[Federal Register Volume 61, Number 86 (Thursday, May 2, 1996)]
[Rules and Regulations]
[Pages 19542-19544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10893]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 500, 582, and 589
[Docket No. 94G-0239]
GRAS Status of Propylene Glycol; Exclusion of Use in Cat Food
AGENCY: Food and Drug Administration, HHS.
[[Page 19543]]
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to exclude from generally recognized as safe (GRAS)
status the use of propylene glycol (PG) in or on cat food. This final
action is based on FDA's review of currently available information
which has raised significant questions about the safety of this use.
Semimoist pet foods containing PG were not in existence when the GRAS
status of PG for use in animal feeds was established, thus the agency's
prior GRAS determination does not apply to the newly intended uses of
PG.
EFFECTIVE DATE: June 3, 1996.
FOR FURTHER INFORMATION CONTACT: David A. Dzanis, Center for Veterinary
Medicine (HFV-222), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0169.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 10, 1995 (60 FR 24808), FDA issued a
proposed rule to amend the animal drug regulations to exclude from GRAS
status the use of PG in or on cat food. In the proposed rule of May 10,
1995, the regulatory history of PG was reviewed as well as the last 13
years of scientific literature on the safety of PG in cat food. FDA
concluded that there are significant questions about the safety of PG
in cat food. FDA also concluded that PG is not GRAS as an ingredient of
cat food, and the use is not subject to a prior sanction. When used in
or on cat food, PG is deemed to be a food additive, subject to section
409 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
348), and its use in cat food must be in accordance with a published
food additive regulation. Comments by the public on the proposed rule
were requested to be submitted by July 24, 1995.
II. Comments on the Proposed Rule
In response to publication of the proposed rule to amend the GRAS
status of PG to exclude its use in cat foods, three parties submitted
comments: Two manufacturers of PG, and one pet food industry
association. One party offered unconditional support of the proposed
rule. The other two parties offered comments to amend the proposed rule
to allow for limited use of PG.
1. One comment argued for the need for PG as a carrier for
antioxidants added to cat food. Antioxidants are needed to prevent
oxidation of unsaturated fats and other components of cat foods, which
could adversely affect nutritional and organoleptic properties of the
products. The amount of PG in the finished food stemming from such use
was estimated to be 0.0009 to 0.007 percent (9 to 70 milligrams per
kilogram (mg/kg).
FDA agrees that the judicious use of antioxidants serves a vital
role in preserving the freshness and quality of cat foods. FDA has
previously reviewed data relative to the use of PG as an antioxidant
carrier and estimates the ``worst case'' inclusion level in the
finished food to be less than 0.02 percent (200 mg/kg) on a dry matter
basis. In such cases, PG would no longer serve any technical or
functional effect in the finished food and would be present at
insignificant levels. Regardless, no argument was made that PG was
unique in its ability to serve as an antioxidant carrier, or that a
suitable substitute for PG was unavailable or impractical.
2. Two comments argued that an establishment of an adequate safety
margin below the known ``no-observed-effect-level'' (NOEL) for cats and
kittens should allow for limited use of PG. The most conservative known
NOEL for growing kittens is 0.135 percent (1,350 mg/kg), well below the
expected levels of inclusion resulting from its use as an antioxidant
carrier. Thus, establishment of an acceptable daily intake level at
some level below the NOEL should allow for safe use of PG in cat foods.
FDA agrees that the estimated level of PG in cat foods resulting
from its use as an antioxidant carrier appears to offer an adequate
margin of safety relative to the known NOEL. Thus, FDA's primary
regulatory concern at this time is limited to cat foods containing PG
at levels exceeding 0.02 percent. However, FDA does not believe that a
specific level of PG for inclusion in cat food can be based solely on
the existing NOEL. This is because the NOEL was determined on the basis
of the presence or absence of Heinz bodies in a study performed in
1979, and it has not been subject to reassessment using the more
sensitive methods available today to evaluate possible adverse effects.
The more current studies using more specific indicators of red blood
cell damage did not look at effects near the existing NOEL, nor did
they establish an NOEL in and of themselves. Also, although data are
known on the effects of PG on adult cats and growing kittens, there are
no data on the potential effects of PG on other life stages of cats.
For example, the possible congenital effects stemming from the feeding
of PG to pregnant cats has not been adequately assessed.
III. Conclusion
The proposed rule has not been changed as a result of received
comments. Therefore, the final rule provides that PG for use in cat
food is not GRAS and is a food additive subject to section 409 of the
act.
