[Federal Register Volume 59, Number 24 (Friday, February 4, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-2472]
[[Page Unknown]]
[Federal Register: February 4, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 73, 74, 168, 172, 173, 182, and 184
[Docket No. 93N-0348]
Lead in Food and Color Additives and GRAS Ingredients; Request
for Data
AGENCY: Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that it
intends to take several related actions to reduce the amount of lead in
food from the use of food and color additives and food ingredients
whose use is generally recognized as safe (GRAS). This action is part
of its ongoing efforts to reduce the levels of lead in food. In this
document, the agency is identifying the lead levels that it intends to
propose as new, lower lead specifications for the most heavily used
food and color additives and GRAS ingredients. Before proposing these
specifications, however, the agency is requesting information on
whether these levels are feasible, and, if they are not, information on
why higher levels will not endanger the public health, and on what
levels are feasible. The agency is requesting specific data and
information on the lead levels and the methods for detecting lead in
these substances. Additionally, the agency is requesting information on
the economic and environmental effects of lowering the lead levels.
DATES: Comments and information provided by May 5, 1994.
ADDRESSES: Submit written comments and information to the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Helen R. Thorsheim, 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: In this advance notice of proposed
rulemaking (ANPRM), the agency is announcing its intention to decrease
the amount of lead derived from food and color additives and GRAS food
ingredients in the diet through several actions. These actions are
prompted by the results of recent studies showing that deleterious
health effects are caused by much lower levels of lead than previous
results indicated, especially in fetuses, infants, and young children.
Also, the development of more sensitive analytical methods has made it
possible to detect lower lead levels in food ingredients.
This ANPRM has four purposes: (1) To discuss the toxic effects of
lead and to describe the multiple sources of lead in the human
environment; (2) to summarize actions that FDA and other Federal
agencies have taken to reduce lead exposures; (3) to discuss available
data and potential exposures to lead from the consumption of food,
including food and color additives and GRAS ingredients used in food;
and (4) to describe the need for new petitions for moderate and high
consumption food and color additives and GRAS ingredients to include
specific information on the levels of lead in these substances. This
information is necessary to assess the substance's contribution of lead
to the diet, and, therefore, whether it is safe for its intended use.
The agency intends to propose new, lower lead specifications for
moderate and high consumption food ingredients that either are the
subject of premarket review or are currently in use, to ensure that the
amount of lead contributed to the diet from the use of these food and
color additives and GRAS ingredients is as low as feasible. The agency
intends to propose adopting specifications of 0.5 part per million
(ppm) for moderate consumption food ingredients and 0.1 ppm for high
consumption food ingredients, unless information is submitted to show
that such levels are not feasible and that higher specifications will
not endanger the public health. Finally, the ANPRM requests specific
information on the lead levels and the methods used to detect lead in
the moderate and high consumption substances identified and on the
economic and environmental effects of lowering the lead levels in these
food and color additives and GRAS ingredients. FDA will review the
information provided in response to this ANPRM before it proposes
modifications to the current specifications for lead in these food and
color additives and GRAS ingredients.
I. Background
A. Lead Toxicity
Lead affects numerous essential body functions and has no known
physiological value. The primary targets of lead are the central and
peripheral nervous systems, the kidneys, and red blood cells. Recent
scientific evidence indicates that lead has deleterious effects on
human health at levels that were once thought to be innocuous. In fact,
there is no known level of lead intake that does not produce adverse
health effects.
FDA discussed the well-documented adverse health effects of lead in
an ANPRM on lead in food published in the Federal Register of August
31, 1979 (44 FR 51233); in a proposed rule on the migration of lead
from ceramic pitchers published in the Federal Register of June 1, 1989
(54 FR 23485); in a proposed rule on tin-coated foil capsules for wine
bottles published in the Federal Register of November 25, 1992 (57 FR
55485); and in a proposed rule on lead-soldered food cans published in
the Federal Register of June 21, 1993 (58 FR 33860). Also, the Centers
for Disease Control and Prevention (CDCP) discuss lead's effects in
their 1991 document entitled ``Preventing Lead Poisoning in Young
Children'' (Ref. 1).
In this ANPRM, FDA's primary concern is the effects of low levels
of lead on fetuses, infants, and children from consumption of food and
color additives and GRAS ingredients used in food. The adverse health
effects of lead exposure in fetuses, infants, and children occur at
lower blood lead levels than in adults. In particular, lead is harmful
to the developing major organs, such as the brain and nervous system,
of these sensitive population groups. Fetuses are sensitive to maternal
dietary lead intake, especially during the development of their nervous
systems. Further, infants and children ingest and absorb a larger
amount of lead per unit of body weight than adults, and they also
retain a larger fraction of absorbed lead.
Blood lead levels of a large number of children in the United
States remain above the toxicity standards recommended by the CDCP
(Ref. 1). Additionally, recent studies show a correlation between
impaired childhood development and lead exposure at levels as low as 10
micrograms/deciliter (g/dL) of lead in blood and below.
Decreased stature or growth, decreased hearing acuity, impaired
neurobehavioral development, and decreased intelligence have all been
linked to these low levels of lead exposure in children (Ref. 1). Lead
also interferes with the synthesis of vitamin D and heme, the iron
containing component of hemoglobin, at blood lead levels of 10 to 15
g/dL.
