytical method sensitive to 1 ppt
for TCDD and 2 ppt for TCDF. These results support the paper industry's
claim that the bleached paper used to manufacture milk cartons is in
compliance with a voluntary specification of 2 ppt for TCDD.
FDA has also recently completed an analysis of milk samples
contained in cartons manufactured using bleached paper (Ref. 22).
Fifteen milk samples were collected in late 1991 and early 1992 from
dairies that use bleached paper from the five major U.S. manufacturers.
None of the samples contained detectable levels of TCDD and TCDF using
analytical methodologies with detection limits in the 2 to 10 ppq
range.
In addition, FDA has developed a new risk assessment to determine
what the current upper-bound lifetime cancer risk is from exposure to
TCDD toxic equivalents resulting from the use of bleached paper and
paperboard products meeting the paper industry's voluntary
specification of 2 ppt or less of TCDD. In the absence of migration
data for bleached paper products containing such low levels of TCDD
(i.e., 2 ppt or less), FDA assumed that the percent migration of TCDD
from a specific type of food-contact article meeting the voluntary 2
ppt TCDD specification would be similar to the percent migration
observed in earlier studies (Ref. 14). Because the percent migration
decreases as the level of the migrant in the food-contact article
decreases, this approach is not likely to underestimate migration
levels. Using the above assumption and assuming that all bleached food-
contact paper products contain residual levels of TCDD low enough to
meet a 2 ppt TCDD specification, FDA estimates that the upper-bound
daily dietary intake of TCDD toxic equivalents is no greater than 1.8
pg/person/day (0.03 pg TCDD equivalents/kg body weight/day for a 60-kg
person) (Ref. 23). FDA used this exposure estimate to determine the
current upper-bound lifetime cancer risk from TCDD toxic equivalents
resulting from the use of bleached food-contact paper products assuming
that virtually all of such products meet a 2 ppt TCDD specification.
The carcinogenic unit risk used by FDA in its 1990 risk assessment
was based on tumor incidence data from the Kociba et al. study (Ref.
15). Following FDA's 1990 risk assessment, however, a group of
pathologists, called the Pathology Working Group (PWG), reanalyzed the
slides of the liver tumors observed in the 1978 Kociba rat bioassay
using the National Toxicological Program's 1986 classification system
for liver tumors (Ref. 24). FDA has reviewed the results of this
reanalysis and agrees with the classification of the tumors made by
PWG. Using the results of this revised reading of the Kociba study
slides, FDA estimates a carcinogenic unit risk of 9 x 10-6 for an
intake of 1 pg TCDD equivalents/kg body weight/day. Using this
carcinogenic unit risk and an upper-bound daily dietary exposure
estimate of 0.03 pg TCDD equivalents/kg body weight/day, FDA estimates
that the upper-bound limit of individual lifetime cancer risk from TCDD
toxic equivalents would be 3 x 10-7 for the use of bleached food-
contact paper products meeting a 2 ppt TCDD specification (Ref. 25).
The agency obtained this 3 x 10-7 risk estimate by assuming
that the lifetime cancer risk from TCDD would be equal in mammalian
species, such as in man and in rodents when the daily feeding doses are
in proportion to body weight raised to the first power (i.e.,
equivalence based on feeding dose/body weight/day). This approach is
the one that FDA has traditionally used in extrapolating results of
rodent carcinogen bioassays to man. However, in the Federal Register of
June 5, 1992 (57 FR 24152), EPA, FDA, and the Consumer Product Safety
Commission published a draft report proposing to establish a common
default methodology for determining equivalence in carcinogenic unit
risks between mammalian species. If adopted, this unified default
approach will be used in those cases where existing agent-specific data
are insufficient to make a case-by-case determination. Based on an
analysis of empirical and theoretical aspects of the cross-species
dose-scaling question, the proposed unified default approach assumes
that the lifetime cancer risk from the intake of a carcinogenic
substance is equal in different mammalian species when the daily
feeding doses are in proportion to body weight raised to the 3/4 power
(i.e., equivalence based on feeding dose/body weight3/4/day).
Although this proposed unified default methodology has not been
adopted by the three agencies, FDA has used it to calculate a second
estimate of the upper-bound lifetime cancer risk from TCDD exposure if
all bleached food-contact paper products meet the paper industry's
voluntary specification of 2 ppt for residual levels of TCDD. Using a
scaling factor based on equivalence of pg/kg3/4/day to extrapolate
the tumor incidence data obtained from the revised reading of the
Kociba rodent bioassay slides to man, FDA estimates a carcinogenic unit
risk of 30 x 10-6 (pg TCDD equivalents/kg body weight/day)-1.
Using this carcinogenic unit risk for TCDD and an upper-bound daily
dietary exposure estimate of 0.03 pg TCDD equivalents/kg body weight/
day, FDA estimates that the upper-bound limit of individual lifetime
risk from TCDD toxic equivalents would be 9 x 10-7 for the use of
bleached food-contact paper products meeting a 2 ppt TCDD specification
(Ref. 25).
