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Voluntary Report - public distribution

**Date:** 7/30/2003

**GAIN Report Number:** JA3052

JA0000

**Japan**

**Sanitary/Phytosanitary/Food Safety**

**New Chemical and Pesticide Regulations**

**2003**

**Approved by:**

![](media/image1.wmf)Kevin Latner

#### U.S.Embassy

**Prepared by:**

Tetsuo Hamamoto

**Report Highlights:**

The government of Japan (GOJ) will change the way it controls farm
chemicals. In the fall the GOJ will issue provisional pesticide maximum
residue limits (MRL). After the 3-year transition period, imports must
comply with MRL on this list or the final list, which will be based on
risk assessments by the GOJ. During the 3-year transition period, for
products without MRL in Japan, residue levels must be safe, usually
meaning they must comply with the stricter of Codex or U.S. standards.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Tokyo \[JA1\]

\[JA\]

The government of Japan (GOJ) will change the way it controls farm
chemicals. In the fall the GOJ will issue draft provisional pesticide
maximum residue limits (MRL). The GOJ will also begin risk assessments
to set MRL. At the end of the 3-year transition period, chemicals with
risk assessments will have their MRL established on a final list. The
MRL for chemicals without a risk assessments performed by the GOJ will
remain on the provisional list. After the transition period, all
products sold in Japan, including imports must comply with either the
provisional or final MRL list. During the transition period, residues
levels on products without an MRL must be safe. Usually this means the
stricter of Codex or the exporting country standards. After the
three-year transition period, MRL not on the provisional or final lists
of chemicals will be illegal. The GOJ intends to replace the provisional
MRL with final MRL based on full risk assessment for all farm chemicals,
but has not determined an expiration date for the provisional list.

# Principal Regulators: Ministry of Health, Labor and Welfare

The Ministry of Health, Labor and Welfare (MHLW) will transition from a
negative list approach to a positive list approach for the regulation of
pesticides, veterinary drugs, and feed additives. Implementation will be
over a three-year transition period. In the past, residues from
chemicals without MRL in Japan were permitted on U.S. exports if residue
levels were considered as safe. MHLW has generally recognized safe
residues levels as those established by Codex or, where there is no
Codex standard, within the limits of U.S. regulations. This will
continue during the transition period. During the transition period, the
GOJ will also develop a list of permitted chemicals. This will be based
on existing internal risk assessments, as well as those from Codex and
other country risk assessments, including the U.S. Environmental
Protection Agency (USEPA). After the transition period, only listed
chemicals with MRL will be considered safe.

# Transition Period Includes a Provisional List Based on Other\'s Risk Assessments

The GOJ will implement the new system over a three-year transition
period. The first phase is to establish provisional maximum residue
limit (MRL) based on Ministry of Agriculture, Forestry and Fisheries
(MAFF) registrations for domestic uses, existing MHLW MRL, Codex MRL,
and science-based MRL established by other countries. During the summer
of 2003, an advisory committee will meet to develop an outline of how
provisional MRL will be set. Japan intends to announce a draft list of
provisional MRL for comments at the end of the summer 2003. The GOJ
foresees a possible need for a subsequent revision and a second
notification to the WTO. During the transition period, chemicals not on
the positive list will be handled according to MHLW\'s traditional
approach of referencing Codex or the exporting country MRL in order to
determine whether the chemical is safe.

# MHLW Willing to Amend the Provisional List During the Transition Period

During the transition period, MHLW indicated they would look favorably
at U.S. requests for newly approved chemicals in the U.S. to be added to
the provisional list. The transition period will conclude when MHLW
establishes a final list. The final list will include those chemicals
for which the GOJ has completed a risk assessment. MRL based on risk
assessments done by Codex or foreign countries will remain on the
provisional list. The provisional list will come into force after the
transition period. The GOJ has not indicated a sunset on the provisional
list.

# GOJ Will Rely on USEPA Risk Assessments 

MHLW indicated that it will rely on risk assessments provided by other
agencies in developing the provisional list, including MAFF, Codex and
foreign countries. The GOJ demonstrated several possible scenarios where
different risk assessment bodies could provide different MRL, leaving
MHLW with a dilemma in deciding which MRL to adopt as a provisional MRL
in Japan. MHLW suggested that the precedence for adopting MRLs, where
they differ, would be the higher of MAFF and Codex, and then consensus
standards in foreign countries. If the product is only approved in the
U.S., the GOJ indicated it would positively consider accepting that MRL.

# Determining a Final List of MRLs

The GOJ has not yet announced data requirements or risk assessment
procedures for the establishment of permanent MRL for chemicals used in
other countries. They intend to consult widely with other countries as
well as expert advisory panels to determine the approach. Japan also
indicated that they intend to develop a specific policy for the
establishment of import MRL, so that residues of pesticides that are not
registered for use in Japan can be evaluated and a MRL established.

# Tolerance Discussed for Farm Chemicals Unapproved for a Particular Use and for Downstream Products

The GOJ indicated that it is evaluating an appropriate approach for
identifying a default enforcement level, but that no decisions have been
made. They also indicated that they have not yet decided on how they
will handle MRL for processed foods.

# Information Requests by GOJ

In response to information requests by MHLW, the U.S. has provided
information regarding U.S. regulation of chemicals including an overview
of EPA procedures for registering pesticides and establishing
tolerances, including for downstream products, EPA\'s risk assessment
procedures, including documents on probabilistic and Monte Carlo risk
assessment approaches, FDA Pesticide Analytical Methods, the Pesticide
Data Program, and an updated version of the U.S. ADI's and guidance on
the establishment of import tolerances.