The symptoms of lead exposure at these low levels are not
pronounced and are therefore difficult to assess. A technique of
grouping data from different studies (meta-analysis), which enhances
the ability to detect a true effect, has been used to retrospectively
analyze 12 studies reported since 1981 on the relationship between
childhood lead exposures and neurobehavioral development (Ref. 2). The
results of this analysis strongly support the hypothesis that there is
an inverse relationship between lead exposure and childhood
intelligence quotient (IQ), even at very low doses. Similarly, a
coordinated study by eight countries showed a significant relationship
between increases in blood-lead concentration and decreases in
behavioral test performance for blood-lead levels ranging from 5 to 60
g/dL (Ref. 3).
Long-lasting adverse effects from low level childhood lead
exposures have also been observed. Early postnatal exposure results in
decreased cognitive performance in the preschool and early school years
(Refs. 4 and 5). Academic success and the fine motor skills of young
adults were also shown to be inversely related to the amount of lead in
the teeth shed by children in the first and second grades (Ref. 6).
Fetuses are also at risk to low levels of lead. The available data
show that the placenta is not a significant barrier to fetal lead
uptake. Maternal and umbilical cord blood-lead levels of 10 to 15
g/dL are associated with reduced gestational age and reduced
weight at birth (Ref. 4). Additionally, there are several studies in
which prenatal blood-lead levels were monitored, followed by monitoring
of the blood-lead level and childhood development for several years
after birth. In most of these studies, prenatal exposures were
associated with slower sensory motor development and delayed early
cognitive development (Ref. 1). Some of these associations may decrease
as the child ages, if postnatal exposures are low, and subsequent
socioeconomic conditions are favorable (Ref. 7).
Adult exposure to lead has been associated with higher occurrences
of cardiovascular disease when blood lead levels are as low as 25 to 30
g/dL (Ref. 8). In particular, there is an increased incidence
of high blood pressure, which may lead to an increase in hypertension-
related diseases. Red blood cell protoporphyrin elevation and
peripheral nerve dysfunction have also been observed at these same
blood lead levels (Ref. 8).
As the amount and duration of lead exposure increases, lead's
effects on the body become more severe. Blood-lead levels above 40
g/dL in all population groups can result in permanent kidney
damage, acute anemia, peripheral nerve dysfunction, and severe
gastrointestinal symptoms. Higher levels of lead affect the central
nervous system. Blood levels greater than 80 g/dL in children
and greater than 100 g/dL in adults can lead to acute
encephalopathy, characterized by massive accumulation of fluid in the
brain, gross mental retardation in children, convulsions, coma, and
even death (Ref. 8).
B. Sources of Lead
Lead is ubiquitous in industrial societies. Known sources of lead
include paint containing lead-based pigments, leaded gasoline, and lead
solder. Lead exposure occurs through pathways such as food, air, dust,
soil, and water. For children under 5 years of age, lead-based paint
remains the primary source of high level lead poisoning, with ingestion
of dust and soils contaminated with this paint being the primary
exposure pathway. In contrast, low level lead exposure in all
population groups is often caused by contributions through a variety of
pathways, with no single source or pathway predominating. Because the
effects of lead from all sources are additive, contributions from any
single source should be well below the amount known to cause
deleterious health effects.
In 1990, FDA estimated that, on average, 16 percent of a 2-year-old
child's lead intake was derived from food (Ref. 9). Most of the rest of
the lead was ingested from dust (75 percent). FDA has also estimated
that women of childbearing age ingest 43 percent of their lead from
food and 53 percent from dust and water. Children, through play and
normal hand-to-mouth activities, ingest larger amounts of lead from
dust and soil than adults.
Lead is introduced into food through a variety of pathways. It can
enter the food chain through water, dust, soil, or air. Naturally
occurring levels of lead in the environment are generally negligible
compared to those caused by humans (Ref. 10). Lead in water comes
primarily from the plumbing systems used for water distribution.
Airborne lead, from the exhaust of cars and machinery that use leaded
gasoline and from industrial activities that emit lead, can be
deposited directly on plants. Lead is also deposited on soil from these
sources. In addition, lead in soils is in part the result of the
historical use of lead-based pesticides. Lead deposited on soil remains
a long-term source of lead exposure because it does not biodegrade or
decay, and it is immobilized by the organic component of soil (Ref.
10).
Food processing also contributes lead to food. Lead can be
introduced through the machinery and water used in food processing,
from food and color additives and GRAS ingredients used in food, and
from food packaging. Cans with lead-soldered seams have been a
predominant source of lead contamination in food in the recent past. If
lead-based paint is present in a food manufacturing or processing
facility, paint dust containing significant quantities of lead may also
contaminate the food.
II. Previous Regulatory Action on Lead
A. FDA Actions
FDA has been involved in reducing the amount of lead in the diet
since the 1930's. Initial efforts were aimed at controlling the use of
lead-containing pesticides on fruits and vegetables. Subsequent
attention has been directed at lead contributions from a variety of
sources including ceramicware, lead-soldered food cans, and tin-lead
capsules for wine bottles.