Both of the above upper-bound lifetime risk estimates (3 x 10-
7 and 9 x 10-7), obtained using cross-species scaling factors
based on equivalence of pg/kg/day and pg/kg3/4/day, respectively,
would generally be viewed as very low. However, until the proposed
unified default methodology has been formally adopted, FDA will use the
3 x 10-7 risk as the best estimate of what the upper-bound
lifetime risk from TCDD toxic equivalents would be when all bleached
food-contact paper products meet the paper industry's voluntary
specification of 2 ppt for residual levels of TCDD.
On the basis of: (1) FDA's 1990 risk assessment which showed an
upper-bound lifetime cancer risk of less than 0.04 in 1 million for
each year of exposure based on residual levels of TCDD and TCDF in
bleached food-contact paper products manufactured between 1988 and
1990; (2) the significant progress made by the paper industry in
reducing residual TCDD and TCDF in bleached paper products (AFPA has
submitted to FDA the results of an industry wide survey conducted
during the first quarter of 1993 showing that U.S. manufacturers have
implemented standard operating procedures that result in bleached food
contact paper products that meet the voluntary specification for 2 ppt
or less of TCDD); and (3) FDA's new risk assessment that the upper-
bound limit of individual lifetime risk from TCDD toxic equivalents is
3 x 10-7 if all bleached food-contact paper products in fact meet
the paper industry's voluntary specification of 2 ppt for residual
levels of TCDD, FDA tentatively concludes that the continued use of
bleached paper and paperboard in contact with food is safe during the
time that has been, and will be, needed by FDA to complete its
evaluation.
FDA will continue to monitor the paper industry's progress in
reducing TCDD and TCDF contamination of bleached food-contact paper
products manufactured in the United States. The agency will also
consider monitoring residual levels of TCDD and TCDF in bleached food-
contact paper and paperboard imported into this country as well as in
the bleached paper and paperboard packaging of imported foods.
Information currently available to the agency shows that imported
bleached food-contact paper products comprise only 3 percent of such
products used in the United States.
Data obtained in a recent human epidemiological study involving
workers exposed to low levels of TCDD may also provide an additional
approach to assessing the carcinogenic risk to humans (Ref. 26). FDA
plans to review these data and determine if they are suitable for risk
assessment purposes. If suitable, the carcinogenic potency for TCDD in
humans obtained using these data would provide an alternative to the
current risk assessment approach which requires the extrapolation from
animal data. FDA will also consider any other data that become
available while it completes its review.
The results of FDA's monitoring of the residual levels of TCDD and
TCDF in bleached food-contact paper products together with data and
comments received in response to this notice will be used by FDA to
determine if any regulatory action is needed to ensure the safe use of
such products. If FDA determines that regulatory action is necessary,
one possible course of action would be to amend the food additive
regulations to establish a specification for maximum allowable levels
of residual TCDD and TCDF in food-contact paper products in accordance
with section 409 of the act. Using this approach, bleached paper that
is intended for use in food-contact articles, and that is expected to
contain TCDD and TCDF that will migrate into food, would be regarded as
a food additive as defined in section 201(s) of the act and be subject
to premarket approval under section 409 of the act (21 U.S.C. 348). A
substance, such as bleached paper, that has not been shown to cause
cancer, but that contains a carcinogenic impurity such as TCDD, is
evaluated under the general safety clause of the statute using risk
assessment procedures to determine whether there is a reasonable
certainty that no harm will result from its use (Scott v. FDA, 728 F.2d
322 (6th Cir. 1984)). The risk assessment procedures could be used by
FDA to determine the residual level of TCDD and TCDF in bleached food-
contact paper at which there is reasonable certainty that no harm will
result from the use of the bleached paper. FDA would institute
rulemaking to amend its food additive regulations to authorize the
food-contact use of bleached paper the contain such levels of TCDD and
TCDF.
A second course of action would be for FDA not to proceed with
rulemaking and to take action against TCDD and TCDF in food-contact
paper products on a case-by-case basis. To clarify the levels that
would be of concern to FDA, the agency could publish an action level
for residual TCDD and TCDF in bleached food-contact paper products. FDA
relies on action levels to provide guidance on the level of added
poisonous or deleterious substances that may render food adulterated.
The agency has found action levels to be particularly useful in cases,
such as the TCDD and TCDF contamination of bleached paper products,
where the technology and science associated with an issue continue to
change. Although the act is mute on the use of action levels, court
decisions on this regulatory approach (Community Nutrition Institute v.
Young, 818 F.2d 943,946 (D.C. Cir. 1987)) have supported their use by
FDA as long as it is made clear that such levels are not legally
binding on either industry or the agency.
FDA requests comments on other possible regulatory approaches that
it could use to ensure that any residual amounts of TCDD and TCDF in
bleached food-contact paper products will be safe.
III. Request for Comments
FDA invites public comment on all aspects of this notice concerning
residual levels of TCDD and TCDF in bleached food-contact paper
products. The preamble to any proposal on this issue will include
consideration of comments received in response to this notice.