IV. Environmental Impact
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
V. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, this final
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
This assessment analyzes the economic effects of this rule to
exclude from GRAS status the use of PG in or on cat food. PG is used as
a humectant, plasticizer, and microbiological preservative in semimoist
cat food. Semimoist cat foods containing PG did not exist when the GRAS
status for its use in animal feeds was established, and this GRAS
determination does not apply to the newly intended use of PG. Currently
available information on the effects of PG demonstrates serious
concerns about its safety in cats.
FDA requested that pet food manufacturers discontinue the use of PG
as an ingredient in semimoist cat foods in 1992. The majority of
manufacturers in the industry have complied with this request. Agency
experts estimate that
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PG is currently used in at most 5 percent of semimoist cat foods and at
most 10 percent of cat snacks, which are similar in texture and content
to semimoist foods. These usage rates continue to decline.
FDA estimates of 1993 sales of semimoist cat foods and snacks to
U.S. households are $85 million and $53 million, respectively (Neilsen
Marketing Research data). Those sales representing semimoist cat foods
and cat snacks which contain PG are approximately $9,550 million (5
percent of $85 million plus 10 percent of $53 million). The effect of
this rule would be to replace these sales with other cat foods and cat
snacks not containing PG. Most of the industry has already substituted
glycerin for PG in semimoist foods and snacks. It is likely that the
remaining portion of the industry would make the substitution of
glycerin for PG rather than surrender their share of the semimoist cat
food and cat snack market. The cost of this substitution to the
production process is expected to be small.
Purchases of PG by semimoist cat food and cat snack manufacturers
represent a very small percentage of total PG sales, estimated at less
than 1 percent. Demand for semimoist cat foods has declined
considerably since 1987. Although demand for cat snacks continues to
grow, its sales are still a small part of the total pet food industry.
Thus, the effect of this final rule on PG manufacturers would also be
small. The effects of this final rule on small businesses would not be
substantial. Although more small sized companies are involved in
manufacturing cat snack foods than in semimoist foods, their costs of
compliance would not be significant.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. For the above reasons, the agency certifies that
this rule will not have a significant economic impact on a substantial
number of small entities. Therefore, under the Regulatory Flexibility
Act, no further analysis is required.
VI. Federalism
FDA has analyzed this rule in accordance with the principles and
criteria set forth in Executive Order 12612 and has determined that
this rule does not warrant the preparation of a Federalism Assessment.
List of Subjects
21 CFR Part 500
Animal drugs, Animal feeds, Cancer, Labeling, Polychlorinated
biphenyls (PCB's).
21 CFR Parts 582 and 589
Animal feeds, Animal foods, Food additives.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
500, 582, and 589 are amended as follows:
PART 500--GENERAL
1. The authority citation for 21 CFR part 500 continues to read as
follows:
Authority: Secs. 201, 301, 402, 403, 409, 501, 502, 503, 512,
701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331,
342, 343, 348, 351, 352, 353, 360b, 371).
2. New Sec. 500.50 is added to subpart B to read as follows:
Sec. 500.50 Propylene glycol in or on cat food.
The Food and Drug Administration has determined that propylene
glycol in or on cat food is not generally recognized as safe and is a
food additive subject to section 409 of the Federal Food, Drug, and
Cosmetic Act (the act). The Food and Drug Administration also has
determined that this use of propylene glycol is not prior sanctioned.
PART 582--SUBSTANCES GENERALLY RECOGNIZED AS SAFE
3. The authority citation for 21 CFR part 582 continues to read as
follows:
Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).
4. Section 582.1666 is amended by revising paragraph (b) to read as
follows:
Sec. 582.1666 Propylene glycol.
* * * * *
(b) Conditions of use. This substance is generally recognized as
safe (except in cat food) when used in accordance with good
manufacturing or feeding practice.
PART 589--SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
5. The authority citation for 21 CFR part 589 continues to read as
follows:
Authority: Secs. 201, 402, 409, 701, of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).
6. New Sec. 589.1001 is added to subpart B to read as follows:
Sec. 589.1001 Propylene glycol in or on cat food.
The Food and Drug Administration has determined that propylene
glycol in or on cat food has not been shown by adequate scientific data
to be safe for use. Use of propylene glycol in or on cat food causes
the feed to be adulterated and in violation of the Federal Food, Drug,
and Cosmetic Act (the act), in the absence of a regulation providing
for its safe use as a food additive under section 409 of the act,
unless it is subject to an effective notice of claimed investigational
exemption for a food additive under Sec. 570.17 of this chapter, or
unless the substance is intended for use as a new animal drug and is
subject to an approved application under section 512 of the act or an
effective notice of claimed investigational exemption for a new animal
drug under part 511 of this chapter.
Dated: April 23, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-10893 Filed 5-1-96; 8:45 am]
BILLING CODE 4160-01-F