In the Federal Register of August 31, 1979 (44 FR 51233), the FDA
published an ANPRM (the 1979 ANPRM) that described the sources of lead
in foods, the health concerns arising from the presence of lead in
foods, and the agency's plan to reduce the level of dietary lead intake
derived from the use of lead solder in food cans. The 1979 ANPRM
identified the maximum tolerable level of total lead intake from all
sources. The notice also announced the agency's tentative plan to
reduce contributions of lead from other sources in foods and requested
information on existing lead levels in foods.
The agency also published a proposed rule in the Federal Register
of June 1, 1989 (54 FR 23485) that proposed limitations on the amount
of lead that could leach from ceramic pitchers (excluding creamers)
that are intended for food contact. This document also proposed that
decorative ceramicware that leaches high lead levels must be
permanently labeled or modified in such a way as to preclude its use
for holding foods. The agency recently revised its Compliance Policy
Guide to include lower enforcement level guidelines for ceramic
foodware (July 6, 1992, 57 FR 29734).
Beginning in 1992, FDA has accelerated its actions to reduce the
level of lead in food. In the Federal Register of November 25, 1992 (57
FR 55485), the agency published a proposed rule to prohibit the use of
tin-coated lead foil capsules as coverings on wine bottles. This action
was based on evidence that under ordinary conditions of use, lead in
these capsules can become a component of wine. In that document, the
agency discussed the relationship between lead exposure and lead in
blood and tentatively defined a provisional tolerable total intake
level (PTTIL) for lead from all food and non-food sources. The agency
calculated the PTTIL based on the most up-to-date knowledge of lead's
lowest toxic effect levels. The agency tentatively set the PTTIL at 25
micrograms per day (g/day) for pregnant women, who are
surrogates for fetal exposure, and 75 g/day for other adults.
These values are provisional because they are based on the current
lowest observed effect level (LOEL) of lead in the blood (30
g/dL for adults and 10 g/dL for infants, children,
and pregnant women), which may need to be reduced further if additional
research shows that even lower blood-lead levels cause adverse health
effects.
In a proposed rule published in the Federal Register of January 5,
1993 (58 FR 389), the agency proposed to establish a maximum level of
0.005 milligram per liter (mg/L) as the quality standard for lead in
bottled water.
In a proposed rule published in the Federal Register of June 21,
1993 (58 FR 33860), the agency proposed to ban the use of lead solder
for domestic and imported food cans. In that document, the agency
tentatively defined the PTTIL for infants and children. The agency used
the LOEL of 10 g/dL to arrive at a PTTIL of 6 g/day
for infants and children (Ref. 8). This lower PTTIL is based on the
fact that children absorb lead more efficiently than do adults. In a
notice published in the Federal Register of April 1, 1993 (58 FR
17233), the agency also announced emergency action levels for lead in
foods packed in lead-soldered cans. These action levels are an interim
measure to protect infants and young children from adverse effects that
could result from daily consumption of foods packaged in lead-soldered
cans, pending completion of the rulemaking to prohibit the use of lead
solder in food cans.
In a final rule published in the Federal Register of January 12,
1994 (59 FR 1638), the agency amended its regulations to require that
decorative ceramicware, which may leach hazardous amounts of lead into
food, bear adequate indications to distinguish it from ceramic foodware
(i.e., ceramicware intended for holding, storing, or serving food).
This rule requires a statement and a stick-on label on the exterior
surface of the decorative ceramicware that the piece is not for food
use, and that it may poison food. Alternatively, the rule provides that
a hole may be bored through the possible food-contact surface of the
piece.
B. Other Federal Agency Actions
The elimination of lead poisoning is a coordinated effort by
several Federal agencies. In 1988, the Agency for Toxic Substances and
Disease Registry (ATSDR) published a report to Congress summarizing the
nature and extent of lead poisoning in children. The report found that
in 1984, 17 percent of metropolitan preschool children had blood lead
levels that exceeded 15 g/dL (Ref. 11). In February 1991, the
Department of Health and Human Services announced a ``Strategic Plan
for the Elimination of Childhood Lead Poisoning.'' This document called
for a concerted, society-wide elimination effort and described the need
for a more comprehensive evaluation of blood lead levels and
environmental lead contamination (Ref. 1).
CDCP also addressed the issues of lead toxicity and poison
prevention in children in their October 1991 document entitled
``Preventing Lead Poisoning in Young Children'' (Ref. 1). This document
included multitiered program, based on blood lead levels, that CDCP
devised to replace the previous single definition of lead poisoning.
The CDCP threshold for initiating action to reduce lead exposure was
lowered from 25 g/dL to 10 g/dL in children because
of the large amount of data showing lead's deleterious effects on
development at blood lead levels of 10 g/dL and above. The
CDCP are also helping laboratories to improve the reliability of blood
lead measurements and are developing improved instrumentation for
analysis of blood lead levels.
In 1978, the Consumer Product Safety Commission (CPSC) banned both
paint containing more than 0.06 percent lead by weight and the
deliberate addition of lead to paint for use on residential surfaces,
toys, and furniture. In addition, in the Federal Register of April 30,
1992 (57 FR 18418), the CPSC announced that it was investigating the
further reduction of this maximum allowable limit to 0.01 percent.