Interested persons may, on or before June 13, 1994, submit to the
Dockets Management Branch (address above) written comments regarding
this notice. Trade secret and commercial confidential information
should be submitted to the contact person identified above. Trade
secret and commercial confidential information will be protected from
public disclosure in accordance with 21 CFR part 20. Two copies of any
comments are to be submitted, except that individuals may submit one
copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. Received comments may be seen
in the office above between 9 a.m. and 4 p.m., Monday through Friday.
IV. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. ``Pilot Study on International Information Exchange on
Dioxins and Related Compounds,'' North Atlantic Treaty Organization,
report no. 178, December 1988.
2. ``Assessment of Health Risks in Infants Associated with
Exposure to PCBs, PCDDs and PCDFs in Breast Milk,'' report on a
World Health Organization working group, pp. 1-7, 1988.
3. ``Assessment of the Risks Associated with Potential Exposure
to Dioxin Through the Consumption of Coffee Brewed Using Bleached
Paper Coffee Filters,'' NCASI Technical Bulletin, No. 546, 1988.
4. Letter from EPA to FDA, containing Canadian study of dioxin
in packaged milk, September 27, 1988.
5. ``Survey of Dioxin-Furan in Milk Packaged in Paper Cartons,''
FDA FY 89 field assignment, August 1989.
6. ``NCASI Milk Carton Migration Study,'' first progress report,
August 1989.
7. ``NCASI Milk Carton Migration Study of Half and Half,''
January 1990.
8. ``NCASI Orange Juice Carton Migration Study,'' interim
report, December 1989.
9. ``NCASI Hot Beverage Paper Cup Coffee Exposure Scenario
Migration Study,'' interim report, October 1989.
10. ``NCASI Hot Beverage Paper Cup Chicken Broth Exposure
Scenario Migration Study,'' interim report, November 1989.
11. ``NCASI Dual Ovenable Tray Migration Study,'' interim
report, November 1989.
12. ``NCASI Plates/Trays/Dishes Migration Study,'' interim
report, November 1989.
13. Letter dated March 6, 1990, from NCASI, containing microwave
popcorn bag migration study.
14. Memorandum dated June 13, 1990, from Food and Color
Additives Review Section, ``Exposure to Dioxin Congeners from Foods
Contacting Bleached Paper Products.''
15. Kociba, R. J., et al., ``Results of a Two-Year Chronic
Toxicity and Oncogenicity Study of 2,3,7,8-Tetrachlorodibenzo-p-
Dioxin in Rats,'' Toxicology and Applied Pharmacology, 46:279-303,
1978.
16. Report of the Quantitative Risk Assessment Committee,
``Carcinogenic Risk Assessment for Dioxins and Furans in Foods
Contacting Bleached Paper Products,'' April 20, 1990.
17. Letter dated March 7, 1991, from the American Paper
Institute, concerning TCDD levels in bleached paper and paperboard
as of December 31, 1990.
18. Letter dated April 17, 1992, from the American Paper
Institute, concerning TCDD levels in bleached paper and paperboard
as of December 31, 1991.
19. Letter dated July 30, 1993, from the American Forest and
Paper Association, concerning TCDD levels in bleached pulp, paper
and paperboard as of the First Quarter of 1993.
20. Memorandum dated November 2, 1992, from Methods Research
Branch, ``TCDD and TCDF Residues in Bleached Paper Stock used in
Milk Cartons.''
21. ``The Determination of 2,3,7,8-tetrachlorodibenzo-p-dioxin
and 2,3,7,8-tetrachlorodibenzofuran in Paper Products,'' Laboratory
Information Bulletin, FDA's Chicago District Laboratory, May 1992.
22. Memorandum dated February 25, 1993, from Methods Research
Branch, HFS-336, ``TCDD and TCDF Residues in Milk Packaged in
Bleached Paper Cartons.''
23. Memorandum dated November 14, 1991, from Food and Color
Additives Review Section, ``Exposure to Dioxin Congeners from Foods
Contacting Bleached Paper Products With Dioxin Levels Not Exceeding
2 ppt.''
24. ``2,3,7,8-Tetrachlorodibenzo-p-dioxin in Sprague-Dawley
Rats,'' Pathco Inc., March 13, 1990.
25. Report of the Quantitative Risk Assessment Committee,
``Upper-Bound Lifetime Carcinogenic Risks From Exposure to Dioxin
Congeners From Foods Contacting Bleached Paper Products With Dioxin
Levels Not Exceeding 2 ppt,'' January 27, 1993.
26. Fingerhut, M., et al., ``Cancer Mortality in Workers Exposed
to 2,3,7,8-Tetrachlorodibenzo-p-dioxin,'' The New England Journal of
Medicine, vol. 324, pp. 212-218, 1991.
Dated: February 2, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-8698 Filed 4-11-94; 8:45 am]
BILLING CODE 4160-01-F
