BILL ANALYSIS �
AB 1400
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CONCURRENCE IN SENATE AMENDMENTS
AB 1400 (Jobs, Economic Development, and the Economy Committee)
As Amended September 3, 2013
Majority vote
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|ASSEMBLY: |70-0 |(May 16, 2013) |SENATE: |39-0 |(September 9, |
| | | | | |2013) |
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Original Committee Reference: J., E.D. & E.
SUMMARY : Makes changes in the state's administration of the
Export Document Program to address an existing backlog and
streamline the process in the future. Specifically, this bill :
1)Requires the Department of Public Health (DPH), to accept
requests for an export document through electronic methods,
including email.
2)Requires DPH to develop procedures to expedite approval of
export document requests when the department previously
approved a request and the label remains unchanged.
3)Extends the term of the export document from 180 days (six
months) to one year.
The Senate amendments clarify the process and conditions by
which DPH will be paid on export document requests made through
email and fax.
EXISTING LAW authorizes, under the Sherman Food, Drug, and
Cosmetic Law, a person who ships to another state or country to
request the DPH to issue a specified export document, which
states that the department does not object to the sale of the
food, drug, device, or cosmetic in this state or the shipment of
the product to any state or country.
In order to make the request, the food, drug, device, or
cosmetic is required to be manufactured or produced in this
state by an individual who has a valid registration, license,
certificate, or permit, as specified. The document request must
include all labels and advertising relating to the product, and
the approximate date of the shipment. Applicants may also
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request and additional statements be incorporated into the
export document. The export label is required to be provided
within five days of application and expires after 180 days.
FISCAL EFFECT : According to the Senate Appropriations
Committee, the Department of Public Health would incur $160,000
(Special Funds) for upgrades to the existing information
technology system and approximately $25,000 (Special Funds)
ongoing to manage the upgraded information technology system.
COMMENTS : This measure, a committee bill, was introduced to
address DPH's significant backlog of requests for export
documents. Statute requires export documents to be provided
within five days, however, the department admits to delays of up
to five to eight weeks.
While businesses are not required to obtain certificates under
California law, other countries often require the certificates
for imported products in order to certify that the manufacturer
and its products are subject to the health standards required by
the DPH. Prior to applying for these export documents, the
manufacturer must already hold valid permits, certificates,
registrations, and licenses to produce products in California.
By improving the process times and extending the term of the
export document, businesses will be able to arrange export
transportation with more certainty and thereby reduce costs and
meet contractual obligations.
Export Document Program: The Export Document Program was
established in 1991 for the purpose of ensuring the public of
the safety of foods, drugs, medical devices, and cosmetics.
There are two factors that the Food and Drug Branch (FDB) of the
DPH uses to determine whether an export document should be
issued to manufacturers. First, following inspections of the
state's manufacturers, distributors, and wholesalers, FDB
determines whether the system of manufacture and quality control
used to produce the product is adequate. The second factor the
FDB considers is whether the product is labeled properly, which
is determined by a review of the product at the time the export
document is requested.
Foreign countries are increasingly requiring export documents.
In 2001, there were 1,731 requests vs. 9,500 requests in 2012.
Although the program has seen significant increases in export
document requests, the staffing levels have remained at their
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initial 1991 levels of one full-time staff service analyst and a
half-time office technician.
The Export Label Program is funded through user fees, which are
deposited in the Export Document Program Fund and available
through an appropriation by the Legislature. By statute,
applicants pay a one-time fee of $100 and a service charge at
the rate of $80 per hour, at a minimum of $25 per request.
Additional costs incurred by DPH may also be required, such as
the need for additional inspection, priority mailing, or notary
services. All fees are required to be itemized and disclosed on
the statement or invoice. In no case can the fees exceed the
reasonable costs of administering the program.
Budget Change Proposal: According to the Assembly Budget
Committee documents, the FDB believes that the eight week
backlog is, in part, due to the increase in specialized
applications, which require multiple product labels, labeling
and advertising, special wording, and notary services. These
requests are further complicated by FDB's lack of scientific or
research staff to assist in the more technical and specialized
label reviews.
The FDB has requested permanent expenditure authority from
Special Funds of $287,000 in 2013-14 and $281,000 ongoing and
three full-time permanent positions for the Export Document
Program. The Legislative Analyst's Office analysis has reviewed
the proposal and states that they have not identified any
issues. The Assembly Budget Subcommittee No. 1 on Health and
Human Services took testimony on the issue at their March 1,
2013, hearing.
Hearing testimony in support of the budget augmentation by the
Grocery Manufacturer Association also included recommendations
to extend the term of the certificate from 180 day to one year
and to allow for electronic, on-line submittal of applications.
This bill makes the statutory changes to implement these
recommendations.
Analysis Prepared by : Toni Symonds / J., E.D. & E. / (916)
319-2090
FN: 0002108
AB 1400
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