Lead-based paint is still available for industrial, marine, and
military use.
In a plan for the abatement of lead-based paint published in 1990,
the U.S. Department of Housing and Urban Development (HUD) found that
approximately 74 percent of occupied, privately-owned houses built
before 1980 still contained lead-based paint. The CDCP report (Ref. 1)
summarizes the results of this report and discusses methods for
decreasing lead exposure in houses painted with lead-based paint.
The Environmental Protection Agency (EPA) has been working for many
years on the removal of lead in gasoline, pesticides, and, more
recently, drinking water (June 7, 1991, 56 FR 26460). EPA has also
recently released a report to Congress outlining a strategy to reduce
human lead exposures from the environment, as summarized in the CDCP
report (Ref. 1). As part of this strategy, EPA published a final rule
on June 30, 1993 (58 FR 35314), that decreased the minimum quantity of
several lead compounds, as emissions from manufacturing facilities,
that must be reported to the agency.
III. Lead in Food and Color Additives and Gras Ingredients
A. Exposure to Lead from Food and Food Ingredients
Based upon the results of FDA's Total Diet Study (the agency's
annual market-basket survey of foods (Ref. 12)), from 1988 through
1990, FDA estimates that 2-year-old children consume about 4.5
g of lead each day from food alone, while women of
childbearing age consume about 9 g/day (Ref. 9). For a 2-year-
old child, lead intake from food is nearly equal to the PTTIL of 6
g/day for lead from all sources, even though food is estimated
to account for only 16 percent of the child's total daily intake of
lead (Ref. 9).
In its 1988 report to Congress, ATSDR estimated that, in 1987,
approximately 1 million young children in this country consumed
sufficient lead in food to cause blood lead levels of 10 g/dL
and greater (Ref. 11).
The relation between dietary lead and lead uptake in the body is
complex. Absorption of lead from the gastrointestinal (GI) tract in
adults is normally about 10 to 15 percent, but it can be as high as 45
percent under fasting conditions (Ref. 8). This difference may be
important, for example, when foods containing lead are consumed between
meals. It has been empirically estimated that for low exposures,
resulting in blood lead levels of up to 30 g/dL, the ingestion
of 1 g of lead per day in the diet results in an increase of
0.04 g/dL of lead in the blood of adults (Ref. 13).
Children are even more efficient at absorbing lead through the GI
tract than are adults, with a rate of absorption of approximately 50
percent (Ref. 8). In children, for exposures resulting in blood lead
levels up to 10 g/dL, every microgram of lead ingested per day
from the diet increases the blood lead level by 0.16 g/dL.
This level is approximately four times as much lead in the blood per
equivalent dose as in adults.
B. Need for Action to Lower Lead Specifications
Since FDA began to regulate food additives in 1958, the agency has
generally considered that the public health was adequately protected by
specifications of 3 ppm for arsenic, 10 ppm for lead, and 40 ppm for
total heavy metals (as lead) (Ref. 14). The agency believed that these
specifications could readily be met in food additives produced under
current good manufacturing practice (CGMP) conditions, and that these
specifications would ensure that food additives would not contribute
significant amounts of heavy metals to the diet. The agency also
believed that the actual heavy-metal levels achieved through adherence
to CGMP's would be significantly lower than these limits (Ref. 15).
When the Food Chemicals Codex was established by the National
Academy of Sciences (NAS) in 1961, the Food Chemicals Codex committee
adopted these specifications for nearly all food additives. These
levels have remained until recently as the levels used as guidance in
establishing specifications in Food Chemicals Codex monographs for food
ingredients.
However, with today's increased knowledge of lead's deleterious
effects at low ingestion levels, it is necessary to decrease lead
specifications for food and color additives and GRAS ingredients to
protect the public health. Specifications must be set at the lowest
lead levels attainable through the diligent application of CGMP's to
ensure that lead is reduced to its lowest possible levels in food.
The potential exists, with the high current levels of lead
specifications, that food and color additives and GRAS ingredients will
contribute significant amounts of lead to the diet. Even if most food
ingredients do not contain the maximum amount of lead permitted by the
specifications, lead ingested from the use of food and color additives
and GRAS ingredients will comprise a small, although not readily
quantifiable, percentage of a person's total dietary lead intake.
Because low level lead exposure is often the result of contributions
from multiple small sources, significant reductions in a person's
overall lead exposure can result from reductions in the levels of lead
in many of those sources. Although some sources may be difficult to
control, the agency believes that industry has the ability to reduce
lead levels in food and color additives and GRAS ingredients, either
through tighter control of starting material purities or improvements
in manufacturing processes.
To illustrate the potential lead exposure from food and color
additives and GRAS ingredients, FDA has calculated the possible per
capita lead intake from the use of those additives and GRAS ingredients
that are added to the U.S. food supply in amounts greater than 25
million pounds per year\1\. These high consumption substances
(currently 38) constitute over 80 percent by weight of all substances
in the 1987 NAS survey. The agency recognizes that the absolute
poundages of these substances may not be accurately portrayed in the
survey because the information is voluntarily reported. However, the
agency believes that the data accurately reflect the relative ranking
of the substances. Therefore, the data are useful for illustrative
purposes and can serve as a means of prioritizing actions on food
ingredients based on relative usage levels.
The 38 substances are listed in Table 1 in decreasing order of
reported use, along with their maximum lead specifications. When
possible, the lead specifications that are either listed or referenced
in FDA regulations for lead or heavy metals (as lead) are shown. If no
lead specification is referenced in FDA regulations, the most recent
specification in the Food Chemicals Codex (Refs. 16 through 18) is
listed. For the few food substances that have no lead specification,
FDA used a lead level of 1 ppm to calculate the potential lead
exposure.
Table 1--Most Widely Used Food Substances and Their Current Lead Specifications\1\
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Substance\2\ Lead Limit\3\ ppm Substance\2\ Lead Limit\3\ ppm
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High fructose corn syrup 0.5 d-Sorbitol 10.0
Sucrose 0.5 Lactose -
Corn syrup 0.5 Calcium oxide 10.0
Corn gluten - Sodium bicarbonate 5.0
Soybean oil 0.1 Mono-diglycerides 10.0
Sodium chloride 4.0 Palm kernel oil 0.1
Sucrose liquid - Phosphoric acid 10.0
Corn oil 0.1 Maltodextrin 0.5
Dextrose 0.1 Iron, reduced 25.0
Whey 10.0 Niacin 20.0
Calcium carbonate 10.0 Sodium phosphate, di- 10.0
Coconut oil 0.1 Monosodium glutamate 10.0
Caramel 10.0 Peanut oil 0.1
Diatomaceous earth 10.0 Casein 5.0
Starch, food, modified 5.0 Azodicarbonamide 10.0
Cottonseed oil 0.1 Calcium sulfate 10.0
Cocoa butter substitute 10.0 Sulfuric acid 5.0
Sodium hydroxide 10.0 Glycerin 5.0
Citric acid 10.0 Sodium citrate 10.0
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\1\Substances are listed in decreasing order of poundage. High volume substances (poundages greater than 100
million pounds per year) are listed on the left, while moderate volume substances (25 million to 100 million
pounds per year) are on the right.
\2\Boldface substances have specifications in the Code of Federal Regulations.
\3\The type of lead specification is indicated by the font type: Boldface type means that the level is an actual
lead specification, italics mean that the lead level is from a specification denoted ``heavy metals as lead,''
and a dash indicates that there is no available lead specification.
Based upon the lead levels listed and the per capita intake of
these substances, FDA calculates that the theoretical maximum per
capita intake of lead from the food use of these 38 widely used
substances could reach 164 g/day if all lead levels were at
their maximum specification limits. Although it is clear from FDA's
total diet study (Ref. 9) that the amount of lead consumed (4.5
g/day for a 2-year-old child and 9 g/day for women of
childbearing age) is not nearly as high as the sum of these
specifications would permit, the calculation illustrates the potential
lead exposure if food and color additives and GRAS ingredients were
consistently produced with lead levels near the specification limits.
It also demonstrates that these specification levels are collectively
well in excess of the levels of lead in the ingredients actually being
added to food.
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\1\This calculation is based upon disappearance data from a 1987
survey by the NAS on the quantities of food substances added by the
U.S. industry to food (Ref. 19). FDA recognizes that disappearance
data identify the amounts of substances available for use in food
and food processing, but do not necessarily mean that all of these
amounts are consumed in food.
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The agency has also calculated the potential effect on the
ingestion of lead if all of the lead specifications for these 38
substances were reduced. If the agency were to replace the current lead
specifications with lower lead levels of 0.1 ppm for high volume
substances (those with disappearance poundages greater than 100 million
pounds/year) and 0.5 ppm for those of moderate volume (between 25
million and 100 million pounds per year), FDA has estimated that the
theoretical per capita intake of lead from these 38 most widely used
food ingredients could be reduced from 164 g/day to 13
g/day (Refs. 19 and 20). Although lead levels are generally
not as high as current lead specifications allow, lowering these
specifications is likely to have the effect of lowering lead exposure.
Manufacturers will be more concerned about monitoring and controlling
the lead content of their products to ensure that the lead levels are
substantially below the new specification levels, and that the normal
variations in lead content that occur from batch to batch do not
produce a violative product. Also, lower lead specifications will
protect subsets of the population that might eat food that has been
produced with food ingredients containing unusually high lead levels,
if, for example, a particular manufacturer uses a process that results
in the food ingredient having a higher level of lead than average.
As a further illustration, the agency has calculated the potential
decrease in lead intake from reduction of lead specifications in a
specific color additive, caramel. Caramel currently has a 10 ppm lead
limit specification in FDA regulations (21 CFR 73.85). However, the
food industry usually controls for contaminants at levels that are
significantly lower than the established specification levels to ensure
that all production batches will be in compliance. From informal
conversations with industry, the agency believes that a reasonable
control level might be one-fifth the specification level. Using the
data from the 1987 NAS poundage survey (Ref. 19), and assuming that all
caramel is produced with lead levels at one-fifth the specification, or
2 ppm, the agency calculates that the potential per capita lead
exposure from caramel could still be as high as 1.6 g/day.
Reducing the specification to 0.1 ppm could result in a potential 100-
fold reduction in lead levels in caramel.
High fructose corn syrup (HFCS), one of the most heavily used food
ingredients in the United States according to the NAS poundage survey,
illustrates the efforts industry has made to aid FDA and a Food
Chemicals Codex committee in setting lower lead specifications that
more accurately reflect actual lead levels. HFCS has been commercially
produced since 1967, and FDA listed HFCS containing 43 percent fructose
as GRAS in 1983 (21 CFR 182.1866). The listing, however, does not
include any specifications for impurities such as lead. In the absence
of lead specifications, industry was guided by the Food Chemicals Codex
committee's general impurities policy that included a 10 ppm lead
specification (Ref. 16). It was not until 1986 that a Food Chemicals
Codex monograph was developed for HFCS, which set a lead specification
of 1 ppm (Food Chemicals Codex, 3d ed., 2d supp. (Ref. 17)). The Food
Chemicals Codex lead specification was further reduced in 1992 to 0.5
ppm as a result of cooperative interactions between FDA, the Food
Chemicals Codex, and industry. In response to a request by the agency
in 1990, industry provided preliminary data on lead levels in a small
sampling of HFCS measured by methods that are more sensitive than
routine quality control methods. Actual lead levels ranged between
0.002 and 0.073 ppm in the samples analyzed (Refs. 21 and 22). Although
measurements with this level of sensitivity are not yet done on a
routine basis, these results suggest the actual amounts of lead in
HFCS. Using these measurements, a 12-ounce (oz) can of soda that
contains 10 percent HFCS probably contains lead in the range of 0.07 to
2.6 g, whereas existing lead specifications would allow 18
g of lead. Lowering the specification for lead in HFCS to 0.1
ppm would reduce the maximum allowable lead from HFCS in a 12 oz can of
soda to 3.6 g.
C. Changes in Food Chemicals Codex Lead Specifications
As part of FDA's initiative to reduce lead in food, the agency has
been working with the Food Chemicals Codex committee of the NAS to
review lead specifications for selected food ingredients. The 3d
edition of the Food Chemicals Codex and its four supplements contain
specifications and analytical methodologies for over 900 food
ingredients. The specifications are used by food processors and
manufacturers of food ingredients in the United States and in other
countries as guidelines for their products' purity. The specifications
are also often incorporated by reference into FDA's regulations for
food and color additives and GRAS ingredients.
The agency's concerns regarding lead levels in food ingredients
were presented to the Food Chemicals Codex committee during a workshop
on May 2, 1991. For many substances, the Food Chemicals Codex currently
specifies a 10-ppm lead limitation (see section III.B. of this
document). Following the workshop, the Food Chemicals Codex committee
updated its policy for establishing lead specifications for food
ingredients. Previously, lead specifications were set at the lowest
practicable levels based on CGMP and the capability of analytical
methodology to determine the lead level in individual food ingredients.
The Food Chemicals Codex committee's policy, announced in the Federal
Register of July 15, 1993 (58 FR 38129), now provides that the Food
Chemicals Codex will set lead specifications by also considering the
estimated lead intake from use of the food ingredient and the potential
health hazard of these intake levels, in a fashion similar to that
which the agency is considering.
As an outgrowth of the Food Chemicals Codex committee workshop, new
and revised lower lead specifications have been published for several
food ingredients in the Food Chemicals Codex (3d ed., 3d supp. (Ref.
18)). For example, included are lead specifications of 0.1 ppm for
dextrose and fructose and 0.5 ppm for less refined products, such as
glucose syrups, maltodextrin, and polydextrose. The Food Chemicals
Codex committee has been reviewing and revising the lead specifications
for other food and color additives and GRAS ingredients as well (Ref.
23). The Food Chemicals Codex committee is expected to continue
reducing lead specifications in future monograph revisions for
inclusion in the fourth edition of the Food Chemicals Codex.
IV. Changes in FDA Lead Specifications
Because of the possibility that significant amounts of lead might
be introduced into food from regulated food and color additives and
GRAS ingredients, and because of the increased knowledge of the
deleterious health effects of low level lead exposure, FDA has started
to take action to limit the potential dietary intake of lead from these
sources. Based on the considerations discussed in section III. of this
document, the agency is focusing on high and moderate consumption
substances, such as those listed in Table 1 of this document.
The agency has begun requesting that information on lead levels be
included in certain food and color additive and GRAS affirmation
petitions. FDA is asking that petitions for either new uses of
regulated high and moderate consumption substances, or new substances
that are expected to be consumed in significant quantities, show that
lead levels in the petitioned products are as low as CGMP's allow.
Given the toxicity of lead, such evidence is necessary if the agency is
to make a determination on the safety of the additive for its proposed
use. The agency will evaluate the data that it receives on lead levels
during the petition review process and set lead specifications at
levels that are necessary to ensure that there is a reasonable
certainty of no harm from use of the additive.
Lower specifications, to be meaningful, will need to be supported
by analytical methods that allow quantification of lead at the reduced
levels. Recent advances in instrumentation should allow for reliable,
quantitative detection of lead in food ingredients at much lower levels
than possible with previous analytical methods. For example, in the
Food Chemicals Codex (3d ed., 3d supp. (Ref. 18)), a graphite furnace
atomic absorption spectrophotometric method is described that detects
lead in substances such as edible oils at levels less than 1
g/g (1 ppm) of lead. A similar method has been developed for
nutritive sweeteners (Ref. 24). Development of more sensitive routine
analytical procedures or expertise in more sophisticated methods will
facilitate routine testing for lead below 0.1 ppm and will enable
industry to further control and eliminate lead from food ingredients.
Thus, the agency is asking petitioners to provide analytical
methodologies that are capable of detecting lead at sub-ppm levels and
to show that these methodologies have been validated.
FDA recognizes the need to lower its lead specifications for high
and moderately high consumption food and color additives and GRAS
ingredients to ensure that their use is safe. Thus, in the absence of
persuasive comments to the contrary, the agency intends to propose
setting specifications at 0.1 ppm lead for high-poundage ingredients
(greater than 100 million pounds per year, such as substances in the
left column of Table 1) and 0.5 ppm lead for moderately high-poundage
ingredients (between 25 and 100 million pounds per year, such as
substances in the right column of Table 1). FDA plans to propose
establishing these specifications for new ingredients, new uses of
previously regulated ingredients, and currently regulated ingredients.
Also, FDA is considering only adopting Food Chemicals Codex lead
specifications for individual ingredients when it finds that the levels
are low enough to protect the public health.
Comments on these approaches to setting specifications for lead,
and suggestions for alternative approaches for developing consistent
lead specifications for all current and future uses of food and color
additives and GRAS ingredients that still protect the public health,
are requested.
V. Request for Information
Although FDA has extensive information concerning lead in its
files, additional information on the following topics will greatly
assist the agency both in setting specifications for lead in food and
color additives and GRAS ingredients and in minimizing the exposure to
lead in a consistent manner:
1. Current data on actual lead levels in: (a) Food and color
additives and GRAS ingredients, the variation in these levels, and
suggested lead specifications for each substance. Of particular
interest are the high consumption substances in the left column of
Table 1 of this document and the moderate consumption substances in the
right column of Table 1. Also of interest are other substances that,
although consumed at a lower rate, contain sufficiently high levels of
lead to be of concern; (b) agricultural commodities that are raw
materials for many food ingredients; and (c) nutrient supplements
(e.g., calcium, iron).
2. Analytical methods for detecting sub-ppm levels of lead in food
components, including detection limits, reliability of the methods for
different food and color additives and GRAS ingredients, and validation
data. Of particular interest are improvements in graphite furnace
atomic absorption spectrophotometry and studies of its applicability to
the 38 substances listed in Table 1.
3. Information on the potential economic impact, if any, associated
with the manufacture of the 38 food and color additives and GRAS
ingredients listed in Table 1 if the lower lead levels are adopted. FDA
is required to assess the economic consequences of any regulation it
proposes, but it does not possess data that would permit detailed
assessment of the economic impact of adopting lower lead
specifications.
4. Information on the potential environmental impact that may be
associated with the manufacture of the 38 food and color additives and
GRAS ingredients if lower lead specifications are adopted. Under the
National Environmental Policy Act, FDA must consider the environmental
impact of its actions. However, the agency does not now possess the
data that would permit detailed analysis of the environmental impact of
adopting lower lead levels. Therefore, the agency is requesting
environmental information that includes, but is not limited to, the
following: (a) A description of the additional steps, if any, required
to produce these food and color additives and GRAS ingredients with the
reduced lead specifications and of the environmental impact of these
steps; (b) the environmental impact of additional testing, if any,
performed to ensure compliance with the lower lead specifications; and
(c) a description of measures that could be taken to avoid or mitigate
adverse environmental impacts, if such impacts are predicted to result
from this action.
VI. Conclusion
FDA has had a longstanding goal of reducing lead exposure from all
dietary sources. Because lead is ubiquitous, and exposure to lead is
from a multitude of different sources, lead levels from each source
must be sufficiently low to ensure that a person's total lead exposure
is not harmful. The agency believes that lead specifications in food
and color additives and GRAS ingredients can be lowered to help achieve
this goal and protect the public health. Therefore, the agency intends
to lower lead specifications in food and color additives and GRAS
ingredients that are consumed in large amounts by the general
population to levels that will offer adequate protection.
FDA plans to propose lead specifications of 0.5 ppm for moderate
consumption food ingredients and 0.1 ppm for high consumption food
ingredients. The agency is requesting information on current lead
levels in food ingredients and analytical methods for determining these
lead levels, and on the economic and environmental effects of complying
with these specifications. The information received in response to this
ANPRM will be used to determine the feasibility of adopting these
target specifications. The agency intends to propose these
specifications unless information is submitted to show that such levels
are not feasible and higher specifications will not endanger the public
health.
VII. 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. CDCP, Department of Health and Human Service, Public Health
Service, ``Preventing Lead Poisoning in Young Children,'' October
1991.
2. Needleman, H. L., and C. A. Gatsonis, ``Low-Level Lead
Exposure and the IQ of Children,'' Journal of the American Medical
Association, 263:673-678, 1990.
3. Winneke, G., A. Brockhaus, U. Ewers, U. Kramer, and M. Neuf,
``Results from the European Multicenter Study on Lead Neurotoxicity
in Children: Implications for Risk Assessment,'' Neurotoxicity and
Teratology, 12:553-559, 1990.
4. Bellinger, D., A. Leviton, C. Waternaux, H. Needleman, and M.
Rabinowitz, ``Longitudinal Analyses of Prenatal and Postnatal Lead
Exposure and Early Cognitive Development,'' New England Journal of
Medicine, 316:1037-1043, 1987.
5. Baghurst, P. A., A. J. McMichael, N. R. Wigg, G. V. Vimpani,
E. F. Robertson, R. J. Roberts, and S. L. Tong, ``Environmental
Exposure to Lead and Children's Intelligence at the Age of Seven
Years: The Port Pirie Cohort Study,'' New England Journal of
Medicine, 327:1279-1284, 1992.
6. Needleman, H. L., A. Schell, D. Bellinger, A. Leviton, and E.
N. Allred, ``The Long-Term Effects of Exposure to Low Doses of Lead
in Childhood: an 11-year Follow-up Report,'' New England Journal of
Medicine, 322:83-88, 1990.
7. Bellinger, D., J. Sloman, A. Leviton, M. Rabinowitz, H. L.
Needleman, and C. Waternaux, ``Low-Level Lead Exposure and
Children's Cognitive Function in the Preschool Years,'' Pediatrics,
87:219-227, 1991.
8. Memorandum, dated November 18, 1991, from Contaminants Team,
Standards and Monitoring Branch, to Additives Evaluation Branch,
``Clarification of Terminology Used in the Development of the
Provisional Total Tolerable Intake Levels for Lead.''
9. Bolger, P. M., C. D. Carrington, S. G. Capar, and M. A.
Adams, ``Reductions in Dietary Lead Exposure in the United States,''
Chemical Speciation and Bioavailability, 3:31-36, 1991.
10. Elias, R. W., ``Lead Exposures in the Human Environment,''
in Dietary and Environmental Lead: Human Health Effects, edited by
K. R. Mahaffey, Elsevier Science Publishers, B. V., Amsterdam, pp.
79-107, 1985.
11. Agency for Toxic Substances and Disease Registry, Public
Health Service, ``The Nature and Extent of Lead Poisoning in
Children in the United States: A Report to Congress,'' pp. (VI-44)-
(VI-49), July 1988.
12. Pennington, J. A. T. and E. L. Gunderson, ``History of the
Food and Drug Administration's Total Diet Study--1961 to 1987,''
Journal of the Association of Official Analytical Chemists, 70:772-
782, 1987.
13. Carrington, C. D. and P. M. Bolger, ``An Assessment of the
Hazards of Lead in Food,'' Regulatory Toxicology and Pharmacology,
16:265-272, 1992.
14. Excerpts from ``Chemical Problems Encountered in the
Administration of the Food Additives Amendment,'' a speech given by
L. L. Ramsey at ``Symposium on Analytical Methods for Food Additive
and Pesticide Chemicals,'' American Chemical Society, New York, NY,
September, 1960.
15. Excerpt from Food Chemicals Codex Advisory Panel Bulletins,
December 1962, letter from Dr. Henry Fischbach, FDA, to Dr. Justin
L. Powers, Food Chemicals Codex Director, NAS.
16. Food Chemicals Codex, 3d ed., National Academy Press,
Washington, DC, 1981.
17. Food Chemicals Codex, 3d ed., 2d supp., National Academy
Press, Washington, DC, 1986.
18. Food Chemicals Codex, 3d ed., 3d supp., National Academy
Press, Washington, DC, 1992.
19. Memorandum, dated July 17, 1992, from Food and Color
Additives Review Section, to Indirect Additives Branch, ``Lead in
Food Additives--Hypothetical Effects on Dietary Lead Intake of
Lowering Lead Specifications.''
20. Memorandum, dated December 16, 1993, from Chemistry Review
Branch, to Indirect Additives Branch, ``Lead in Food Additives.
Fructose Disappearance Data and Predicted Lead Intake. Request for
Additional Information dated 12-14-93.''
21. Letter, dated February 5, 1990, from Kyd D. Brenner, Corn
Refiners Association, Inc., to John W. Gordon, FDA.
22. Letter, dated March 22, 1990, from Kyd D. Brenner, Corn
Refiners Association, Inc., to John W. Gordon, FDA.
23. Bigelow, S. W., ``Role of the Food Chemicals Codex in
Lowering Dietary Lead Consumption: A Review'' Journal of Food
Protection, 55:455-458, 1992.
24. ILSI North America, Subcommittee on Trace Minerals in Foods,
``Report to the FCC Committee on Methodology for Lead in
Sweeteners,'' June 28, 1993.
VIII. Comments
Interested persons may, on or before May 5, 1994, submit to the
Dockets Management Branch (address above) written comments regarding
this advance notice of proposed rulemaking. 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.
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.
Dated: January 12, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-2472 Filed 2-3-94; 8:45 am]
BILLING CODE 4160-01-F
